夏枯草中药制剂治疗桥本甲状腺炎Meta分析

A Meta-Analysis of the Xiakucao Herbal Preparations on Hashimoto′s Thyroiditis

目的:观察夏枯草中药制剂治疗桥本甲状腺炎(Hashimoto′s thyroiditis,HT)的临床疗效,为其在临床上的广泛应用提供循证医学依据。方法:计算机检索国内外文献数据库,包括万方数据、中国知网、SinoMed中国生物医学文献服务系统、维普中文期刊服务平台以及Embase、PubMed、Web of Science和Cochrane等外文数据库。检索时间限定为各数据库建库至2023年7月。纳入标准为使用夏枯草中药制剂治疗桥本甲状腺炎的临床随机对照试验。采用Cochrane协作网推荐的RevMan 5.4软件中的偏倚风险评价标准对文献质量进行评估,并使用同一软件对有效率、血清促甲状腺激素(thyroid stimulating hormone,TSH)、甲状腺球蛋白抗体(thyroglobulin Antibody,TPO-Ab)、抗甲状腺球蛋白抗体(anti-thyroglobulin antibodies,TG-Ab)以及中医证候积分进行Meta分析,并对安全性进行评价。结果:共检索到中文文献5770篇,未检测有专门使用夏枯草治疗HT的外文文献,最终纳入16篇文献,涉及1170例研究对象,治疗组592例,对照组578例,单纯夏枯草中药制剂4篇,夏枯草中药制剂联合对照组治疗12篇。Meta分析显示,治疗组在提高桥本甲状腺炎患者的临床有效率方面显著优于对照组[RR=1.29,95%CI(1.21,1.37),Z=7.85,P<0.00001];在降低TSH方面效果显著[MD=-0.72,95%CI(-1.54,0.10),Z=1.73,P=0.08]、TG-Ab[MD=-45.03,95%CI(-49.59,-40.48),Z=19.39,P<0.00001]以及TPO-Ab抗体滴度[MD=-71.85,95%CI(-90.28,-53.42),Z=7.64,P<0.00001];同时,治疗组中医证候积分降低幅度显著[MD=-3.24,95%CI(-4.48,-2.00),Z=5.11,P<0.00001]。结论:夏枯草中药制剂联合西药治疗或单独使用均能在一定程度上提高桥本甲状腺炎的临床疗效,降低TSH、TG-Ab和TPO-Ab抗体滴度,降低中医证候积分,具有良好的安全性。

Objective:To evaluate the clinical efficacy of Xiakucao(Spica Prunellae)herbal preparations on Hashimoto′s thyroiditis(HT)and provide evidence-based medical support for its widespread clinical application.Methods:This study conducted a comprehensive search of domestic and international literature databases,including Wanfang Data,China National Knowledge Infrastructure,SinoMed,VIP Chinese Journal Service Platform,and international databases,such as Embase,PubMed,Web of Science,and Cochrane.The search was limited to the databases′inception until July 2023.The inclusion criteria were clinical randomized controlled trials using Xiakucao herbal preparations to treat HT.The quality of the literature was assessed using the bias risk assessment standard recommended by Cochrane Collaboration Network in RevMan 5.4 software,and a Meta-analysis of treatment efficacy,serum TSH,TPO-Ab,TG-Ab levels,and TCM syndrome scores was conducted using the same software.The safety of the treatment was also evaluated.Results:A total of 5770 Chinese-language articles were retrieved,and no foreign-language articles specifically using Xiakucao for HT were found.Finally,16 articles involving 1170 subjects were included,with 592 cases in the treatment group and 578 cases in the control group.Four articles used Xiakucao herbal preparations alone,and 12 articles combined Xiakucao herbal preparations with control group′s treatments.The Meta-analysis showed that the treatment group significantly outperformed the control group in improving the clinical efficacy rate for HT patients[RR=1.29,95%CI(1.21,1.37),Z=7.85,P<0.00001];reducing TSH levels[MD=-0.72,95%CI(-1.54,0.10),Z=1.73,P=0.08],TG-Ab levels[MD=-45.03,95%CI(-49.59,-40.48),Z=19.39,P<0.00001],and TPO-Ab antibody titers[MD=-71.85,95%CI(-90.28,-53.42),Z=7.64,P<0.00001];and significantly reducing TCM syndrome scores[MD=-3.24,95%CI(-4.48,-2.00),Z=5.11,P<0.00001].Conclusion:Xiakucao herbal preparations,either combined with Western medicine or used alone,can significantly improve the clinical efficacy of treating HT,reduce TSH,TG-Ab,and TPO-Ab antibody titers,lower TCM syndrome scores,and have good safety.