Objective This study aimed to analyze the clinical efficacy of the Jianpi Shengxue tablet for treating renal anemia.Methods A total of 200 patients with renal anemia from December 2020 to December 2022 were enrolled a...Objective This study aimed to analyze the clinical efficacy of the Jianpi Shengxue tablet for treating renal anemia.Methods A total of 200 patients with renal anemia from December 2020 to December 2022 were enrolled and randomly divided into two groups.Patients in the control group were treated with polysaccharide-iron complex,and those in the experimental group were administered Jianpi Shengxue tablet.After 8 weeks of continuous treatment,the therapeutic outcomes regarding anemia were compared between the two groups.Results After treatment,the red blood cell(RBC)count,hematocrit(HCT),reticulocyte percentage(RET),ferritin(SF),serum iron(SI),transferrin saturation(TSAT),and serum albumin(ALB)all increased(P<0.01),and the clinical symptom score and total iron binding capacity decreased(P<0.01)in the experimental group.Moreover,the improvements in RBC,HCT,RET,SF,SI,TAST,ALB,and clinical symptoms(fatigue,anorexia,dull skin complexion,numbness of hands and feet)in the experimental group were significantly greater than those in the control group(P<0.05).The total effective rate for treating renal anemia was significantly higher in the experimental group than in the control group(P<0.01).Conclusion The Jianpi Shengxue tablet demonstrates efficacy in treating renal anemia,leading to significant improvements in the laboratory examination results and clinical symptoms of patients with renal anemia.展开更多
Hepatitis B virus(HBV)is a serious global public health concern.Although nucleoside drugs and interferons can significantly inhibit HBV replication,issues such as drug resistance and low clinical cure rates remain.Tra...Hepatitis B virus(HBV)is a serious global public health concern.Although nucleoside drugs and interferons can significantly inhibit HBV replication,issues such as drug resistance and low clinical cure rates remain.Traditional Chinese medicine(TCM)is widely used in the treatment of chronic hepatitis B(CHB)in China,with anti-inflammatory,anti-fibrotic,and liver-protective effects;however,reports on its antiviral effects are still inconsistent.We retrieved multicenter clinical studies and meta-analyses of TCM treatment for CHB over the past two decades.The results revealed that TCM has a certain anti-HBV effect,and when combined with antiviral drugs,it can significantly improve antiviral efficacy.It was demonstrated that TCM most effectively promotes serum HBV e antigen conversion to negative,followed by the ability to reduce HBV DNA levels,facilitating HBV surface antigen loss,and improving the treatment of CHB.展开更多
The Realgar-Indigo Naturalis formula(RIF)is a proprietary Chinese medicine,which is one of the important drugs in the treatment of pediatric acute promyelocytic leukemia(APL).However,the dose of RIF in clinical applic...The Realgar-Indigo Naturalis formula(RIF)is a proprietary Chinese medicine,which is one of the important drugs in the treatment of pediatric acute promyelocytic leukemia(APL).However,the dose of RIF in clinical application is not uniform and the long-term effectiveness and safety of combining RIF with all-trans retinoic acid(ATRA)in a larger population of pediatric APL patients remains undocumented.We conducted a multicenter single-arm clinical trial(ChiCTR-OIC-16010014)in China.Individuals newly diagnosed with APL were treated with CCCG-APL-2017 protocol which is based on RIF and ATRA in consolidation.The event-free survival(EFS)and overall survival(OS)outcomes were evaluated.We recruited 200 patients diagnosed with APL.The six-year OS rate was 100%in the low-risk(LR)group and 97.6%in the high-risk(HR)group.The six-year EFS rate was 98.3%in the LR group and 97.6%in the HR group.Plasma levels of arsenic remained stable after the administration of RIF at a dosage of 60 mg/kg/d for seven days and returned to baseline levels within fourteen days after discontinuation of RIF administration,which is consistent with a concentration of 135 mg/d/kg.Furthermore,controlling white blood cells(WBC)to maintain levels at or below 30×10^(9)/L during induction therapy can decrease the incidence of induced differentiation syndrome(DS)or alleviate its symptoms.Our study demonstrated that the CCCG-APL-2017 protocol,which combines RIF with ATRA,is both effective and safe in treating children with APL.展开更多
Background Absorbable cranial flap fixation products,represented by Aesculap^(®)CranioFix absorbable clamp,are widely used in neurosurgery.However,the product has some shortcomings,as it is not entirely biodegrad...Background Absorbable cranial flap fixation products,represented by Aesculap^(®)CranioFix absorbable clamp,are widely used in neurosurgery.However,the product has some shortcomings,as it is not entirely biodegradable,the lower disc’s angle cannot be adjusted,and there is a failure to readjust after fixation.To address these issues,MedArt Technology Co.,Ltd.from China has come up with a high-purity PLLA combined with an innovative structural design to develop a novel cranial flap fixation system that is more convenient to operate,has a better resetting effect,and can be fully absorbed.This study aims to verify its safety and effectiveness through in vitro experiments and clinical trials.Methods In this study,the absorbable cranial flap fixation system of MedArt was used as the experimental group,and the CranioFix absorbable clamp constituted the control group.The material properties and the changing trend of mechanical properties of the two groups were compared by accelerated degradation experiments in vitro.A multicenter,randomized,parallel,positive-controlled,non-inferiority clinical study was conducted with a 48-week follow-up.The shortening degree of the bone flap gap,qualified rate of bone flap displacement,changing trend of implant volume,and occurrence of postoperative adverse events were compared between the two groups.Results The results of the in vitro accelerated degradation showed that in terms of the decrease in intrinsic viscosity,the control and experimental groups took 7 days and 14 days,respectively,to reach the test endpoint.For mechanical properties,the control group and experimental groups lost clinical safety fixation significance on the 3rd and 4th day after the degradation began,respectively.Regarding the release of degradation products,the control group showed a burst of lactic acid release during the first 3-7 days,while the experimental group released lactic acid slowly and constantly.In the clinical study,90 patients were randomly enrolled,87 of whom completed the operation,with an average age of 50.The 3D reconstruction of CT images showed that the bone flap gaps in both groups were less than 2 mm after surgery.The qualified rate of bone flap displacement in the experimental group was 100%after surgery.In contrast,in the control group,there was one unqualified case at 1 week after surgery and two unqualified cases at 6 weeks,12 weeks,24 weeks,and 48 weeks.The residual volume of the implant in the experimental group was closer to 50%(about 48.8%)48 weeks after surgery,than in the control group(about 43.9%)12 weeks after surgery.Regarding safety,only one possible device-related adverse event occurred in the control group,with an incidence rate of 2.22%,manifested as poor healing at the incision site.Conclusions The study has verified that the experimental group had better stability,longer biodegradation time,and better mechanical properties than the control group.Moreover,the experimental group could significantly narrow the cranial flap gap,reduce the flap displacement,and promote skull healing after craniotomy.It shows a fairly reliable fixation effect and safety.展开更多
The aim was to investigate whether using a removing blood stasis method in hyperacute intracranial hemorrhage stage can lead to hematoma enlargement and its clinical efficacy.A multicenter retrospective randomized dou...The aim was to investigate whether using a removing blood stasis method in hyperacute intracranial hemorrhage stage can lead to hematoma enlargement and its clinical efficacy.A multicenter retrospective randomized double-blind placebo-controlled clinical study.We recruited patients aged 18 years or older and presenting at less than 6 h from symptom onset in 8 research centers.All the patients展开更多
基金financially supported by the National Natural Science Foundation of China(No.82170701).
文摘Objective This study aimed to analyze the clinical efficacy of the Jianpi Shengxue tablet for treating renal anemia.Methods A total of 200 patients with renal anemia from December 2020 to December 2022 were enrolled and randomly divided into two groups.Patients in the control group were treated with polysaccharide-iron complex,and those in the experimental group were administered Jianpi Shengxue tablet.After 8 weeks of continuous treatment,the therapeutic outcomes regarding anemia were compared between the two groups.Results After treatment,the red blood cell(RBC)count,hematocrit(HCT),reticulocyte percentage(RET),ferritin(SF),serum iron(SI),transferrin saturation(TSAT),and serum albumin(ALB)all increased(P<0.01),and the clinical symptom score and total iron binding capacity decreased(P<0.01)in the experimental group.Moreover,the improvements in RBC,HCT,RET,SF,SI,TAST,ALB,and clinical symptoms(fatigue,anorexia,dull skin complexion,numbness of hands and feet)in the experimental group were significantly greater than those in the control group(P<0.05).The total effective rate for treating renal anemia was significantly higher in the experimental group than in the control group(P<0.01).Conclusion The Jianpi Shengxue tablet demonstrates efficacy in treating renal anemia,leading to significant improvements in the laboratory examination results and clinical symptoms of patients with renal anemia.
基金Supported by The Funding of Scientific and Technological Innovation Project of China Academy of Chinese Medical Sciences,No.CI2021A00810The Escort Project of Guang’anmen Hosital,China Academy of Chinese Medical Science-Backbone Talent Cultivation Project,No.9323013。
文摘Hepatitis B virus(HBV)is a serious global public health concern.Although nucleoside drugs and interferons can significantly inhibit HBV replication,issues such as drug resistance and low clinical cure rates remain.Traditional Chinese medicine(TCM)is widely used in the treatment of chronic hepatitis B(CHB)in China,with anti-inflammatory,anti-fibrotic,and liver-protective effects;however,reports on its antiviral effects are still inconsistent.We retrieved multicenter clinical studies and meta-analyses of TCM treatment for CHB over the past two decades.The results revealed that TCM has a certain anti-HBV effect,and when combined with antiviral drugs,it can significantly improve antiviral efficacy.It was demonstrated that TCM most effectively promotes serum HBV e antigen conversion to negative,followed by the ability to reduce HBV DNA levels,facilitating HBV surface antigen loss,and improving the treatment of CHB.
基金supported by National Key Research and Development Program of China(2021YFE0106900)the Chinese Academy of Medical Sciences(CAMS)Innovation Fund for Medical Sciences(2021-I2M-1-041,2021-I2M-1-001)the National Natural Science Foundation of China(82270144).
文摘The Realgar-Indigo Naturalis formula(RIF)is a proprietary Chinese medicine,which is one of the important drugs in the treatment of pediatric acute promyelocytic leukemia(APL).However,the dose of RIF in clinical application is not uniform and the long-term effectiveness and safety of combining RIF with all-trans retinoic acid(ATRA)in a larger population of pediatric APL patients remains undocumented.We conducted a multicenter single-arm clinical trial(ChiCTR-OIC-16010014)in China.Individuals newly diagnosed with APL were treated with CCCG-APL-2017 protocol which is based on RIF and ATRA in consolidation.The event-free survival(EFS)and overall survival(OS)outcomes were evaluated.We recruited 200 patients diagnosed with APL.The six-year OS rate was 100%in the low-risk(LR)group and 97.6%in the high-risk(HR)group.The six-year EFS rate was 98.3%in the LR group and 97.6%in the HR group.Plasma levels of arsenic remained stable after the administration of RIF at a dosage of 60 mg/kg/d for seven days and returned to baseline levels within fourteen days after discontinuation of RIF administration,which is consistent with a concentration of 135 mg/d/kg.Furthermore,controlling white blood cells(WBC)to maintain levels at or below 30×10^(9)/L during induction therapy can decrease the incidence of induced differentiation syndrome(DS)or alleviate its symptoms.Our study demonstrated that the CCCG-APL-2017 protocol,which combines RIF with ATRA,is both effective and safe in treating children with APL.
基金funded by MedArt Technology Co.,Ltd.,located in Chengdu,China.The company supplied cranial flap fixation products utilized in the study and provided financial support for the research.
文摘Background Absorbable cranial flap fixation products,represented by Aesculap^(®)CranioFix absorbable clamp,are widely used in neurosurgery.However,the product has some shortcomings,as it is not entirely biodegradable,the lower disc’s angle cannot be adjusted,and there is a failure to readjust after fixation.To address these issues,MedArt Technology Co.,Ltd.from China has come up with a high-purity PLLA combined with an innovative structural design to develop a novel cranial flap fixation system that is more convenient to operate,has a better resetting effect,and can be fully absorbed.This study aims to verify its safety and effectiveness through in vitro experiments and clinical trials.Methods In this study,the absorbable cranial flap fixation system of MedArt was used as the experimental group,and the CranioFix absorbable clamp constituted the control group.The material properties and the changing trend of mechanical properties of the two groups were compared by accelerated degradation experiments in vitro.A multicenter,randomized,parallel,positive-controlled,non-inferiority clinical study was conducted with a 48-week follow-up.The shortening degree of the bone flap gap,qualified rate of bone flap displacement,changing trend of implant volume,and occurrence of postoperative adverse events were compared between the two groups.Results The results of the in vitro accelerated degradation showed that in terms of the decrease in intrinsic viscosity,the control and experimental groups took 7 days and 14 days,respectively,to reach the test endpoint.For mechanical properties,the control group and experimental groups lost clinical safety fixation significance on the 3rd and 4th day after the degradation began,respectively.Regarding the release of degradation products,the control group showed a burst of lactic acid release during the first 3-7 days,while the experimental group released lactic acid slowly and constantly.In the clinical study,90 patients were randomly enrolled,87 of whom completed the operation,with an average age of 50.The 3D reconstruction of CT images showed that the bone flap gaps in both groups were less than 2 mm after surgery.The qualified rate of bone flap displacement in the experimental group was 100%after surgery.In contrast,in the control group,there was one unqualified case at 1 week after surgery and two unqualified cases at 6 weeks,12 weeks,24 weeks,and 48 weeks.The residual volume of the implant in the experimental group was closer to 50%(about 48.8%)48 weeks after surgery,than in the control group(about 43.9%)12 weeks after surgery.Regarding safety,only one possible device-related adverse event occurred in the control group,with an incidence rate of 2.22%,manifested as poor healing at the incision site.Conclusions The study has verified that the experimental group had better stability,longer biodegradation time,and better mechanical properties than the control group.Moreover,the experimental group could significantly narrow the cranial flap gap,reduce the flap displacement,and promote skull healing after craniotomy.It shows a fairly reliable fixation effect and safety.
文摘The aim was to investigate whether using a removing blood stasis method in hyperacute intracranial hemorrhage stage can lead to hematoma enlargement and its clinical efficacy.A multicenter retrospective randomized double-blind placebo-controlled clinical study.We recruited patients aged 18 years or older and presenting at less than 6 h from symptom onset in 8 research centers.All the patients
