活血定痛方治疗气滞血瘀型早中期膝骨关节炎临床研究

Clinical Study on Huoxue Dingtong Prescription for Knee Osteoarthritis of Blood Stasis Due to Qi Stagnation Type in Early and Middle Stage

目的:观察活血定痛方治疗气滞血瘀型早、中期膝骨关节炎(KOA)的临床疗效。方法:选择早、中期气滞血瘀型KOA患者120例,按照随机数字表法分成治疗组与对照组各60例。对照组予以玻璃酸钠关节腔注射配合塞来昔布胶囊口服治疗,治疗组在对照组的基础上加用活血定痛方治疗。观察比较2组临床疗效,以及治疗前后视觉模拟评分法(VAS)、Lysholm膝关节评分、疼痛介质[前列腺素E2(PGE2)、P物质(SP)]、促炎因子[白细胞介素-1β (IL-1β)、基质金属蛋白酶-3 (MMP-3)]、抗炎因子[转化生长因子-β1蛋白(TGF-β1)、白细胞介素-13 (IL-13)]的水平。结果:治疗组临床总有效率为95.00%,对照组为83.33%,2组比较,差异有统计学意义(P<0.05)。治疗前,2组VAS、Lysholm膝关节评分比较,差异无统计学意义(P>0.05);治疗后,2组VAS评分较治疗前降低(P<0.05)、Lysholm膝关节评分较治疗前升高(P<0.05),且治疗组上述2项评分改善较对照组更显著(P<0.05)。治疗前,2组PGE2、SP水平比较,差异无统计学意义(P>0.05);治疗后,2组血清PGE2、SP水平均较治疗前降低(P<0.05),且治疗组PGE2、SP水平均低于对照组(P<0.05)。治疗前,2组血清促炎因子IL-1β、MMP-3水平比较,差异无统计学意义(P>0.05);治疗后,2组IL-1β、MMP-3水平均较治疗前降低(P<0.05),且治疗组IL-1β、MMP-3水平均低于对照组(P<0.05)。治疗前,2组血清TGF-β1、IL-13水平比较,差异无统计学意义(P>0.05);治疗后,2组TGF-β1、IL-13水平均较治疗前降低(P<0.05),且治疗组TGF-β1、IL-13水平均低于对照组(P<0.05)。结论:活血定痛方联合常规西药治疗气滞血瘀型早、中期KOA,可有效减轻患者疼痛症状,提高膝关节功能,减轻炎症反应。

Objective:To observe the curative effect of the therapy of Huoxue Dingtong Prescription on knee osteoarthritis(KOA) of blood stasis due to qi stagnation type in early and middle stage.Methods:A total of 120 patients with KOA of blood stasis due to qi stagnation type were selected and divided into the treatment group and the control group according to the random number table methos,with 60 cases in each group.The control group was treated with intra-articular injection with sodium hyaluronate assisting Celecoxib Capsules,and the control group was additionally treated with Huoxue Dingtong Prescription based on the treatment of the control group.The clinical effects and scores of Visual Analogue Scale(VAS),Lysholm scores of knee joints and levels of pain mediators,including prostaglandin E2(PGE2),substance P(SP),proinflammatory factors,including interleukin-1β(IL-1β) and matrix metalloproteinase-3(MMP-3),and anti-inflammatory factors,including transforming growth factor-β1(TGF-β1) and interleukin-13(IL-13),in the two groups before and after treatment were observed and compared.Results:The total clinical effective rate was 95.00%in the treatment group and 83.33%in the control group,the difference being significant(P<0.05).Before treatment,there was no significant difference being found in the comparisons of scores of VAS and Lysholm scores for knee joints between the two groups(P>0.05);after treatment,the scores of VAS in the two groups were decreased when compared with those before treatment(P<0.05),and the Lysholm scores for knee joints were increased(P<0.05),and the improvement in the above two scores in the treatment group was better than that in the control group(P<0.05).Before treatment,there was no significant difference being found in the comparisons of levels of PGE2and SP,between the two groups(P>0.05);after treatment,the levels of serum pain mediators,including PGE2and SP,in the two groups were decreased when compared with those before treatment(P<0.05),and the levels of PGE2and SP in the treatment group were lower than those in the control group(P<0.05).Before treatment,there was no significant difference being found in the comparisons of levels of proinflammatory factors,including IL-1β and MMP-3,between the two groups(P>0.05);after treatment,the levels of IL-1β and MMP-3 in the two groups were decreased when compared with those before treatment(P<0.05),and the above two levels in the treatment group were lower than those in the control group(P<0.05).Before treatment,there was no significant difference being found in the comparisons of levels of anti-inflammatory factors,including TGF-β1and IL-13,between the two groups(P>0.05);after treatment,the levels of TGF-β1and IL-13 in the two groups were decreased when compared with those before treatment(P<0.05),and the above two levels in the treatment group were lower than those in the control group(P<0.05).Conclusion:The therapy of Huoxue Dingtong Prescription combined with routine western medicine can effectively alleviate the pain of patients with KOA of blood stasis due to qi stagnation type in early and middle stage,enhance the knee joint function,and reduce the inflammatory responses.