目的 评价膝悦颗粒治疗慢性膝关节滑膜炎(气虚血瘀证)的疗效和安全性。方法 采用随机、双盲、安慰剂对照并剂量探索多中心临床试验,共纳入慢性膝关节滑膜炎(气虚血瘀证)患者240例,低剂量组、高剂量组、安慰剂组各80例。低剂量组口服膝悦颗粒、膝悦颗粒模拟剂,每次各1袋,2次/d,高剂量组口服膝悦颗粒,2袋/次,2次/d,安慰剂组服膝悦颗粒模拟剂,2袋/次,2次/d,疗程4周。治疗后,观察3组患者综合疗效、中医证候疗效、膝关节肿胀程度、膝关节疼痛程度和运动功能视觉模拟评分法(VAS)评分及关节积液深度(一径)。结果 治疗4周后,高、低剂量组的关节肿胀消失率、疼痛程度VAS评分下降值、膝关节运动功能VAS评分下降值和关节积液(深度)下降值均显著高于安慰剂组(P<0.05)。高、低剂量组的综合疗效、中医证候疗效总有效率均显著高于安慰剂组(P<0.05)。结论 膝悦颗粒能显著改善气虚血瘀型慢性膝关节滑膜炎的关节肿胀和疼痛情况,促进积液吸收,恢复关节运动功能,缓解中医证候,无明显不良反应。

Objective To evaluate the efficacy and safety of Xiyue Granules in the treatment of chronic knee synovitis (qi deficiency and blood stasis syndrome). Methods A randomized, double-blind, placebo-controlled, dose-controlled multicenter clinical trial was conducted in 240 patients with chronic knee synovitis (qi deficiency and blood stasis syndrome), there were 80 cases each in low dose group, high dose group and placebo group. The low dose group was po administered with Xiyue Granules and Xiyue Granules Simulator, 1 bag/time, twice daily. The high dose group was po administered with Xiyue Granules, 2 bags/time, twice daily, and the placebo group was po administered with Xiyue Granules simulator, 2 bags/time, twice daily, all patients in three groups were treated for 4 weeks. After treatment, the comprehensive efficacy, therapeutic effect of TCM Syndromes, total VAS score analysis of knee joint swelling, knee joint pain and knee movement function, and depth of joint effusion in three groups were observed. Results After 4 weeks of treatment, the disappearance rate of joint swelling, the decrease of VAS score of pain degree and knee joint motor function, and the decrease of joint effusion (depth) in the high and low dose groups were significantly higher than those in the placebo group (P＜0.05). The comprehensive curative effect and the total effective rate of TCM syndrome in the high and low dose groups were significantly higher than those in the placebo group (P＜0.05). Conclusion Xiyue Granules can significantly improve the joint swelling and pain of chronic knee synovitis of qi deficiency and blood stasis type, promote the absorption of effusion, restore joint motor function, alleviate TCM syndrome, and there is no obvious adverse reaction.

R914

河南省重大科技专项(161100310500)