扩血管剂治疗突发性聋随机对照试验的系统评价

Vasodilators for sudden sensorinenral hearing loss: a systematic review of randomized controlled trials

目的 评价扩血管剂治疗突发性聋的疗效及安全性。方法 通过对Medline,Embase,Cochrane临床对照试验资料库,中国生物医学文摘数据库的机检,5种中文耳鼻咽喉科杂志手检,和参考文献的查阅,选出以扩血管剂为干预措施来治疗突发性聋的随机对照试验(randomized controlled trials,RCT),并且至少有两位研究者独立评估试验质量和提取数据。结果 共13篇文章,1155例病人(耳)符合纳入标准进入研究。扩血管剂与安慰剂比较的4个试验中,没有一个发现扩血管剂疗效优于安慰剂。扩血管剂相互比较的7个试验中,没有发现哪一种扩血管剂疗效更好。扩血管剂与其他疗法进行比较的两个试验,提示其他治疗(泛影葡胺或腹蛇抗栓酶)可能优于某些扩血管剂(低右、烟酸、654-2、丹参)。8个试验描述了瘙痒、过敏等副作用。结论 尚缺乏证据表明扩血管剂治疗突发性聋的疗效优于安慰剂或其他治疗,也缺乏证据表明哪一种扩血管剂疗效最佳。扩血管剂对突发性聋的疗效尚不能作最后结论,并且须防止它的副作用。

Objectives To assess the effects and safety of vasodilators for sudden sensorineurial hearing loss(SSHL) .Search strategy Electronic databases-. MEDLINE from 1966, EMBASE from 1974, the Cochrane Controlled Trials Register, Chinese Bio-medicine Database from 1989. Hand search;Five kinds of Chinese otolaryngology journals were searched. Literature references were checked intensively. Selection criteria Randomized controlled trials comparing vasodilators with placebo or other drugs in patients with SSHL. Data collection and analysis At least two reviewers independently assessed trials quality and extracted data. Main results Thirteen trials with 1,155 patients were eligible and included in the systematic review. Ten of the trials were from developed countries and them were from P. R. China. None of the four trials showed that the effects of vasodilators were better than placebo for SSHL. None of the seven trials showed that the effects of one kind of vasodilators were better than that of the other vasodilators. Two trials showed that other drugs, such as batroxobin and hypaque.were probably better than some vasodilators (dextran, papaverine, 654 - 2, danshen). Eight trials reported the side effects of vasodilators, such as pruritus, allergy, etc. Reviewers' conclusions Base on the systematic review of current eligible randomized controlled trials, there is no evidence to prove that vasodilator therapy is better than placebo or other therapies for SSHL, or the effects of one kind of vasodilator are better than that of the other vasodilators. We can't draw a reliable conclusion about the effects of vasodilators for SSHL at the moment. And we must pay attention to their potential adverse reactions.