苦黄注射液治疗病毒性肝炎有效性和安全性随机对照试验系统评价和Meta分析.docVIP

苦黄注射液治疗病毒性肝炎有效性和安全性随机对照试验系统评价和Meta分析 　　[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 51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RevMan 53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（612%），女性859例（269%），未知男女比例378例（119%），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=135，95%CI=[110，166]，P=061）。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?O计严紧、高质量、多中心随机双盲对照试验以增加证据强度。 　　[关键词]苦黄注射液； 病毒性肝炎； 黄疸； 系统评价 　　[Abstract]To systematically evaluate the effectiveness and safety of Kuhuang injection in treating viral hepatitis Eight electronic databases and clinic trials were searched to collect randomized controlled trials for the effect of Kuhuang injection in the treatment of viral hepatitis According to the Cochrane Handbook 51， two independent reviewers screened out the literatures， extracted data and assessed the quality of thestudies included RevMan53 software was used for the data analysis A total of 32 articles were included， involving 3 188 patients， including male 1 951 cases （612%）， female 859 cases （269%）， and 378 cases of unknown sex （119%）. All the clinical studies showed a low quality Due to the complication of diseases and difficulty in intervention measures， most trails were classified by the condition of diseases， and then a descriptive analysis was made The results showed that the test group was better than the control group in total efficiency of treating severe icteric viral hepatitis， and the test group was advantageous over the control group in jaundice removal and liver function recovery rate in treating icteric hepatitis In the Metaanalysis on the RCTs for icteric viral hepatitis， the total efficiency of Kuhuang injection + comprehensive treatment group was higher than that of the compre