基于倾向性评分的脉络舒通丸治疗周围血管疾病疗效的真实世界研究

Treatment of Peripheral Vascular Diseases by Mailuo Shutong Pill(脉络舒通丸):A Real World Study based on Propensity Score

目的基于真实世界医疗电子数据库,探索脉络舒通丸治疗周围血管疾病的疗效。方法基于全国14家大型三级甲等医院的医疗电子数据库,以周围血管疾病的患者为研究对象,将服用脉络舒通丸患者作为脉络舒通丸组,未服用脉络舒通丸患者作为对照组,以性别、年龄±5岁且入院病情相同为匹配条件,按照1︰1比例匹配,匹配后两组均为293例,以用药疗效为结局评价指标,通过倾向性评分方法控制本研究中存在的混杂因素,采用χ^(2)检验、单变量的Logistic回归、不带协变量的倾向评分加权Logistic回归、带协变量的倾向评分加权Logistic回归进行疗效分析。结果脉络舒通丸组有效290例(98.98%),无效3例(1.02%);对照组有效269例(91.81%),无效24例(8.19%),两组治疗结局比较差异有统计学意义(χ^(2)值=15.53,P<0.001)。采用倾向性评分方法筛选出27个影响程度较高的混杂因素,加权平衡了其中14个混杂因素,4种统计学方法得到的结果均显示两组差异有统计学意义(P<0.001),脉络舒通丸组的治疗结果优于对照组。结论脉络舒通丸对周围血管疾病有良好的临床治疗效果。

Objective To explore the effectiveness of Mailuo Shutong Pill(脉络舒通丸,MSP)in the treatment of peripheral vascular diseases based on the real-world medical electronic database.Methods The data was collected from the electronic medical cases of 14 tertiary hospitals,and patients with peripheral vascular disease were included in the study.According to whether MSP was taken or not,patients were classified into MSP group and control group.The two groups were matched in gender,age(+/-five years)and the hospital admission condition at a ratio of 1∶1,with 293 patients in each group.The outcome on the effectiveness was evaluated.Propensity score was used to control the potential confounding factors.Four statistical methods includingχ^(2) test,univariate logistic regression,propensity score weighted logistic regression with or without covariates,and propensity score weighted logistic regression with or without covariates were used to analyze the effectiveness.Results There were 290(98.98%)effective cases and 3(1.02%)ineffective cases in MSP group,while the corresponding numbers in the control group were 269(91.81%)and 24(8.19%)respectively,with significant differences between groups(χ^(2)=15.53,P<0.001).Twenty-seven confounding factors with high degree of influence were identified based on propensity score,among which 14 factors were adjusted.The adjusted results obtained by the four statistical methods all showed significant difference(P<0.001),indicating that the efficacy of MSP group was better than the control group.Conclusion MSP has a good clinical effect on peripheral vascular diseases.