抗骨增生胶囊治疗膝骨关节炎的临床研究

Clinical efficacy of Kanggu Zengsheng capsule on treatment of knee-osteoarthritis

目的评价抗骨增生胶囊治疗骨关节炎(KOA)的临床疗效,对血清和关节液中炎症因子、抗氧化酶表达的影响。方法入选100例符合骨关节炎患者,随机分为试验组50例和对照组50例,试验组口服抗骨增生胶囊,每次1750 mg,tid。对照组口服双醋瑞因50 mg,bid和塞来昔布200 mg,qd,疼痛症状缓解以后停用塞来昔布,双醋瑞因继续使用。2组均每4周为1个疗程。观察治疗前后疗效评价(视觉模拟评分,Womac评分,Lequesne指数),血清及关节液中炎症因子(白细胞介素-1β、肿瘤坏死因子-α、基质金属蛋白酶-3、透明质酸)和抗氧化指标(一氧化氮、一氧化氮合酶、脂质过氧化物、超氧化物歧化酶)。结果治疗后,2组患者的视觉模拟评分值、Womac评分及膝关节炎病人疼痛指数均有明显的改善(P<0.05)。试验组抑制白细胞介素-1β,肿瘤坏死因子-α、一氧化氮、一氧化氮合酶、脂质过氧化物的能力优于对照组,升高超氧化物歧化酶的能力也优于对照组(P<0.05)。结论抗骨增生胶囊治疗骨关节炎的疗效较好,优于目前临床的双醋瑞因+塞来昔布常规治疗方案。

Objective To evaluate the clinical effect of Kanggu Zengsheng capsule on treatment of knee-osteoarthritis and its effect on anti-inflammation and anti-oxidation.Methods One hundred patients with knee-osteoarthritic were randomly divided into two groups.Patients in the treatment group（n = 50） were orally administrated with 3Kanggu Zengsheng capsules each time,tid,and those in the control group（n = 50） were given diacerein（50 mg bid,po） and celecoxib（200 mg qd,po） for four weeks.The data of Visual Analogue Scale（VAS）,Womac score,Lequesne index and interleukin 1 beta（IL-1β）,tumor necrosis factor alpha（TNF-α）,matrix metalloproteinases-3（MMP-3）,hyaluronic acid（HA）,nitric oxide（NO）,nitric oxide synthase（i NOS）,lipid peroxide（LPD） and superoxide dismutase（SOD） in serum and synovia were observed in two groups.Results After treatment,the data of VAS score,Womac score,Lequesne index in two groups were significantly improved,and the abilities to inhibit IL-1β,TNF-α,MMP-3,NO,i NOS and LPD in treatment group were better than the control group.The treatment group also displayed a better capability in increasing SOD compared with the control group.Conclusion Kanggu Zengsheng capsule has a better efficacy on knee-OA than traditional treatment methods（diacereinand plus celecoxib）.