A traditional Chinese medicinal capsule capable of curing HIV/AIDS has been put under clinical test with the approval of the State Food and Drug Administration.
Objective:To verify the efficacy and safety of Quxie Capsule(祛邪胶囊) in patients with metastatic colorectal cancer(mC RC).Methods:The present study was a randomized,double-blind,placebo-controlled trial.Sixty ...Objective:To verify the efficacy and safety of Quxie Capsule(祛邪胶囊) in patients with metastatic colorectal cancer(mC RC).Methods:The present study was a randomized,double-blind,placebo-controlled trial.Sixty patients with mC RC were randomized into two groups at a 1:1 ratio by sealed envelope.The treatment group received conventional therapy combined with Quxie Capsule for 3 months.The control group was treated with conventional therapy combined with placebo for 3 months.Main outcome measures were overall survival(OS) and progression-free survival(PFS).Subgroup analysis was performed according to age,right or left-sided disease,and second-line therapy to determine the differences in PFS and OS between the two groups.Patients were followed up every 3 months until Dec 31 st 2016.Results:The median OS was 23 months in the treatment group [95% confidence interval(CI):15–not calculated] vs.14 months in the control group(95% CI:11–22,P=0.060).The OS of the treatment group tended to be longer than that of the control group(P〉0.05).In the subgroups of patients 〈65 years old,left-sided colon,and 2 nd-line therapy,the treatment group showed a significant survival benefit compared with the control group(P=0.006,0.038,0.013,respectively).There were no significant differences between the two groups in PFS(P〉0.05).Safety analysis showed no severe hematological toxicity or liver and renal function injury in the treatment group.Conclusions:Quxie Capsule showed good safety and efficacy,and could prolong the OS of patients with mC RC.展开更多
Objective:To assist decision-makers interpret and choose among conflicting meta-analyses,as well as to offer treatment recommendations based on current best evidence by performing a systematic review of overlapping m...Objective:To assist decision-makers interpret and choose among conflicting meta-analyses,as well as to offer treatment recommendations based on current best evidence by performing a systematic review of overlapping meta-analyses regarding Shenyi Capsule(参一胶囊,SC) plus chemotherapy versus chemotherapy of non-small cell lung cancer(NSCLC).Methods:A literature search was conducted to select systematic reviews comparing SC plus chemotherapy with chemotherapy for NSCLC.Meta-analyses only composed of randomized controlled trials(RCTs) met the inclusion criteria.Two authors individually estimated the quality of meta-analysis and extracted data.The Jadad decision algorithm was applied to guarantee which meta-analysis provided the best original evidence.Results:A total of 5 meta-analyses were included.All the studies composed of RCTs or quasi-RCTs and were regarded as level-Ⅱ evidence.The scores of the Assessment of Multiple Systematic Reviews ranged from 3 to 6(median 4).A high-quality meta-analysis with more RCTs was chosen,which suggested that SC plus chemotherapy could increase incidence of short-term efficacy,improve the quality of life and survival rate in comparison to chemotherapy.However,there was no statistically significant difference between SC plus chemotherapy and chemotherapy regarding chemotherapy-induced side effect,such as liver and kidney function obstacle,leukopenia,hemoglobin decrement and gastrointestinal adverse reaction.Conclusions:Based on the best available evidence,treatment effect of SC plus chemotherapy was better than chemotherapy and did not increase side effects.Therefore,SC plus chemotherapy may be superior to chemotherapy for treating NSCLC.However,due to some limitations,SC plus chemotherapy should be cautiously considered,and further high-quality meta-analyses are needed.展开更多
Objective:To investigate the effect of Longbishu Capsule(癃闭舒胶囊,LBS),doxazosin,and combination therapy on benign prostatic hyperplasia(BPH).Methods:A randomized,double-blind,multi-center parallel trial was c...Objective:To investigate the effect of Longbishu Capsule(癃闭舒胶囊,LBS),doxazosin,and combination therapy on benign prostatic hyperplasia(BPH).Methods:A randomized,double-blind,multi-center parallel trial was conducted involving 360 patients in hospitals in Beijing(108 cases),Heilongjiang(90 cases),Sichuan(90 cases),Shanghai(72 cases),China.They were randomly assigned with central randomization method to group A(LBS placebo plus doxazosin),group B(LBS plus doxazosin)or group C(LBS plus doxazosin placebo),120 cases for each group.The international prostate symptom score,maximum urinary flow rate,postvoid residual urine volume and prostate volume were measured for evaluating the efficacy of the three treatments.Results:At baseline,there was no significant difference in the measured variables among the three groups.After 12-month treatment,the three groups showed significant improvements in IPSS and maximum urinary flow rate from baseline(P〈0.01).Although postvoid residual urine volume was not significantly different from the baseline in group A(P〉0.05),it significantly decreased in group B and C(P〈0.05).The incidence of adverse events were similar among the three groups.Conclusions:The treatment of LBS alone or LBS plus doxazosin was able to significantly improve IPSS in patients with BPH.The treatments may reduce the increase in prostate volume and postvoid residual urine volume as well.展开更多
Objective:To determine the impact of adjunctive Buchang Naoxintong Capsule(步心脑心通胶囊,NXT) on dual antiplatelet therapy in patients with cytochrome P450 2C19*2(CYP2C19*2) polymorphism undergoing percutaneou...Objective:To determine the impact of adjunctive Buchang Naoxintong Capsule(步心脑心通胶囊,NXT) on dual antiplatelet therapy in patients with cytochrome P450 2C19*2(CYP2C19*2) polymorphism undergoing percutaneous coronary intervention(PCI).Methods:Ninety patients with CYP2C19*2 polymorphism were enrolled,and their genotypes were confirmed by polymerase chain reaction(PCR).The patients were randomly assigned to receive either adjunctive NXT(triple group,45 cases) or dual antiplatelet therapy(dual group,45 cases) using a computer-generated randomization sequence and sealed envelopes.Platelet function was assessed at baseline and 7 days after treatment with conventional aggregometry.Subsequent major adverse cardiovascular events(MACE,including sudden cardiac arrest and acute coronary syndrome) were recorded during a 12-month followup.Results:Baseline platelet function measurements were similar in both groups.After 7 days,percent inhibitions of maximum platelet aggregation and late platelet aggregation were significantly greater in the triple versus dual group(42.3%±16.0%vs.20.8%±15.2%,P〈0.01,and 54.7%±18.3%vs.21.5%±29.2%,P〈0.01,respectively).During the 12-month follow-up,the rate of subsequent MACE(6/45) was significantly lower in the triple group compared with the dual group(14/45;P〈0.05).Conclusion:Adjunctive NXT to maintenance dose clopidogrel(75 g) could enhance the antiplatelet effect and decrease subsequent MACE in patients with the CYP2C19'2polymorphism undergoing PCI.展开更多
文摘A traditional Chinese medicinal capsule capable of curing HIV/AIDS has been put under clinical test with the approval of the State Food and Drug Administration.
基金Supported by National Natural Science Foundation of China(No.81373824)Science and Technology Program of Beijing(No.Z131107002213101)Project of the Chinese Academy of Traditional Chinese Medicine(No.ZZ070854)
文摘Objective:To verify the efficacy and safety of Quxie Capsule(祛邪胶囊) in patients with metastatic colorectal cancer(mC RC).Methods:The present study was a randomized,double-blind,placebo-controlled trial.Sixty patients with mC RC were randomized into two groups at a 1:1 ratio by sealed envelope.The treatment group received conventional therapy combined with Quxie Capsule for 3 months.The control group was treated with conventional therapy combined with placebo for 3 months.Main outcome measures were overall survival(OS) and progression-free survival(PFS).Subgroup analysis was performed according to age,right or left-sided disease,and second-line therapy to determine the differences in PFS and OS between the two groups.Patients were followed up every 3 months until Dec 31 st 2016.Results:The median OS was 23 months in the treatment group [95% confidence interval(CI):15–not calculated] vs.14 months in the control group(95% CI:11–22,P=0.060).The OS of the treatment group tended to be longer than that of the control group(P〉0.05).In the subgroups of patients 〈65 years old,left-sided colon,and 2 nd-line therapy,the treatment group showed a significant survival benefit compared with the control group(P=0.006,0.038,0.013,respectively).There were no significant differences between the two groups in PFS(P〉0.05).Safety analysis showed no severe hematological toxicity or liver and renal function injury in the treatment group.Conclusions:Quxie Capsule showed good safety and efficacy,and could prolong the OS of patients with mC RC.
文摘Objective:To assist decision-makers interpret and choose among conflicting meta-analyses,as well as to offer treatment recommendations based on current best evidence by performing a systematic review of overlapping meta-analyses regarding Shenyi Capsule(参一胶囊,SC) plus chemotherapy versus chemotherapy of non-small cell lung cancer(NSCLC).Methods:A literature search was conducted to select systematic reviews comparing SC plus chemotherapy with chemotherapy for NSCLC.Meta-analyses only composed of randomized controlled trials(RCTs) met the inclusion criteria.Two authors individually estimated the quality of meta-analysis and extracted data.The Jadad decision algorithm was applied to guarantee which meta-analysis provided the best original evidence.Results:A total of 5 meta-analyses were included.All the studies composed of RCTs or quasi-RCTs and were regarded as level-Ⅱ evidence.The scores of the Assessment of Multiple Systematic Reviews ranged from 3 to 6(median 4).A high-quality meta-analysis with more RCTs was chosen,which suggested that SC plus chemotherapy could increase incidence of short-term efficacy,improve the quality of life and survival rate in comparison to chemotherapy.However,there was no statistically significant difference between SC plus chemotherapy and chemotherapy regarding chemotherapy-induced side effect,such as liver and kidney function obstacle,leukopenia,hemoglobin decrement and gastrointestinal adverse reaction.Conclusions:Based on the best available evidence,treatment effect of SC plus chemotherapy was better than chemotherapy and did not increase side effects.Therefore,SC plus chemotherapy may be superior to chemotherapy for treating NSCLC.However,due to some limitations,SC plus chemotherapy should be cautiously considered,and further high-quality meta-analyses are needed.
基金Supported by the Project of Science Research for the 11th FiveYear Plan(No.2007BAI20B044)
文摘Objective:To investigate the effect of Longbishu Capsule(癃闭舒胶囊,LBS),doxazosin,and combination therapy on benign prostatic hyperplasia(BPH).Methods:A randomized,double-blind,multi-center parallel trial was conducted involving 360 patients in hospitals in Beijing(108 cases),Heilongjiang(90 cases),Sichuan(90 cases),Shanghai(72 cases),China.They were randomly assigned with central randomization method to group A(LBS placebo plus doxazosin),group B(LBS plus doxazosin)or group C(LBS plus doxazosin placebo),120 cases for each group.The international prostate symptom score,maximum urinary flow rate,postvoid residual urine volume and prostate volume were measured for evaluating the efficacy of the three treatments.Results:At baseline,there was no significant difference in the measured variables among the three groups.After 12-month treatment,the three groups showed significant improvements in IPSS and maximum urinary flow rate from baseline(P〈0.01).Although postvoid residual urine volume was not significantly different from the baseline in group A(P〉0.05),it significantly decreased in group B and C(P〈0.05).The incidence of adverse events were similar among the three groups.Conclusions:The treatment of LBS alone or LBS plus doxazosin was able to significantly improve IPSS in patients with BPH.The treatments may reduce the increase in prostate volume and postvoid residual urine volume as well.
基金Supported by the Provincial Natural Science Foundation of Fujian(No.2011J0133)the National Natural Science Foundation of China(No.81373838)
文摘Objective:To determine the impact of adjunctive Buchang Naoxintong Capsule(步心脑心通胶囊,NXT) on dual antiplatelet therapy in patients with cytochrome P450 2C19*2(CYP2C19*2) polymorphism undergoing percutaneous coronary intervention(PCI).Methods:Ninety patients with CYP2C19*2 polymorphism were enrolled,and their genotypes were confirmed by polymerase chain reaction(PCR).The patients were randomly assigned to receive either adjunctive NXT(triple group,45 cases) or dual antiplatelet therapy(dual group,45 cases) using a computer-generated randomization sequence and sealed envelopes.Platelet function was assessed at baseline and 7 days after treatment with conventional aggregometry.Subsequent major adverse cardiovascular events(MACE,including sudden cardiac arrest and acute coronary syndrome) were recorded during a 12-month followup.Results:Baseline platelet function measurements were similar in both groups.After 7 days,percent inhibitions of maximum platelet aggregation and late platelet aggregation were significantly greater in the triple versus dual group(42.3%±16.0%vs.20.8%±15.2%,P〈0.01,and 54.7%±18.3%vs.21.5%±29.2%,P〈0.01,respectively).During the 12-month follow-up,the rate of subsequent MACE(6/45) was significantly lower in the triple group compared with the dual group(14/45;P〈0.05).Conclusion:Adjunctive NXT to maintenance dose clopidogrel(75 g) could enhance the antiplatelet effect and decrease subsequent MACE in patients with the CYP2C19'2polymorphism undergoing PCI.