目的 評價(jià)膝悅顆粒治療慢性膝關(guān)節(jié)滑膜炎(氣虛血瘀證)的療效和安全性。方法 采用隨機(jī)、雙盲、安慰劑對照并劑量探索多中心臨床試驗(yàn),共納入慢性膝關(guān)節(jié)滑膜炎(氣虛血瘀證)患者240例,低劑量組、高劑量組、安慰劑組各80例。低劑量組口服膝悅顆粒、膝悅顆粒模擬劑,每次各1袋,2次/d,高劑量組口服膝悅顆粒,2袋/次,2次/d,安慰劑組服膝悅顆粒模擬劑,2袋/次,2次/d,療程4周。治療后,觀察3組患者綜合療效、中醫(yī)證候療效、膝關(guān)節(jié)腫脹程度、膝關(guān)節(jié)疼痛程度和運(yùn)動(dòng)功能視覺模擬評分法(VAS)評分及關(guān)節(jié)積液深度(一徑)。結(jié)果 治療4周后,高、低劑量組的關(guān)節(jié)腫脹消失率、疼痛程度VAS評分下降值、膝關(guān)節(jié)運(yùn)動(dòng)功能VAS評分下降值和關(guān)節(jié)積液(深度)下降值均顯著高于安慰劑組(P<0.05)。高、低劑量組的綜合療效、中醫(yī)證候療效總有效率均顯著高于安慰劑組(P<0.05)。結(jié)論 膝悅顆粒能顯著改善氣虛血瘀型慢性膝關(guān)節(jié)滑膜炎的關(guān)節(jié)腫脹和疼痛情況,促進(jìn)積液吸收,恢復(fù)關(guān)節(jié)運(yùn)動(dòng)功能,緩解中醫(yī)證候,無明顯不良反應(yīng)。

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

河南省重大科技專項(xiàng)(161100310500)