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开元骨泰胶囊为治疗ＲＡ早期及活动期、痹病属湿热痹之药。选择ＲＡ属湿热痹患者４５６例。开元骨泰胶囊治疗组３１６例，痹琪胶囊对照组１４０例。经８周临床治疗，开元骨泰胶囊Ⅱ期临床试验结果表明：治疗组总有效率为９１．７７％，对照组总有效率为７４．２９％，两组具有显著差异，Ｐ＜０．００５，两组对湿热痹主症有效率比较开元骨泰胶囊优于痹滇胶囊，Ｐ＜０。００１。开元骨泰胶囊治疗前后比较亦有非常显著意义，Ｐ＜０．００１。试验中未出现心、肝、肾等重要脏器的不良反应。试验结果表明，该药具有较强的抗炎、镇痛作用和一定免疫作用。不良反应少，服用安全，是一种具有开发前景值得推荐的中药新药。
Kaiyuan Gutai Capsule is a medicine for treating early and active RA, and diarrhea disease is a hot and humid expectorant. The selected RA patients were 456 cases of damp heat. There were 316 cases of Kaiyuan Gutai capsule treatment group and 140 cases of Qiqi capsule control group. After 8 weeks of clinical treatment, Kaiyuan Gutai Capsule Phase II clinical trials showed that the total effective rate was 91.77% in the treatment group and 74.29% in the control group. There was a significant difference between the two groups, P<0.005. The efficacy of Kaiyuan Gutai capsules was better than that of Qi capsules in the two groups, and the effective rate of the main symptoms of damp heat phlegm was P<0.001. There were also significant differences between before and after treatment of Kaiyuan Gutai capsules, P<0.001. There was no adverse reaction of important organs such as heart, liver and kidney in the test. The test results show that the drug has strong anti-inflammatory, analgesic and certain immune effects. Less adverse reactions, taking safety, is a new Chinese medicine with development prospects worth recommending.