Kaiyuexin Ointment For Lung And Stomach Accumulate Heat Type Acne Vulgaris Efficacy And Safety Of Clinical Studies

Objectives:The study was aimed to assess the validity and s afety of Kaiyuexin Paste relieving skin lesion and symptoms in trea ting acne with the pattern of accumulated lung-stomach heat.Methods:1.Design:The study was performed under the clini cal principle of positive control (Dikang Acne Ointment), random, d ouble-blinded, and multi-center.2.Treatment:The paste or the oint ment was evenly smeared on the faces, which were washed with w arm water before the treatment,(1-1.5g t.i.d.), with two weeks as a period and four weeks as a standard treatment period.3.Observati on:A survey was employed to assess the characteristics of skin er uptions including type, amount, shape, itching, and pain e.t.c. at the initiative visit,14th day, and28th day, meanwhile, obedience and side-events were recorded as well.4.Therapeutic Effect Evaluatio n:The therapeutic effect was evaluated based on Guide for Clinical Trials of New Chinese Medicine Drugs (2002). A marking system was established to rank the syndrome, side-events before, during an d after the treatment. Evaluation was carried out once every two w eeks. Therapeutic effect and safety evaluations were performed after the unbinding.Results:1.There were no statistical differences between the ge nders, ages, morbid course, and ranks of primary symptoms and sec ondary symptoms of the two groups respectively,(P>0.05), showi ng a favorable comparability.2. A significant improvement or comprehensive therapeutic effect was obtained from the inter-group comparison in both groups (w2and w4)(P=0.00); no statistical differences of the comprehensive therapeutic effect, FAS and PPS were obtained between the two groups (P>0.05)3. A significant difference of TCM syndrome ranks was obtained from the inter-group comparison in both groups (w2and w4)(P=0.00); no statistical differences of the TCM syndrome ranks, FAS and PPS were obtained between the two groups (P>0.05)4. Skin lesions (type, amount, shape, itching and pain of eruption) were significantly improved after treatment in both groups (w2and w4)(P=0.00); no statistical differences of the skin lesions, FAS and PPS were obtained between the two groups (P>0.05)Conclusions:Kaiyuexin Paste is as effective and safe as Di kang Acne Ointment on the safety and effectiveness in relieving ski n lesion and symptoms in treating acne vulgaris with the pattern of accumulated lung-stomach heat.