清肺饮加减治疗肺经风热型痤疮的临床研究
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摘要
目的:对清肺饮加减治疗肺经风热型痤疮的临床研究,综合评价其临床疗效和安全性,并对其作用机制进行初步探讨。
     方法:1.按纳入病例的先后顺序将患者随机分配到治疗组(清肺饮加减组)和对照组(丹参酮胶囊组)2.治疗方法:治疗组35例,内服清肺饮加减,药物组成:枇杷叶15g,桑白皮10g,黄芩15g,金银花20g.连翘10g,黄柏15g,知母10g,白花蛇舌草30g,生甘草6g,丹参30g,生地黄20g,牛蒡子10g。1日1剂,分2次服用。对照组33例,内服丹参酮胶囊,1次4粒,1日3次。两组患者合并外用姜黄消痤擦剂,用棉纤取药涂患处,1日2-3次。3.疗程及观察方法:6周为疗程,所有患者2周复诊1次,记录皮损积分及其不良反应。4.疗效评价方法:参考1997年10月中华医学会美学与美容分会皮肤美容学组制定的《寻常痤疮严重程度分级和疗效判定标准》进行疗效观察。根据治疗第2周、第4周、第6周前后皮损数目计数计算疗效指数,并依据综合疗效评价标准评价疗效;根据炎性皮损、非炎性皮损的积分标准进行积分,观察治疗组、对照组对两类皮损的影响。每2周进行一次疗效评价及比较。同时根据与入组时比较,试验过程中患者新出现或加重的症状、体征和疾病,进行安全性评价。
     结果:1.清肺饮加减治疗肺经风热型痤疮的显效率14.28%,有效率为57.14%,总有效率为82.86%,丹参酮胶囊组的显效率为5.88%,有效率为58.82,总有效率为70.59%,经X2检验,P<0.05,有显著差异。说明清肺饮加减治疗肺经风热型痤疮的疗效优于对照组。
     2.治疗组与对照组综合疗效经卡方检验得出治疗组与对照组治疗2周后,4周后综合疗效相比无显著性差异P>0.05;治疗6周后,两组综合疗效比较有显著性差异P<0.05。
     3.治疗组对痤疮患者非炎性皮疹的改善优于对照组,P<0.05,对炎性皮疹的改善与对照组没有显著差异,P>0.05。
     4.清肺饮加减治疗组不良反应发生少,说明清肺饮加减治疗肺经风热型痤疮为临床安全方药。
     结论:1.清肺饮加减治疗肺经风热型痤疮的疗效确切,用药安全,是治疗痤疮的有效中药复方。2.清肺饮加减对痤疮患者总皮损及非炎性皮损的改善优于对照组。3.清肺饮加减治疗肺经风热型痤疮疗程以不低于6周较为适宜。
The Clinical research of Modified Qing-fei-yin in treatment of Acne about Lung Channel with wind-heat type.
     Objective:Generally assess the clinical effect and security of Modified Qing-fei-yin in treatment of Acne about Lung Channel with wind-heat type by clinical study.
     Methods:1. Divide the patients who are suffering from acne into two groups randomly.2. The experimental group contains35cases. And the treatment of the experimental group is based on Modified Qing-fei-yin. The ingredients of Modified Qing-fei-yin are:15g loquat, lOg morus,15g scute,20g honeysuckle., lOg forsythia,15g phellodendron, lOg rhizoma anemarrhenae,30g hedyotis,6g wild,30g salvia miltiorrhiza,20g radix rehmanniae recen,10g lappa.one day one pack, twice a day. The control group contains34cases, taking Danshentong Capsules three times a day. The patients taking jiang-huang-xiao-cuo-cha-ji gel twice a day2.3. Period of treatment and observing indicator:The period of treatment is six weeks, take records the number of inflammatory lesions, and take notes of the change of symptoms, adverse reactions every second weeks.4. Clinical criteria testimonial to the effectiveness criteria on "effectiveness criteria and grading standard of acne vulgaris'" establish by Chinese Medical Association dermatology and between the treatment group Oct.1997.
     Result:The general effective rate of the treatment group is82.86%and the control group is70.59%; There is a expressive difference between the treatment group and control group of the curative index after6weeks; There is no expressive difference between the treatment group and control group of total skin rash score. The safety indicators Modified Qing-fei-yin in treatment of Acne about Lung Channel with wind-heat type in safe.
     Conclusion:1. Modified Qing-fei-yin has good clinical effects and high safety in treatment of Acne about Lung Channel with wind-heat type.2. It can improve Modified Qing-fei-yin in an effiective therapy principle in treatment of Acne about Lung Channel with wind-heat type.3. Modified Qing-fei-yin in treatment of acne about Lung Channel with wind heat type is relatively appropriate for more than six weeks.
引文
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