膝痹宁Ⅱ方内服治疗寒湿痹阻型膝骨关节炎临床疗效的回顾性队列研究

Clinical Efficacy of Medication of XibiningⅡPrescription in Treatment of Knee Osteoarthritis with Cold-dampness Blockage Syndrome:A Retrospective Cohort Study

目的:回顾性分析膝痹宁Ⅱ方在内服药物治疗寒湿痹阻型膝骨关节炎中的临床疗效,探索终点事件的影响因素。方法:采用真实世界回顾性队列设计,收集江苏省中医院骨科门诊内服药物治疗寒湿痹阻型膝骨关节炎病案资料。所有患者接受西医常规治疗,根据是否服用膝痹宁Ⅱ方治疗分为非暴露组(573例)和暴露组(427例),应用IBM SPSS 27.0对筛选出的1000例基线资料进行描述性分析。依据病案基线资料,采用倾向性评分匹配法匹配出334对,两组共668例病案,比较两组治疗前,治疗2、6、12周后视觉模拟评分法(VAS)、西安大略和麦克马斯特大学骨关节炎指数(WOMAC)总评分、日本膝骨关节炎功能评估量表(JKOM)评分、中医证候积分的变化,不良反应发生情况。根据治疗前后WOMAC总分改善率判定的临床治愈作为终点事件进行多因素logistic回归分析,分析终点事件的影响因素。结果:治疗12周后,与治疗前比较,两组患者VAS、WOMAC总评分、JKOM评分、中医证候积分均显著降低(P<0.01);与非暴露组比较,暴露组VAS、WOMAC总评分、JKOM评分、中医证候积分显著降低(P<0.01)。治疗12周后,与非暴露组比较,暴露组临床治愈率、显效率更高(χ^(2)=14.36、64.80,P<0.05)。与本组治疗前比较,两组治疗2、6、12周后VAS,WOMAC疼痛、僵硬、功能评分、JKOM评分、中医症状积分显著降低(P<0.01)。与同时间点非暴露组比较,暴露组治疗2、12周后VAS,6、12周后WOMAC疼痛,12周后功能评分明显降低(P<0.05,P<0.01);暴露组治疗6、12周后JKOM评分降低,治疗2、6、12周后中医症状积分明显降低(P<0.05,P<0.01)。治疗12周后的多因素logistic回归显示影响临床治愈的因素包括病程,饮酒史,高血压,冠心病和服用膝痹宁Ⅱ(P<0.05,P<0.01)。与同时间点非暴露组比较,暴露组治疗2、12周后胃脘不适发生率显著降低(P<0.01);腹泻、呕吐的发生稍高于非暴露组,但差异无统计学意义。结论:临床应用膝痹宁Ⅱ口服联合常规西药治疗寒湿痹阻型膝骨关节炎疗效优于常规西药治疗,可显著降低VAS、WOMAC总评分、JKOM评分、中医症状积分,其中远期疗效差异更明显,不良反应发生率低。

Objective:To retrospectively analyze the clinical efficacy of XibiningⅡprescription in the treatment of knee osteoarthritis with cold-dampness blockage syndrome by oral medication and to explore the influencing factors of endpoint events.Method:A real-world retrospective cohort design was adopted,and medical records of knee osteoarthritis patients with cold-dampness blockage syndrome treated with oral medication from the orthopedics outpatient department of Jiangsu Province Hospital of Chinese Medicine were collected.All patients received conventional Western medicine treatment and were divided into non-exposure group(573 cases)and exposure group(427 cases)according to whether or not they received treatment with XibiningⅡprescription.Descriptive analysis of the baseline data of the 1000 screened cases was performed using IBM SPSS 27.0.According to the baseline data,334 pairs were matched using the propensity score matching method,resulting in a total of 668 cases in both groups.The changes in visual analogous scale(VAS),Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)total score,Japanese Knee Osteoarthritis Measure(JKOM)score,and traditional Chinese medicine(TCM)syndrome score before treatment and at 2,6,12 weeks after treatment,as well as the incidence of adverse reactions,were compared between the two groups.A multivariate logistic regression analysis was conducted to analyze the influencing factors of endpoint events,with clinical cure judged based on the improvement rate of WOMAC total score before and after treatment.Result:After 12 weeks of treatment,compared to the results before treatment,the VAS,WOMAC total score,JKOM score,and TCM syndrome score of patients in both groups significantly decreased(P<0.01).Compared to the non-exposure group,the exposure group showed a more significant reduction in VAS,WOMAC total score,JKOM score,and TCM syndrome score(P<0.01).After 12 weeks of treatment,the clinical cure rate and significant efficiency were higher in the exposure group than in the nonexposure group(P<0.05).Compared to the results before treatment within each group,VAS,WOMAC pain,stiffness,function scores,JKOM score,and TCM syndrome score significantly decreased at 2,6,12 weeks after treatment in both groups(P<0.01).Compared to the non-exposure group at the same time points,the exposure group showed a reduction in VAS at 2,12 weeks,WOMAC pain at 6,12 weeks,and function scores at 12 weeks(P<0.05,P<0.01).The JKOM score decreased at 6,12 weeks,and the TCM syndrome score significantly decreased at 2,6,12 weeks in the exposure group(P<0.05,P<0.01).Multivariate logistic regression analysis at 12 weeks showed that factors affecting clinical cure included the course of disease,history of alcohol consumption,hypertension,coronary heart disease,and the use of XibiningⅡprescription(P<0.05,P<0.01).Compared to the non-exposure group at the same time points,the incidence of epigastric discomfort in the exposure group was lower at 2,12 weeks(P<0.01),the incidence of diarrhea and vomiting was slightly higher than that in the non-exposure group,but the difference was not statistically significant.Conclusion:The clinical application of XibiningⅡprescription combined with conventional Western medicine treatment in the treatment of knee osteoarthritis with cold-dampness blockage syndrome is more effective than conventional Western medicine treatment alone.It can significantly reduce VAS,WOMAC total score,JKOM score,and TCM syndrome score,with more pronounced long-term effects and a low incidence of adverse reactions.