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
BACKGROUND Even in the immuno-oncology era,transcatheter arterial chemoembolisation(TACE)is the most effective way to treat intermediate stage hepatocellular carcinoma(HCC).Postembolisation syndrome(PES)is the most co...BACKGROUND Even in the immuno-oncology era,transcatheter arterial chemoembolisation(TACE)is the most effective way to treat intermediate stage hepatocellular carcinoma(HCC).Postembolisation syndrome(PES)is the most common side effect from TACE and there is still no standard prevention guideline.AIM To evaluate the efficacy of single dose intravenous dexamethasone regimen to prevent PES after TACE among patients with HCC.METHODS This study enrolled patients with HCC who had eligible indication for TACE without macrovascular invasion/extrahepatic metastasis.Patients were randomly assigned to either an intravenous single dose of dexamethasone 8 mg or placebo one hour before TACE.The primary outcome was a negative result of PES at 48 h after TACE,which was defined as score<2 of Southwest Oncology Group toxicity coding criteria using fever,nausea,vomiting and pain to calculated.And the secondary end point was duration of admission between two groups.RESULTS One hundred patients were randomly assigned 1:1.Under intention-to-treat analysis,49 patients were randomly assigned to the dexamethasone and 51 to the placebo groups.Both groups were similar for baseline characteristics.The negative PES rate was significantly higher in the dexamethasone group than in the placebo group(63.3%vs 29.4%;P=0.005).Mean Southwest Oncology Group toxicity coding PES was 2.14(95%CI:1.41-2.8)vs 3.71(95%CI:2.97-4.45)between the dexamethasone and placebo groups,respectively.Cumulative incidence of fever was significantly lower in dexamethasone group with P<0.001,pain,nausea and vomiting were also lower in the dexamethasone group compared with the placebo group(P=0.16,P=0.11,and P=0.49).The dexamethasone regimen was generally well tolerated by patients with HCC patients including those with hepatitis B virus infection and well-controlled diabetes mellitus.CONCLUSION Single dose dexamethasone was effective at preventing PES among patients with HCC treated with TACE.The study showed no adverse events of special interest related to dexamethasone.展开更多
OBJECTIVE: To evaluate the safety and efficacy of Tongkuaixiao ointment(TKXO) in treating moderate-to-severe cancer induced somatalgia.METHODS: Totally 130 patients with moderateto-severe cancer induced somatalgia wer...OBJECTIVE: To evaluate the safety and efficacy of Tongkuaixiao ointment(TKXO) in treating moderate-to-severe cancer induced somatalgia.METHODS: Totally 130 patients with moderateto-severe cancer induced somatalgia were randomly divided into a TKXO group and a control group.The patients were treated with either TKXO applied externally or placebo, with opioid analgesics orally at the same time. Observation parameters were included numerical rating scale(NRS) scores,analgesic efficacy, initiation effective time, persistent analgesic time, equivalent morphine dose,National Comprehensive Cancer Network(NCCN)grade in Impact of Pain Measurement Scores, and safety and satisfaction extent investigation.RESULTS: NRS scores and NCCN grade in Impact of Pain Measurement Scores decreased significantly after 5-days' treatment in the two groups(P <0.0001). Compared to the control group, initiation effective time was significantly shorter(P < 0.05)and persistent analgesic time was significantly longer(P < 0.01), equivalent oral morphine doses of the first day and the whole treatment course were significantly decreased in the TKXO treatment group(P < 0.01 or P < 0.05). No obvious adverse effects were found in the TKXO group.CONCLUSION: TKXO combined with opioid analgesics possesses the advantages of high efficacy,fast action, long persistent action, safety and convenience in use, and it can reduce the dose of opioid.展开更多
Background： Lipid-lowering effect ofRhus coriaria L. （Rhus） has been investigated in multiple animal stud- ies with promising results. Nonetheless, its clinical efficacy has not been adequately examined. Objective...Background： Lipid-lowering effect ofRhus coriaria L. （Rhus） has been investigated in multiple animal stud- ies with promising results. Nonetheless, its clinical efficacy has not been adequately examined. Objective： The aim of this study was to evaluate the lipid-lowering effects of Rhus among patients with hyperlipidemia. Design, setting, participants and interventions： The study was designed as a two-arm, double-blind placebo-controlled randomized clinical trial, using a parallel design. Eighty patients with primary hyper- lipidemia were randomly assigned to receive Rhus capsules or placebo for 6 weeks. Main outcome measures： The serum lipid levels, apolipoprotein-A1 （Apo-A1） and apolipoprotein-B （Apo-B） were measured. Results： Mean serum high-density lipoprotein cholesterol （HDL-C） and Apo-Al levels were significantly increased in the Rhus group, compared with the placebo group, after 6 weeks of intervention （P= 0.001）. The analysis of covariance test including age, gender, body mass index （BMI）, and smoking as co-variables revealed that the increase in HDL-C and Apo-A1 levels remained significant, and increases in HDL-C were dependent on the increase in Apo-A1 levels. No significant difference was observed between Rhus and placebo groups in terms of mean reductions in total cholesterol, low-density lipopro- tein cholesterol and triglyceride levels; however, more significant improvement was observed among obese patients （BMI≥ 30 kg/m^2）. Conclusion： The study showed significant increases in HDL-C and Apo-Al levels in response to Rhus sup- plementation in patients with hyperlipidemia. Trial registration： ClinicalTrials.gov ID： NCT02295293.展开更多
Objective： To investigate the influence of the depth of skin press in blunt tip placebo acupuncture needles on patient blinding and its relationship to needle diameter.Methods： Forty healthy volunteers were enrolled...Objective： To investigate the influence of the depth of skin press in blunt tip placebo acupuncture needles on patient blinding and its relationship to needle diameter.Methods： Forty healthy volunteers were enrolled as subjects for patient blinding. Four acupuncturists applied the following needles randomly at three points in each forearm： 0.18 mm and 0.25 mm diameter penetrating needles inserted to a depth of 5 mm, and 0.18 mm and 0.25 mm diameter skin-touch needles depressing the skin at the acupoint to a depth of 1 mm and 2 mm from the skin surface. The subjects reported their guesses at the nature of needles they received, and rated needle pain and de qi. A blinding index was calculated to define the success of blinding for subjects.Results： The blinding status of subjects for 1 mm press needles of 0.18 mm diameter was ＂random guess＂,but ＂unblinded＂ for 1 mm press needles of 0.25 mm diameter. For 2 mm press needles of both diameters,the blinding status was ＂opposite guess＂ and the blinding status for penetrating needles of both diameters was ＂unblinded.＂ The percentages of ＂felt pain＂ with 2 mm press needles of both diameters were similar to that with penetrating needles, but those were not similar for 1 mm press needles. The frequency of de qi occurrence with 2 mm press needles of 0.18 mm diameter was similar to that of penetrating needles of both diameters.Conclusion： Placebo needles of 2 mm press made more subjects guess that the needles penetrated the skin than 1 mm press needles. The use of small diameter needles increased patient blinding.展开更多
目的:比较连续股神经阻滞(continuous femoral nerve block,CFNB)和CFNB联合关节周围浸润镇痛(periarticular local infiltration analgesia,PLIA)对膝关节置换术后镇痛及早期功能恢复的影响。方法:选择择期行膝关节置换手术患者100例,...目的:比较连续股神经阻滞(continuous femoral nerve block,CFNB)和CFNB联合关节周围浸润镇痛(periarticular local infiltration analgesia,PLIA)对膝关节置换术后镇痛及早期功能恢复的影响。方法:选择择期行膝关节置换手术患者100例,随机分为CFNB组(n=50)和CFNB联合PLIA组(简称PLIA组,n=50),以视觉模拟评分(visual analogue score,VAS)评价患者疼痛程度,在术后各时点记录静息及被动运动时患侧膝关节前、后部VAS评分。记录术后患者被动屈膝90°时间、主动直腿抬高时间,记录患者术前及术后72 h美国特种外科医院膝关节评分(hospital for special surgery knee score,HSS)。结果:术后静息时膝关节前部VAS评分在各时点两组间差异均无统计学意义(P>0.05),但膝关节后部VAS评分在术后4、8、12、24 h时PLIA组明显低于CFNB组(P<0.05)。被动运动时PLIA组膝关节前部VAS评分在术后24 h明显低于CFNB组(P<0.05),膝关节后部VAS评分在术后12、24 h明显低于CFNB组(P<0.05)。两组术前及术后72 h HSS评分差异无统计学意义(P>0.05)。与CFNB组比较,PLIA组被动屈膝90°时间和主动直腿抬高时间均明显缩短(P<0.05)。结论:CFNB联合PLIA镇痛可以降低术后膝关节后部疼痛评分,减少被动运动疼痛,缩短被动屈膝90°时间,改善患者术后早期康复效果。展开更多
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.
文摘BACKGROUND Even in the immuno-oncology era,transcatheter arterial chemoembolisation(TACE)is the most effective way to treat intermediate stage hepatocellular carcinoma(HCC).Postembolisation syndrome(PES)is the most common side effect from TACE and there is still no standard prevention guideline.AIM To evaluate the efficacy of single dose intravenous dexamethasone regimen to prevent PES after TACE among patients with HCC.METHODS This study enrolled patients with HCC who had eligible indication for TACE without macrovascular invasion/extrahepatic metastasis.Patients were randomly assigned to either an intravenous single dose of dexamethasone 8 mg or placebo one hour before TACE.The primary outcome was a negative result of PES at 48 h after TACE,which was defined as score<2 of Southwest Oncology Group toxicity coding criteria using fever,nausea,vomiting and pain to calculated.And the secondary end point was duration of admission between two groups.RESULTS One hundred patients were randomly assigned 1:1.Under intention-to-treat analysis,49 patients were randomly assigned to the dexamethasone and 51 to the placebo groups.Both groups were similar for baseline characteristics.The negative PES rate was significantly higher in the dexamethasone group than in the placebo group(63.3%vs 29.4%;P=0.005).Mean Southwest Oncology Group toxicity coding PES was 2.14(95%CI:1.41-2.8)vs 3.71(95%CI:2.97-4.45)between the dexamethasone and placebo groups,respectively.Cumulative incidence of fever was significantly lower in dexamethasone group with P<0.001,pain,nausea and vomiting were also lower in the dexamethasone group compared with the placebo group(P=0.16,P=0.11,and P=0.49).The dexamethasone regimen was generally well tolerated by patients with HCC patients including those with hepatitis B virus infection and well-controlled diabetes mellitus.CONCLUSION Single dose dexamethasone was effective at preventing PES among patients with HCC treated with TACE.The study showed no adverse events of special interest related to dexamethasone.
基金Supported by the Eleventh Five-year National Plan of Sciences and Technology(Clinical Research of Traditional Chinese Medicine External Treatment by Investigating Pathogenesis and Syndrome Differentiation of Cancer Pain,No.2008BAI53B023)Key Project of Beijing Municipal Science and Technology Commission(Standardization of Traditional Chinese Medicine External Treatment in Cancer Induced Pain,Ascites or Pleural Effusion,No.D13110002213004)the Postdoctoral Fund of Sciences(Effects of the Method for Tonifying Kidney to Strengthen the Bone in Treating Bone Cancer Pain,No.2012M510358)
文摘OBJECTIVE: To evaluate the safety and efficacy of Tongkuaixiao ointment(TKXO) in treating moderate-to-severe cancer induced somatalgia.METHODS: Totally 130 patients with moderateto-severe cancer induced somatalgia were randomly divided into a TKXO group and a control group.The patients were treated with either TKXO applied externally or placebo, with opioid analgesics orally at the same time. Observation parameters were included numerical rating scale(NRS) scores,analgesic efficacy, initiation effective time, persistent analgesic time, equivalent morphine dose,National Comprehensive Cancer Network(NCCN)grade in Impact of Pain Measurement Scores, and safety and satisfaction extent investigation.RESULTS: NRS scores and NCCN grade in Impact of Pain Measurement Scores decreased significantly after 5-days' treatment in the two groups(P <0.0001). Compared to the control group, initiation effective time was significantly shorter(P < 0.05)and persistent analgesic time was significantly longer(P < 0.01), equivalent oral morphine doses of the first day and the whole treatment course were significantly decreased in the TKXO treatment group(P < 0.01 or P < 0.05). No obvious adverse effects were found in the TKXO group.CONCLUSION: TKXO combined with opioid analgesics possesses the advantages of high efficacy,fast action, long persistent action, safety and convenience in use, and it can reduce the dose of opioid.
基金supported by a grant from Shiraz University of Medical Sciences–Iran (Grant No. 92-5581)
文摘Background： Lipid-lowering effect ofRhus coriaria L. （Rhus） has been investigated in multiple animal stud- ies with promising results. Nonetheless, its clinical efficacy has not been adequately examined. Objective： The aim of this study was to evaluate the lipid-lowering effects of Rhus among patients with hyperlipidemia. Design, setting, participants and interventions： The study was designed as a two-arm, double-blind placebo-controlled randomized clinical trial, using a parallel design. Eighty patients with primary hyper- lipidemia were randomly assigned to receive Rhus capsules or placebo for 6 weeks. Main outcome measures： The serum lipid levels, apolipoprotein-A1 （Apo-A1） and apolipoprotein-B （Apo-B） were measured. Results： Mean serum high-density lipoprotein cholesterol （HDL-C） and Apo-Al levels were significantly increased in the Rhus group, compared with the placebo group, after 6 weeks of intervention （P= 0.001）. The analysis of covariance test including age, gender, body mass index （BMI）, and smoking as co-variables revealed that the increase in HDL-C and Apo-A1 levels remained significant, and increases in HDL-C were dependent on the increase in Apo-A1 levels. No significant difference was observed between Rhus and placebo groups in terms of mean reductions in total cholesterol, low-density lipopro- tein cholesterol and triglyceride levels; however, more significant improvement was observed among obese patients （BMI≥ 30 kg/m^2）. Conclusion： The study showed significant increases in HDL-C and Apo-Al levels in response to Rhus sup- plementation in patients with hyperlipidemia. Trial registration： ClinicalTrials.gov ID： NCT02295293.
基金supported by Grant-in-Aid for Scientific Research(JP15K08938 and JP16K09266)
文摘Objective： To investigate the influence of the depth of skin press in blunt tip placebo acupuncture needles on patient blinding and its relationship to needle diameter.Methods： Forty healthy volunteers were enrolled as subjects for patient blinding. Four acupuncturists applied the following needles randomly at three points in each forearm： 0.18 mm and 0.25 mm diameter penetrating needles inserted to a depth of 5 mm, and 0.18 mm and 0.25 mm diameter skin-touch needles depressing the skin at the acupoint to a depth of 1 mm and 2 mm from the skin surface. The subjects reported their guesses at the nature of needles they received, and rated needle pain and de qi. A blinding index was calculated to define the success of blinding for subjects.Results： The blinding status of subjects for 1 mm press needles of 0.18 mm diameter was ＂random guess＂,but ＂unblinded＂ for 1 mm press needles of 0.25 mm diameter. For 2 mm press needles of both diameters,the blinding status was ＂opposite guess＂ and the blinding status for penetrating needles of both diameters was ＂unblinded.＂ The percentages of ＂felt pain＂ with 2 mm press needles of both diameters were similar to that with penetrating needles, but those were not similar for 1 mm press needles. The frequency of de qi occurrence with 2 mm press needles of 0.18 mm diameter was similar to that of penetrating needles of both diameters.Conclusion： Placebo needles of 2 mm press made more subjects guess that the needles penetrated the skin than 1 mm press needles. The use of small diameter needles increased patient blinding.
文摘目的:比较连续股神经阻滞(continuous femoral nerve block,CFNB)和CFNB联合关节周围浸润镇痛(periarticular local infiltration analgesia,PLIA)对膝关节置换术后镇痛及早期功能恢复的影响。方法:选择择期行膝关节置换手术患者100例,随机分为CFNB组(n=50)和CFNB联合PLIA组(简称PLIA组,n=50),以视觉模拟评分(visual analogue score,VAS)评价患者疼痛程度,在术后各时点记录静息及被动运动时患侧膝关节前、后部VAS评分。记录术后患者被动屈膝90°时间、主动直腿抬高时间,记录患者术前及术后72 h美国特种外科医院膝关节评分(hospital for special surgery knee score,HSS)。结果:术后静息时膝关节前部VAS评分在各时点两组间差异均无统计学意义(P>0.05),但膝关节后部VAS评分在术后4、8、12、24 h时PLIA组明显低于CFNB组(P<0.05)。被动运动时PLIA组膝关节前部VAS评分在术后24 h明显低于CFNB组(P<0.05),膝关节后部VAS评分在术后12、24 h明显低于CFNB组(P<0.05)。两组术前及术后72 h HSS评分差异无统计学意义(P>0.05)。与CFNB组比较,PLIA组被动屈膝90°时间和主动直腿抬高时间均明显缩短(P<0.05)。结论:CFNB联合PLIA镇痛可以降低术后膝关节后部疼痛评分,减少被动运动疼痛,缩短被动屈膝90°时间,改善患者术后早期康复效果。
