重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白关节腔注射联合中药薰洗治疗膝骨关节炎的临床研究

Clinical study on intra-articular injection of TypeⅡrecombinant human tumor necrosis factor receptor- Fc fusion protein combined with Chinese herbal steaming and washing therapy for treatment of knee osteoarthritis

目的:观察注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(recombinant human tumor necrosis factor receptor-Fc fusion protein,rh TNFR:Fc)关节腔注射联合中药薰洗治疗膝骨关节炎的临床疗效。方法:将60例膝骨关节炎患者随机分为2组,每组30例。分别采用关节腔注射rh TNFR:Fc联合中药薰洗和关节腔注射玻璃酸钠联合中药薰洗治疗。比较治疗前后2组膝关节疼痛视觉模拟评分(visual analogue score,VAS)及西安大略和麦克马斯特大学(Western Ontario and Mc Master Universities,WOMAC)骨关节炎评分,并于治疗结束后3个月比较2组患者的综合疗效。结果:治疗前2组患者的膝关节VAS评分及WOMAC评分比较,组间差异均无统计学意义[(7.15±1.09)分,(6.90±1.52)分,t=1.045,P=0.309;(54.75±3.23)分,(55.45±3.11)分,t=0.700,P=0.493]。治疗结束后3个月,2组患者的膝关节VAS评分[(3.05±0.76)分,(4.10±0.97)分]及WOMAC评分[(16.55±2.65)分,(27.20±3.17)分]均较治疗前下降(t=14.173,P=0.000;t=10.101,P=0.000;t=34.451,P=0.000;t=39.161,P=0.000);rh TNFR:Fc组的膝关节VAS评分及WOMAC评分下降幅度均大于玻璃酸钠组[(4.10±1.29)分,(2.80±1.31)分,t=3.771,P=0.001;(38.20±4.96)分,(28.25±3.23)分,t=8.132,P=0.000]。治疗结束后3个月,rh TNFR:Fc组治愈10例、显效12例、有效7例、无效1例,玻璃酸钠组治愈6例、显效8例、有效13例、无效3例,rh TNFR:Fc组疗效优于玻璃酸钠组(Z=﹣1.987,P=0.047)。结论:采用关节腔注射rh TNFR:Fc联合中药薰洗治疗膝骨关节炎,可以有效缓解膝关节疼痛,促进膝关节运功功能恢复,疗效优于关节腔注射玻璃酸钠联合中药薰洗治疗,值得临床推广应用。

Objective：To observe the clinical curative effects of intra-articular injection of TypeⅡrecombinant human tumor necrosis factor receptor -Fc fusion protein（rhTNFR：Fc）combined with Chinese herbal steaming and washing therapy for treatment of knee osteoar-thritis（KOA）.Methods：Sixty patients with KOA were randomly divided into 2 groups,30 cases in each group.The patients were treated with combination therapy of intra-articular injection of rhTNFR：Fc with Chinese herbal steaming and washing（rhTNFR：Fc group）and com-bination therapy of intra-articular injection of sodium hyaluronate（SH）with Chinese herbal steaming and washing（SH group）respectively. The knee visual analogue score（VAS）and Western Ontario and McMaster Universities（WOMAC）osteoarthritis score were compared be-tween the 2 groups before and after the treatment,and the total clinical curative effects were also compared between the 2 groups at 3 months after the end of the treatment.Results：There was no statistical difference in the knee VAS scores and WOMAC scores between the 2 groups before the treatment（7.15 ＋/-1.09 vs 6.90 ＋/-1.52 points,t =1.045,P =0.309;54.75 ＋/-3.23 vs 55.45 ＋/-3.11 points,t =0.700, P =0.493）.The knee VAS scores（3.05 ＋/-0.76,4.10 ＋/-0.97 points）and WOMAC scores（16.55 ＋/-2.65,27.20 ＋/-3.17 points）of all patients decreased at 3 months after the end of the treatment（t =14.173,P =0.000;t =10.101,P =0.000;t =34.451,P =0.000;t =39.161,P =0.000）.The decreased degree of knee VAS scores and WOMAC scores of rhTNFR：Fc group were greater than those of SH group（4.10 ＋/-1.29 vs 2.80 ＋/-1.31 points,t =3.771,P =0.001;38.20 ＋/-4.96 vs 28.25 ＋/-3.23 points,t =8.132,P =0.000）. At 3 months after the end of the treatment,10 patients were cured,12 got a good result,7 fair and 1 poor in the rhTNFR：Fc group;while 6 patients were cured,8 got a good result,13 fair and 3 poor in the SH group.The rhTNFR：Fc group surpassed the SH group in the curativeeffect（Z =-1.987,P =0.047）.Conclusion：The therapy of intra-articular injection of rhTNFR：Fc combined with Chinese herbal steaming and washing can effectively relieve the knee pain and promote the knee function recovery in the treatment of KOA,and its curative effect is better than that of intra-articular injection of SH combined with Chinese herbal steaming and washing,so it is worthy of popularizing in clinic.