基于真实世界的藤黄健骨片治疗膝骨关节炎患者临床特征及用药分析

A Real-world Study of Treatment of Knee Osteoarthritis with Tenghuang Jiangu Tablets

目的:基于“藤黄健骨片治疗膝骨关节炎病例注册登记研究”的方法探索真实世界中藤黄健骨片治疗膝骨关节炎患者的临床特征及用药规律,分析中成药治疗膝骨关节炎的优势环节与用药特点。方法:选取2019年9月至2021年1月注册登记研究资料中全国43家医院2505例患者数据,分析患者总体及不同分期的临床特征、用药规律。结果:2505例患者中女1717例,男788例,缓解期2439例,发作期66例,康复期0例,平均年龄(60.54±6.80)岁,平均体质量指数(24.05±2.74)kg/m^(2),K-L分级多为Ⅱ级。藤黄健骨片最常用时长为8周,单次剂量3~6片,2次/d,平均总用药量(444.41±164.72)片,发生不良反应33例,合并疾病的膝骨关节炎患者452例,单用藤黄健骨片1471例,联合用药1034例,临床上常联用药物类别为西药口服、中成药口服、西药关节腔注射、中成药外用等;不同分期间的患者年龄、合并疾病比较,差异有统计学意义(P<0.05)。结论:真实世界中藤黄健骨片治疗膝骨关节炎人群女性多于男性,K-L分级以Ⅱ级分布为主,分期主要以缓解期为主,发作期在更高年龄占比更大;藤黄健骨片的用法用量与专家共识一致,临床联合用药类别主要为西药口服、中成药口服、西药关节腔注射、中成药外用等,具有良好的安全性。

Objective:To explore the clinical characteristics and application rules of Tenghuang Jiangu Tablets in the treatment of knee osteoarthritis(KOA)patients in the real world based on the method of“Study project for the case registration of Tenghuangjiangu tablets in the treatment to osteoarthritis of the knee”,and analyze the advantages and medication characteristics of Chinese patent medicines in the treatment of KOA.Methods:The registered study data of 2505 patients from 43 hospitals in China from September 2019 to January 2021 were included in this study and used to analyze the clinical characteristics and medication rules of the patients in general and at different stages.Results:The 2505 patients included 1717 females and 788 males,with the mean age of(60.54±6.80)years old and the mean body mass index of(24.05±2.74)kg/m^(2).Among the patients,2439 and 66 patients were in remission and attack,respectively,and no patient was in recovery.Most of the patients were rated in Kellgren-Lawrence grade II.In most cases,Tenghuang Jiangu Tablets were administrated for 8 weeks,3 to 6 tablets each time,2 times/day,with the average total dosage of(444.41±164.72)tablets.Adverse reactions occurred in 33 patients.Complicated diseases occurred in 452 KOA patients.Among the 2505 patients,1471 patients were treated with Tenghuang Jiangu Tablets alone,and 1034 patients with Tenghuang Jiangu Tablets combined other drugs.The commonly used other drugs include oral western medicines,oral Chinese patent medicines,western medicines for joint cavity injection,and Chinese patent medicines for external use.The patient age and complicated diseases varied in different disease stages(P<0.05).Conclusion:More women than men with KOA in the real world were treated with Tenghuang Jiangu Tablets.Most patients were in the K-L grade II and remission,and the patients in attack mostly had older age.The usage and dosage of Tenghuang Jiangu Tablets were consistent with expert consensus.The common drugs used in combination with Tenghuang Jiangu Tablets included oral western medicines,oral Chinese patent medicines,western medicines for joint cavity injection,and Chinese patent medicines for external use,which demonstrated good security.