目的:评价牛黄降压方制剂治疗原发性高血压的疗效和安全性。方法:通过检索Cochrane临床试验注册库,MEDLINE,EMBASE,中国生物医学文献数据库(CBM)以及CNKI和VIP等中文数据库(截至2007年1月),全面搜集有关牛黄降压方制剂治疗原发性高血压的随机对照试验,并对文献进行筛选,资料提取和质量评价,质量评价参照cochrane handbook4.26标准,数据分析采用Revman4.2。结果:有3篇文献纳入评价。3个研究采用降压有效率指标,合并效应量RR(random)及95%可信区间为1.16[0.79,1.71],P=0.45。2个研究用血压值变化为指标,收缩压(SBP)数据分析结果:RR(Random)及95%CI为:-6.65[-42.62,29.31],P=0.72;舒张压(DBP)分析结果RR(Random)及95%CI为:-5.17[-15.55,5.21],P=0.33。用固定效应模型进行敏感性分析,以上结果均发生逆转,提示结果不稳定。牛黄降压方制剂的不良反应主要表现为轻度腹泻,发生率约为2.56%。结论:由于牛黄降压制剂治疗高血压临床研究开展较少(仅有3篇),纳入研究质量较低,故牛黄降压方制剂治疗原发性高血压的有效性,尚缺乏足够的证据,有待进一步研究来验证。
Objective: To assess the efficacy and safety of Niuhuang Jiangya prescription for the treatment of essential hypertension. Material and Methods: An extensive search including MEDLINE, EMBASE, CBM, and Cochrane Centre Controlled Trials Register was performed up to Jan, 2007. Randomized controlled trials (RCTs) about Niuhuang Jiangya prescription for essential hypertension will be included irrespective of any language. The quality of each trial was assessed according to the Co-chrane Reviewers' Handbook 4.2.6. Statistical software ( RevMan 4.2 ) provided by the Cochrane Collaboration was applied. Results : Three RCTs were included in this review. The methodological quality of the trials was low. Statistical pooling of the results showed that Niuhuang Jiangya prescription for essential hypertension still lack of sufiqcient evidence. Depressurizatlon effective power ( pooled RR(random) = 1.16, 95% CI[0.79,1.71 ] ), SBP ( pooled RR = - 6.65, 95% CI [ -42.62,29.31 ], and DBP(pooled RR = -5.17, 95% CI [ -15.55,5.21 ] ) all reversing when use fixed effects model to carry out sensitivity analysis, pointing out result instability. The adverse effect is diarrhoea , incidence rate is about 2.56% . Conclusions : Because of the clinical trials of Niuhuang Jiangya prescription for the treatment of essential hypertension carrying out very few (only three). The efficacy ofNiuhuang Jiangya prescription for the treatment of essential hypertension is still lack of sufficient evidence. There is still lack of high quality evidence, because of low methodological quality of clinical trials.