目的 探究痹祺胶囊联合针刀治疗膝骨性关节炎（knee osteoarthritis，KOA）的临床疗效。方法 研究纳入了2021年10月—2023年12月收治的64例符合标准的KOA患者，通过随机分组法将其分为治疗组和对照组，各32例。对照组采用针刀治疗，而治疗组则采用痹祺胶囊与针刀联合治疗。比较两组KOA患者治疗前后膝关节功能［西安大略和麦克马斯特大学（Western Ontario and McMaster University，WOMAC）骨关节炎指数评分］、疼痛程度［视觉模拟量表（visual analog scales，VAS）］、日常生活活动量表（activity of daily living scale，ADL）以及膝关节活动度（包括屈伸度和内外旋角）等指标变化，并统计两组的总有效率和治疗过程中的不良反应发生率。结果 治疗后两组KOA患者WOMAC、VAS、ADL评分以及膝关节活动度均较治疗前改善，且治疗组改善程度显著优于对照组（P＜0.05）。治疗组的总有效率达到93.75%，显著高于对照组的71.875%（P＜0.05）。在总不良反应率方面，治疗组出现恶心呕吐1例，对照组出现晕针1例，均未出现严重不良反应和并发症。结论 痹祺胶囊联合针刀治疗KOA疗效显著，可有效缓解KOA患者疼痛程度、改善膝关节活动度，并提高患者日常生活能力。

Objective To explore the clinical efficacy of Biqi Capsule (痹祺胶囊) combined with needle knife in the treatment of knee osteoarthritis (KOA). Methods A total of 64 patients with KOA who met the criteria and were admitted between October 2021 and December 2023 were included in the study, were divided into a treatment group and a control group of 32 cases each by randomized grouping method. The control group was treated with needle knife, while the treatment group implemented the combination of Biqi capsule and needle knife. The study compares the changes of knee joint function [Western Ontario and McMaster University (WOMAC) osteoarthritis index], pain level [visual analog scales (VAS), activity of daily living scale (ADL), and knee joint mobility (including flexion/extension and internal/external rotation) before and after treatment in the two groups of KOA patients, counts the changes of indicators in the two groups. The total effective rate and the rate of adverse reactions during the treatment process of the two groups were also counted. Results The WOMAC, VAS, ADL scores and knee mobility of KOA patients in both groups improved after treatment compared with those before treatment, and the extent of improvement in the treatment group was obviously better than that in the control group (P < 0.05). The total active rate of the therapeutic group reached 93.75%, which was remarkably superior to that of the contract group, which was 71.875% (P < 0.05). In terms of the overall adverse reaction rate, there was one case of nausea and vomiting in the treatment group and one case of needle-sickness in the control group, and none of them had serious adverse reactions or complications. Conclusion The therapeutic effect of the combination of Biqi capsule and needle knife in the treatment of KOA is remarkable, which can effectively relieve the pain level of patients with KOA, improve the mobility of knee joints, and improve the daily life ability of patients.

R285.64

安徽省教育厅科学研究重点项目（2022AH040074）；安徽省中医药传承创新科研项目（2022CCZC02）；长三角名中医工作室（詹红生工作室）[皖中医药发展秘（2023）16号]；安徽省卫生健康骨干人才项目（0211）