摘要
目的:评价小金丸治疗甲状腺结节的疗效和安全性,为临床应用提供指导和参考依据。方法:计算机检索CNKI、VIP、WanFang Data、SinoMed和PubMed数据库,搜集小金丸治疗甲状腺结节的随机对照试验(RCT),检索时限均为建库至2018年12月31日,由两名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.3软件进行Meta分析。结果:共纳入10个RCT,包含患者1275例,其中对照组600例,试验组675例。Meta分析结果显示,小金丸试验组治疗甲状腺结节的临床总有效率优于对照组(左甲状腺素钠片),组间差异有统计学意义[RR=3.67,95%CI(2.76,4.86),P<0.00001]。此外,亚组分析结果表明,与仅用西药的对照组相比,试验组在使用不同剂量、不同疗程以及小金丸单用或联合等不同情况下,均可以提高临床有效率。同时,小金丸组的药品不良反应发生率低于西药对照组。结论:小金丸单用或联合西药左甲状腺素钠片治疗甲状腺结节能够提高临床总有效率,且相对西药对照组,具有较好的安全性。
Objective:To evaluate the efficacy and safety of Xiaojin pill in treatment of thyroid nodules,to provide guidance and reference for clinical application.Methods:CNKI,VIP,WanFang Data,SinoMed and Pubmed database were electronically searched to collect randomized controlled trials(RCT)of Xiaojin pill in treatment of thyroid nodules,search time until December 31,2018.Two reviewers independently screened literature,extracted data and assessed the risk of bias of included studies,and Meta-analysis was performed by RevMan 5.3 software.Results:A total of 10 RCTs involving 1275 patients were included,among this 600 in the control group and 675 in the experimental group.Meta-analysis results showed that the total effective rate of Xiaojin pill experimental group in treating thyroid nodules was better than levothyroxine sodium tablets in the control group,and the difference was statistically significant(RR=3.67,95%CI 2.76 to 4.86,P<0.00001).In addition,the results of the subgroup analysis showed that compared with the control group using only western medicine,the experimental group could improve the clinical efficiency in using different doses,courses of treatment,and alone or in combination.At the same time,the incidence of adverse reactions in Xiaojin pill group was lower than that in the western medicine control group.Conclusion:Xiaojin pill alone or in combination with western medicine levothyroxine sodium tablets can improve the clinical efficacy of thyroid nodules,relative to the western medicine control group,it has better safety.
作者
田志平
张冰
张丹
张晓朦
林志健
Tian Zhiping;Zhang Bing;Zhang Dan;Zhang Xiaomeng;Lin Zhijian(Shanxi Traditional Chinese Medicine School,Jinzhong 030619,Shanxi,China;School of Chinese Pharmacy,Beijing University of Chinese Medicine;Center for Pharmacovigilance and Rational Use of Chinese Medicine,Beijing University of Chinese Medicine)
出处
《药物流行病学杂志》
CAS
2020年第2期84-88,共5页
Chinese Journal of Pharmacoepidemiology
基金
国家自然科学基金项目(编号:81874349)
国家中医药管理局项目(编号:10400633210004).
关键词
小金丸
甲状腺结节
左甲状腺素钠片
META分析
随机对照试验
Xiaojin pill
Thyroid nodules
Levothyroxine sodium tablets
Meta-analysis
Randomized controlled trial
作者简介
通讯作者:张冰,Tel:(010)84738606,E-mail:zhangbing6@263.net
