目的 探讨通痹胶囊联合酮洛芬治疗类风湿性关节炎的临床疗效。方法 选取2019年10月—2022年7月东营市东营区人民医院收治的128例类风湿性关节炎患者，按随机数字表法将所有患者分为对照组和治疗组，每组各64例。对照组口服酮洛芬肠溶片，50 mg/次，3次/d，饭后整片吞服。治疗组在对照组基础上口服通痹胶囊，1粒/次，3次/d，饭后口服。两组治疗疗程均为12周。观察两组的临床疗效，比较治疗前后两组主要临床表现、中医症状积分、28个关节疾病活动度（DAS28）-C反应蛋白（CRP）、关节炎生活质量量表2-短卷（AIMS2-SF）总分以及血浆D-二聚体（D-D）、纤维蛋白原（FIB）水平和血清CRP、Nod样受体蛋白3（NLRP3）、白细胞介素（IL）-1β、基质金属蛋白酶-3（MMP-3）水平。并统计两组不良反应情况。结果 治疗后，治疗组总有效率是93.75%，较对照组的81.25%显著提高（P<0.05）。治疗后，两组关节压痛数、肿胀数、关节疼痛VAS评分均显著降低，晨僵时间显著缩短（P<0.05）；治疗后，治疗组主要临床表现改善优于对照组（P<0.05）。治疗后，两组中医症状积分、DAS28-CRP均显著下降，而AIMS2-SF总分均显著升高（P<0.05）；以治疗组改善更显著（P<0.05）。治疗后，两组血浆D-D、FIB水平均显著下降（P<0.05）；治疗后治疗组D-D、FIB显著低于对照组（P<0.05）。治疗后，两组血清CRP、NLRP3、IL-1β、MMP-3水平均显著下降（P<0.05）；且治疗后，治疗组血清CRP、NLRP3、IL-1β、MMP-3水平均显著低于对照组（P<0.05）。治疗组和对照组不良反应发生率分别是6.25%、4.69%，两组不良反应发生率比较差异无统计学意义。结论 通痹胶囊联合酮洛芬治疗类风湿性关节炎有确切疗效，在改善患者主要临床表现、降低疾病活动度以及提高生活质量方面的效果满意，并可进一步纠正机体凝血功能障碍、减轻炎症损伤，且具有较好的安全性。

Objective To investigate the clinical efficacy of Tongbi Capsules combined with ketoprofen in treatment of rheumatoid arthritis. Methods A total of 128 patients with rheumatoid arthritis admitted to Dongying District People's Hospital of Dongying from October 2019 to July 2022 were selected and divided into control group and treatment group according to random number table method, with 64 cases in each group. Patients in the control group were po administered with Ketoprofen Enteric-coated Tablets, and swallowed tablets whole after meals, 50 mg/time, three times daily. Patients in the treatment group were po administered with Tongbi Capsules on the basis of the control group, 1 capsule/time, 3 times daily, orally after meals. After treatment, the clinical efficacy was evaluated, the main clinical manifestations, TCM symptom scores, 28 joint disease activity (DAS28)-C-reactive protein (CRP), total score of Arthritis Life Quality Scale 2-Short Scale (AIMS2-SF) and plasma dimer (D-D), fibrinogen (FIB) levels and serum CRP, Nod-like receptor protein 3 (NLRP3), interleukin (IL)-1β, matrix metalloproteinase-3 (MMP-3) levels in two groups before and after treatment were compared. The adverse reactions of the two groups were analyzed. Results After treatment, the total effective rate of the treatment group was 93.75%, which was significantly higher than that of the control group (81.25%) (P < 0.05). After treatment, the number of joint tenderness, swelling and joint pain VAS score were significantly decreased in both groups, and the time of morning stiffness was significantly shortened (P < 0.05). After treatment, the improvement of main clinical manifestations in the treatment group was better than that in the control group (P < 0.05). After treatment, TCM symptom scores and DAS28-CRP were significantly decreased in both groups, while AIMS2-SF total scores were significantly increased (P < 0.05). The improvement was more significant in the treatment group (P < 0.05). After treatment, plasma D-D and FIB levels in two groups were significantly decreased (P < 0.05). After treatment, D-D and FIB in the treatment group were significantly lower than those in the control group (P < 0.05). After treatment, serum CRP, NLRP3, IL-1β and MMP-3 levels in two groups were significantly decreased (P < 0.05). After treatment, serum CRP, NLRP3, IL-1β and MMP-3 levels in the treatment group were significantly lower than those in the control group (P < 0.05). The incidence of adverse reactions in the treatment group and the control group were 6.25% and 4.69%, respectively, and there was no statistical significance in the incidence of adverse reactions between the two groups. Conclusion Tongbi Capsules combined with ketoprofen has definite curative effect in treatment of rheumatoid arthritis, and the effect is satisfactory in improving the main clinical manifestations, reducing the disease activity and improving the quality of life, and can further correct the coagulation dysfunction and reduce the inflammatory injury, which has better security.

R982

山东省东营市卫生和计划生育委员会基金项目（2017HW252）