正清风痛宁治疗幼年类风湿性关节炎的临床观察

目的探讨正清风痛宁等多种中西药联合治疗幼年类风湿性关节炎的疗效。方法将32例多关节型幼年类风湿性关节炎病人,按随机、双盲原则分为治疗组和对照组。对照组16例予来氟米特,甲氨蝶呤（MTX）,尼美舒利,泼尼松;治疗组16例在对照组治疗基础上加用正清风痛宁60~120 mg。观察关节肿胀数（SJC）、关节压痛数（TJC）、晨僵时间、血沉（ESR）、C-反应蛋白（CRP）、类风湿因子（RF）水平、抗环胍氨酸肽抗体（CCP）等指标,以总改善百分率对疗效进行综合评估。疗程1年。结果除治疗组1例末坚持治疗,对照组1例失访外,两组患儿的临床症状、体征及实验室指标都有所改善,关节肿胀数、关节压痛数、晨僵时间减少,ESR、CRP、RF均较治疗前有显著的改善（P〈0.01）;治疗组的疗效优于对照组。用药1年后治疗组的总有效率为93.3%,对照组的总有效率为86.7%,两组差异有统计学意义（P〈0.05）。两组的主要不良反应表现为乏力、头晕、皮疹、轻度食欲不振、轻度恶心、白细胞下降、转氨酶升高。治疗组不良反应的发生率为20.0%,对照组不良反应发生率为12.3%。结论正清风痛宁联合甲氨蝶呤和来氟米特等多种中西药治疗幼年类风湿性关节炎,效果显著,安全性较好。

Clinical observation of Zhengqing Fengtongning in treatment of juvenile rheumatoid arthritis

Objective To evaluate the efficacy and safety of Zhengqing Fengtongning and leflunomide in the patients with juvenile rheumatoid arthritis（JRA）.Methods 32 patients with active polyarthritis JRA were divided into 2 groups according to random and double-blind principle.The patients in the control group（n=16） were given with leflunomide,methotrexate,nimesulide and prednisone,while those in the treatment group（n=16） were given with Zhengqing Fengtongning tablets（60-120mg/per day） besides the medicine used in the control group.SJC,TJC,early morning stiffness time,ESR,CRP,RF and CCP were observed to evaluate the effect according to total improvement rate.The course of treatment lasted one year.Results After treatment a year,except 1 case of treatment group did not adhered to treatment and 1 case of control group lost to follow-up,SJC,TJC,early morning stiffness time,ESR,CRP,RF of two groups had significantly improvement（P0.01）.Effect of treatment group was better than that of control group.The total effective rate of treatment group and control group were 93.3% and 86.7% respectively.The difference had statistical significance（P0.05）.The main adverse reactions were hypodynamia,dizziness,erythra,inappetence,nausea,leucocyte decreased and transaminase increased.The adverse reaction incidence of treatment group and control group were 20.0% and 12.3% respectively.Conclusion Our data indicated that Zhengqing Fengtongning with leflunomide and methotraxate to treat rheumatoid arthritis has the safe,significant effects.