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。
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 vi- ral hepatitis. According to the Cochrane Handbook 5.1, two independent reviewers screened out the literatures, extracted data and as- sessed the quality of thestudies included. RevManS. 3 software was used for the data analysis. A total of 32 articles were included, in- volving 3 188 patients, including male 1 951 cases （61.2%） , female 859 cases （26.9%） , and 378 cases of unknown sex （ 11.9% ）. 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 Meta-analysis on the RCTs for ic- teric viral hepatitis, the total efficiency of Kuhuang injection ＋ comprehensive treatment group was higher than that of the comprehen- sive treatment group （RR = 1.35, 95% CI = [ 1.10,1.66 ], P = 0. 61 ）. In addition, when Kuhuang injection was dripped too fast, pa- tients had such adverse reactionsas dizziness, palpitation, nausea, vomiting and skin rash, which could be relieved at a lower dripping speed. Based on the existing evidences, Kuhuang injection had a certain effect in treating viral hepatitis. Most clinic trails did not include viral hepatitis etiology, clinical classification and diversified intervention measures, which resulted in a high clinical heterogeneity and poor comparability between trails. Besides, most trials had a low methodological quality, which affected the authenticity of the results. Therefore, more high-quality, multi-center, large-sample, randomized double-blind controlled trialsarerequired to prove the evidences.
作者
赵君
廖星
赵晖
杨静
邹雯
王乐
支英杰
ZHAO Jun LIAO Xing ZHAO Hui YANG Jing ZOU Wen WANG Le ZHI Ying-jie(Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700 China Academy of Chinese Medical Science, Beijing 100700, China Graduate School of China Academy of Chinese Medical Sciences, Beijing 100700, China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2017年第20期4007-4026,共20页
China Journal of Chinese Materia Medica
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)
关键词
苦黄注射液
病毒性肝炎
黄疸
系统评价
Kuhuang injection
virus hepatitis
jaundice
systematic review
