目的:系统评价穴位贴敷治疗颈椎病的有效性与安全性。方法:检索中国知网(CNKI)、维普(VIP)、万方(Wanfang Data)、PubMed、Web of science等数据库有关穴位贴敷治疗颈椎病的随机对照试验(RCT),检索时间从建库至2022年9月,结局指标选用...目的:系统评价穴位贴敷治疗颈椎病的有效性与安全性。方法:检索中国知网(CNKI)、维普(VIP)、万方(Wanfang Data)、PubMed、Web of science等数据库有关穴位贴敷治疗颈椎病的随机对照试验(RCT),检索时间从建库至2022年9月,结局指标选用总有效率、痊愈率,以及治疗后疼痛视觉模拟评分(VAS)、Northwick Park颈痛量表(NPQ)评分。采用RevMan 5.4软件对数据进行Meta分析,再使用TSA V0.9软件对研究结果进行试验序贯分析。结果:共纳入7篇RCT,1121例患者,Meta分析结果显示,试验组总有效率[OR=3.04,95%CI(2.13,4.34),P<0.00001]、痊愈率[OR=3.10,95%CI(1.73,5.53),P=0.0001]均高于对照组,VAS评分低于对照组[MD=-0.61,95%CI(-0.94,-0.29),P=0.0002];试验组NPQ评分与对照组比较,差异无统计学意义(P>0.05);试验组的不良反应发生率低于对照组(P<0.05)。试验序贯分析结果显示,总有效率的累计Z曲线穿过传统界值和试验序贯分析界值,但样本量未达到期望信息值量。结论:与传统中西药治疗比较,联合或单用穴位贴敷治疗颈椎病的疗效确切,安全性更高,值得进一步推广应用。但鉴于纳入文献数量较少,质量偏低,仍需开展高质量的RCT,以进一步验证其临床疗效。展开更多
OBJECTIVE:To provide the evidence for the efficacy of acupoint application(AA)for patients with diarrhea in a real-world setting.METHODS:This study is a national multicenter retrospective cohort study.Our study consec...OBJECTIVE:To provide the evidence for the efficacy of acupoint application(AA)for patients with diarrhea in a real-world setting.METHODS:This study is a national multicenter retrospective cohort study.Our study consecutively collected outpatient medical records of patients with diarrhea from hundreds of primary hospitals nationwide registered in Chun Bo Wan Xiang cloud platform from 22nd August,2020 to 5th November,2020.The patients were divided into the treatment group and the control group according to patient's condition and willingness.The control group was treated with Western Medicine,oral Chinese Medicine decoction,or both.The treatment group was added with AA based on the control group.Multiple logistic regression was used to evaluate the independent efficacy of AA in diarrheal recovery on the 3rd,7th,14th and 28th day.As a next step,we also performed stratified analysis and likelihood ratio test(LRT).Sensitivity analyses included propensity score matching(PSM),four PSM-related analyses and E-value.RESULTS:The treatment group showed better efficacy than the control group on the 14th and 28th day[the 14th day:OR=1.58,95%CI(1.15,2.19),P=0.005;the 28th day:OR=2.03,95%CI(1.43,2.88),P<0.001].No difference was observed in efficacy of AA for the treatment of diarrhea among the subgroups(P>0.05).PSM-related analyses confirmed the efficacy of AA in diarrheal recovery.The findings are unlikely to be nullified by an unmeasured confounding variable according to the results of E-values.CONCLUSIONS:The efficacy in the treatment group was significantly more improved than that in the control group on the 14th and 28th day.展开更多
不良反应是试验药物及上市药品重要的安全性数据之一,对其进行标准化的编码有利于不良反应的规范分析与阐述。但目前国际上普通使用的不良反应编码术语集均不包含中医学中的特有术语。本文简述世界卫生组织不良反应术语集(World Health ...不良反应是试验药物及上市药品重要的安全性数据之一,对其进行标准化的编码有利于不良反应的规范分析与阐述。但目前国际上普通使用的不良反应编码术语集均不包含中医学中的特有术语。本文简述世界卫生组织不良反应术语集(World Health Organization Adverse Reaction Terminology,WHOART)与人用药品注册技术规范国际协调会(The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use,ICH)开发的监管活动医学词典(Medical Dictionary for Regulatory Activities,MedDRA)的异同点,并基于当前中医学不良反应编码术语集的研制情况,提出制定国际公认的中医学不良反应编码术语集的基本路径。展开更多
基金Major Science and Technology Innovation Project of China Academy of Chinese Medical Sciences:Research on the Key Techniques of Clinical Evaluation of New Chinese Medicine under the System of Three-in-one Combination Evidence Review(No.CI2021A04701)。
文摘OBJECTIVE:To provide the evidence for the efficacy of acupoint application(AA)for patients with diarrhea in a real-world setting.METHODS:This study is a national multicenter retrospective cohort study.Our study consecutively collected outpatient medical records of patients with diarrhea from hundreds of primary hospitals nationwide registered in Chun Bo Wan Xiang cloud platform from 22nd August,2020 to 5th November,2020.The patients were divided into the treatment group and the control group according to patient's condition and willingness.The control group was treated with Western Medicine,oral Chinese Medicine decoction,or both.The treatment group was added with AA based on the control group.Multiple logistic regression was used to evaluate the independent efficacy of AA in diarrheal recovery on the 3rd,7th,14th and 28th day.As a next step,we also performed stratified analysis and likelihood ratio test(LRT).Sensitivity analyses included propensity score matching(PSM),four PSM-related analyses and E-value.RESULTS:The treatment group showed better efficacy than the control group on the 14th and 28th day[the 14th day:OR=1.58,95%CI(1.15,2.19),P=0.005;the 28th day:OR=2.03,95%CI(1.43,2.88),P<0.001].No difference was observed in efficacy of AA for the treatment of diarrhea among the subgroups(P>0.05).PSM-related analyses confirmed the efficacy of AA in diarrheal recovery.The findings are unlikely to be nullified by an unmeasured confounding variable according to the results of E-values.CONCLUSIONS:The efficacy in the treatment group was significantly more improved than that in the control group on the 14th and 28th day.
文摘不良反应是试验药物及上市药品重要的安全性数据之一,对其进行标准化的编码有利于不良反应的规范分析与阐述。但目前国际上普通使用的不良反应编码术语集均不包含中医学中的特有术语。本文简述世界卫生组织不良反应术语集(World Health Organization Adverse Reaction Terminology,WHOART)与人用药品注册技术规范国际协调会(The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use,ICH)开发的监管活动医学词典(Medical Dictionary for Regulatory Activities,MedDRA)的异同点,并基于当前中医学不良反应编码术语集的研制情况,提出制定国际公认的中医学不良反应编码术语集的基本路径。
