苦黄注射液治疗病毒性肝炎的有效性和安全性:随机对照试验的系统评价和Meta分析

发布时间：2019-01-05 16:28

【摘要】：系统评价苦黄注射液治疗病毒性肝炎的有效性和安全性。系统全面检索国内外8大电子数据库及Clinical Trials,收集关于苦黄注射液治疗病毒性肝炎的随机对照试验。根据Cochrane Handbook 5.1评价标准,2人进行文献筛选、资料提取和质量评价。对最终纳入的文献采用Rev Man 5.3软件进行Meta分析或仅做描述性分析。共计纳入32篇文献,涉及3 188例患者,男性1 951例(61.2%),女性859例(26.9%),未知男女比例378例(11.9%),所纳入的临床研究总体质量偏低。由于研究疾病复杂,干预措施不尽相同,大部分研究按疾病分类进行描述性分析:重度黄疸型病毒性肝炎的试验组总有效率优于对照组;黄疸型肝炎试验组在退黄、肝功能复常率方面优于对照组;在少数Meta分析中,对于黄疸性病毒性肝炎,在苦黄注射液+综合治疗组对比综合治疗组中,前者总有效率高于后者(RR=1.35,95%CI=[1.10,1.66],P=0.61)。另外,当苦黄注射液滴速过快时会出现头晕、心慌、恶心呕吐及皮疹等不良反应,减慢滴速可缓解。根据现有证据,苦黄注射液对病毒性肝炎有一定的疗效,但由于大部分研究未对病毒性肝炎进行病原学、临床表现分类以及干预措施多样性,导致临床异质性较大,各研究间的可比性较差,加之研究质量普遍偏低,影响结果的准确性,需更多设计严紧、高质量、多中心随机双盲对照试验以增加证据强度。
[Abstract]:To evaluate the efficacy and safety of Kuhuang injection in the treatment of viral hepatitis. Eight electronic databases at home and abroad and Clinical Trials, were systematically searched for randomized controlled trials of Kuhuang injection in the treatment of viral hepatitis. According to Cochrane Handbook 5. 1 evaluation standard, 2 people were selected, data extraction and quality evaluation. Rev Man 5.3 software was used for Meta analysis or only descriptive analysis. A total of 32 articles were included, involving 3 188 patients, male 1 951 (61.2%), female 859 (26. 9%) and unknown male / female ratio 378 (11. 9%). Because of the complexity of disease research, intervention measures are not the same, most of the research according to disease classification descriptive analysis: severe jaundice viral hepatitis in the experimental group total effective rate is better than the control group; In the jaundice hepatitis test group, the recovery rate of liver function was better than that of the control group. In a few Meta analysis, for jaundice viral hepatitis, the total effective rate of the former group was higher than that of the latter group (RR=1.35,95%CI= [1.101.66, P < 0.61]). In addition, dizziness, palpation, nausea and vomiting, rash and other adverse reactions may occur when the drip speed of Kuhuang injection is too fast, which can be alleviated by slowing down the drip speed. According to the available evidence, Kuhuang injection has a certain curative effect on viral hepatitis, but because most of the studies have not carried on the etiology, the clinical manifestation classification and the intervention measure diversity, the clinical heterogeneity is great. The comparability among the studies is poor, and the quality of the research is generally low, which affects the accuracy of the results. More tightly designed, high-quality, multi-center randomized double-blind controlled trials are needed to increase the strength of the evidence.
【作者单位】：中国中医科学院中医临床基础医学研究所;中国中医科学院;中国中医科学院研究生院;
【基金】：国家自然科学基金面上项目(81774159) 国家自然科学青年基金项目(81403324,81503571) 中医基础理论研究所自主选题项目(YZ-1662)
【分类号】：R259

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