独活寄生汤加减联合玻璃酸钠治疗肝肾亏虚型膝骨关节炎临床研究

Clinical research of modified Duhuo Jisheng Decoction combined with sodium hyaluronate in the treatment of knee osteoarthritis with liver and kidney deficiency

目的观察独活寄生汤加减联合玻璃酸钠关节腔注射治疗肝肾亏虚型膝骨关节炎(KOA)的临床疗效及安全性。方法将108例KOA肝肾亏虚型患者利用随机数字表法分为玻璃酸钠组、中药组、联合组,每组36例。玻璃酸钠组予玻璃酸钠注射液关节腔注射,中药组予独活寄生汤加减,联合组予独活寄生汤加减联合玻璃酸钠关节腔注射治疗,共治疗8周。比较3组治疗前后西安大略和麦克马斯特大学(WOMAC)骨关节炎指数评分、中医证候积分及肿瘤坏死因子α(TNF-α)、白细胞介素1(IL-1)、丙氨酸氨基转移酶(ALT)、血肌酐(SCr)水平。结果本研究104例受试者参与完整的研究过程,其中玻璃酸钠组36例,中药组33例,联合组35例。3组治疗后WOMAC骨关节炎指数评分及中医证候积分均较本组治疗前降低(P<0.05);治疗后联合组WOMAC骨关节炎指数评分及中医证候积分低于玻璃酸钠组、中药组(P<0.05),改善值高于玻璃酸钠组、中药组(P<0.05)。3组治疗后TNF-α、IL-1水平均较本组治疗前降低(P<0.05),治疗后联合组TNF-α、IL-1水平低于玻璃酸钠组、中药组(P<0.05)。3组治疗前后ALT、SCr比较差异无统计学意义(P>0.05)。结论独活寄生汤加减联合玻璃酸钠关节腔注射比单纯运用独活寄生汤加减、玻璃酸钠关节腔注射治疗KOA疗效更加显著,能控制症状,改善关节功能,控制炎症反应,且用药安全,疗效可靠。

Objective To observe the safety and clinical efficacy of modified Duhuo Jisheng Decoction plus intra-articular injection of sodium hyaluronate in the treatment of knee osteoarthritis(KOA)with liver and kidney deficiency.Methods A total of 108 patients with KOA of liver and kidney deficiency who met the research criteria were selected.They were assigned in a 1∶1∶1 to intra-articular injection of sodium hyaluronate(sodium hyaluronate group),modified Duhuo Jisheng Decoction(traditional Chinese medicine[TCM]group)or modified Duhuo Jisheng Decoction plus sodium hyaluronate(combined group)using a random number table for 8 weeks.The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC),osteoarthritis index score,TCM syndrome score,tumor necrosis factor-α(TNF-α),interleukin-1(IL-1),alanine aminotransferase(ALT)and serum creatinine(SCr)levels were assessed among the three groups before and after treatment.Results A total of 104 subjects participated in the complete research process,including 36 cases of the sodium hyaluronate group,33 cases of the TCM group,and 35 cases of the combined group.After treatment,the scores of WOMAC,osteoarthritis index and TCM syndrome of the three groups were significantly lower than those before treatment(P<0.05),which were significantly lower in the combined group than in the sodium hyaluronate group and the TCM group(P<0.05).After treatment,TNF-αand IL-1 in the three groups were significantly lower than those before treatment(P<0.05),which in the combined group were significantly lower than those in the sodium hyaluronate group and the TCM group(P<0.05).There was no significant difference in ALT and Cr between the three groups before and after treatment(P>0.05).Conclusion The combination of modified Duhuo Jisheng Decoction and intra-articular injection of sodium hyaluronate is superior to the simple use one of them for KOA,it can control symptoms,improve joint function,control inflammatory response,and with safe and reliable.