自拟消肿方治疗膝骨关节炎并急性滑膜炎的临床研究

Clinical study on the treatment of knee osteoarthritis with acute synovitis by self-made Xiaozhong Decoction

目的观察自拟消肿方治疗膝骨关节炎并急性滑膜炎的有效性及安全性。方法采用双盲随机对照研究方法,共纳入2018年6月—2019年10月望京医院诊治的166例符合标准膝骨关节炎并急性滑膜炎患者,脱落14例,剩余152例。随机分为2组:试验组78例接受消肿方颗粒及洛索洛芬钠模拟片治疗,对照组74例接受洛索洛芬钠片及消肿方颗粒模拟剂治疗,2组疗程均为2周。比较2组治疗后关节积液量、消肿指数、VAS评分、WOMAC积分及安全性。结果试验组和对照组治疗后积液量分别为(4.91±2.78)mm,(7.00±2.91)mm,试验组明显低于对照组(P<0.05);试验组和对照组消肿显效率分别为34.6%(27/78),10.8%(8/74),试验组明显高于对照组(P<0.05);2组治疗后VAS评分比较差异无统计学意义(P>0.05);2组治疗后WOMAC积分均明显降低(P均<0.05),且试验组明显低于对照组(P<0.05);试验组和对照组膝关节功能显效率分别为11.5%(9/78),2.7%(2/74),试验组明显高于照组(P<0.05)。2组均未发生严重不良反应。结论自拟消肿方能显著改善膝骨关节炎并滑膜炎患者的关节肿胀和疼痛情况,促进关节积液吸收,恢复关节运动功能,且安全。

Objective It is to observe the effectiveness and safety of self-made Xiaozhong Decoction in the treatment of knee osteoarthritis with acute synovitis.Methods A double-blind randomized controlled study method was used.A total of 166 patients with knee osteoarthritis and acute synovitis treated in Wangjing Hospital from June 2018 to October 2019 were enrolled,in which 14 cases fell off and 152 cases remained.They were randomly divided into 2 groups:78 patients in the experimental group were treated with Xiaozhong Decoction granules and loxoprofen sodium simulation tablets,and 74 patients in the control group were treated with loxoprofen sodium tablets and Xiaozhong Decoction granules simulation tablets.Both groups were treated for 2 weeks.The volume of joint effusion,swelling index,VAS score,WOMAC score and safety were compared between the two groups after treatment.Results The volume of joint effusion in the experimental group and the control group after treatment were(4.91±2.78)mm and(7.00±2.91)mm,respectively,the experimental group was significantly lower than the control group(P<0.05);the marked effective rate of diminishing swelling in the experimental group and the control were 34.6%(27/78),10.8%(8/74),respectively,the experimental group was significantly higher than the control group(P<0.05);the VAS score of the experimental group after treatment was not significantly different from that of the control group after treatment(P>0.05);the WOMAC score of the two groups after treatment were significantly reduced(P<0.05),and the experimental group was significantly lower than the control group(P<0.05);the marked effective rate of knee joint function in the experimental group and the control were 11.5%(9/78),2.7%(2/74),respectively,and the experimental group was significantly higher than the control group(P<0.05).Conclusion The self-made Xiaozhong Decoction can significantly improve the joint swelling and pain of knee osteoarthritis with synovitis,promote the absorption of joint effusion,restore joint movement function,and relieve TCM syndromes.No obvious adverse reactions is found.The treatment is safe and reliable.