痹祺胶囊治疗膝骨关节炎的临床疗效及影像学评价

目的探索痹祺胶囊治疗膝骨关节炎(KOA)的临床疗效及其对KOA影像学的影响。方法采取随机对照临床试验,试验对象为100例就诊于广东省中医院风湿科门诊就诊的KOA患者。随机分为治疗组(痹祺胶囊治疗)50例和对照组(骨化三醇胶囊+碳酸钙D3片治疗)50例。观察治疗前后两组的骨关节炎指数(The Western Ontario and McMaster Universities Osteoarthritis,WOMAC评分)、疼痛的视觉模拟(VAS)评分以及磁共振膝关节评分(MRI osteoarthritis knee Score,MOAKS评分)的变化,以及血常规、肝肾功能、心电图等安全性指标及不良事件。结果共纳入患者100例,脱落16例,纳入分析84例。治疗组在治疗24周后WOMAC评分以及24周与0周WOMAC评分差值与对照组比较差异显著(P0.05),痹祺胶囊对WOMAC评分的改善优于对照组。两组治疗24周后MOAKS评分差异无统计学意义(P0.05)。亚组分析结果提示,对于未使用非甾体消炎药(NSAIDs)的患者,在治疗24周后,治疗组MOAKS评分与对照组比较,差异显著(P0.05),在未使用NSAIDs药物的患者中,痹祺胶囊对MOAKS评分的改善优于对照组。治疗组共有2例,对照组有1例发生不良反应,两组之间不良反应发生率差异无统计学意义(P0.05)。结论痹祺胶囊可以更好地改善KOA患者的关节僵硬和功能状态,可以更好地改善未合并服用止痛药患者膝关节影像学。

Clinical observation and radiographic evaluation of Biqi Capsule in treating knee osteoarthritis

Objective To evaluate the clinical efficacy of Biqi Capsule in treating knee osteoarthritis through randomized controlled trial, and investigate its effect on radiography. Methods One hundred eligible patients were randomly assigned at a 1:1 ratio to receive Biqi Capsule (intervention group) and Calcitriol Capsule (control group). The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) and VAS for pain were assessed at week 12 and 24. MRI Osteoarthritis Knee Score (MOAKS) was assessed at week 24. The safety index and adverse event were also tested before and after the trial. Results A total of 100 participants were enrolled in this trial, of which 16 patients were lost to follow-up, and 84 patients were included into analysis for per-protocol set. The intervention group could better improve the WOMAC than the control group after 24-week treatment (P<0.05). There was no significant difference between the two groups after the week 24 on MOAKS (P > 0.05). However, in the sub-group analysis, the intervention group had an improvement on the MOAKS score in the patients who did not take the non-steroid anti-inflammatory drugs (NSAIDs) (P<0.05). There was no significant difference between the two groups for the adverse effects (P > 0.05). Conclusion Biqi Capsule had a better treatment effects on the improvement of joint stiffness and function of patients with knee osteoarthritis. It also had a better effect in the patients who did not take NSAIDs on the radiographic evaluation.