草药叶下珠治疗慢性乙型肝炎病毒感染的系统评价
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中医循证医学
刘建平1，林 辉2，Heather Mclntosh3
(1.中国循证医学/Cochrane中心，四川大学华西医院 成都 610041
2.重庆第三军医大学流行病学教研室
3.英国国家卫生服务评价与传播中心，约克大学)
摘要：目的 评价叶下珠属治疗慢性乙型肝炎病毒感染的疗效和安全性。设计 随机临床试验的系统评价。方法 用电子和手工检索鉴定比较叶下珠与安慰剂、不治疗、非特异性治疗、其他草药治疗、或干扰素治疗慢性乙型肝炎病炎病毒感染者的随机临床试验。叶下珠合用干扰素与单用干扰素比较的随机试验也予以纳入。无论使用盲法与否或以何种语言发表均无限制。纳入试验的质量用Jadad记分量表加随机隐藏评价。结果 22篇试验包含1947名患者符合纳入标准。5篇双盲试验被评为高质量试验，其余均为低质量试验。合并的结果表明，与安慰剂或不治疗比较，叶下珠属对于血清HBsAg转阴有积极效果(相对危险度5.64，95%可信区间1.85～17.21)。叶下珠与干扰素比较，在血清HBsAg、HBeAg和HBV DNA转阴效果方面没有显著差异。在血清HBsAg、HBeAg、HBV DNA转阴以及转氨酶复常方面，叶下珠优于非特异性治疗或其他草药治疗。分析表明叶下珠与干扰素联合用药比单用干扰素效果更好，HBeAg转阴相对危险度1.56，95%可信区间1.06～2.32，HBV DNA转阴的相对危险度1.52，95%可信区间1.05～2.21。这些试验没有报告发生严重的副性事件。结论 根据本系统评价，某些叶下珠属可能具有抗乙型肝炎病毒和改善肝功能的作用。然而，由于试验的方法学质量普遍较低以及该草药使用的变异性大，目前尚无足够的证据支持它的治疗应用，需要进一步的大样本试验。
, 百拇医药
关键词: 叶下珠属 中草药 慢性乙型肝炎病毒感染 系统评价 随机临床试验 Meta-分析
Genus Phyllanthus for Chronic Hepatitis B Virus Iinfection: A Systematic Review
LIU Jian-ping1，LIN Hui2，Heather McIntosh3
(1. The Chinese Cochrane Centre, West China Hospital，Sichuan University,Chengdu 610041, China
2. The Department of Epidemiology, Third Military Medical University, Chongqing 400038, China
, 百拇医药
3. NHS Centre for Reviews and Dissemination, University of York, York, UK)
ABSTRACT: Objectives To evaluate the efficacy and safety of genus Phylolanthus for chronic HBV infection. Design a systematic review of randomised clinical trials. Methods Randomised trials comparing genus Phyllanthus versus placebo, no intervention，general non-specific treatmen, other herbal medicine, or interferon treatment for chronic HBV infection were identified by electronic and manual searches. Trials of Phyllanthus herb plus interferon versus interferon alone were also included. No blinding and language limitations were applied. The methodological quality of trials was assessed by the Jadadscale plus allocation concealment. Results Twenty-two randomised trials (n=1947) were identified. The methodological quality was high in five double blind trials and rest was low. The combined results showed that Phyllanthus species had positive effect on clearance of serum HBsAg (relative risk 5.64, 95% CI 1.85～17.21) compared with placebo or no intervention. There was no significant difference on clearance of serum HBsAg, HBeAg and HBV DNA between Phyllanthus and interferon. Phyllanthus species were better than non-specific treatment or other herbal medicines on clearance of serum HBsAg, HBeAg, HBV DNA, and liver enzyme normalisation. Analyses showed a better effect of the Phyllanthus plus interferon combination on clearance of serum HBeAg (1.56，1.06～2.32) and HBV DNA (1.52, 1.05～2.21) than interferon alone. No serious adverse events were reported. Conclusions Based on the review Plyllanthus species may have positive effect on antiviral activity and liver biochemistry in chronic HBV infection. However, the evidence is not strong due to the general low methodological quality and the variations of the herb. Further large trials are needed.
Key words: Genus Phyllanthus；mdeicinal herb；chronic hepatitis B virus infection；systematic review；randomised clinical trial；Meta-analysis, 百拇医药
(1.中国循证医学/Cochrane中心，四川大学华西医院 成都 610041
2.重庆第三军医大学流行病学教研室
3.英国国家卫生服务评价与传播中心，约克大学)
摘要：目的 评价叶下珠属治疗慢性乙型肝炎病毒感染的疗效和安全性。设计 随机临床试验的系统评价。方法 用电子和手工检索鉴定比较叶下珠与安慰剂、不治疗、非特异性治疗、其他草药治疗、或干扰素治疗慢性乙型肝炎病炎病毒感染者的随机临床试验。叶下珠合用干扰素与单用干扰素比较的随机试验也予以纳入。无论使用盲法与否或以何种语言发表均无限制。纳入试验的质量用Jadad记分量表加随机隐藏评价。结果 22篇试验包含1947名患者符合纳入标准。5篇双盲试验被评为高质量试验，其余均为低质量试验。合并的结果表明，与安慰剂或不治疗比较，叶下珠属对于血清HBsAg转阴有积极效果(相对危险度5.64，95%可信区间1.85～17.21)。叶下珠与干扰素比较，在血清HBsAg、HBeAg和HBV DNA转阴效果方面没有显著差异。在血清HBsAg、HBeAg、HBV DNA转阴以及转氨酶复常方面，叶下珠优于非特异性治疗或其他草药治疗。分析表明叶下珠与干扰素联合用药比单用干扰素效果更好，HBeAg转阴相对危险度1.56，95%可信区间1.06～2.32，HBV DNA转阴的相对危险度1.52，95%可信区间1.05～2.21。这些试验没有报告发生严重的副性事件。结论 根据本系统评价，某些叶下珠属可能具有抗乙型肝炎病毒和改善肝功能的作用。然而，由于试验的方法学质量普遍较低以及该草药使用的变异性大，目前尚无足够的证据支持它的治疗应用，需要进一步的大样本试验。
, 百拇医药
关键词: 叶下珠属 中草药 慢性乙型肝炎病毒感染 系统评价 随机临床试验 Meta-分析
Genus Phyllanthus for Chronic Hepatitis B Virus Iinfection: A Systematic Review
LIU Jian-ping1，LIN Hui2，Heather McIntosh3
(1. The Chinese Cochrane Centre, West China Hospital，Sichuan University,Chengdu 610041, China
2. The Department of Epidemiology, Third Military Medical University, Chongqing 400038, China
, 百拇医药
3. NHS Centre for Reviews and Dissemination, University of York, York, UK)
ABSTRACT: Objectives To evaluate the efficacy and safety of genus Phylolanthus for chronic HBV infection. Design a systematic review of randomised clinical trials. Methods Randomised trials comparing genus Phyllanthus versus placebo, no intervention，general non-specific treatmen, other herbal medicine, or interferon treatment for chronic HBV infection were identified by electronic and manual searches. Trials of Phyllanthus herb plus interferon versus interferon alone were also included. No blinding and language limitations were applied. The methodological quality of trials was assessed by the Jadadscale plus allocation concealment. Results Twenty-two randomised trials (n=1947) were identified. The methodological quality was high in five double blind trials and rest was low. The combined results showed that Phyllanthus species had positive effect on clearance of serum HBsAg (relative risk 5.64, 95% CI 1.85～17.21) compared with placebo or no intervention. There was no significant difference on clearance of serum HBsAg, HBeAg and HBV DNA between Phyllanthus and interferon. Phyllanthus species were better than non-specific treatment or other herbal medicines on clearance of serum HBsAg, HBeAg, HBV DNA, and liver enzyme normalisation. Analyses showed a better effect of the Phyllanthus plus interferon combination on clearance of serum HBeAg (1.56，1.06～2.32) and HBV DNA (1.52, 1.05～2.21) than interferon alone. No serious adverse events were reported. Conclusions Based on the review Plyllanthus species may have positive effect on antiviral activity and liver biochemistry in chronic HBV infection. However, the evidence is not strong due to the general low methodological quality and the variations of the herb. Further large trials are needed.
Key words: Genus Phyllanthus；mdeicinal herb；chronic hepatitis B virus infection；systematic review；randomised clinical trial；Meta-analysis, 百拇医药