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真实世界中脉络舒通丸治疗骨外科疾病的临床实效研究

Effective Research of Mailuo Shutong Pills in Treatment of Orthopedic Diseases in Real-World Study
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摘要 目的:评价脉络舒通丸治疗骨外科疾病的临床疗效,为临床实践提供参考。方法:基于全国20家三级甲等医院信息管理系统,选取主要诊断为骨外科疾病的患者为研究对象,其中筛选出使用脉络舒通丸治疗骨外科疾病的患者1604例作为试验组,并与试验组年龄正负3岁、性别相同、入院病情相近为条件,1∶1匹配未使用脉络舒通丸的骨外科疾病患者作为对照组,采用倾向性评分法平衡2组间的混杂因素,并通过Logistic回归方法比较2组间治疗骨外科疾病疗效的差异。结果:单因素分析得出,使用脉络舒通丸的骨外科疾病患者治疗有效率与未使用该药患者的治疗有效率比较差异有统计学意义(P<0.05),苯巴比妥、右旋糖酐、冠状动脉粥样硬化性心脏病是该人群使用脉络舒通丸治疗骨外科疾病疗效评价的主要混杂因素,单因变量Logistic回归、倾向性评分加权的Logistic回归以及带协变量调整的倾向性评分加权Logistic回归的回归系数均大于0,其中单因变量Logistic回归与带协变量调整的倾向性评分加权Logistic回归得P值小于0.05。结论:基于现有数据可以认为,使用脉络舒通丸有助于骨外科疾病的治疗,这可为临床实践提供一定的参考依据,但仍需设计前瞻性试验进一步验证。 Objective:Evaluate the clinical efficacy of Mailuo Shutong Pills in the treatment of orthopedic diseases,so as to provide reference for the use of Mailuo Shutong Pills in clinical work.Methods:This study was based on the database of electronic medical records of 20 large-scale tertiary-level hospitals across the country,and 1:1 matching of patients with orthopedic diseases who used and not used Mailuo Shutong Pills.After matching,test group included 1604 cases treated with Mailuo Shutong Pills and Control group also included 1604 cases treated without Mailuo Shutong Pills.Then,the propensity scoring method was used to balance the confounding factors between the two groups and the logistic regression method was used to compare the differences in the efficacy of treatment of orthopedic surgery diseases between the two groups.Results:According to univariate analysis,there is a statistically significant difference between the effective rate of treatment of orthopedic surgery patients who use Mailuo Shutong pills and that of patients who do not use the drug(P<0.05);phenobarbital,dextran,and coronary Atherosclerotic heart disease are the main confounding factors in the evaluation of the efficacy of Mailuo Shutong pills in the treatment of orthopedic surgery diseases in this population;single dependent variable Logistic regression,propensity score-weighted Logistic regression,and covariate-adjusted propensity score-weighted Logistic regression are all greater than 0,and the logistic regression of single dependent variable and the weighted logistic regression of propensity score with covariate adjustment have P value less than 0.05.Conclusion:Based on existing data,it can be considered that the use of Mailuo Shutong Pills is helpful for the treatment of orthopedic diseases.This study provides a certain reference for clinical practice,but it still needs to be further verified by prospective design trials.
作者 王旭 张利丹 谢雁鸣 吕健 成冯镜茗 苗雨 WANG Xu;ZHANG Li-dan;XIE Yan-ming;LYU Jian;CHENG Feng-jing-ming;MIAO Yu(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Wangjing Hospital,China Academy of Chinese Medical Sciences,Beijing 100102,China;School of Statistics,Renmin University of China,Beijing 100872,China)
出处 《中国中医基础医学杂志》 CAS CSCD 北大核心 2021年第11期1777-1784,共8页 JOURNAL OF BASIC CHINESE MEDICINE
基金 国家重点研发计划项目(2018YFC1707400)-十种中成药大品种和经典名方上市后治疗重大疾病的循证评价及其效应机制的示范研究 中国中医科学院自主选题项目(Z0597)-真实世界中新农合政策对患者结局指标的中介作用分析。
关键词 脉络舒通丸 骨外科疾病 真实世界 实效研究 倾向性评分 医院信息系统 Mailuo Shutong pills Orthopedic diseases Real world Effective research Propensity score Hospital information system
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