目的 评价口服痹祺胶囊联合关节腔内臭氧注射治疗膝骨性关节炎的临床效果。方法 选取60例膝骨性关节炎患者，按随机数字表法分为治疗组和对照组，每组各30例。两组患者均给予关节腔内臭氧注射治疗，每周1次，共注射2次；在此基础上，对照组患者口服双氯芬酸钠双释放肠溶胶囊，50 mg/次，2次/d；治疗组患者口服痹祺胶囊4粒/次，2次/d；两组患者均治疗1个疗程（14 d）。观察两组的临床疗效，比较治疗前后两组疼痛视觉模拟评分（visual analogue score，VAS）、症状和体征量表分值、膝关节功能评分（knee society score，KSS）、生活能力量表（activity of daily living scale，ADL）评分。结果 治疗1个疗程后，治疗组的总有效率93%，明显高于对照组的80%，两组差异具有统计学意义（P＜0.05）；治疗结束1个月后，对两组患者进行随访、评分，治疗组总有效率90%，对照组总有效率70%，两组差异具有统计学意义（P＜0.05）。治疗后，两组VAS评分、症状和体征量表分值较治疗前明显降低（P＜0.05），而KSS评分、ADL评分较治疗前明显升高（P＜0.05），且治疗组VAS评分、症状和体征量表分值、KSS评分、ADL评分明显优于对照组（P＜0.05）。两组均未出现明显不良反应。结论 痹祺胶囊联合关节腔内臭氧注射治疗膝骨性关节炎疗效较好，在缓解患者症状、改善患膝功能方面效果更好，远期疗效明显。

Objective To evaluate the clinical effect of oral Biqi Capsules (痹祺胶囊) combined with intra-articular ozone injection in the treatment of knee osteoarthritis. Methods A total of 60 patients with knee osteoarthritis were selected and randomly divided into treatment group (oral Biqi Capsules) and control group (oral diclofenac sodium) according to random number table method, with 30 cases in each group. Both groups were given intra-articular ozone injection, once in a week, twice in all. On this basis, the control group were given Diclofenac Sodium Dual Release Enteric-coated Capsules, 50 mg twice a day; Treatment group were given Biqi Capsules, four capsules twice a day. The two groups were both treated for one course, 14 days. The clinical effects of the two groups were observed, and the visual analogue score (VAS), symptom and sign scale scores, knee society score (KSS) and activity of daily living scale (ADL) of the two groups were compared before and after treatment. Results After one course of treatment, the total effective rate of the treatment group was 93%, which was significantly higher than that of the control group (80%), and the difference between the two groups was statistically significant (P < 0.05). One month after the end of treatment, the two groups of patients were followed up and scored, the total effective rate of the treatment group was 90%, the total effective rate of the control group was 70%, and the difference between the two groups was statistically significant (P < 0.05). After treatment, VAS score and symptom and sign scale score of the two groups were significantly decreased compared with before treatment (P < 0.05), while KSS score and ADL score were significantly increased compared with before treatment (P < 0.05), and VAS score, symptom and sign scale score, KSS score and ADL score of the treatment group were significantly better than those of the control group (P < 0.05). There was no obvious adverse reaction in the two groups. Conclusion Oral Biqi Capsules combined with intra-articular ozone injection has good curative effect in the treatment of knee osteoarthritis, and has better effect in alleviating the symptoms of patients and improving the function of the affected knee, with obvious long-term curative effect.

R285.64

苏国宏名中医工作室 [中发展（2021）8]；安徽省“十三五”临床重点专科建设项目（卫科教秘 [2017] 529）