热炎宁颗粒治疗风热证148例临床观察及中医“以证统病”的临床科研思路探讨

Clinical observation of 148 patients with wind-heat syndrome treated with Reyanningkeli and discussion on the clinical research assessment idea of syndrome leading diseases

目的:根据中医异病同治之理,探讨"以证统病"的临床研究评价思路。方法:采用随机分组、阳性药物(炎热清片)平行对照及双盲观察临床试验设计方案,观察热炎宁颗粒治疗同属风热证的化脓性扁桃体炎、急性气管-支气管炎及单纯性肺炎148例。结果:热炎宁颗粒对中医风热证的改善作用与阳性对照药物相似(非劣);对各不同病种(化脓性扁桃体炎、急性气管-支气管炎及单纯性肺炎)亦均有较好的改善作用,其作用均与对照药物相似。结论:本研究结果为"以证统病"的中药临床研究与评价模式提供了临床依据,亦提示这种在中医理论指导下的"以证统病"的临床研究与评价方法具有科学性,值得深入研究。

Objective： To research and discuss the clinical research assessment idea of syndrome leading diseases based on the theory of treating different diseases with the same treatment in traditional Chinese medicine. Methods： The clinical effect of Reyanningkeli on the treatment of 148 patients with suppurative tonsillitis, acute tracheal-bronchitis and simple pneumonia with the same syndrome of wind-heat in lung guided by the clinical trial program of grouped randomly, positive drug （Yanreqingpian）parallelled control, double-blind observation was observed. Results： The results showed that the improvement of Reyanningkeli to the syndrome of wind-heat in lung was similar as positive drug （not worse）. It also showed improvement to different diseases, such as suppurative tonsillitis, acute tracheal-bronchitis and simple pneumonia, and the improvement was similar as positive drug. Conclusion： The clinical resuhs could support the model of syndrome leading diseases in clinical research and assessment of Chinese mcdicine. The results also reveal that the clinical research and as sessment guided by the theory of traditional Chinese medicine of syndrome leading diseases is scientific, and worthy of researching deeply.