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| 问荆合剂联合西药治疗湿热痹阻型类风湿关节炎临床观察 |
| Clinical Observation of Wenjing Mixture Combined with Western Medicine for Rheumatoid Arthritis of Dampness heat Obstruction Pattern |
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| DOI： |
| 中文关键词: 问荆合剂 类风湿关节炎 临床观察 甲氨喋呤 来氟米特 |
| 英文关键词:Wenjing Mixture Rheumatoid arthritis Clinical observation Methotrexate Leflunomide |
| 基金项目:上海市中医医院中药制剂能力提升项目（编号：ZY3-JSFC-2-1001） |
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| 中文摘要: |
| 摘 要 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。 |
| 英文摘要: |
| ABSTRACT Objective:To evaluate the clinical efficacy and safety of hospital preparation Wenjing Mixture combined with western medicine in the treatment of rheumatoid arthritis of dampness heat obstruction pattern. Methods:132 cases were randomized into two groups: observation group in which 66 cases were treated by Wenjing Mixture, methotrexate (MTX) and leflunomide, and control group in which 66 cases were treated by MTX and leflunomide with the course of 12 weeks. The clinical efficacy, syndrome of TCM and adverse drug reaction(ADR) were observed. Results:The duration of morning stiffness, visual analogue scale(VAS), SJC, TJC, ESR, CRP and DAS28 index were significantly improved after treatment of 4 weeks in the experimental group and control group (P<0.01) .There were significant differences of visual analogue scale (VAS) after 4 weeks of treatment (P＜0.05) , duration of morning stiffness (P＜0.05) and VAS after 8 weeks of treatment (P＜0.01), while the others showed there was no significant difference between groups (P>0.05). The remission rate of disease activity score (DAS28) in observation group after treating 12 weeks was 13.11%, which was better than that of control group’s 5.08% (P>0.05). The total effective rate and the total effective rate of TCM syndromes between the two groups were statistically significant(P<0.05 or P<0.001).The incidence of ADR in observation group was less than that in control group, but there was no significant difference between two group (P＞0.05). Conclusion:Wenjing Mixture combined western medicine could improve the clinical efficacy and reduce risk of ADR, it was the effective therapeutic regimen of rheumatoid arthritis of dampness heat obstruction pattern. |
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