补肾活血方联合塞来昔布治疗轻中度肾虚血瘀型膝骨关节炎的临床疗效观察

Observation on Clinical Efficacy of Bushen Huoxue Formula Combined with Celecoxib in the Treatment of Mild-to-moderate Knee Osteoarthritis of Kidney Deficiency and Blood Stasis Type

【目的】探讨补肾活血方联合塞来昔布胶囊治疗轻中度肾虚血瘀型膝骨关节炎(KOA)患者的临床疗效。【方法】将120例轻中度肾虚血瘀型KOA患者随机分为对照组和治疗组,每组各60例。对照组给予口服塞来昔布胶囊治疗,治疗组在对照组的基础上给予加服补肾活血方治疗,疗程为4周。观察2组患者治疗前后美国膝关节协会评分(AKSS)、关节炎生活质量测量量表2-短卷(AIMS2-SF)评分、疼痛视觉模拟量表(VAS)评分、西安大略和麦克马斯特大学骨关节炎指数(WOMAC)评分以及血清白细胞介素1(IL-1)和肿瘤坏死因子α(TNF-α)水平的变化情况,并评价2组患者的临床疗效和安全性。【结果】(1)治疗4周后,治疗组的总有效率为93.3%(56/60),对照组为78.3%(47/60),组间比较,治疗组的临床疗效明显优于对照组(P<0.01)。(2)治疗后,2组患者AKSS和AIMS2-SF的各项评分均较治疗前明显升高(P<0.05),且治疗组的升高幅度均明显优于对照组(P<0.05)。(3)治疗后,2组患者的VAS评分和WOMAC评分均较治疗前明显降低(P<0.01),且治疗组的降低幅度均明显优于对照组(P<0.05或P<0.01)。(4)治疗后,2组患者血清IL-1、TNF-α水平均较治疗前明显降低(P<0.01),且治疗组的降低幅度均明显优于对照组(P<0.01)。(5)治疗组的不良反应发生率为1.67%(1/60),对照组为5.00%(3/60),组间比较,差异无统计学意义(P>0.05)。【结论】补肾活血方联合塞来昔布治疗轻中度肾虚血瘀型KOA患者疗效确切,能有效改善患者临床症状,促进患者膝关节功能恢复,提高患者生活质量,其机制可能与降低血清IL-1、TNF-α等炎性因子水平有关。

Objective To observe the clinical efficacy of Bushen Huoxue Formula combined with celecoxib in the treatment of mild-to-moderate knee osteoarthritis(KOA)of kidney deficiency and blood stasis type.Methods A total of 120 patients with mild-to-moderate kidney deficiency and blood stasis type of KOA were randomly divided into the control group and the treatment group,60 cases in each group.The control group was treated with oral use of celecoxib capsules,and the treatment group was treated with Bushen Huoxue Formula on the basis of treatment for the control group.The treatment for the two groups lasted for 4 weeks.The American Knee Society Score(AKSS),Arthritis Impact Measurement Scales 2-Short Form(AIMS2-SF)score,visual analogue scale(VAS)pain score,Western Ontario and McMaster Universities Arthritis Index(WOMAC)score,and serum levels of interleukin-1(IL-1)and tumor necrosis factor alpha(TNF-α)in the two groups were observed before and after treatment,and the clinical efficacy and safety of the two groups of patients were evaluated after treatment.Results(1)After 4 weeks of treatment,the total effective rate of the treatment group was 93.3%(56/60)and that of the control group was 78.3%(47/60),and the intergroup comparison showed that the clinical efficacy of the treatment group was significantly superior to that of the control group(P<0.01).(2)After treatment,the AKSS and AIMS2-SF scores in both groups were significantly increased compared with those before treatment(P<0.05),and the degree of the increase in the treatment group was significantly superior to that in the control group(P<0.05).(3)After treatment,the VAS scores and WOMAC scores of the two groups were significantly decreased compared with those before treatment(P<0.01),and the degree of the decrease in the treatment group was significantly superior to that in the control group(P<0.05 or P<0.01).(4)After treatment,serum IL-1 and TNF-αlevels in both groups were significantly decreased compared with those before treatment(P<0.01),and the degree of the decrease in the treatment group was significantly superior to that in the control group(P<0.01).(5)The incidence of adverse reactions was 1.67%(1/60)in the treatment group and was 5.00%(3/60)in the control group,and the intergroup comparison showed that the difference was not statistically significant(P>0.05).Conclusion Bushen Huoxue Formula combined with celecoxib exerts certain effect in treating mild-to-moderate KOA with kidney deficiency and blood stasis type,and the combined therapy is effective on improving the clinical symptoms,promoting the recovery of knee function and improving the quality of life of the patients.The mechanism may be related to the reduction of serum levels of inflammatory factors such as IL-1 and TNF-α.