摘要
乌梅丸是中医经典方剂,广泛用于治疗蛔厥、腹泻。研究发现乌梅丸治疗2型糖尿病(T2DM)有一定的优势,但目前尚无系统评价关于乌梅丸治疗T2DM疗效的相关报道,该研究采用系统评价与Meta分析其有效性和安全性,为临床提供循证依据。系统检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、EMbase、PubMed、Cochrane Library、Web of Science,纳入建库至2024年9月发表的乌梅丸治疗T2DM的随机对照试验(RCT)。使用RevMan 5.3软件进行Meta分析。共纳入18篇RCTs,样本量1 437例。结果显示,(1)乌梅丸治疗T2DM的总有效率(RR=1.28,95%CI[1.14,1.43],P<0.000 1)、空腹血糖(FPG)(WMD=-0.69,95%CI[-0.93,-0.46],P<0.000 01)、餐后2 h血糖(2hPG)(WMD=-0.74,95%CI[-1.17,-0.31],P=0.000 7)、糖化血红蛋白(HbA1c)(WMD=-0.39,95%CI[-0.60,-0.18],P=0.000 3)、高密度脂蛋白(HDL)(WMD=0.38,95%CI[0.28,0.48],P<0.000 01)、体质量指数(BMI)(WMD=-1.41,95%CI[-2.40,-0.42],P=0.005)方面,治疗组疗效优于对照组,差异均具有统计学意义。(2)总胆固醇(TC)(WMD=-0.53,95%CI[-1.13,0.08],P=0.09)、低密度脂蛋白(LDL)(WMD=-0.25,95%CI[-0.56,0.06],P=0.12)方面,2组效果相当,差异无统计学意义。(3)甘油三酯(TG)(WMD=-0.28,95%CI [-0.59,0.03],P=0.08)敏感性分析显示有潜在降低效应(WMD=-0.20,95%CI[-0.36,-0.04],P=0.01);不良反应(RR=0.43,95%CI [0.23,0.80],P=0.007)敏感性分析显示显著性消失(RR=0.56,95%CI[0.26,1.22],P=0.14),提示尚不能认为治疗组疗效优于对照组。结果表明,乌梅丸治疗T2DM与改善患者糖代谢、脂代谢、提高临床疗效有显著相关性,为临床应用提供了依据,但还需更高质量的临床研究进一步证实。
Wumei Pills,a classic traditional Chinese medicine(TCM)formula,are widely used in the treatment of biliary ascariasis and diarrhea.In recent years,studies have shown that Wumei Pills have advantages in the treatment of type 2 diabetes mellitus(T2DM),while there are no relevant reports that systematically evaluate the efficacy of Wumei Pills in the treatment of T2DM.This study addresses this issue by systematically evaluating the efficacy and safety of Wumei Pills,aiming to provide an evidence-based basis for clinical practice.PubMed,Cochrane Library,EMbase,Web of Science,CNKI,Wanfang,and VIP were researched for the randomized controlled trial(RCT)involving Wumei Pills for the treatment of T2DM that were published from inception to September 2024.RevMan 5.3 was used for the Meta-analysis of the data.A total of 18 RCTs were included,with a total of 1437 patients.Meta-analysis produced the following results.Treatment group outperformed control group in terms of overall response rate(RR=1.28,95%CI[1.14,1.43],P<0.0001),fasting blood glucose(FPG)(WMD=-0.69,95%CI[-0.93,-0.46],P<0.00001),two-hour postprandial plasma glucose(2hPG)(WMD=-0.74,95%CI[-1.17,-0.31],P<0.0007),glycated hemoglobin(HbAlc)(WMD=-0.39,95%CI[-0.60,-0.18],P=0.0003),high-density lipoprotein(HDL)(WMD=0.38,95%CI[0.28,0.48],P<0.00001),and body mass index(BMI)(WMD=-1.41,95%CI[-2.40,-0.42],P=0.005).②The two groups had comparable effects regarding total cholesterol(TC)(WMD=-0.53,95%CI[-1.13,0.08],P=0.09)and low-density lipoprotein(LDL)(WMD=-0.25,95%CI[-0.56,0.06],P=0.12).③Triglycerides(TG)(WMD=-0.28,95%CI[-0.59,0.03],P=0.08),sensitivity analysis showed potential reduction effect(WMD=-0.20,95%CI[-0.36,-0.04],P=0.01).Occurrence of adverse drug reaction(RR=0.43,95%CI[0.23,0.80],P=0.007),sensitivity analysis showed significant disappearance(RR=0.56,95%CI[0.26,1.22],P=0.14),suggesting that the efficacy of treatment group was not better than that of control group.The results indicate that the treatment of T2DM with Wumei Pills is greatly related to the improvement of glucose metabolism,lipid metabolism,and clinical efficacy.The findings provide a basis for clinical application of Wumei Pills in treating T2DM,while the conclusion remains to be verified by clinical studies with higher quality.
作者
黄薇瑾
杨芸艺
蔡佳媛
曲笑啸
何燕铭
杨宏杰
HUANG Wei-jin;YANG Yun-yi;CAI Jia-yuan;QU Xiao-xiao;HE Yan-ming;YANG Hong-jie(Endocrinology Department,Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 200437,China)
出处
《中国中药杂志》
北大核心
2025年第12期3441-3451,共11页
China Journal of Chinese Materia Medica
基金
上海市申康促进市级医院临床技能与临床创新三年行动计划-研究型医师创新转化能力培训项目(SHDC2022CRD009)
上海市医院中药制剂产业转化协同创新中心项目。
关键词
乌梅丸
2型糖尿病
系统评价
META分析
Wumei Pills
type 2 diabetes mellitus
systematic review
Meta-analysis
