抗生素相关性腹泻治疗方案的有效性及安全性评价:基于15种中药联合益生菌治疗方案的网状Meta分析

Efficacy and Safety Evaluation of Treatment Protocols for Antibiotic-Associated Diarrhea: Meta-Analysis Based on 15 Kinds of Traditional Chinese Medicine Combined with Probiotics

目的:基于网状Meta分析,评价不同中药联合益生菌治疗抗生素相关性腹泻(AAD)的疗效及安全性,为临床安全用药方案提供循证医学依据。方法:在万方数据库、维普数据库、中国知网、中华医学期刊数据库、PubMed、Web of Science等数据库中检索中药联合益生菌治疗AAD的随机对照试验(观察组干预措施为中药联合益生菌,对照组干预措施为单纯使用益生菌),检索时间截至2023年1月。采用贝叶斯网状Meta分析方法,对不同中药联合益生菌治疗AAD的安全性和有效性进行评价。结果:筛选出21篇随机对照试验文献,涉及患者2 093例;使用的中药包括健脾补肾固摄汤、人参败毒散或健脾止泻汤、四逆汤联合四神汤、参术止泻汤、乌梅丸、巴特日-7味丸、胃肠安丸、参苓白术颗粒(参苓白术散)、小儿腹泻散、参苓白术散+补肺汤、醒脾养儿颗粒、儿泻停颗粒、黄芪建中汤、马齿苋煎煮液、固本益肠片共15种。以总有效率为基础指标进行贝叶斯网状Meta分析,结果显示,人参败毒散或健脾止泻汤的效果最佳(OR=12,95%CI=3.1~78.0),且差异有统计学意义(P<0.05)。结论:文献研究前后患者的身体指标未见异常,15种中药联合益生菌治疗AAD的研究方案未对患者造成伤害;同时在鼠类的AAD模型复现上也得到了相应的证实,可以认为本次网状Meta分析的结果是安全、可靠的。本研究中的中药联合益生菌治疗AAD的疗效均优于单纯使用益生菌,能有效缩短病程,为临床用药提供了循证医学证据,但仍需要更多的研究支持和验证。

OBJECTIVE:To evaluate the efficacy and safety of different traditional Chinese medicine combined with probiotics in the treatment of antibiotic-associated diarrhea(AAD),so as to provide evidence-based medical evidence for safe drug use in clinic.METHODS:Wanfang Data,VIP,CNKI,Chinese Medical Journal Network,PubMed and Web of Science databases were retrieved to collect randomized controlled trial of traditional Chinese medicine combined with probiotics in the treatment of AAD(the observation group was given traditional Chinese medicine combined with probiotics,while the control group received probiotics),the retrieval time was from the establishment of the database to Jan.2023.Bayesian network Meta-analysis was used to evaluate the safety and efficacy of different traditional Chinese medicine combined with probiotics in the treatment of AAD.RESULTS:A total of 21 randomized controlled trials including 2093 patients were enrolled.The 15 kinds of traditional Chinese medicines were respectively Jianpi Bushen Gushe decoction,Renshen Baidu powder or Jianpi Zhixie decoction,Sini decoction combined with Sishen decoction,Shenzhu Zhixie decoction,Wumei pill,Bateriqiwei pill,Weichang’an pill,Shenling Baizhu granule(Shenling Baizhu powder),Xiao’er Fuxie powder,Shenling Baizhu powder combined with Bufei decoction,Xingpi Yang’er granule,Erxieting granule,Huangqi Jianzhong decoction,Portulane decoction,Guben Yichang tablet.Bayesian network Meta-analysis based on total effective rate showed that the efficacy of Renshen Baidu powder or Jianpi Zhixie decoction was the most effective(OR=12,95%CI=3.1-78.0),the difference was statistically significant(P<0.05).CONCLUSIONS:No abnormalities were seen in the physical parameters of patients before and after the literature research,and the protocol of 15 kinds of traditional Chinese medicine combined with probiotics in the treatment of AAD do not cause any harm to the patients.Corresponding verification in a mouse model of AAD also supports the safety and reliability of the results of network Meta-analysis for AAD treatment.Moreover,the efficacy of traditional Chinese medicine combined with probiotics in the treatment of AAD is superior to probiotics alone,which can effectively shorten the course of disease,and provide evidence-based medicine for the treatment of AAD,but require further research support and validation.