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目的:评价医院制剂问荆合剂联合西药治疗湿热痹阻型类风湿关节炎(RA)的临床疗效和安全性。方法:132例湿热痹阻型RA患者随机分为两组各66例。观察组给予问荆合剂、甲氨喋呤和来氟米特治疗,对照组给予甲氨喋呤和来氟米特治疗,疗程均为12周。观察两组患者的疾病疗效、中医证候疗效、28个关节病情活动评分(DAS28)等指标改善情况和安全性。结果:治疗第4周开始,两组晨僵持续时间、受试者整体状况评估、SJC、TJC、ESR、CRP及DAS28等指标均较治疗前明显改善(P<0.01);治疗第4周开始,两组间受试者整体状况评估存在差异(P<0.05),治疗第8周开始,两组间受试者晨僵持续时间存在差异(P<0.05),整体状况评估存在显著差异(P<0.01),其余指标组间差异无统计学意义(P>0.05)。治疗后观察组与对照组DAS28达到缓解标准的有效率分别为13.11%和5.08%,差异无统计学意义(P>0.05)。观察组和对照组的疾病疗效总有效率和中医证候总有效率比较,差异有统计学意义(P<0.05或P<0.001)。两组药品不良反应发生率差异无统计学意义(P>0.05)。结论:问荆合剂联合西药治疗湿热痹阻型RA,能提高临床疗效,减少不良反应,是治疗湿热痹阻型类风湿关节炎的有效方案。
Objective: To evaluate the clinical efficacy and safety of hospital preparation Wen Jing He agent combined with western medicine in the treatment of rheumatoid arthritis (RA) with damp-heat syndrome. Methods: 132 patients with rheumatoid arthritis were randomly divided into two groups of 66 cases. The observation group was administered with Wenjing Mixture, methotrexate and leflunomide, while the control group was treated with methotrexate and leflunomide for 12 weeks. The curative effect of the two groups of patients, curative effect of traditional Chinese medicine and the score of 28 joint activity score (DAS28) were observed to improve the situation and safety. Results: The duration of morning stiffness, assessment of overall condition, SJC, TJC, ESR, CRP, DAS28 and other indexes in the two groups were significantly improved from the 4th week to the 4th week (P <0.01) (P <0.05). There was a significant difference in the duration of morning stiffness between the two groups (P <0.05), and there was significant difference between the two groups in the assessment of overall condition (P <0.05) <0.01). There was no significant difference between other groups (P> 0.05). After treatment, the effective rates of DAS28 in the observation group and the control group were 13.11% and 5.08%, respectively, with no significant difference (P> 0.05). The total effective rate of disease treatment and the total effective rate of TCM syndrome in observation group and control group were statistically significant (P <0.05 or P <0.001). There was no significant difference in the incidence of adverse drug reactions between the two groups (P> 0.05). Conclusion: It is an effective treatment for rheumatoid arthritis of rheumatoid arthritis with rheumatoid arthritis and rheumatoid arthritis.