依那西普联合雷公藤多苷治疗老年类风湿关节炎的临床观察

Etanercept Combined with Tripterygium wilfordii Polyglycoside for Treatment of Rheumatoid Arthritis in the Elderly: a Clinical Study

目的评价依那西普联合雷公藤多苷与依那西普联合甲氨蝶呤治疗老年类风湿关节炎(RA)的疗效与安全性。方法 46例未接受过依那西普治疗的老年活动性RA患者随机分为试验组(22例)和对照组(24例)。两组均予依那西普25 mg/次,皮下注射,2次/周,3个月后依那西普减为25 mg/次,皮下注射,1次/周。试验组给予口服雷公藤多苷片10 mg/次,3次/天;对照组给予甲氨蝶呤片10 mg/次,1次/周,疗程为24周。在治疗0、4、8、12、24周观察两组患者的休息痛(疼痛VAS评分)、压痛关节数、肿胀关节数、评价评估问卷(HAQ)、患者对病情总体状况VAS评分(简称患者VAS评分)、医生对病情总体状况VAS评分(简称医生VAS评分)、红细胞沉降率(ESR)、C反应蛋白(CRP)、类风湿因子(RF),采用美国风湿病学会(ACR)制定的ACR20、ACR50、ACR70标准来评价疗效,并记录治疗过程中的任何不良事件。结果最终完成试验的有41例,脱落5例,其中试验组3例,对照组2例;与对照组比较,试验组各治疗期ACR20、ACR50和ACR70差异均无统计学意义(P>0.05)。与本组治疗前比较,两组治疗后压痛关节数、肿胀关节数、疼痛VAS评分、医生VAS评分、患者VAS评分、ESR、CRP和HAQ均有改善,差异有统计学意义(P<0.05),但与对照组同期比较,差异均无统计学意义(P>0.05)。两组间不良事件发生率差异亦无统计学意义(P>0.05)。结论依那西普联合雷公藤多苷治疗RA与依那西普联合甲氨蝶呤治疗RA的疗效相当,两者均能迅速改善与RA相关的各项症状、体征和生活质量,尚有良好的安全性。

Objective To evaluate the efficacy and safety of etanercept plus Tripterygium wilfor- dii polyglycoside （TWP） in elderly patients with active rheumatoid arthritis （RA）. Methods Totally 46 elderly patients with active RA were randomly assigned to the treatment group （22 cases） and the con- trol group （24 cases）. All patients received subcutaneous injection of etanercept, 25 mg each time, twice per week. The dosage was reduced to once per week 3 months later. Patients in the treatment group took TWP Tablet （10 mg each time, three times per day）, while those in the control group took metho- trexate （MTX）, 10 mg each time, once per week. The whole course lasted for 24 weeks. Patients＇ rest pain, tender joint number, swollen joint number, health assessment questionnaire （ HAQ）, patients＇ glob- al assessment, physicians＇ global assessment, erythrocyte sediment rate （ESR）, C reactive protein （ CRP）, rheumatic factor were assessed at week 0,4,8, 12, and 24. The curative effect was statistically evaluated by the United States Institute of Rheumatology ACR20, ACR50, and ACR70 improvement crite-ria. Meanwhile, any adverse event was recorded and evaluated. Results Totally 41 completed the trial, and 5 dropped off （3 in the treatment group and 2 in the control group）. Compared with the control group, there was no statistical difference in ACR20, ACR50, or ACR70 in the treatment group （P 〉0.05）. Com- pared with before treatment in the same group, there was some improvement in tender joint number, swollen joint number, visual analogue scale （VAS） for patients＇ global assessment, VAS for physicians＇ global assessment, ESR, CRP, and HAQ between the two groups, showing statistical difference （P 〈 0.05）. Compared with the control group in the same phase, there was no statistical difference in the treatment group （P 〉0.05）. There was no statistical difference in the occurrence of adverse events be- tween the two groups. Conclusions Etanercept plus TWP could achieve equivalent therapeutic effect to that of Etanercept plus MTX. The two regimens could improve clinical signs, symptoms, and QOL related to RA. They were well tolerated in the treatment of elderly patients with active RA.