黄芪注射液治疗慢性乙型肝炎随机对照试验的系统评价

Systematic Review on the Randomized Controlled Trials of Huangqi Injection for Treatment of Chronic Hepatitis B

目的:系统评价黄芪注射液治疗慢性乙型肝炎(CHB)的疗效及安全性。方法:计算机检索中国生物医学文献数据库(CBM)、中国期刊全文数据库(CNKI)、中文科技期刊全文数据库(VIP)、Cochrane图书馆、Pubmed、EMbase等数据库,全面搜集有关黄芪注射液治疗CHB的随机对照试验(RCTs)和半随机对照试验,质量评价参照Cochrane Reviewer’s Handbook 5.0.1标准,数据分析采用RevMan5.0软件。结果:共纳入24篇文献,1篇采用随机抽样法,2篇采用入院顺序随机分组,其他未描述具体的随机方法。纳入文献均未提及隐蔽分组及盲法。Meta分析结果显示,黄芪注射液与抗病毒药物联用后疗效明显高于单用抗病毒药物。而由于黄芪注射液和非特异性疗法联用,与单用非特异性疗法比较的样本量较少,虽然差异具有统计学意义,但疗效并不明确;黄芪注射液与安慰剂比较,二者差异无统计学意义。2个研究报告了黄芪注射液治疗后的不良反应,主要为心慌、轻微鼻塞、流涕、一过性白细胞下降等类似感冒的症状,无严重不良反应/事件的报道。结论:黄芪注射液治疗CHB有一定效果,可使血清乙肝病毒(HBV)e抗原(HBeAg)和HBV-DNA转阴、氨基转移酶的正常化,但由于本研究纳入的原始文献质量不高,影响研究结果的论证强度,有待于更多高质量研究的开展以进一步证实其疗效和安全性。

Objective： To assess the efficacy and safety ofhuangqi injection used in the treatment of chronic Hepatitis B （CHB）. Methods： The data of randomized controlled trials （RCTs） and quasi-randomized controlled trials of hunngqi injection used in the treatment of CHB were collected through comprehensive searches of CBM, CNKI, VIP, Cochrane Library, Pubmed and EMbase. The predefined inclusion and quality criteria （Version 5.0.1 ofCochrane Reviewer＇s Handbook ） and the RevMan 5.0 software were used for the data analysis and evaluation. Results： Twenty-four articles were included but the use of allocation concealment or blind method was not mentioned in those articles. The meta analysis showed that the combined use of huangqi injection and antiviral drugs proved more effective than antiviral drugs alone in the treatment of CHB. Only a few studies reported the efficacy ofhuangqi injection combined with non-specific therapy and the non-specific therapy alone. The comparison showed the difference with statistical significance but the efficacy was undefined. No statistic significance was showed in the efficacy difference between huangqi injection and placebo treatment. The adverse reactions of huangqi injection reported from two papers mainly included palpitation, rhinorrhea, transient decrease of WBC and other cold-like symptoms, but no serious adverse reactions/events were ever reported. Conclusion： Huangqi injection proved effective in the treatment of CHB by turning serum HBeAg and HBV-DNA negative and normalizing aminotransferase level. However since the articles enrolled in the study were not in high quality, more qualified studies should be conducted for the assessment of efficacy and safety of huangqi injection for CHB.