目的 探讨附桂骨痛胶囊联合依托考昔治疗膝骨关节炎急性期的安全性与有效性。方法 选取2019年10月—2020年9月在天津市津南医院就诊的117例膝骨关节炎急性期患者，按照入院顺序分成对照组（58例）和治疗组（59例）。对照组口服依托考昔片，60 mg/次，1次/d。治疗组患者在对照组用药基础上口服附桂骨痛胶囊，4粒/次，3次/d。两组患者均连续治疗4周。观察两组患者的临床疗效，比较两组治疗前后Lequesne指数评分、血清学指标及不良反应。结果 治疗后，治疗组总有效率是94.92%，明显高于对照组的81.03%（P<0.05）。治疗后，两组患者疼痛或不适评分、行走距离评分、每日活动能力评分及Lequesne指数总评分均显著下降，与同组治疗前相比较均具有显著性差异（P<0.05）；且治疗后治疗组疼痛或不适、行走距离、每日活动能力及总评分均要明显低于对照组（P<0.05）。治疗后，两组患者白细胞介素-23（IL-23）、基质金属蛋白酶9（MMP-9）及软骨寡聚基质蛋白（COMP）水平均较治疗前显著下降（P<0.05）；治疗后治疗组各指标相较于对照组下降的更显著（P<0.05）。治疗过程中，治疗组不良反应发生率是3.39%，明显低于对照组的13.79%（P<0.05）。结论 附桂骨痛胶囊联合依托考昔能显著提升膝骨关节炎急性期的临床治疗效果，改善患者的病情程度和关节功能状态，降低血清学指标水平，具有一定的临床推广应用价值。

Objective To investigate the safety and effectiveness of Fugui Gutong Capsules combined with etoricoxib in treatment of acute stage of knee osteoarthritis. Methods A total of 117 patients with acute stage of knee osteoarthritis admitted to Tianjin Jinnan Hospital from October 2019 to September 2020 were selected and divided into control group (58 cases) and treatment group (59 cases) according to admission order. Patients in the control group were po administered with Etoricoxib Tablets, 60 mg/time, once daily. Patients in the treatment group were po administered with Fugui Gutong Capsules on the basis of the control group, 4 grains/time, three times daily. Patients in two groups were treated for 4 weeks. After treatment, the clinical efficacy was evaluated, and the levels of Lequesne index score, serological indexes before and after treatment and adverse reactions were compared between two groups. Results After treatment, the total effective rate of the treatment group was 94.92%, which was significantly higher than that of the control group (81.03%, P<0.05). After treatment, pain or discomfort score, walking distance score, daily activity score and Lequesne index score in two groups were significantly decreased, and there were significant differences compared with before treatment (P<0.05). After treatment, the pain or discomfort, walking distance, daily activity ability and total score in the treatment group were significantly lower than those in the control group (P<0.05). After treatment, the levels of interleukin-23 (IL-23), matrix metalloproteinase-9 (MMP-9) and cartilage oligomer matrix protein (COMP) in two groups were significantly decreased compared with before treatment (P<0.05). After treatment, each index in the treatment group decreased more significantly than that in the control group (P<0.05). During the course of treatment, the incidence of ADR in the treatment group was 3.39%, which was significantly lower than that in the control group (13.79%, P<0.05). Conclusion Fugui Gutong Capsules combined with etoricoxib can significantly improve the clinical treatment effect of acute knee osteoarthritis, also can improve the severity of the patient's condition and joint function, and reduce the level of serological indicators, which has a certain clinical application value.

R977

天津市重点实验室开放基金项目（SY-04-201902-003）