Introduction:With the incidence of chronic kidney disease(CKD)increasing year by year,it is particularly important to intervene in the early stage of CKD(stages 1–3).Unfortunately,the effective drug treatment methods...Introduction:With the incidence of chronic kidney disease(CKD)increasing year by year,it is particularly important to intervene in the early stage of CKD(stages 1–3).Unfortunately,the effective drug treatment methods for CKD(stages 1–3)are lacking.Guben Tongluo Formula(GTF)is the experience formula of Professor Liqun He,a famous traditional Chinese medicine(TCM)doctor in Shanghai.Our previous studies demonstrated that GTF might effectively alleviate CKD via multi-mechanisms.As the first angiotensin-2 receptor antagonist for treating hypertension,losartan potassium(LP)could effectively reduce blood pressure,decrease cardiovascular risk,and delay the occurrence of end-stage renal disease.Thus,we design this clinical protocol of GTF combining LP to observe the efficacy and safety of GTF and try to provide a novel drug treatment method for treating CKD(stages 1–3)patients.Methods and analysis:This is a multicenter randomized controlled clinical trial.160 participants will be enrolled in this trial and divided into LP group,GTF group,LP+GTF group,and placebo group randomly assigning 1:1:1:1 principle.LP group will receive general treatments combining LP,GTF group will receive general treatments combining GTF,and the GTF+LP group will receive general treatments combining GTF and LP.Placebo group will receive general treatments combining placebo treatment.The primary evaluation index will be the change of serum creatinine after treatment.Secondary evaluation indexes include changes in blood urea nitrogen,serum uric acid,estimated glomerular filtration rate,etc.;immune indicators and renal fibrosis indicators,as well as TCM symptoms.Besides,vital sign indicators and adverse events will be closely observed.Ethics and dissemination:The protocol has been approved by the Ethics Committee of Seventh People’s Hospital of Shanghai University of Traditional Chinese Medicine(reference number:2024-7th-HIRB-094)and other ethics committees at each center.With the implementation of this clinical trial,it would offer a TCM formula for the treatment of CKD(stages 1–3)and clarify the underlying mechanism of GTF for alleviating CKD.Trial registration:This trial is registered with ChiCTR2400090125 and registered on September 24,2024.展开更多
BACKGROUND： Rheumatoid arthritis（RA） is a systemic inflammatory disease characterized by functional disability and pain. Although acupuncture is widely used, until now Western acupuncture studies on RA have not sho...BACKGROUND： Rheumatoid arthritis（RA） is a systemic inflammatory disease characterized by functional disability and pain. Although acupuncture is widely used, until now Western acupuncture studies on RA have not shown conclusive positive results. Acupuncture is regarded as a reflex therapy that has effects on the human autonomic nervous system. By establishing a traditional Chinese medicine（TCM） diagnosis first, the practitioner is able to choose acupoints according to the state of each individual patient.METHODS/DESIGN： We are interested if acupuncture, using a classical diagnostic procedure to allocate acupoints to the patient according to the Shang Han Lun theory, can be effective in relieving pain, improving hand function and increasing health-related quality of life in RA.The authors intend to harmonize TCM diagnosis according to clinical and genetic profiles. Patients with the TCM diagnosis of a so-called Turning Point syndrome will be followed up in a randomized, prospective, double-blind, placebo-controlled, multicenter and three-armed parallel-group study with a standardized treatment in order to optimize potential therapeutic effects of acupuncture on pain, strength and muscle function of patients with RA as well as the influence on inflammation and quality of life.DISCUSSION： The findings of this study will provide important clinical information about the feasibility and efficacy of acupuncture treatment for RA patients. In addition, it will explore the feasibility of further acupuncture research.TRIAL REGISTRATION NUMBER： Clinical Trials.gov Identifier NCT02553005.展开更多
Human umbilical cord mesenchymal stem cells(hUC-MSCs)support revascularization,inhibition of inflammation,regulation of apoptosis,and promotion of the release of beneficial factors.Thus,they are regarded as a promisin...Human umbilical cord mesenchymal stem cells(hUC-MSCs)support revascularization,inhibition of inflammation,regulation of apoptosis,and promotion of the release of beneficial factors.Thus,they are regarded as a promising candidate for the treatment of intractable spinal cord injury(SCI).Clinical studies on patients with early chronic SCI(from 2 months to 1 year post-injury),which is clinically common,are rare;therefore,we will conduct a prospective,multicenter,randomized,placebo-controlled,single-blinded clinical trial at the Third Affiliated Hospital of Sun Yat-sen University,West China Hospital of Sichuan University,and Shanghai East Hospital,Tongji University School of Medicine,China.The trial plans to recruit 66 early chronic SCI patients.Eligible patients will undergo randomization at a 2:1 ratio to two arms:the observation group and the control group.Subjects in the observation group will receive four intrathecal transplantations of stem cells,with a dosage of 1×106/kg,at one calendar month intervals.Subjects in the control group will receive intrathecal administrations of 10 mL sterile normal saline in place of the stem cell transplantations.Clinical safety will be assessed by the analysis of adverse events and laboratory tests.The American Spinal Injury Association(ASIA)total score will be the primary efficacy endpoint,and the secondary efficacy outcomes will be the following:ASIA impairment scale,International Association of Neural Restoration-Spinal Cord Injury Functional Rating Scale,muscle tension,electromyogram,cortical motor and cortical sensory evoked potentials,residual urine volume,magnetic resonance imaging–diffusion tensor imaging,T cell subtypes in serum,neurotrophic factors and inflammatory factors in both serum and cerebrospinal fluid.All evaluations will be performed at 1,3,6,and 12 months following the final intrathecal administration.During the entire study procedure,all adverse events will be reported as soon as they are noted.This trial is designed to evaluate the clinical safety and efficacy of subarachnoid transplantation of hUC-MSCs to treat early chronic SCI.Moreover,it will establish whether cytotherapy can ameliorate local hostile microenvironments,promote tracking fiber regeneration,and strengthen spinal conduction ability,thus improving overall motor,sensory,and micturition/defecation function in patients with early chronic SCI.This study was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2018]-02)on March 30,2018,and was registered with ClinicalTrials.gov(registration No.NCT03521323)on April 12,2018.The revised trial protocol(protocol version 4.0)was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2019]-10)on February 25,2019,and released on ClinicalTrials.gov on April 29,2019.展开更多
OBJECTIVE: To evaluate the clinical efficacy and safety of Qiguiyin(QGY) formula in patients with severe pneumonia in China compared with a placebo.METHODS: This is a multicenter double-blind, placebo-controlled, rand...OBJECTIVE: To evaluate the clinical efficacy and safety of Qiguiyin(QGY) formula in patients with severe pneumonia in China compared with a placebo.METHODS: This is a multicenter double-blind, placebo-controlled, randomized clinical trial with two parallel arms. There will be 530 patients enrolled and randomized into either the experimental group(QGY formula) or the control group(placebo). Therapies for patients in the two groups above will be based on the conventional therapy. The primary outcome is 28-day mortality. Secondary outcomes include:(a) duration of hospital stay;(b) duration of time in the intensive care unit(ICU) stays;(c) duration of mechanical ventilation;(d) antibiotic DDD value(which means the doses of antibotics during the treatment period);(e) serum procalcitonin(PCT) level;(f) serum C-reactive protein(CRP)level;(g) Pneumonia severity index(PSI) score;(h)Sequential Organ Failure Assessment(SOFA) score;(i) sputum culture results;(j) blood routine examination results;(k) routine urine test results;(l) stool routine examination results;(m) electrocardiogram results;(n) alanine aminotransferase levels;(o) aspartate amino transferase levels;(p) total bilirubin;(q) creatinine levels;(r) urea nitrogen levels;and(s)adverse events.ETHICS AND DISSEMINATION: The protocol has been approved by the Research Ethics Committee of Beijing Hospital of Traditional Chinese Medicine,Affiliated with Capital Medical University(2018 BL-053-02). This trial aims to provide evidence for QGY formula combined with conventional therapy in treating patients with severe bacterial pneumonia,and to verify the clinical effectiveness and safety of QGY formula in China compared with placebo. Additionally, this trial will reveal the effect of QGY formula on delaying/reversing the characteristics of drug-resistant bacteria.Trial registration number: Chi CTR1800019785.展开更多
BACKGROUND Gambling disorder is characterized by excessive and recurrent gambling and can have serious negative social consequences.Although several psychotherapeutic and pharmacological approaches have been used to t...BACKGROUND Gambling disorder is characterized by excessive and recurrent gambling and can have serious negative social consequences.Although several psychotherapeutic and pharmacological approaches have been used to treat gambling disorder,new treatment strategies are needed.Growing evidence suggests that dopamine D3 receptor plays a specific role in the brain reward system.AIM To investigate if blonanserin,a dopamine D3 receptor antagonist,would be effective in reducing gambling impulses in patients with gambling disorder.METHODS We developed a study protocol to measure the efficacy and safety of blonanserin as a potential drug for gambling disorder,in which up to 12 mg/d of blonanserin was prescribed for 8 wk.RESULTS A 37-year-old female patient with gambling disorder,intellectual disability,and other physical diseases participated in the pilot study.The case showed improvement of gambling symptoms without any psychotherapy.However,blonanserin was discontinued owing to excessive saliva production.CONCLUSION This case suggests that blonanserin is potentially an effective treatment for patients with gambling disorder who resist standard therapies,but it also carries a risk of adverse effects. Further studies are needed to confirm the findings.展开更多
BACKGROUND Diabetic foot ulcers(DFUs)are a common complication of diabetes,often leading to severe infections,amputations,and reduced quality of life.The current standard treatment protocols for DFUs have limitations ...BACKGROUND Diabetic foot ulcers(DFUs)are a common complication of diabetes,often leading to severe infections,amputations,and reduced quality of life.The current standard treatment protocols for DFUs have limitations in promoting efficient wound healing and preventing complications.A comprehensive treatment approach targeting multiple aspects of wound care may offer improved outcomes for patients with DFUs.The hypothesis of this study is that a comprehensive treatment protocol for DFUs will result in faster wound healing,reduced amputation rates,and improved overall patient outcomes compared to standard treatment protocols.AIM To compare the efficacy and safety of a comprehensive treatment protocol for DFUs with those of the standard treatment protocol.METHODS This retrospective study included 62 patients with DFUs,enrolled between January 2022 and January 2024,randomly assigned to the experimental(n=32)or control(n=30)group.The experimental group received a comprehensive treatment comprising blood circulation improvement,debridement,vacuum sealing drainage,recombinant human epidermal growth factor and anti-inflammatory dressing,and skin grafting.The control group received standard treatment,which included wound cleaning and dressing,antibiotics administration,and surgical debridement or amputation,if necessary.Time taken to reduce the white blood cell count,number of dressing changes,wound healing rate and time,and amputation rate were assessed.RESULTS The experimental group exhibited significantly better outcomes than those of the control group in terms of the wound healing rate,wound healing time,and amputation rate.Additionally,the comprehensive treatment protocol was safe and well tolerated by the patients.CONCLUSION Comprehensive treatment for DFUs is more effective than standard treatment,promoting granulation tissue growth,shortening hospitalization time,reducing pain and amputation rate,improving wound healing,and enhancing quality of life.展开更多
With the internationalization and modernization of traditional Chinese medicine （TCM）, TCM clinical research has accumulated a lot of research information resources. However, these information resources are often sc...With the internationalization and modernization of traditional Chinese medicine （TCM）, TCM clinical research has accumulated a lot of research information resources. However, these information resources are often scattered in various retrieval systems, which brings some difficulties to the reference and use of this information. Therefore, we collected TCM clinical research protocols which were published in international journals and established Traditional Chinese Medicine Clinical Research Protocol Database （TCMCRPD）, in order to promote the localization of high-quality researches and improve the ability of TCM clinical research in China. After analyzing the major existing problems of TCM clinical research protocols, this essay describes the necessities and feasibilities of building Traditional Chinese Medicine Clinical Research Protocol Database （TCMCRPD） and puts forward some basic technological ideas, so as to provide a theoretical foundation for building the database.展开更多
Background:Irritable bowel syndrome(IBS)is a common functional bowel disorder that can severely affect the quality of life of patients.Limited drugs have been reported for modern medical IBS treatment.The advantages o...Background:Irritable bowel syndrome(IBS)is a common functional bowel disorder that can severely affect the quality of life of patients.Limited drugs have been reported for modern medical IBS treatment.The advantages of traditional Chinese medicine(TCM)treatment are gradually becoming prominent.Xi-Feng-Hua-Shi granules have been clinically used for diarrhea-predominant IBS(IBS-D)treatment for many years in TCM practice.Thus,this study aimed to further verify the effectiveness and safety of Xi-Feng-Hua-Shi(XFHS)granules in IBS-D treatment through a randomized,double-blind,placebo-controlled multi-center clinical trial and provide high-quality evidence for its effectiveness and safety in treatment,as well as provide a basis for clinical rational drug use and explore new clinical IBS-D treatment plans.Methods:A randomized,double-blind,placebo-controlled multi-center clinical trial will be performed in 23 hospitals.A total of 300 participants will be randomly divided into the experimental group(prescribed with XFHS granules)and the control group(prescribed with the placebo granules),with 150 participants in each group.The appearance,shape,color,and taste of the placebo granules are the same as those of XFHS granules.All participants will receive a 4-week treatment and a 6-month follow-up.The primary outcome is the overall clinical efficacy;the secondary outcomes are the IBS-Symptom Severity Score(IBS-SSS),TCM Syndrome Evaluation,and the IBS-Quality of Life(IBS-QoL)score,mental state assessment,and recurrence rate.Outcome measures(including primary and secondary outcome measures)are collected at baseline,as well as 2,4,16,and 28 weeks post-intervention.Discussion:This randomized,placebo-controlled,multi-center trial may provide high-quality evidence for the clinical XFHS granule efficacy in IBS-D treatment.Additionally,this study will conduct safety evaluations to provide a basis for clinical rational drug use.展开更多
The study explained features of severe facial paralysis of early stage from the level and degree of nerve injury,syndromes and clinical manifestations of peripheral facial paralysis.Treating protocols with acupuncture...The study explained features of severe facial paralysis of early stage from the level and degree of nerve injury,syndromes and clinical manifestations of peripheral facial paralysis.Treating protocols with acupuncture were worked out concerning its characteristics to acquire the law of treatment,especially on the severe case.Severe facial paralysis is not only known as the focus of the study on acupuncture treatment,but also the key point to approve the effectiveness of acupuncture on peripheral facial paralysis.展开更多
Transcranial direct current stimulation(tDCS)has been reportedly beneficial for different neurodegenerative disorders.tDCS has been reported as a potential adjunctive or alternative treatment for auditory verbal hallu...Transcranial direct current stimulation(tDCS)has been reportedly beneficial for different neurodegenerative disorders.tDCS has been reported as a potential adjunctive or alternative treatment for auditory verbal hallucination(AVH).This study aims to review the effects of tDCS on AVH in patients with schizophrenia through combining the evidence from randomized clinical trials(RCTs).The databases of PsycINFO(2000–2019),PubMed(2000–2019),EMBASE(2000–2019),CINAHL(2000–2019),Web of Science(2000–2019),and Scopus(2000–2019)were systematically searched.The clinical trials with RCT design were selected for final analysis.A total of nine RCTs were eligible and included in the review.Nine RCTs were included in the final analysis.Among them,six RCTs reported a significant reduction of AVH after repeated sessions of tDCS,whereas three RCTs did not show any advantage of active tDCS over sham tDCS.The current studies showed an overall decrease of approximately 28%of AVH after active tDCS and 10%after sham tDCS.The tDCS protocols targeting the sensorimotor frontal-parietal network showed greater treatment effects compared with the protocols targeting other regions.In this regard,cathodal tDCS over the left temporoparietal area showed inhibitory effects on AVHs.The most effective tDCS protocol on AVHs was twice-daily sessions(2 mA,20-minute duration)over 5 consecutive days(10 sessions)with the anode over the left dorsolateral prefrontal cortex and the cathode over the left temporal area.Some patient-specific and diseasespecific factors such as young age,nonsmoking status,and higher frequencies of AVHs seemed to be the predictors of treatment response.Taken together,the results of tDCS as an alternative treatment option for AVH show controversy among current literatures,since not all studies were positive.However,the studies targeting the same site of the brain showed that the tDCS could be a promising treatment option to reduce AVH.Further RCTs,with larger sample sizes,should be conducted to reach a conclusion on the efficacy of tDCS for AVH and to develop an effective therapeutic protocol for clinical setting.展开更多
This study assesses the long-term outcomes in Han Chinese patients with clinical stage I non-seminomatous germ cell testicular cancer （CSI NSGCT） treated with surveillance, retroperitoneal lymph node dissection （RP...This study assesses the long-term outcomes in Han Chinese patients with clinical stage I non-seminomatous germ cell testicular cancer （CSI NSGCT） treated with surveillance, retroperitoneal lymph node dissection （RPLND） and adjuvant chemotherapy. We retrospectively evaluated 89 patients with a mean age of 26.5 years. After orchiectomy, 37 patients were treated with surveillance, 34 underwent RPLND and 18 were managed with chemotherapy. The overall survival rate, the recurrence-free survival rate and the risk factors were evaluated. The median follow-up length was 92 months （range： 6-149 months）. Thirteen of the 89 patients （14.6%） had relapses, and one died by the evaluation date. The overall survival rate was 98.9%. The cumulative 4-year recurrence-free rates were 80.2%, 92.0% and 100% for the surveillance, RPLND and chemotherapy groups, respectively. The disease-free period tended to be briefer in patients with a history of cryptorchidism and those with stage Is. Therefore, surveillance, RPLND and adjuvant chemotherapy might be reliable strategies in compliant patients with CSI NSGCT. Surveillance should be recommended for patients with the lowest recurrence rate, especially those without lymphovascular invasion. This study might aid the establishment of a standard therapy for CSI NSGCT in China.展开更多
Introduction: In elderly, the progressive degenerations in the nervous system and vestibular system compromise the human body balance leading to a greater risk of falls. The Dynamic Gait Index is a protocol that predi...Introduction: In elderly, the progressive degenerations in the nervous system and vestibular system compromise the human body balance leading to a greater risk of falls. The Dynamic Gait Index is a protocol that predicts risks to falls in seniors. Objective: To analyze the results of the application of the Dynamic Gait Index (DGI)-Brazilian brief proposal and establish correlation with the original version. Methods: Study approved by the Ethics and Research Committee of Federal University of Sergipe (number 0197.0.107000.09). We analyzed 223 files of socially active elderly, female gender, aged ranged 60 to 85 years, mean 68.54 (±7.61) years since 2014. The volunteers were evaluated by the DGI-Brazil. For the statistical analysis, the Pearson Correlation Momentum Correlation Test with Spearman Correlation was used, with p ≤ 0.05 and r = 1.0. Results: Sixty-three (27.8%) of the volunteers presented an altered DGI scores. The statistical analysis indicated that Task 1 and Task 2 did not contribute to decrease the total score in the test. The worst performances occurred in Tasks 3, 5 and 6. There was founded a positive correlation between Tasks 1 and 2;1 and 8;3 and 4;3 and 5;4 and 5;2 and 4;2 and 7. Negative correlation occurred between Tasks 4 and 8, and 6 was not correlated with another Task. Conclusion: The DGI-Brazilian brief version presented an excellent correlation with the original proposal and may be useful in clinical practice as a tool to evidence future risks of falls in the elderly people.展开更多
Delivery of acupuncture in the setting of a clinical trial is a unique practice that diverges significantly from the delivery of acupuncture in a real-world clinical setting. Research acupuncturists, particularly thos...Delivery of acupuncture in the setting of a clinical trial is a unique practice that diverges significantly from the delivery of acupuncture in a real-world clinical setting. Research acupuncturists, particularly those trained in traditional Chinese medicine(TCM), are often required to set aside valued precepts of traditional care, including diagnosing imbalances, individualizing treatment, and forging a therapeutic relationship with patients. TCM-trained acupuncturists express mixed feelings about participating in clinical trials. Many are eager to play a vital role in the advancement of acupuncture science and appreciate the need for strict protocol adherence to minimize bias. However, the acupuncturist(s) may also have concerns about clinical trial methodology, including but not limited to the delivery of a control condition, e.g., sham acupuncture. Investigators should anticipate certain questions and even a level of resistance to the requirements of research among acupuncturists and be prepared to address them. This manuscript presents a brief review of the subjective experience of the research acupuncturist within the available scientific literature as it pertains to the delivery of active and sham clinical research protocols. Our goals are to better understand the perspectives of acupuncturists who may participate in clinical research, so that their concerns may be addressed in study design and methodology. To that end, we suggest the creation of a novel training program specifically for clinical trial acupuncturists, intended for qualified TCM-and Western-trained practitioners, that would help to standardize the research acupuncturist’s role and help to strengthen the design and execution of acupuncture studies.展开更多
Background:Mesalazine preparations serve as first-line therapy for active mild-to-moderate ulcerative colitis(UC),however,not all patients respond to mesalazine.Patients with mesalazine-refractory UC often switch to c...Background:Mesalazine preparations serve as first-line therapy for active mild-to-moderate ulcerative colitis(UC),however,not all patients respond to mesalazine.Patients with mesalazine-refractory UC often switch to corticosteroids,immunological therapy,and biological agents,but their use is limited owing to their well-characterised side effects(e.g.osteoporosis and cushingoid feature).Therefore,there is an unmet medical need for novel treatments with a manageable safety profile for patients with mesalazine-refractory UC.New Wumei Pill is a novel and effective herbal prescription for the treatment of UC,and our preliminary study suggested that New Wumei Pill has a significant effect on patients with mesalazine-refractory UC.However,its effectiveness and safety has not been evaluated convincingly.Objectives:This trail aims to evaluate efficacy,safety and mechanisms of New Wumei Pill in the treatment of patients with mesalazine-refractory UC.Methods:This is a prospective,randomized,double-blind control trial,in which 72 patients with mesalazine-refractory mild-to-moderate UC will be randomized in a 1:1 ratio in the treatment and control group.Patients will be screened for eligibility at the outpatient and ward of the Department of Gastroenterology in Dongfang Hospital,Beijing University of Chinese Medicine.72 participants will undergo strict screening to meet the diagnostic criteria of mildly to moderately active UC,with modified Mayo score of 3-10 points.All patients will be administered by mesalazine enteric-coated tablets for 8 weeks,at the same time,the patients in treatment group will receive New Wumei Pill,while patients from control group will be administered by dummy New Wumei Pill.Results:The primary outcomes are clinical efficacy rate and clinical remission rate according to the modified Mayo score.The secondary outcomes are individual symptom score,TCM syndrome score,endoscopic response rate,mucosal healing rate,and quality of life scale score.Finally,biological samples from participants will be preserved to reveal the mechanisms of New Wumei Pill on UC.Conclusions:We hypothesize that the patients with mesalazine-refractory mild-to-moderate UC will benefit from New Wumei Pill.If successful,this trial will provide evidence of traditional Chinese medicine in the treatment of UC,and hold promises for novel options UC patients and policymakers.展开更多
Primary liver cancer(PLC) is the third major cause of cancer related death, which seriously affects the survival period and quality of life of patients. However, there is currently no evidence to prove which treatment...Primary liver cancer(PLC) is the third major cause of cancer related death, which seriously affects the survival period and quality of life of patients. However, there is currently no evidence to prove which treatment method is most effective. Traditional Chinese Medicine(TCM) has shown certain advantages in the treatment of PLC, especially in the side effects of Western Medicine. Therefore, we designed a clinical trial protocol for the treatment of PLC using TCM granules. Our purpose is to explore the efficacy and safety of Yangxiao Fukang granule(YXFKG, 养消复康颗粒) in the treatment of stage Ⅲ hepatitis B related PLC. A total of 216 patients from three hospitals in Henan Province will be enrolled and randomly divided into a trial group and a control group in a 1 ∶ 1 ratio. The trial group will be treated with conventional western medicine plus YXFKG, while the control group will receive conventional western medicine plus a placebo for YXFKG. All patients will receive a daily dose of either YXFKG or a placebo for six months, followed by a six-month follow-up period. The main observation outcome includes 1-year survival rate, while secondary outcomes include conversion rate to remission, objective response rate, progression free survival, overall survival, quality of life score, and TCM clinical symptom score. Blood routine, urine routine, stool routine, electrocardiogram, liver and kidney function, coagulation function test, and D-dimer are safety indicators. Collect data before treatment and during the 3rd, 6th, 9th, and 12th months of treatment, and conduct statistical analysis. This study will preliminarily verify the effectiveness and safety of YXFKG in the treatment of stage Ⅲ hepatitis B related PLC, which may provide a new choice for clinical treatment of PLC.展开更多
Computer analysis of electrocardiograms(ECGs)was introduced more than 50 years ago,with the aim to improve efficiency and clinical workflow.[1,2]However,inaccuracies have been documented in the literature.[3,4]Researc...Computer analysis of electrocardiograms(ECGs)was introduced more than 50 years ago,with the aim to improve efficiency and clinical workflow.[1,2]However,inaccuracies have been documented in the literature.[3,4]Research indicates that emergency department(ED)clinician interruptions occur every 4-10 min,which is significantly more common than in other specialties.[5]This increases the cognitive load and error rates and impacts patient care and clinical effi ciency.[1,2,5]De-prioritization protocols have been introduced in certain centers in the United Kingdom(UK),removing the need for clinician ECG interpretation where ECGs have been interpreted as normal by the machine.展开更多
OBJECTIVE: To investigate the efficacy and safety of Xinglouchengqi(XLCQ) decoction in treatment of acute ischemic stroke with constipation.METHODS: In this prospective, multicenter, assessor-blinded, randomized contr...OBJECTIVE: To investigate the efficacy and safety of Xinglouchengqi(XLCQ) decoction in treatment of acute ischemic stroke with constipation.METHODS: In this prospective, multicenter, assessor-blinded, randomized controlled trial, 360 eligible participants will be randomized to the XLCQ group or the control group. Participants in the XLCQ group will receive XLCQ decoction, while those in the control group will undergo clysis therapy using glycerin enemas or oral administration of lactulose solution. Both groups will undergo a treatment period of(5 ± 2) d and a 1-month follow-up.The primary outcome measure will be the Constipation Scale score. The secondary outcome measures will include scores on the National Institutes of Health Stroke Scale, the Traditional Chinese Medicine(TCM) Stroke Scale, the Diagnostic Scale for TCM Syndromes of Ischemic Stroke and TCM Scale for Syndrome of Phlegm-heat and Fu-organ Excess.Therapeutic mechanism outcomes and safety outcomes will also be assessed. Assessments will be conducted at baseline, at the end of the treatment period, and at the follow-up. Moreover, daily visits will be scheduled to grade the status of constipation during the treatment period.DISCUSSION: The results of this study will provide scientific and objective data with which to assess the efficacy and safety of XLCQ decoction for patients with acute ischemic stroke and constipation.展开更多
BACKGROUND： Rheumatoid arthritis （RA）, as a common systemic inflammatory autoimmune disease, affects approximately 1 in 100 individuals. Effective treatment for RA is not yet available because current research does...BACKGROUND： Rheumatoid arthritis （RA）, as a common systemic inflammatory autoimmune disease, affects approximately 1 in 100 individuals. Effective treatment for RA is not yet available because current research does not have a clear understanding of the etiology and pathogenesis of RA. Xinfeng Capsule, a patent Chinese herbal medicine, has been used in the treatment of RA in recent years. Despite its reported clinical efficacy, there are no large-sample, multicenter, randomized trials that support the use of Xinfeng Capsule for RA. Therefore, we designed a randomized, double-blind, multicenter, placebo-controlled trial to assess the efficacy and safety of Xinfeng Capsule in the treatment of RA. METHODS AND DESIGN： This is a 12-week, randomized, placebo-controlled, double-blind, multicenter trial on the treatment of RA. The participants will be randomly assigned to the experimental group and the control group at a ratio of 1：1. Participants in the experimental group will receive Xinfeng Capsule and a pharmaceutical placebo （imitation leflunomide）. The control group will receive leflunomide and an herbal placebo （imitation Xinfeng Capsule）. The American College of Rheumatology （ACR） Criteria for RA will be used to measure the efficacy of the Xinfeng Capsule. The primary outcome measure will be the percentage of study participants who achieve an ACR 20% response rate （ACR20）, which will be measured every 4 weeks after randomization. Secondary outcomes will include the ACR50 and ACR70 responses, the side effects of the medications, the Disease Activity Score 28, RA biomarkers, quality of life, and X-rays of the hands and wrists. The first four of the secondary outcomes will be measured every 4 weeks and the others will be measured at baseline and after 12 weeks of treatment. DISCUSSION： The result of this trial will help to evaluate whether Xinfeng Capsule is effective and safe in the treatment of RA. TRIAL REGISTRATION： This trial has been registered in ClinicalTrials.gov. The identifier is N CT01774877.展开更多
Acupuncture is widely used to treat functional dyspepsia with satisfactory outcomes. Combination of the He and Mu acupoints is commonly used and has a synergistic effect on functional dyspepsia; however, its underlyin...Acupuncture is widely used to treat functional dyspepsia with satisfactory outcomes. Combination of the He and Mu acupoints is commonly used and has a synergistic effect on functional dyspepsia; however, its underlying mechanisms remain unclear. Therefore, a randomized controlled parallel clinical trial is currently underway at Chengdu University of Traditional Chinese Medicine, China. This trial is designed to explore the efficacy of and central responses to the He-Mu point combination in patients with functional dyspepsia using functional magnetic resonance imaging. A total of 105 patients with functional dyspepsia will be allocated into 3 groups： the low-He point group（puncturing at Zusanli（ST36））, Mu point group（puncturing at Zhongwan（CV12））, and He-Mu point combination group（puncturing at ST36 and CV12）. Every participant will receive 20 sessions of manual acupuncture for 4 weeks. The needles will be inserted perpendicularly to a depth of 1 to 2 cun. The angle of rotation and twisting will range from 90 to 180 degrees, while lifting and thrusting will range from 0.3 to 0.5 cm. The various manipulations will be performed 60 to 90 times per minute. The needles will remain in place for 30 minutes, during which manipulation will be applied every 10 minutes. Magnetic resonance imaging will be performed before and after 20 sessions of acupuncture. The primary outcome is symptom improvement according to the Chinese version of the Nepean Dyspepsia Index. Secondary outcomes include the Leeds dyspepsia questionnaire, Self-Rating Anxiety Scale, Self-Rating Depression Scale, Beck Anxiety Inventory, Beck Depression Inventory, and visual analogue scale scores before and after 10 and 20 sessions of acupuncture. Needle sensation and adverse events will be used to assess the therapeutic effects. This study will promote more widespread awareness of the benefits of acupoint combination in the clinical setting and provide a further explanation of the neuromechanism by which acupuncture at the He-Mu point combination for functional dyspepsia. Registration： Chinese Clinical Trial Registry, Chi CTR-IOR-15006402.展开更多
基金supported by grants from Pudong New Area Traditional Chinese Medicine Brand Multiplication Plan-Chronic Nephropathy(PDZY-2021-0302)Construction of He Liqun’s famous TCM studio(PDZY-2022-0703)+2 种基金Clinical Observation on the Efficacy of Guben Tongluo Formula in Treating Chronic Kidney Disease Phase 1-3(PW2022D-12)Pilot Project of Inheritance,Innovation and Development of Traditional Chinese Medicine in Pudong New Area(YC-2023-0602)Pudong New Area’s Peak and Plateau Discipline Development in Clinical Medicine for Novel and Special Diseases(2025-PWXZ-15).
文摘Introduction:With the incidence of chronic kidney disease(CKD)increasing year by year,it is particularly important to intervene in the early stage of CKD(stages 1–3).Unfortunately,the effective drug treatment methods for CKD(stages 1–3)are lacking.Guben Tongluo Formula(GTF)is the experience formula of Professor Liqun He,a famous traditional Chinese medicine(TCM)doctor in Shanghai.Our previous studies demonstrated that GTF might effectively alleviate CKD via multi-mechanisms.As the first angiotensin-2 receptor antagonist for treating hypertension,losartan potassium(LP)could effectively reduce blood pressure,decrease cardiovascular risk,and delay the occurrence of end-stage renal disease.Thus,we design this clinical protocol of GTF combining LP to observe the efficacy and safety of GTF and try to provide a novel drug treatment method for treating CKD(stages 1–3)patients.Methods and analysis:This is a multicenter randomized controlled clinical trial.160 participants will be enrolled in this trial and divided into LP group,GTF group,LP+GTF group,and placebo group randomly assigning 1:1:1:1 principle.LP group will receive general treatments combining LP,GTF group will receive general treatments combining GTF,and the GTF+LP group will receive general treatments combining GTF and LP.Placebo group will receive general treatments combining placebo treatment.The primary evaluation index will be the change of serum creatinine after treatment.Secondary evaluation indexes include changes in blood urea nitrogen,serum uric acid,estimated glomerular filtration rate,etc.;immune indicators and renal fibrosis indicators,as well as TCM symptoms.Besides,vital sign indicators and adverse events will be closely observed.Ethics and dissemination:The protocol has been approved by the Ethics Committee of Seventh People’s Hospital of Shanghai University of Traditional Chinese Medicine(reference number:2024-7th-HIRB-094)and other ethics committees at each center.With the implementation of this clinical trial,it would offer a TCM formula for the treatment of CKD(stages 1–3)and clarify the underlying mechanism of GTF for alleviating CKD.Trial registration:This trial is registered with ChiCTR2400090125 and registered on September 24,2024.
文摘BACKGROUND： Rheumatoid arthritis（RA） is a systemic inflammatory disease characterized by functional disability and pain. Although acupuncture is widely used, until now Western acupuncture studies on RA have not shown conclusive positive results. Acupuncture is regarded as a reflex therapy that has effects on the human autonomic nervous system. By establishing a traditional Chinese medicine（TCM） diagnosis first, the practitioner is able to choose acupoints according to the state of each individual patient.METHODS/DESIGN： We are interested if acupuncture, using a classical diagnostic procedure to allocate acupoints to the patient according to the Shang Han Lun theory, can be effective in relieving pain, improving hand function and increasing health-related quality of life in RA.The authors intend to harmonize TCM diagnosis according to clinical and genetic profiles. Patients with the TCM diagnosis of a so-called Turning Point syndrome will be followed up in a randomized, prospective, double-blind, placebo-controlled, multicenter and three-armed parallel-group study with a standardized treatment in order to optimize potential therapeutic effects of acupuncture on pain, strength and muscle function of patients with RA as well as the influence on inflammation and quality of life.DISCUSSION： The findings of this study will provide important clinical information about the feasibility and efficacy of acupuncture treatment for RA patients. In addition, it will explore the feasibility of further acupuncture research.TRIAL REGISTRATION NUMBER： Clinical Trials.gov Identifier NCT02553005.
基金supported by the National Key Research and Development Program of China,No.2017YFA0105403(to LMR)the Key Research and Development Program of Guangdong Province of China,No.2019B020236002(to LMR)+4 种基金The Clinical Innovation Research Program of Guangzhou Regenerative Medicine and Health Guangdong Laboratory of China,No.2018GZR0201006(to LMR)the National Natural Science Foundation of China,Nos.81772349(to BL),31470949(to BL)the Guangzhou Science and Technology Project of China,Nos.201704020221(to LMR),201707010115(to BL)the Natural Science Foundation of Guangdong Province of China,No.2017A030313594(to BL)the Medical Scientific Research Foundation of Guangdong Province of China,No.A2018547(to MP)
文摘Human umbilical cord mesenchymal stem cells(hUC-MSCs)support revascularization,inhibition of inflammation,regulation of apoptosis,and promotion of the release of beneficial factors.Thus,they are regarded as a promising candidate for the treatment of intractable spinal cord injury(SCI).Clinical studies on patients with early chronic SCI(from 2 months to 1 year post-injury),which is clinically common,are rare;therefore,we will conduct a prospective,multicenter,randomized,placebo-controlled,single-blinded clinical trial at the Third Affiliated Hospital of Sun Yat-sen University,West China Hospital of Sichuan University,and Shanghai East Hospital,Tongji University School of Medicine,China.The trial plans to recruit 66 early chronic SCI patients.Eligible patients will undergo randomization at a 2:1 ratio to two arms:the observation group and the control group.Subjects in the observation group will receive four intrathecal transplantations of stem cells,with a dosage of 1×106/kg,at one calendar month intervals.Subjects in the control group will receive intrathecal administrations of 10 mL sterile normal saline in place of the stem cell transplantations.Clinical safety will be assessed by the analysis of adverse events and laboratory tests.The American Spinal Injury Association(ASIA)total score will be the primary efficacy endpoint,and the secondary efficacy outcomes will be the following:ASIA impairment scale,International Association of Neural Restoration-Spinal Cord Injury Functional Rating Scale,muscle tension,electromyogram,cortical motor and cortical sensory evoked potentials,residual urine volume,magnetic resonance imaging–diffusion tensor imaging,T cell subtypes in serum,neurotrophic factors and inflammatory factors in both serum and cerebrospinal fluid.All evaluations will be performed at 1,3,6,and 12 months following the final intrathecal administration.During the entire study procedure,all adverse events will be reported as soon as they are noted.This trial is designed to evaluate the clinical safety and efficacy of subarachnoid transplantation of hUC-MSCs to treat early chronic SCI.Moreover,it will establish whether cytotherapy can ameliorate local hostile microenvironments,promote tracking fiber regeneration,and strengthen spinal conduction ability,thus improving overall motor,sensory,and micturition/defecation function in patients with early chronic SCI.This study was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2018]-02)on March 30,2018,and was registered with ClinicalTrials.gov(registration No.NCT03521323)on April 12,2018.The revised trial protocol(protocol version 4.0)was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2019]-10)on February 25,2019,and released on ClinicalTrials.gov on April 29,2019.
基金Supported by Capital Health Development Project:The efficacy and Bacterial Resistance of Qiguiyin Formula in the Treatment of Severe Bacterial Pneumonia(SF-2018-1-1161)Protocol Version:(3.0,Nov-13-2018)。
文摘OBJECTIVE: To evaluate the clinical efficacy and safety of Qiguiyin(QGY) formula in patients with severe pneumonia in China compared with a placebo.METHODS: This is a multicenter double-blind, placebo-controlled, randomized clinical trial with two parallel arms. There will be 530 patients enrolled and randomized into either the experimental group(QGY formula) or the control group(placebo). Therapies for patients in the two groups above will be based on the conventional therapy. The primary outcome is 28-day mortality. Secondary outcomes include:(a) duration of hospital stay;(b) duration of time in the intensive care unit(ICU) stays;(c) duration of mechanical ventilation;(d) antibiotic DDD value(which means the doses of antibotics during the treatment period);(e) serum procalcitonin(PCT) level;(f) serum C-reactive protein(CRP)level;(g) Pneumonia severity index(PSI) score;(h)Sequential Organ Failure Assessment(SOFA) score;(i) sputum culture results;(j) blood routine examination results;(k) routine urine test results;(l) stool routine examination results;(m) electrocardiogram results;(n) alanine aminotransferase levels;(o) aspartate amino transferase levels;(p) total bilirubin;(q) creatinine levels;(r) urea nitrogen levels;and(s)adverse events.ETHICS AND DISSEMINATION: The protocol has been approved by the Research Ethics Committee of Beijing Hospital of Traditional Chinese Medicine,Affiliated with Capital Medical University(2018 BL-053-02). This trial aims to provide evidence for QGY formula combined with conventional therapy in treating patients with severe bacterial pneumonia,and to verify the clinical effectiveness and safety of QGY formula in China compared with placebo. Additionally, this trial will reveal the effect of QGY formula on delaying/reversing the characteristics of drug-resistant bacteria.Trial registration number: Chi CTR1800019785.
基金Supported by The Grant from Council for Addiction Behavior Studies。
文摘BACKGROUND Gambling disorder is characterized by excessive and recurrent gambling and can have serious negative social consequences.Although several psychotherapeutic and pharmacological approaches have been used to treat gambling disorder,new treatment strategies are needed.Growing evidence suggests that dopamine D3 receptor plays a specific role in the brain reward system.AIM To investigate if blonanserin,a dopamine D3 receptor antagonist,would be effective in reducing gambling impulses in patients with gambling disorder.METHODS We developed a study protocol to measure the efficacy and safety of blonanserin as a potential drug for gambling disorder,in which up to 12 mg/d of blonanserin was prescribed for 8 wk.RESULTS A 37-year-old female patient with gambling disorder,intellectual disability,and other physical diseases participated in the pilot study.The case showed improvement of gambling symptoms without any psychotherapy.However,blonanserin was discontinued owing to excessive saliva production.CONCLUSION This case suggests that blonanserin is potentially an effective treatment for patients with gambling disorder who resist standard therapies,but it also carries a risk of adverse effects. Further studies are needed to confirm the findings.
基金Supported by General Medical Research Fund Project,No.TYYLKYJJ-2022-021.
文摘BACKGROUND Diabetic foot ulcers(DFUs)are a common complication of diabetes,often leading to severe infections,amputations,and reduced quality of life.The current standard treatment protocols for DFUs have limitations in promoting efficient wound healing and preventing complications.A comprehensive treatment approach targeting multiple aspects of wound care may offer improved outcomes for patients with DFUs.The hypothesis of this study is that a comprehensive treatment protocol for DFUs will result in faster wound healing,reduced amputation rates,and improved overall patient outcomes compared to standard treatment protocols.AIM To compare the efficacy and safety of a comprehensive treatment protocol for DFUs with those of the standard treatment protocol.METHODS This retrospective study included 62 patients with DFUs,enrolled between January 2022 and January 2024,randomly assigned to the experimental(n=32)or control(n=30)group.The experimental group received a comprehensive treatment comprising blood circulation improvement,debridement,vacuum sealing drainage,recombinant human epidermal growth factor and anti-inflammatory dressing,and skin grafting.The control group received standard treatment,which included wound cleaning and dressing,antibiotics administration,and surgical debridement or amputation,if necessary.Time taken to reduce the white blood cell count,number of dressing changes,wound healing rate and time,and amputation rate were assessed.RESULTS The experimental group exhibited significantly better outcomes than those of the control group in terms of the wound healing rate,wound healing time,and amputation rate.Additionally,the comprehensive treatment protocol was safe and well tolerated by the patients.CONCLUSION Comprehensive treatment for DFUs is more effective than standard treatment,promoting granulation tissue growth,shortening hospitalization time,reducing pain and amputation rate,improving wound healing,and enhancing quality of life.
文摘With the internationalization and modernization of traditional Chinese medicine （TCM）, TCM clinical research has accumulated a lot of research information resources. However, these information resources are often scattered in various retrieval systems, which brings some difficulties to the reference and use of this information. Therefore, we collected TCM clinical research protocols which were published in international journals and established Traditional Chinese Medicine Clinical Research Protocol Database （TCMCRPD）, in order to promote the localization of high-quality researches and improve the ability of TCM clinical research in China. After analyzing the major existing problems of TCM clinical research protocols, this essay describes the necessities and feasibilities of building Traditional Chinese Medicine Clinical Research Protocol Database （TCMCRPD） and puts forward some basic technological ideas, so as to provide a theoretical foundation for building the database.
基金supported by National Administration of Traditional Chinese Medicine:2019 Project of building evidence based practice capacity for TCM(No.ZZ13-042-2,No.2019XZZX-XH007)the Jiangsu Administration of traditional Chinese Medicine(No.JD2019SZXZD04).
文摘Background:Irritable bowel syndrome(IBS)is a common functional bowel disorder that can severely affect the quality of life of patients.Limited drugs have been reported for modern medical IBS treatment.The advantages of traditional Chinese medicine(TCM)treatment are gradually becoming prominent.Xi-Feng-Hua-Shi granules have been clinically used for diarrhea-predominant IBS(IBS-D)treatment for many years in TCM practice.Thus,this study aimed to further verify the effectiveness and safety of Xi-Feng-Hua-Shi(XFHS)granules in IBS-D treatment through a randomized,double-blind,placebo-controlled multi-center clinical trial and provide high-quality evidence for its effectiveness and safety in treatment,as well as provide a basis for clinical rational drug use and explore new clinical IBS-D treatment plans.Methods:A randomized,double-blind,placebo-controlled multi-center clinical trial will be performed in 23 hospitals.A total of 300 participants will be randomly divided into the experimental group(prescribed with XFHS granules)and the control group(prescribed with the placebo granules),with 150 participants in each group.The appearance,shape,color,and taste of the placebo granules are the same as those of XFHS granules.All participants will receive a 4-week treatment and a 6-month follow-up.The primary outcome is the overall clinical efficacy;the secondary outcomes are the IBS-Symptom Severity Score(IBS-SSS),TCM Syndrome Evaluation,and the IBS-Quality of Life(IBS-QoL)score,mental state assessment,and recurrence rate.Outcome measures(including primary and secondary outcome measures)are collected at baseline,as well as 2,4,16,and 28 weeks post-intervention.Discussion:This randomized,placebo-controlled,multi-center trial may provide high-quality evidence for the clinical XFHS granule efficacy in IBS-D treatment.Additionally,this study will conduct safety evaluations to provide a basis for clinical rational drug use.
文摘The study explained features of severe facial paralysis of early stage from the level and degree of nerve injury,syndromes and clinical manifestations of peripheral facial paralysis.Treating protocols with acupuncture were worked out concerning its characteristics to acquire the law of treatment,especially on the severe case.Severe facial paralysis is not only known as the focus of the study on acupuncture treatment,but also the key point to approve the effectiveness of acupuncture on peripheral facial paralysis.
文摘Transcranial direct current stimulation(tDCS)has been reportedly beneficial for different neurodegenerative disorders.tDCS has been reported as a potential adjunctive or alternative treatment for auditory verbal hallucination(AVH).This study aims to review the effects of tDCS on AVH in patients with schizophrenia through combining the evidence from randomized clinical trials(RCTs).The databases of PsycINFO(2000–2019),PubMed(2000–2019),EMBASE(2000–2019),CINAHL(2000–2019),Web of Science(2000–2019),and Scopus(2000–2019)were systematically searched.The clinical trials with RCT design were selected for final analysis.A total of nine RCTs were eligible and included in the review.Nine RCTs were included in the final analysis.Among them,six RCTs reported a significant reduction of AVH after repeated sessions of tDCS,whereas three RCTs did not show any advantage of active tDCS over sham tDCS.The current studies showed an overall decrease of approximately 28%of AVH after active tDCS and 10%after sham tDCS.The tDCS protocols targeting the sensorimotor frontal-parietal network showed greater treatment effects compared with the protocols targeting other regions.In this regard,cathodal tDCS over the left temporoparietal area showed inhibitory effects on AVHs.The most effective tDCS protocol on AVHs was twice-daily sessions(2 mA,20-minute duration)over 5 consecutive days(10 sessions)with the anode over the left dorsolateral prefrontal cortex and the cathode over the left temporal area.Some patient-specific and diseasespecific factors such as young age,nonsmoking status,and higher frequencies of AVHs seemed to be the predictors of treatment response.Taken together,the results of tDCS as an alternative treatment option for AVH show controversy among current literatures,since not all studies were positive.However,the studies targeting the same site of the brain showed that the tDCS could be a promising treatment option to reduce AVH.Further RCTs,with larger sample sizes,should be conducted to reach a conclusion on the efficacy of tDCS for AVH and to develop an effective therapeutic protocol for clinical setting.
文摘This study assesses the long-term outcomes in Han Chinese patients with clinical stage I non-seminomatous germ cell testicular cancer （CSI NSGCT） treated with surveillance, retroperitoneal lymph node dissection （RPLND） and adjuvant chemotherapy. We retrospectively evaluated 89 patients with a mean age of 26.5 years. After orchiectomy, 37 patients were treated with surveillance, 34 underwent RPLND and 18 were managed with chemotherapy. The overall survival rate, the recurrence-free survival rate and the risk factors were evaluated. The median follow-up length was 92 months （range： 6-149 months）. Thirteen of the 89 patients （14.6%） had relapses, and one died by the evaluation date. The overall survival rate was 98.9%. The cumulative 4-year recurrence-free rates were 80.2%, 92.0% and 100% for the surveillance, RPLND and chemotherapy groups, respectively. The disease-free period tended to be briefer in patients with a history of cryptorchidism and those with stage Is. Therefore, surveillance, RPLND and adjuvant chemotherapy might be reliable strategies in compliant patients with CSI NSGCT. Surveillance should be recommended for patients with the lowest recurrence rate, especially those without lymphovascular invasion. This study might aid the establishment of a standard therapy for CSI NSGCT in China.
文摘Introduction: In elderly, the progressive degenerations in the nervous system and vestibular system compromise the human body balance leading to a greater risk of falls. The Dynamic Gait Index is a protocol that predicts risks to falls in seniors. Objective: To analyze the results of the application of the Dynamic Gait Index (DGI)-Brazilian brief proposal and establish correlation with the original version. Methods: Study approved by the Ethics and Research Committee of Federal University of Sergipe (number 0197.0.107000.09). We analyzed 223 files of socially active elderly, female gender, aged ranged 60 to 85 years, mean 68.54 (±7.61) years since 2014. The volunteers were evaluated by the DGI-Brazil. For the statistical analysis, the Pearson Correlation Momentum Correlation Test with Spearman Correlation was used, with p ≤ 0.05 and r = 1.0. Results: Sixty-three (27.8%) of the volunteers presented an altered DGI scores. The statistical analysis indicated that Task 1 and Task 2 did not contribute to decrease the total score in the test. The worst performances occurred in Tasks 3, 5 and 6. There was founded a positive correlation between Tasks 1 and 2;1 and 8;3 and 4;3 and 5;4 and 5;2 and 4;2 and 7. Negative correlation occurred between Tasks 4 and 8, and 6 was not correlated with another Task. Conclusion: The DGI-Brazilian brief version presented an excellent correlation with the original proposal and may be useful in clinical practice as a tool to evidence future risks of falls in the elderly people.
基金the National Institute of Nursing Research of the National Institutes of Health(No.R01-NR017917)。
文摘Delivery of acupuncture in the setting of a clinical trial is a unique practice that diverges significantly from the delivery of acupuncture in a real-world clinical setting. Research acupuncturists, particularly those trained in traditional Chinese medicine(TCM), are often required to set aside valued precepts of traditional care, including diagnosing imbalances, individualizing treatment, and forging a therapeutic relationship with patients. TCM-trained acupuncturists express mixed feelings about participating in clinical trials. Many are eager to play a vital role in the advancement of acupuncture science and appreciate the need for strict protocol adherence to minimize bias. However, the acupuncturist(s) may also have concerns about clinical trial methodology, including but not limited to the delivery of a control condition, e.g., sham acupuncture. Investigators should anticipate certain questions and even a level of resistance to the requirements of research among acupuncturists and be prepared to address them. This manuscript presents a brief review of the subjective experience of the research acupuncturist within the available scientific literature as it pertains to the delivery of active and sham clinical research protocols. Our goals are to better understand the perspectives of acupuncturists who may participate in clinical research, so that their concerns may be addressed in study design and methodology. To that end, we suggest the creation of a novel training program specifically for clinical trial acupuncturists, intended for qualified TCM-and Western-trained practitioners, that would help to standardize the research acupuncturist’s role and help to strengthen the design and execution of acupuncture studies.
基金supported by the Unveiling and Leading Projects of Beijing University of Chinese Medicine(No.2023-JYB-JBQN-014)the China Association of Chinese Medicine Young Talent Support Project(No.CACM-2022-QNRC2-A02).
文摘Background:Mesalazine preparations serve as first-line therapy for active mild-to-moderate ulcerative colitis(UC),however,not all patients respond to mesalazine.Patients with mesalazine-refractory UC often switch to corticosteroids,immunological therapy,and biological agents,but their use is limited owing to their well-characterised side effects(e.g.osteoporosis and cushingoid feature).Therefore,there is an unmet medical need for novel treatments with a manageable safety profile for patients with mesalazine-refractory UC.New Wumei Pill is a novel and effective herbal prescription for the treatment of UC,and our preliminary study suggested that New Wumei Pill has a significant effect on patients with mesalazine-refractory UC.However,its effectiveness and safety has not been evaluated convincingly.Objectives:This trail aims to evaluate efficacy,safety and mechanisms of New Wumei Pill in the treatment of patients with mesalazine-refractory UC.Methods:This is a prospective,randomized,double-blind control trial,in which 72 patients with mesalazine-refractory mild-to-moderate UC will be randomized in a 1:1 ratio in the treatment and control group.Patients will be screened for eligibility at the outpatient and ward of the Department of Gastroenterology in Dongfang Hospital,Beijing University of Chinese Medicine.72 participants will undergo strict screening to meet the diagnostic criteria of mildly to moderately active UC,with modified Mayo score of 3-10 points.All patients will be administered by mesalazine enteric-coated tablets for 8 weeks,at the same time,the patients in treatment group will receive New Wumei Pill,while patients from control group will be administered by dummy New Wumei Pill.Results:The primary outcomes are clinical efficacy rate and clinical remission rate according to the modified Mayo score.The secondary outcomes are individual symptom score,TCM syndrome score,endoscopic response rate,mucosal healing rate,and quality of life scale score.Finally,biological samples from participants will be preserved to reveal the mechanisms of New Wumei Pill on UC.Conclusions:We hypothesize that the patients with mesalazine-refractory mild-to-moderate UC will benefit from New Wumei Pill.If successful,this trial will provide evidence of traditional Chinese medicine in the treatment of UC,and hold promises for novel options UC patients and policymakers.
基金Supported by Henan Provincial Department of Science and Technology Project:Clinical Study on Yangxiao Fukang granule in the Treatment of StageⅢhepatitis B related Liver Cancer(232102310188)Henan Province Characteristic Backbone Discipline Construction Project:Guidelines for Traditional Chinese Medicine Diagnosis and Treatment of Hepatocellular Carcinoma after Hepatic Arterial Chemotherapy and Embolization(STG-ZYX03-202126)。
文摘Primary liver cancer(PLC) is the third major cause of cancer related death, which seriously affects the survival period and quality of life of patients. However, there is currently no evidence to prove which treatment method is most effective. Traditional Chinese Medicine(TCM) has shown certain advantages in the treatment of PLC, especially in the side effects of Western Medicine. Therefore, we designed a clinical trial protocol for the treatment of PLC using TCM granules. Our purpose is to explore the efficacy and safety of Yangxiao Fukang granule(YXFKG, 养消复康颗粒) in the treatment of stage Ⅲ hepatitis B related PLC. A total of 216 patients from three hospitals in Henan Province will be enrolled and randomly divided into a trial group and a control group in a 1 ∶ 1 ratio. The trial group will be treated with conventional western medicine plus YXFKG, while the control group will receive conventional western medicine plus a placebo for YXFKG. All patients will receive a daily dose of either YXFKG or a placebo for six months, followed by a six-month follow-up period. The main observation outcome includes 1-year survival rate, while secondary outcomes include conversion rate to remission, objective response rate, progression free survival, overall survival, quality of life score, and TCM clinical symptom score. Blood routine, urine routine, stool routine, electrocardiogram, liver and kidney function, coagulation function test, and D-dimer are safety indicators. Collect data before treatment and during the 3rd, 6th, 9th, and 12th months of treatment, and conduct statistical analysis. This study will preliminarily verify the effectiveness and safety of YXFKG in the treatment of stage Ⅲ hepatitis B related PLC, which may provide a new choice for clinical treatment of PLC.
文摘Computer analysis of electrocardiograms(ECGs)was introduced more than 50 years ago,with the aim to improve efficiency and clinical workflow.[1,2]However,inaccuracies have been documented in the literature.[3,4]Research indicates that emergency department(ED)clinician interruptions occur every 4-10 min,which is significantly more common than in other specialties.[5]This increases the cognitive load and error rates and impacts patient care and clinical effi ciency.[1,2,5]De-prioritization protocols have been introduced in certain centers in the United Kingdom(UK),removing the need for clinician ECG interpretation where ECGs have been interpreted as normal by the machine.
基金Supported by the National Science and Technology Pillar Program during the 12th Five-year Plan Period of the People's Republic of China:Heritage Study on the Special Therapeutic Principles and Methods of Famous Experts in Traditional Chinese Medicine(No.2013BAI13B022)
文摘OBJECTIVE: To investigate the efficacy and safety of Xinglouchengqi(XLCQ) decoction in treatment of acute ischemic stroke with constipation.METHODS: In this prospective, multicenter, assessor-blinded, randomized controlled trial, 360 eligible participants will be randomized to the XLCQ group or the control group. Participants in the XLCQ group will receive XLCQ decoction, while those in the control group will undergo clysis therapy using glycerin enemas or oral administration of lactulose solution. Both groups will undergo a treatment period of(5 ± 2) d and a 1-month follow-up.The primary outcome measure will be the Constipation Scale score. The secondary outcome measures will include scores on the National Institutes of Health Stroke Scale, the Traditional Chinese Medicine(TCM) Stroke Scale, the Diagnostic Scale for TCM Syndromes of Ischemic Stroke and TCM Scale for Syndrome of Phlegm-heat and Fu-organ Excess.Therapeutic mechanism outcomes and safety outcomes will also be assessed. Assessments will be conducted at baseline, at the end of the treatment period, and at the follow-up. Moreover, daily visits will be scheduled to grade the status of constipation during the treatment period.DISCUSSION: The results of this study will provide scientific and objective data with which to assess the efficacy and safety of XLCQ decoction for patients with acute ischemic stroke and constipation.
基金supported by the Twelfth Five-Year Support Project of the Ministry of Science and Technology for clinical studies investigating Xin'an medicine in the treatment of complicated ascites diseases(No.2012BAI26B02)
文摘BACKGROUND： Rheumatoid arthritis （RA）, as a common systemic inflammatory autoimmune disease, affects approximately 1 in 100 individuals. Effective treatment for RA is not yet available because current research does not have a clear understanding of the etiology and pathogenesis of RA. Xinfeng Capsule, a patent Chinese herbal medicine, has been used in the treatment of RA in recent years. Despite its reported clinical efficacy, there are no large-sample, multicenter, randomized trials that support the use of Xinfeng Capsule for RA. Therefore, we designed a randomized, double-blind, multicenter, placebo-controlled trial to assess the efficacy and safety of Xinfeng Capsule in the treatment of RA. METHODS AND DESIGN： This is a 12-week, randomized, placebo-controlled, double-blind, multicenter trial on the treatment of RA. The participants will be randomly assigned to the experimental group and the control group at a ratio of 1：1. Participants in the experimental group will receive Xinfeng Capsule and a pharmaceutical placebo （imitation leflunomide）. The control group will receive leflunomide and an herbal placebo （imitation Xinfeng Capsule）. The American College of Rheumatology （ACR） Criteria for RA will be used to measure the efficacy of the Xinfeng Capsule. The primary outcome measure will be the percentage of study participants who achieve an ACR 20% response rate （ACR20）, which will be measured every 4 weeks after randomization. Secondary outcomes will include the ACR50 and ACR70 responses, the side effects of the medications, the Disease Activity Score 28, RA biomarkers, quality of life, and X-rays of the hands and wrists. The first four of the secondary outcomes will be measured every 4 weeks and the others will be measured at baseline and after 12 weeks of treatment. DISCUSSION： The result of this trial will help to evaluate whether Xinfeng Capsule is effective and safe in the treatment of RA. TRIAL REGISTRATION： This trial has been registered in ClinicalTrials.gov. The identifier is N CT01774877.
基金supported by the National Scientific Foundation Committee in China,No.81473602the Education Ministry’s New Century Excellent Talents Supporting Plan in China+3 种基金the Foundation for the Author of National Excellent Doctoral Dissertation of China,No.201486the Youth Foundation of Science and Technology Department of Sichuan Province in China,No.15QNJJ0008the National Natural Science Foundation-Excellent Youth Foundation in China,No.81622052the 2011 Co-Innovation Center of Sichuan Province named Acupoint Effects of Acupuncture Co-Innovation Center
文摘Acupuncture is widely used to treat functional dyspepsia with satisfactory outcomes. Combination of the He and Mu acupoints is commonly used and has a synergistic effect on functional dyspepsia; however, its underlying mechanisms remain unclear. Therefore, a randomized controlled parallel clinical trial is currently underway at Chengdu University of Traditional Chinese Medicine, China. This trial is designed to explore the efficacy of and central responses to the He-Mu point combination in patients with functional dyspepsia using functional magnetic resonance imaging. A total of 105 patients with functional dyspepsia will be allocated into 3 groups： the low-He point group（puncturing at Zusanli（ST36））, Mu point group（puncturing at Zhongwan（CV12））, and He-Mu point combination group（puncturing at ST36 and CV12）. Every participant will receive 20 sessions of manual acupuncture for 4 weeks. The needles will be inserted perpendicularly to a depth of 1 to 2 cun. The angle of rotation and twisting will range from 90 to 180 degrees, while lifting and thrusting will range from 0.3 to 0.5 cm. The various manipulations will be performed 60 to 90 times per minute. The needles will remain in place for 30 minutes, during which manipulation will be applied every 10 minutes. Magnetic resonance imaging will be performed before and after 20 sessions of acupuncture. The primary outcome is symptom improvement according to the Chinese version of the Nepean Dyspepsia Index. Secondary outcomes include the Leeds dyspepsia questionnaire, Self-Rating Anxiety Scale, Self-Rating Depression Scale, Beck Anxiety Inventory, Beck Depression Inventory, and visual analogue scale scores before and after 10 and 20 sessions of acupuncture. Needle sensation and adverse events will be used to assess the therapeutic effects. This study will promote more widespread awareness of the benefits of acupoint combination in the clinical setting and provide a further explanation of the neuromechanism by which acupuncture at the He-Mu point combination for functional dyspepsia. Registration： Chinese Clinical Trial Registry, Chi CTR-IOR-15006402.
