类风湿关节炎患者中雷公藤多苷片与甲氨蝶呤的2年药物存活率分析

Analysis on the 2-year survival-on-drug of tripterygium glycoside and methotrexate in patients with rheumatoid arthritis

关键词:  类风湿关节炎  雷公藤多苷片  甲氨蝶呤  药物存活率  倾向评分匹配  不良反应

Key words:  rheumatoid arthritis  tripterygium glycoside  methotrexate  survival-on-drug  propensity score matching  adverse effects

摘要:

[目的] 通过统计类风湿关节炎患者中雷公藤多苷片与甲氨蝶呤2年内的药物存活时间，比较两者2年药物存活率的差异及影响因素。[方法] 选取2016年5月—2019年8月就诊于江苏省中医院风湿免疫科并符合纳入要求的类风湿关节炎患者，观察时间2年，运用SPSS 25.0中的倾向评分匹配，配对出观察组（雷公藤组）和对照组（甲氨蝶呤组）各143例，比较两组2年药物存活率及停药原因。[结果] 1）2年药物存活率方面：雷公藤组与甲氨蝶呤组间比较无统计学差异（P>0.05）。雷公藤组低临床疾病活动度患者2年药物存活率高于高临床疾病活动度患者（P<0.01），甲氨蝶呤组低、中临床疾病活动度患者2年药物存活率均高于高临床疾病活动度患者（P<0.05），甲氨蝶呤组2年期间未住院患者2年药物存活率高于曾住院的患者（P<0.001）。2）在停药原因方面：①雷公藤组因好转自行停药例数多于甲氨蝶呤组（P<0.01），因血液系统受损停药例数少于甲氨蝶呤组（P<0.05）。②在停药患者中，药物存活时间方面：雷公藤组因好转自行停药的时间短于甲氨蝶呤组，因控制不佳、肝功能受损、胃肠道不适的停药时间长于甲氨蝶呤组，且差异均具有统计学意义（P<0.05）。[结论] 雷公藤多苷片与甲氨蝶呤在实际运用中的2年药物存活率无统计学差异，两组的2年药物存活率均受入组时临床疾病活动度的影响，其中甲氨蝶呤组还受入组期间是否住院的影响。在停药原因方面：雷公藤组因好转停药的例数更多，甲氨蝶呤组因血液系统受损停药的例数更多；对具体的药物存活时间分析发现，与甲氨蝶呤组相比，雷公藤组起效更快、疗效更好，在肝功能受损、胃肠道不适方面耐受性更好。

Abstract:

[Objective] By analyzing the 2-year survival-on-drug (SOD) of tripterygium glycoside (TG) and methotrexate (MTX) in rheumatoid arthritis (RA) patients,to compare the difference of SOD and influencing factors.[Methods] Patients with RA who were admitted to the rheumatology ward of Jiangsu Provincial Hospital of Chinese Medicine from May 2016 to August 2019 and met the requirements were selected. Observation time was 2 years. After propensity score matching (PSM) with SPSS 25.0,143 patients in the observation group (TG group) and 143 patients in the control group (MTX group) were respectively applied and 2-year SOD and reasons for discontinuation were compared.[Results] 1) In terms of 2-year SOD:there's no significant differences between the 2-year SOD of two groups (P>0.05). In the TG group,the patients of low clinical disease activity index (CDAI) whose 2-year SOD was higher than the high CDAI (P<0.01). In the MTX group,the patients of low,moderate CDAI whose 2-year SOD were higher than high CDAI (P<0.05),the patients haven't hospitalized whose 2-year SOD were higher than patients were hospitalized (P<0.001). 2) In terms of the reasons for drug withdrawal:① The number of patients in the TG group who voluntarily stopped drugs due to improvement was higher than that in the MTX group (P<0.01),and the number of patients who stopped drugs due to damage to the blood system was lower than that in the MTX group (P<0.05). ② In terms of drug survival time:the self-stopping time of the TG group due to improvement was shorter than that of the MTX group,and the stopping time of the observation group due to poor control,liver function damage and gastrointestinal discomfort was longer than that of the MTX group,with statistically significant differences (P<0.05).[Conclusion] There was no significant difference in 2-year SOD between TG and MTX. The 2-year SOD of TG and MTX were both affected by the CDAI,and the MTX group was also affected by hospitalization. In terms of the reasons for drug withdrawal:In terms of the drug withdrawal,the number of patients in TG group was more than that in the MTX group because of heath improvement. The number of patients of the MTX group was more than that in the TG group because of the blood system damage. By analysis of drug survival time,compared with the MTX group,the TG group showed faster onset,better efficacy,and better tolerance to liver function involvement,gastrointestinal discomfort.