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中药治疗寻常性痤疮的文献分析及中医药内外结合治疗痤疮的临床研究

【作者】 杨彦洁

【导师】 黄尧洲;

【作者基本信息】 北京中医药大学 , 中医外科学, 2014, 博士

【摘要】 本论文主要分为两个相关联的部分,第一部分为中药治疗寻常性痤疮的文献分析;第二部分为中医药内外结合治疗痤疮的临床研究。1中药治疗寻常性痤疮的文献分析目的:中药内服治疗寻常性痤疮的现代文献较多,但临床用药及辨证分型多样,缺乏系统总结。本研究在查阅近15年中医临床文献资料的基础上,分析、归纳和总结中医药治疗寻常性痤疮的规律,为临床治疗及科学研究提供一定理论依据。方法:搜索CNKI中国期刊全文数据库中发表日期为1998年1月至2013年8月的相关文献。阅读文献题目及摘要,排除重复的文献报道和不符合纳入标准者。使用Excel2007表格进行统计和分析,对文献中使用中药的情况和痤疮的辨证分型统计频次及频率。结果:1.共选出符合标准的文献72篇,包含128首方剂,195种中药材,43种痤疮证型。2.所有中药共出现2062次,中药频次最大的为79次,最小的为1次,中位数是31次。排名前十位的是:黄芩、生甘草、栀子、丹皮、连翘、生地、赤芍、蒲公英、丹参、金银花。195种中药被《中药学》记载的有192种,涵盖了中药品18个大类,28个小类。排名前五位的是:清热药、补虚药、活血祛瘀药、解表药、化痰止咳平喘药。3.192种中药,四气以寒最多,五味以苦最多,归经以肝经最多。4.43种痤疮证型排名前五的是:肺经风热证、胃肠湿热证、冲任不调证、肺胃湿热证、湿热蕴结证。43种证型共归纳出19类证型,排名前3位是:湿热类、肺热类与痰瘀类。5.治疗湿热类痤疮,用药排名前五位是茵陈、黄芩、栀子、生大黄、白花蛇舌草,中药类别排名前三位的是清热药、利水渗湿药、解表药;治疗肺热类痤疮,用药排名前五位是黄芩、桑白皮、枇杷叶、生地、甘草,中药类别排名前三位的是清热药、解表药、活血祛瘀药;治疗痰瘀类痤疮,用药排名前五位是夏枯草、陈皮、生甘草、红花、丹参,中药类别排名前三位的是清热药、活血祛瘀药、补虚药。结论:临床治疗痤疮运用清热药最多,清热是贯穿痤疮治疗过程始终的总原则。最常见的痤疮类型为湿热类、肺热类和痰瘀类。2中医药内外合治痤疮的临床研究目的:观察中药口服加祛痘面膜外用治疗痤疮的临床疗效;规范中药面膜外敷的操作流程;通过观察不良事件发生率,评价本方案的安全性。方法:1.按先后顺序将符合纳入标准的痤疮患者以3:1随机分配到试验组与对照组。试验组病例根据中医辨证分为肺经风热证组、肺胃湿热证组和痰瘀互结证组。2.肺经风热证组口服Ⅰ号方,外用面膜Ⅰ号方治疗;肺胃湿热证组口服Ⅱ号方,外用面膜Ⅱ号方治疗;痰瘀互阻证组口服Ⅲ号方,外用面膜Ⅲ号方治疗;对照组口服丹参酮胶囊外用0.3%维胺酯维E乳膏。共治疗6周。3.所有患者于初诊及治疗后2周、4周、6周分别填写观察表,记录皮损个数、痤疮等级、中医症状评分以及不良反应。治疗6周后计算疗效指数。4.在初诊及治疗后2周、4周、6周分别记录患者非炎性皮损和炎性皮损个数,两者相加的总皮损个数即为总皮损分数。根据治疗前后皮损分数变化来计算疗效指数。同时根据痤疮等级、中医症状评分来评价临床疗效。5.通过观察患者治疗前与治疗后血常规、尿常规、肝肾功能的检验结果,以及治疗过程中发生的不良反应事件,评价本次实验的安全性。6.采用SPSS for windows19.0统计分析软件进行计算,所有统计检验均采用双侧检验,P<0.05具有显著性差异。结果:1.治疗6周后,试验组痊愈27例,显效77例,有效52例,无效22例,总有效率为87.64%;对照组痊愈8例,显效15例,有效22例,无效18例,总有效率为71.43%,差异有统计学意义(P=0.003)。肺经风热组总有效率为87.50%,肺胃湿热组总有效率为88.33%,痰瘀互阻组总有效率为87.03%,均高于对照组,差异有统计学意义。(P=0.025、0.020和0.040)2.在痤疮等级变化方面,两组治疗前后痤疮等级比较均有显著性差异,P值<0.05。试验组在治疗6周后Ⅲ级、Ⅳ级痤疮患者数明显减少,Ⅱ级痤疮患者数基本不变,Ⅰ级痤疮患者数量增加。3.中医症状评分方面,治疗6周后两组中医症状评分出现显著性差异,P值<0.05。患者包括口臭、腹胀、便秘、小便赤黄、痛经等中医症状均有不同程度的减轻。4.本次试验共完成241例,治疗前后患者血、尿常规、肝功能、肾功能均无异常,在治疗全过程患者未发现与药物有关和可能有关的严重不良反应。结论:1.中药配合面膜辨证治疗痤疮的临床疗效好,能够显著减少患者不同类型皮损数目。2.能够降低患者痤疮等级,改善痤疮的严重程度。3.能有效改善中医症状。4.本治疗方案安全性高,副作用小,值得推广。

【Abstract】 This dissertation contains two relevant parts:the literature analysis of traditional Chinese medicine in the treatment of acne vulgaris, and the Clinical study of TCM internal and external treatment of acne vulgaris.1Literature analysis of traditional Chinese medicine in the treatment of acne vulgarisObjective:Though there are many modern literature of TCM in the treatment of acne vulgaris, there is no systematic summery on clinical medicine and syndrome differentiation type diversity. Based on the clinical literature of TCM in recent15years, this study analyzed and summarized the TCM treatment of acne vulgaris rules, and will provide a theoretical basis for clinical treatment and scientific research.Methods:Relevant literatures published from January1998to August2013on TCM treatment of acne were gathered and analyzed from CNKI. By reading the title and abstract, we removed reports that repeated or did not meet the inclusion criteria. And we use Excel2007to statistics and analysis, counting the frequency of TCM medicine use and acne type diversity.Result:1. A total of72articles met the criteria were selected, including128prescriptions,195kinds of medicinal herbs,43kinds of acne TCM syndrome.2. All TCM herbs appears2062times, the largest medicine frequency is79times, the minimum is1, the median is31times. The top ten are:Radix Scutellariae, licorice root, gardenia, Cortex Moutan, forsythia, radix paeoniae rubra, rehmannia, Salvia miltiorrhiza, dandelion, honeysuckle.192of195kinds of TCM herbs were recorded by "Pharmacy", covering18categories,28small classes. The top five are:heat clearing drug, the tonic medicine, promoting blood circulation and removing blood stasis drugs, diaphoretic, resolving phlegm and relieving cough and asthma medicine.3.In192kinds of traditional Chinese medicine, the most of four properties is cold, the most of five tastes is bitter, and the main meridian of traditional Chinese Medicine is liver channel tropism.4. In43kinds of TCM syndrome, the top five are:the lung by wind heat syndrome, gastrointestinal damp heat syndrome, the syndrome of disharmony, lung and stomach damp heat syndrome, and damp heat retention.43syndromes were summarized in the19types of syndromes, The top3are:damp heat type, lung heat type and phlegm and blood stasis type.5. To treat damp heat type acne, the top five use of TCM herb is:Yin Chen, Scutellaria, gardenia, rhubarb, and Oldenlandia diffusa, the top3of medicine category is heat clearing drugs, diuresis medicine, and diaphoretic; To treat lung heat type acne, the top five use of TCM herb is:the baikal skullcap root, mulberry bark, loquat leaf, raw land, and Radix glycyrrhizae, the top3of medicine category is heat clearing drug, diaphoretic drug, and promoting blood circulation and removing blood stasis drugs; To treat phlegm and blood stasis type acne, the top five use of TCM herb is:Prunella vulgaris, tangerine peel, licorice root, safflower, and Danshen, the top3of medicine category is heat clearing drug, promoting blood circulation and removing blood stasis drugs, and tonifying drug.Conclusion:The largest use of TCM herbs in clinical treatment of acne is heat clearing drugs. Clearing heat is the general principles through the acne treatment process. The most common types of acne are damp heat type, lung heat type and phlegm and blood stasis type.2Clinical study of TCM internal and external treatment of acne vulgaris.Objective:To observe the clinical curative effect of TCM treatment with Oral medicine and external mask, standardize herbal mask treatment process, and to evaluate the safety of this study.Methods:1. The acne patients who met the inclusion criteria were randomly assigned to the experimental group and the control group with3:1. The control group were divided into the lung by wind heat syndrome group, lung and stomach damp heat syndrome group and the phlegm and blood stasis syndrome group, according to TCM syndrome differentiation.2. The lung by wind heat syndrome group oral prescription No.1, and take external mask No.1treatment; The lung and stomach damp heat syndrome group oral prescription No.2, and take external mask No.2treatment; The phlegm and blood stasis syndrome group oral prescription No.3, and take external mask No.3treatment; The control group oral Danshentong Capsules and use0.3%Viaminate and Vitamin E Cream. All patients were treated for6weeks.3. All patients completed the observation table Before treatment and after2,4,6weeks treatment. The observation table record number of acne lesions, grades, scores of TCM symptoms and adverse reaction. After6weeks of treatment, the curative effect index was calculated.4. Numbers of both non inflammatory lesions and inflammatory lesions were recorded before treatment and after2,4,6weeks treatment. The two together is the total lesion score, which is used to calculate therapeutic index. At the same time, according to the grade of acne and TCM symptom score, we evaluated the clinical efficacy.5. By observing patients’blood test, urine test, liver and kidney function test results before and after treatment, and the adverse events occurred in the process, we evaluate the safety of this experiment.6. We use SPSS for windows19.0to statistics. All statistical tests were two-sided test, P<0.05shows significant differences.Result:1. After6weeks of treatment, the test group total effective rate was87.64%; the control group total efficiency is71.43%, the difference was statistically significant (P=0.003). The lung by wind heat group total effectiveness is87.50%, lung and stomach damp heat group total effectiveness is88.33%, phlegm and blood stasis group, the total effective rate was87.03%, all of which were higher than the control group, and the difference was statistically significant.(P=0.025,0.020和0.040)2. The acne level in both test group and control group were reduced after6weeks treatment, and the difference was statistically significant(P<0.05). In the test group, after6weeks treatment acne patients in grade III, IV decreased obviously, the number of patients with acne in grade II was unchanged, the number of grade I was increased.3. The TCM symptom score in both test group and control group were reduced. However, after6weeks treatment, there was significant difference in the changes of TCM symptom score (P<0.05). TCM symptom including bad breath, abdominal distension, constipation, red or yellow urine, dysmenorrhea reduced in varying degrees.4. The tests were completed in241cases. Patients’blood test, urine test, liver function, and renal function showed no abnormality before or after treatment. There were no found of seriously related adverse reactions associated with drug in the treatment of the whole process.Conclusion:1. Treatment of traditional Chinese medicine combined with Chinese herb mask on acne vulgaris showed significant clinical effect. It can obviously reduce the number of skin lesions with different types.2. This treatment can lower the level of patients with acne vulgaris and reduce its severity.3. It can effectively improve the symptoms of TCM.4. This treatment has high safety, little side effect, and is worth promoting.

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