目的 探讨昆仙胶囊联合硫酸羟氯喹治疗类风湿性关节炎的临床疗效。方法 选取2016年2月-2017年8月在西安市第五医院就诊的类风湿关节炎患者156例，随机分为对照组和治疗组，每组各78例。对照组口服硫酸羟氯喹片，0.2 g/次，2次/d。治疗组在对照组基础上饭后口服昆仙胶囊，0.3~0.6 g/次，3次/d。两组患者治疗24周。观察两组患者临床疗效，同时比较治疗前后两组患者关节疼痛评分、关节肿胀和20 m步行时间及血沉（ESR）、C-反应蛋白（CRP）、类风湿因子（RF）和抗环瓜氨酸多肽抗体（An-CCPA）水平。结果 治疗后，对照组和治疗组的总有效率分别为80.77%和94.87%，两组比较差异具有统计学意义（P<0.05）。治疗后，两组患者关节疼痛评分、关节肿胀分级和20 m步行时间均明显减少，同组比较差异具有统计学意义（P<0.05）；且治疗组上述观察指标明显优于对照组，两组比较差异具有统计学意义（P<0.05）。治疗后，两组患者ESR、CRP、RF和An-CCPA水平显著降低，同组比较差异具有统计学意义（P<0.05）；且治疗组ESR、CRP、RF和An-CCPA水平明显低于对照组（P<0.05）。结论 昆仙胶囊联合硫酸羟氯喹治疗类风湿关节炎临床效果好，不良反应轻微，具有一定的临床推广应用价值。

Objective To investigate the clinical efficacy of Kunxian Capsules combined with hydroxychloroquine sulfate in treatment of rheumatoid srthritis. Methods Patients (156 cases) with rheumatoid srthritis in Xi'an NO.5 Hospital from February 2016 to August 2017 were randomly divided into control and treatment groups, and each group had 78 cases. Patients in the control group were po administered with Hydroxychloroquine Sulfate Tablets, 0.2 g/time, twice daily. Patients in the treatment group were po administered with Kunxian Capsules on the basis of the control group, 0.3-0.6 g/time, three times daily. Patients in two groups were treated for 24 weeks. After treatment, the clinical efficacy was evaluated, and the joint pain scores, joint swelling, 20 m walking time, ESR, CRP, RF and An-CCPA levels in two groups before and after treatment were compared. Results After treatment, the clinical efficacy in the control and treatment groups was 80.77% and 94.87% respectively, and there were differences between two groups (P<0.05). After treatment, the joint pain scores, joint swelling, and 20 m walking time in two groups was significantly decreased, and the difference was statistically significant in the same group (P<0.05), and these indexes in the treatment group after treatment were significantly better than those in the control group, with significant difference between two groups (P<0.05). After treatment, the ESR, CRP, RF, and An-CCPA levels in two groups were significantly decreased, and there were differences in the same group (P<0.05). After treatment, the ESR, CRP, RF, and An-CCPA levels in the treatment group after treatment were significantly lower than those in the control group (P<0.05). Conclusion Kunxian Capsules combined with hydroxychloroquine sulfate in treatment of rheumatoid srthritis has significant clinical effect with less adverse reaction, which has a certain clinical application value.