中草药治疗乙型肝炎病毒无症状携带者的系统评价
http://www.100md.com
中医循证医学
刘建平1 秦献魁2 Heather Mclntosh3
(1.四川大学华西医院中国循证医学/Cochrane中心 成都 610041
2.北京军区联勤部卫生部(北京)3.英国国家卫生服务系统评价与传播中心 约克大学)
摘要：目的 评价中草药治疗乙型肝炎病毒无症状携带者的疗效与安全性。设计 Cochrane系统评价。研究的鉴定 检索Cochrane肝胆疾病组、Cochrane图书馆、Cochrane另证医学领域试验注册数据库,MEDLLNE、EMBASE以及BIOSIS数据库存。手工检索发表与未发表之中文文献。纳入标准 收集比较中草药与安慰剂、未治疗、非特异性治疗或干扰素治疗乙型肝炎病毒无症状携带者并随访达3个月以上的随机临床试验。试验无论是否使用盲法或发表语种均不受纳入限制。资料提取与统计方法 两名评价人员独市提取资料。纳入试验的方法学质量采用Jadad评分标准与随机分配隐藏。数据采用Cochrane协作网专用软件RevMan4.1版进行统计分析。结果 3篇共涉及307名病人随访达3个月及以上的随机临床试验符合纳入标准。均为低质量试验。健脾温肾方与干扰素比较对清除乙型肝炎病毒具有显著效果:消除乙型肝炎病毒血清表面抗原(HBsAg)相对危险度为2.40(95%可信区间1.01～5.72),血清e抗原(HBeAg)转化为e抗体的效应为2.54(1.13～5.70)。草药叶下珠和黄芪与安慰剂比较未见显著的抗病毒效果。对8个随访少于3个月的随机临床试验的分析表明中草药对病毒标志物免显著疗效。试验未发现严重的副作用。结论 由于小样本及低质量的随机对照试验,中草药治疗乙型肝炎病毒携带者的证据无够充分。需要进一步的随机双盲安慰剂对照试验。
, 百拇医药
关键词： 中草药 乙型肝炎病毒 携带状态 系统评价 随机对照试验 Cochrane
A Systematic Review on Chinese Medicinal Herbs for A Symptomatic Carriers of Hepatitis B Virus
LIU Jian-ping1,QIN Xian-kui2,McIntosh Heather3
(l. The Chinese EBM/Corchrane Centre,West China Hospital,Sichuan University, Chengdu 610041, China；2.The Department of Health,Beifing Military Region, Beijing, China；3. NHS Centre for Reviews and Dissemination, University of York, UK)
, http://www.100md.com
Abstract: Objective To assess the efficacy and safety of Chinese medicinal herbs for a symptomatic hepatitis B virus(HBV) infection. Data Source The trials registers of the Cochrane Hepato-Biliary Group, the Cochrane Library and the Cochrane Complementary Medicine Fiele were searched in combination with MEDLINE, EMBASE, and hand searches of Chinese journals and conference proceedings. Data Selection Randomised clinical trials with 3 months follow-up comparing Chinese medicinal herbs versus placebo, no intervention, non-specific treatme for asymptomatic HBV Carriers were included. No language and blinding limitations were applied. Data Extraction Data were extracted independently by two reviewers. The methodological quality of trials was assessed by the Jadad-acale plus allocation concealment. Results Three randmosed clinical trials (307 patients) with low methodological quality following patients for three months or more after the end of treatment were included. Herbal compound Jianpi Wenshen recipe showed significant effects on clearance of HBV markers compared to interferon: relative risk 2.40(95%CI 1.01～5.72)for clearance of serum HBsAg, and 2.54(1.13～5.70) for seroconversion of HBeAg to anti-HBe. Phyllanthus amarus and Astragalus membranaceus showed no significant antiviral effect compared with placebo. Analysis of pooling eight randomised clinical trials with less than three months follow-up did not show a significant benefit of Chinese medicinal herbs on viral markers.No serious adverse event was observed. Conlcusions There is insufficient evidence for treatment of asymptomatic HBV carriers using Chinese medicinal herbs due to the low quality of the trials. Further randomised, double blind, placebo controlled trials are needed.
Key words: Traditional Chinese Medicine；medicinal plants；hepatitis B virus；carrier state；randomised clinical trials；systematic review, 百拇医药
(1.四川大学华西医院中国循证医学/Cochrane中心 成都 610041
2.北京军区联勤部卫生部(北京)3.英国国家卫生服务系统评价与传播中心 约克大学)
摘要：目的 评价中草药治疗乙型肝炎病毒无症状携带者的疗效与安全性。设计 Cochrane系统评价。研究的鉴定 检索Cochrane肝胆疾病组、Cochrane图书馆、Cochrane另证医学领域试验注册数据库,MEDLLNE、EMBASE以及BIOSIS数据库存。手工检索发表与未发表之中文文献。纳入标准 收集比较中草药与安慰剂、未治疗、非特异性治疗或干扰素治疗乙型肝炎病毒无症状携带者并随访达3个月以上的随机临床试验。试验无论是否使用盲法或发表语种均不受纳入限制。资料提取与统计方法 两名评价人员独市提取资料。纳入试验的方法学质量采用Jadad评分标准与随机分配隐藏。数据采用Cochrane协作网专用软件RevMan4.1版进行统计分析。结果 3篇共涉及307名病人随访达3个月及以上的随机临床试验符合纳入标准。均为低质量试验。健脾温肾方与干扰素比较对清除乙型肝炎病毒具有显著效果:消除乙型肝炎病毒血清表面抗原(HBsAg)相对危险度为2.40(95%可信区间1.01～5.72),血清e抗原(HBeAg)转化为e抗体的效应为2.54(1.13～5.70)。草药叶下珠和黄芪与安慰剂比较未见显著的抗病毒效果。对8个随访少于3个月的随机临床试验的分析表明中草药对病毒标志物免显著疗效。试验未发现严重的副作用。结论 由于小样本及低质量的随机对照试验,中草药治疗乙型肝炎病毒携带者的证据无够充分。需要进一步的随机双盲安慰剂对照试验。
, 百拇医药
关键词： 中草药 乙型肝炎病毒 携带状态 系统评价 随机对照试验 Cochrane
A Systematic Review on Chinese Medicinal Herbs for A Symptomatic Carriers of Hepatitis B Virus
LIU Jian-ping1,QIN Xian-kui2,McIntosh Heather3
(l. The Chinese EBM/Corchrane Centre,West China Hospital,Sichuan University, Chengdu 610041, China；2.The Department of Health,Beifing Military Region, Beijing, China；3. NHS Centre for Reviews and Dissemination, University of York, UK)
, http://www.100md.com
Abstract: Objective To assess the efficacy and safety of Chinese medicinal herbs for a symptomatic hepatitis B virus(HBV) infection. Data Source The trials registers of the Cochrane Hepato-Biliary Group, the Cochrane Library and the Cochrane Complementary Medicine Fiele were searched in combination with MEDLINE, EMBASE, and hand searches of Chinese journals and conference proceedings. Data Selection Randomised clinical trials with 3 months follow-up comparing Chinese medicinal herbs versus placebo, no intervention, non-specific treatme for asymptomatic HBV Carriers were included. No language and blinding limitations were applied. Data Extraction Data were extracted independently by two reviewers. The methodological quality of trials was assessed by the Jadad-acale plus allocation concealment. Results Three randmosed clinical trials (307 patients) with low methodological quality following patients for three months or more after the end of treatment were included. Herbal compound Jianpi Wenshen recipe showed significant effects on clearance of HBV markers compared to interferon: relative risk 2.40(95%CI 1.01～5.72)for clearance of serum HBsAg, and 2.54(1.13～5.70) for seroconversion of HBeAg to anti-HBe. Phyllanthus amarus and Astragalus membranaceus showed no significant antiviral effect compared with placebo. Analysis of pooling eight randomised clinical trials with less than three months follow-up did not show a significant benefit of Chinese medicinal herbs on viral markers.No serious adverse event was observed. Conlcusions There is insufficient evidence for treatment of asymptomatic HBV carriers using Chinese medicinal herbs due to the low quality of the trials. Further randomised, double blind, placebo controlled trials are needed.
Key words: Traditional Chinese Medicine；medicinal plants；hepatitis B virus；carrier state；randomised clinical trials；systematic review, 百拇医药