氨甲喋呤羟氯喹合通痹Ⅰ号方治疗类风湿关节炎风寒湿痹36例观察

【作者】 潘利；

【导师】 杨德才；

【作者基本信息】 湖北中医学院 ， 中西医结合临床， 2006， 硕士

【摘要】 目的： 为了延缓类风湿关节炎患者骨侵蚀的进展，降低致残率，国内外主张早期联合使用改变病情药。本课题旨在研究中西医结合疗法(氨甲喋呤、羟氯喹与通痹Ⅰ号方合用)治疗类风湿关节炎风寒湿痹的疗效及安全性，与西药对照组(氨甲喋呤+羟氯喹)比较，为临床治疗类风湿关节炎提供新的综合治疗方案。由于近期国内已有文献报道氨甲喋呤与羟氯喹合用疗效优于氨甲喋呤，故本课题不另设单用氨甲喋呤治疗的对照组。 方法： 1 临床资料：全部病例系2005年9月～2005年12月湖北省中医院风湿科的门诊或住院病人共72例，随机分为治疗组和对照组，其中治疗组36例、对照组36例。两组患者在年龄、性别、病程分布、以及关节X线分级、关节功能分级等方面比较，经统计学检验，无显著性差异(P＞0.05)，具有可比性。 2 治疗方法：治疗组口服羟氯喹200mg／d，每次100mg、分两次服；氨甲喋呤10mg、静滴、每周一次；通痹Ⅰ号方水煎服300ml，每天一剂、分两次服。通痹Ⅰ号方及组成：黄芪10g、桂枝6～10g、当归10g、白芍10g、威灵仙10g、伸筋草15g、青风藤20g、秦艽10g、制大黄6g、甘草10g，临床根据病人症状随症加减。对照组口服羟氯喹200mg／d，每次100mg、分两次服；氨甲喋呤10mg、静滴、每周一次。以上两组患者若是在进入试验前接受非甾体类抗炎药和激素治疗，剂量必须至少稳定30天，并且在以后的治疗中维持不变。两组共观察8周。 3 疗效及安全性观测：观察治疗前后主要相关体征如关节压痛数、关节肿胀数、晨僵时间、双手平均握力、疼痛指数等以及治疗前后中医证候及其评分的变化，并对中医次症如关节作冷、畏恶风寒、关节重着、乏力的改善进行比较；观察治疗前后实验室指标的改善情况如RF、ESR、CRP等；观察可能出现的不良反应，每四周复查血尿便常规、肝肾功能(ALT、AST、BUN、SCr)、心电图，必要时随时复查以上指标。 4 统计方法：计量资料的比较采用t检验，与治疗前基础值进行比较时采用配对t检验比较组内前后的差异。计数资料采用X~2检验。等级资料用非参数方法评估有效性指标。安全性分析时采用X~2检验比较两组不良事件发生率。 结果： 1 临床疗效比较：治疗组总有效率为91.67％、显效率为55.56％；对照组总有效率为84.38％、显效率为31.25％，治疗组显效率明显优于对照组(P＜0.05)，治疗组疗效总体分布优于对照组(P＜0.05)。 2 主要临床症状体征比较：两组治疗前后在改善晨僵、关节压痛数、关节肿胀数、双手平均握力、关节疼痛指数方面均有显著疗效(P＜0.01)；在减少关节压痛数及关节疼痛指数方面，治疗组优于对照组(P＜0.01)；在改善关节肿胀更多还原

【Abstract】 Objective:To investigate the therapeutic effect and adverse reaction of using MTX. HCQ and Prescription Tongbi No.1 together to treat rheumatoid arthritis , which syndrome is wind-cold-damp arthralgia in TCM.Methods:1 Clinical date: All the patients came from Hubei Hospital of TCM,from September ,2005 to December,2005. 72 patients with rheumatoid arthritis ,which syndrome was wind-cold-damp arthralgia in TCM,were divided into two groups at random. Each group had 36 patients.2 The medical usage : The patients in treatment group were treated with HCQ(200mg/d,100mg , po . bid) . MTX(10mg , iv drip , qw) , and Prescription Tongbi No.1(300ml/d,po,bid). The patients in comparison group were treated with HCQ(200mg/d,100mg, po, bid) and MTX(10mg. iv drip, qw).3 The therapeutic effect and adverse reaction : The main clinical symptoms and physical signs were observed and recorded after 8 weeks treatment. But during the research all the patients must be obsearved carefully in order to make the research secure. Indexes in laboratory tests including blood-rt , urine-rt, stool-rt , electrocardiogram, hepatic function, renal function, blood sedimentation rate, rheumatoid factor and C-reactive protein were tested before the research and after 4 weeks or 8 weeks treatment. Then the result of indexes was compared between two groups .4 The statistic method: After four or eight weeks, we analyzed the data. The count materials were examined with X~2.The measuring materials were examined with t-test and the grade materials with Rank sum test.Result:1 The total effective rate of the treatment group was 91.67% and that of the contrast group was 84.38%. Examined with Rank sum test,the treatment group’s therapeutic effect was better than the other one’s on the whole (P<0.05). The marked effective rate of treatment group and comparison group was 55.56% and 37.25% respectively after 8 weeks treatment, so there was statistically significant difference between 2 groups(P<0.05).2 The main symptoms and physical sign included time of moning stiffness, count of joint tenderness, count of joint swollen, rest pain, average grasp force of both hands. After 8-week treatment, it proved that the result of each index before and after therapy was significantly different in each group (P<0.01). However, in relieving count of joint tenderness, count of joint swollen and rest pain, the treatment group’s therapeutic effect is better than that of the contrast更多还原