中成药治疗突发性耳聋随机对照试验的Meta分析与系统评价

目的：突发性耳聋的中医病因病机尚未完全统一,中成药治疗突发性耳聋有较多的文献报道,也取得了一定的疗效,因此,有必要对中成药治疗突发性耳聋进行系统评价,为今后临床上中成药治疗突发性耳聋提供依据。方法：采用Cochrane系统综述方法,检索1980—2010年维普数据库、中文期刊全文数据库、万方数据库和中国Cochrane协作网提供的RevMan 5.0软件进行meta分析,对异质研究进行描述性分析。结果：关于葛根素注射液、金纳多及复方丹参注射液治疗的3篇系统评价[2-4]已表明复方丹参注射液、葛根素注射液与金纳多可提高突发性耳聋治疗的有效率,临床上可优先考虑使用。共检索出210篇文献,符合纳入标准的只有101篇文献,其中针剂的90篇,口服剂型的11篇,采用Jadad评分标准对纳入研究的每篇文献的方法学质量进行评价。只有1篇文献[27]采用随机数字表进行随机分配,随机方法质量较高,其余100篇文献均未描述具体的随分配隐藏的方法,仅有5篇文献提及采用盲法,均为单盲,其余文献均未提及盲法,仅有1篇文献[28]提及随访,但随访结果未明确给出,其余100篇文献均未提及随访及退出病例,属于低质量文献。Meta分析结果显示川芎嗪、血栓通、银杏达莫、杏丁注射液及唇香草聪耳片治疗组有效率优于对照组,差异有统计学意义,其他中成药由于文献以及病例数不足,暂未能肯定其疗效。结论：现有临床证据表明,与对照组比较,中成药可以提高突发性耳聋的治疗有效率,临床可考虑选择中成药结合其他疗法治疗突发性耳聋,提高患者的治疗有效率。但本系统综述纳入的随机对照试验多属低质量文献,进一步证实其临床疗效尚须开展大规模的设计严谨、方法可靠的多中心临床研究以获得更高强度的证据。

Meta-analysis and Systematic Reviews on Randomized Controlled Trials of Chinese Medicine Treatment of Suddenhearing Loss

Objective：Despite plenty of literatureshave been reported that Chinese medicine is effective on treatment of suddenhearing loss（SHL）,the mechanism of Traditional Chinese Medicine（TCM）in the management of SHL has not been fully explained.Therefore,it is necessary to do a systematic review on the effectiveness of TCM in the management of SHL to provide evidences for future clinical practice.Methods：In this study,the relative trials published from 1980 to 2010 were searched in VIP Database,CNKI,SinoMed and Wanfang Database by using the method of Cochrane systematic review.The methodological quality of the included trials was assessed by two evaluators,andhomogeneous evaluation by meta-analysis was performed.Statistical analysis of clinical data was performed by using RevMan 5.0 software provided by the Cochrane Collaboration.Results：There are three systematic reviewshad shown that compound Danshen injection,puerarin and Ginaton can increase the effective rate of SHL.A total of 210 reports were found,while only 101 randomized controlled trials met the inclusion criteria.The methodology quality of the reports included in the study was evaluated by the Jadad scale.All the trials did not report the randomization method and allocation concealment,only 1 article mentioned using random allocation and 5 articles mentioned using single-blinding method but did not describehow to conduct blinding.Only 1 article mentioned that follow-up treatment,but the follow-up results are not clearly given.Meta-analysis results showed that TMP,Xueshuantong,Yinxingdamo,Xingding injection and ears and lips vanilla chip treatment groups were better at increasing the total effective rate compared with the control groups.Conclusion：Chinese medicine can improve clinical symptoms and increase the total effective rate of the treatment of SHL.however,we can not get the trusted results in this study because of the low qualities of the RCT reports including and not enough patients included.Its clinical effects should be further confirmed byhigh quality,multicenter and randomized controlled trials with large-scale design.