关节克痹丸联合西药治疗寒湿痹阻型膝骨关节炎临床研究

Clinical Study on Guanjie Kebi Pills Combined with Western Medicine for Knee Osteoarthritis of Cold-Damp Obstruction Type

目的:观察关节克痹丸联合西药治疗膝骨关节炎(KOA)寒湿痹阻证的临床疗效。方法:选取90例KOA患者,按随机数字表法分为对照组及研究组各45例。对照组予以常规西药治疗,研究组在对照组基础上加用关节克痹丸治疗。比较2组临床疗效及不良反应发生率,比较2组治疗前后血清炎性因子[白细胞介素-6 (IL-6)、白细胞介素-1β (IL-1β)、肿瘤坏死因子-α (TNF-α)]、关节液Wntβ-catenin信号通路相关指标(Wnt-5a m RNA、β-catenin mRNA表达量)、中医证候积分、疼痛视觉模拟评分法(VAS)、美国特种外科医院(HSS)评分的变化。结果:研究组临床疗效总有效率为93.33%,对照组为77.78%,2组比较,差异有统计学意义(P<0.05)。治疗后,2组IL-6、IL-1β及TNF-α水平均较治疗前下降(P<0.05),研究组上述3项水平均低于对照组(P<0.05)。治疗后,2组Wnt-5a mRNA、β-catenin mRNA指标值均较治疗前下降(P<0.05),研究组上述2项指标值均低于对照组(P<0.05)。治疗后,2组中医证候积分及VAS评分均较治疗前下降(P<0.05),HSS评分均较治疗前上升(P<0.05);研究组中医证候积分及VAS评分均低于对照组(P<0.05),HSS评分高于对照组(P<0.05)。研究组不良反应发生率为6.67%,对照组不良反应发生率为11.11%,2组不良反应发生率比较,差异无统计学意义(P>0.05)。结论:关节克痹丸联合西药治疗KOA能提升治疗有效率,改善临床症状,安全性高。

Objective:To observe the clinical effect of the therapy of Guanjie Kebi Pills combined with western medicine on knee osteoarthritis(KOA) of cold-damp obstruction type. Methods:A total of 90 KOA patients were selected and divided into the control group and the study group according to the random number table method,with 45 cases in each group. The control group was given routine western medicine for treatment,and the study group was additionally treated with Guanjie Kebi Pills based on the treatment of the control group. The clinical effects,incidence of adverse reactions,and changes of levels of serum inflammatory factors [interleukin-6(IL-6),interleukin-1β(IL-1β) and tumor necrosis factor-α(TNF-α)],related indexes of Wntβ-catenin signal pathway in synovial fluid(levels of Wnt-5a mRNA and β-catenin mRNA),traditional Chinese medicine(TCM) syndrome scores,and scores of Visual Analogue Scale(VAS)of pain and Hospital for Special Surgery(HSS) were compared before and after treatment between the two groups. Results:The total clinical effective rate was 93.33% in the study group and 77.78% in the control group,the difference being significant(P<0.05). After treatment,the levels of IL-6,IL-1β and TNF-α in the two groups were decreased when compared with those before treatment(P<0.05), and the above three levels in the study group were lower than those in the control group(P<0.05). After treatment,the levels of Wnt-5a m RNA and β-catenin mRNA in the study group were significantly decreased when compared with those in the control group,the difference being significant(P<0.05). After treatment,the TCM syndrome scores and VAS scores in the two groups were decreased when compared with those before treatment(P<0.05), and the HSS scores were increased when compared with those before treatment(P<0.05);the TCM syndrome score and VAS score in the study group were lower than those in the control group(P<0.05),and the HSS score was higher than that in the control group(P<0.05). The incidence of adverse reactions was 6.67% in the study group and 11.11% in the control group,there being no significance in the difference(P>0.05). Conclusion: The therapy of Guanjie Kebi Pills combined with western medicine can improve the curative effect on KOA and clinical symptoms,with great safety.