A clinical study on Gutong plaster in the treatment for joint pain of rheumatoid arthritis with Cold Dampness Syndrome
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摘要: 目的 通过随机对照试验，观察骨通贴膏治疗类风湿关节炎（RA）寒湿痹阻型关节症状的疗效。 方法 将140例RA患者随机分为空白组（n=40）、试验组（n=50）、对照组（n=50），空白组维持原内服药治疗方案不变，不予其他治疗；试验组给予骨通贴膏外用每日1贴；对照组给予电热式蜡疗每日1次。记录并统计分析患者治疗前、治疗3 d、14 d后视觉模拟评分（VAS评分）、握力、晨僵时间、中医证候积分，治疗前及治疗14 d后类风湿因子（RF）、C反应蛋白（CRP）、血沉（ESR）情况。评价临床疗效，观察不良反应。 结果 1治疗3 d后，试验组在VAS评分、晨僵时间、握力及中医证候积分上较治疗前有好转，差异有统计学意义（P < 0.05）。2周后，空白组各观察指标无明显变化（P > 0.05），试验组、对照组在VAS评分、握力、晨僵时间（h）、中医证候积分、CRP、ESR上较治疗前均有改善（P < 0.05）；组间比较，试验组改善情况优于空白组及对照组（P < 0.05），差异有统计学意义；治疗14 d后试验组RF轻度下降，但差异无统计学意义（P>0.05）。2试验组总有效率（94%）、临床控制率及显效率（控显率）83%均优于对照组总有效率（81%）、控显率（69%），差异有统计学意义（P < 0.05）。3试验组及对照组各有2例轻微不良反应，均未退出试验。 结论 骨通贴膏能有效缓解RA寒湿痹阻型小关节晨僵、疼痛、肿胀的临床症状，具有起效快、作用持久、携带及使用方便的优势，对类风湿关节炎患者临床疗效肯定。Abstract: Objective To study the effectiveness of Gutong Plaster for the treatment of Rheumatoid arthritis joint pain with Cold dampness syndrome based on RCT. Methods 140 cases of RA patients were randomly divided into blank group (n=40), test group (n=50), control group (n=50). Blank group maintained the original medication therapies. Test group received Gutong plaster once daily. Control group received electric therapy once daily. VAS, grip strength, morning stiffness, TCM syndrome integral were recorded for all the patients before treatment, 3 and 14 days after treatment. Patients' RF, CRP and ESR were obtained before treatment and 14 days after treatment. Clinical efficacy was evaluated, and adverse reactions were recorded. Results 1. After 3-day treatment, VAS, morning stiffness, grip strength and TCM syndrome integral were improved in test group compared with pre-treatment (P<0.05). After two weeks, no significant changes were observed in blank group (P>0.05), while both test group and control group exhibited better VAS, grip strength morning stiffness, TCM syndrome integral, CRP and ESR compared with the data before treatment (P<0.05). Test group had better improvement than blank group and control group(P<0.05). There was no statistically significant decline of RF in test group(P>0.05). 2. The total effective rate (94%) and the control rate (83%) for test group are better than control group (81% and 69%)(P<0.05). 3. There were two patients having mild adverse reactions in test group and control group, which were not statistically significant. Conclusion Gutong plaster can effectively relieve joints pain for RA patients with Cold dampness syndrome with fast onset and persistent effect. It is convenient to carry and administration. Its effectiveness was clinically confirmed.
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