基于症证结合评价润燥止痒方止痒作用及其特点的临床研究
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湖南省中医药科研基金资助项目(编号:2008035);国家中医药管理重大项目——湖湘欧阳氏杂病流派工作室建设(国中医药人教函[2012]228号)


Evaluation on the Effect of Runzao Zhiyang Decoction and Its Clinical Characteristics Based on Syndrome and Symptom Combination
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    摘要:

    目的:评价润燥止痒方治疗阴虚风燥型皮肤瘙痒症止痒、证候疗效及其相关性,探索以症为主,症证结合的疗效评价模式。方法:采用分层随机、阳性药物平行对照、双盲双模拟观察设计方案,按1:1纳入符合病例选择标准的受试者240例,主要观察指标为皮肤瘙痒症主症及阴虚风燥证主次症状。评价该方止痒效应及证候疗效,分析主症及证候改善的相关性。结果:1)润燥止痒方止痒总显效率为55.93%,总有效率为92.37%,疗效优于对照药(P<0.05);治疗阴虚风燥证的总显效率、总有效率分别为67.80%和98.31%,与对照组比较组间差异无统计学意义(P>0.05)。2)治疗组止痒、证候疗效及治疗前后积分差值均显著相关(P<0.05);证候主要症状瘙痒入夜尤甚、皮肤干燥与瘙痒积分变化相关有统计学意义(P<0.05);典型阴虚风燥证患者证、病积分变化显著相关(P<0.05)而非典型证无相关性;结论:润燥止痒方对阴虚风燥型皮肤瘙痒具有较好止痒作用,其作用特点在于改善瘙痒及其伴随的入夜尤甚、皮肤干燥等症状。临床证候的典型性是影响疗效的因素。症证结合评价有助于评价中药改善症状的作用及其特点。

    Abstract:

    To observe the clinical effect of Runzao Zhiyang decoction on reliving itching and its correlation with curative effect.Besides,to explore the evaluation mode of syndrome and symptom combination.Methods:According to 1:1 criteria,240 cases were collected as the subjects.Using stratified random,positive drug parallel control,double blind double simulation,evaluate the antipruritic effect and symptom relief effect of Runzao Zhiyang decoction and the correlation of main symptoms and syndrome by observing the main symptom of skin pruritus of yin deficiency and wind dryness syndrome.Results:1) The total efficiency rate of Runzao Zhiyang decoction is 55.93%,and total effective rate is 92.37%.The effect is more evident that of the control drug (P<0.05).The total efficiency rate of Runzao Zhiyang decoction in treating yin deficiency and wind dryness syndrome is 67.80%,and total effective rate is 98.31%.While there are no statistical significance (P>0.05) between the decoction and the control drug.2) There are obvious correlations among the curative effect,symptom relief effect and TCM scores before and after the treatment,with P<0.05.The major symptoms itching increased at night and skin prutitus have obvious correlations to itching scores (P<0.05).Besides,there are clear correlation between syndrome and symptom scores of patients of yin deficiency and wind dryness syndrome while none in atypical syndrome patients (P<0.05).Conclusion:Runzao Zhiyang decoction has a good antipruritic effect on skin pruritus with yin deficiency and wind dryness syndrome.It can improve itching,increase itching in the night and skin dryness.The typicality of clinical syndrome is the influential factor of its curative effect.In addition,combination of symptom and syndrome evaluation mode is suitable in researching Chinese medicine’s effect and its characteristics.

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程晓燕,丁正香,朱沛,尹天雷,刘天舒,朱克俭.基于症证结合评价润燥止痒方止痒作用及其特点的临床研究[J].世界中医药,2016,(06).

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  • 收稿日期:2016-05-25
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  • 在线发布日期: 2016-07-08
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