中医药内外合治黄褐斑的疗效观察及抗氧化机理研究
发布时间：2018-10-05 14:29
【摘要】：目的： 观察中药内服加消斑膜外用配合耳穴压豆治疗黄褐斑的临床疗效；通过观察其对患者血清SOD、MDA的影响,探讨其可能的治疗机制；通过观察其可能出现的不良事件,对其安全性做出评价。通过以上的研究,为黄褐斑的临床治疗提供一种安全、有效的治疗方案。 方法： 1临床部分 1.1研究设计方法 采用随机对照方法。用密闭信封法,参照随机数字表按照2：1产生试验组和对照组的随机安排。将对应的治疗分配信笺密封入信封,形成随机信件。按纳入病例的先后顺序将患者随机分配到试验组或对照组。最后纳入研究165例患者,其中试验组112例,对照组53例。 1.2治疗方法 试验组112例,肝郁血滞型内服中药消斑1号方及中药祛斑膜1号方外用配合耳穴压豆治疗；肾虚型内服消斑2号方及中药祛斑膜2号方外用配合耳穴压豆治疗。对照组53例,维生素C片和维生素E胶丸口服,0.1%维A酸乳膏外用治疗,治疗12周后进行疗效判定。 1.3观察方法 所有患者于初诊、治疗第4周、第8周、第12周复诊时,记录皮损面积、皮损颜色、皮损严重程度评分等观察指标,并于初诊及治疗12周结束时进行血尿常规、肝肾功能等安全指标检测。询问用药依从性,记录合并用药及不良反应。 1.4疗效判定方法 ①黄褐斑皮损改变评分方法和标准：根据中国中西医结合皮肤性病学会色素性疾病分会2003年制定的标准。 ②疗效评价标准：按四级疗效标准评定(尼莫地平法)。 评分下降指数计算方法： 下降指数=(治疗前总积分一治疗后总积分)/治疗前总积分。 1.5安全性评价方法： 所有患者于试验前后分别检测血常规、尿常规,肝功能、肾功能,记录两组不良事件发生率,临床全过程观察。 2实验部分 2.1研究对象：为第二部分中用“中药内服及外用面膜配合耳穴压豆联合治疗”试验组的40例患者；健康对照组10例。 2.2分别抽取受试者治疗前、治疗后及健康志愿者空腹外周静脉血5ml,注入试管中,离心(2000r/min,10min)吸取上层血清注入EP管中,加盖塞紧,置于-87℃冰箱保存待检,避免反复冻融。 2.3血清SOD和MDA的检测：采用酶联免疫分析试剂盒检测,严格按照说明书操作。 3统计学方法 比较两组的疗效、不良反应采用t检验；多组间的比较采用方差分析；不同疗效及安全性评价采用Ridit分析；有效率的比较采用x2检验。P0.05具有显著性差异。统计软件为SAS8.1。 结果： 1.两组各项症状改善情况的比较：治疗前后两组总评分及下降指数比较有显著性差异(P0.05)。 2.两组疗效比较：试验组总有效率87.50%,对照组总有效率66.04%,两组比较差异有统计学意义(P0.05)。 3.安全性比较： 试验组治疗前后实验室检查无异常,试验组和对照组的安全性比较,无显著性差异(P0.05)。 4.血清SOD和MDA的水平变化：黄褐斑患者与健康人比较,血清中SOD的水平明显降低,MDA水平明显升高,且差异有统计学意义(P0.05)：试验组治疗后血清SOD水平比治疗前升高,MDA水平比治疗前降低,且差异均有统计学意义(P0.05)；肝郁血滞组与肾虚组比较,肾虚组患者的血清SOD、 MDA水平变化更为显著。 结论： 1.中医药“内外合治”黄褐斑的临床疗效肯定。 2.中医药“内外合治”黄褐斑能升高患者血清SOD水平,降低血清MDA水平。 3.中医药“内外合治”黄褐斑是一种安全有效的值得推广的治疗方案。 基于以上结果,本研究初步证实了中医药“内外合治”黄褐斑,疗效肯定,安全性高,值得临床推广应用。同时初步证实中医药“内外合治”黄褐斑可能是通过抗氧化机制发挥作用的。
[Abstract]:Purpose: To observe the clinical curative effect of traditional Chinese medicine oral and anti-plaque membrane combined with the traditional Chinese medicine pressed bean for the treatment of melalma; observe the effect of its influence on the serum SOD and MDA of the patients, discuss its possible treatment mechanism; observe the possible adverse events, and make it safe to the patients. Evaluation. Through the above research, it provides a safe and effective treatment for the clinical treatment of melmelia. Programme. METHODOLOGY: 1 Clinical part 1. 1 Study set The method adopts a randomized controlled method. With closed envelope method, the reference to the random number table is 2: 1. The randomization schedule for the test group and the control group was generated. The corresponding treatment was assigned The letterhead is sealed into the envelope to form a random letter. The order in which the case is incorporated will Patients were randomized to either the test group or the control group. Finally, 165 patients were enrolled in the study, of which 112 cases of test group In the control group, there were 112 cases of control group, 1. 2 treatment method test group, 1 prescription of traditional Chinese medicine Xiaoyan No.1 and the traditional Chinese medicine spot removing film No. 1 for external use. Prescription and traditional Chinese medicine spot removing film No. 2 for external use in combination with pressed bean treatment. In control group, 53 cases, vitamin C tablets and vitamin E gel pill were taken orally, 0. 1% dimensional A Application of acid cream for external use After 12 weeks of treatment, after 12 weeks of treatment, all patients were treated for the first week, the 4th week, the 8th week and the 12th week, and the lesion area, the color of the lesions, the severity of the lesions were recorded and other observation indexes were recorded. At the end of 12 weeks of treatment, blood urine routine, liver and kidney function, etc. were performed. Safety index detection. Query Medication compliance, record of concomitant medications and adverse reactions. 1. 4 Methods of evaluation of efficacy determination methods and criteria for the change of skin lesions: According to the Chinese traditional Chinese and western medicine combined with the dermatology of dermatology, the branch of the disease branch 200 The standard developed in 3 years. Evaluation criteria for clinical efficacy: assessed by four levels of efficacy criteria (NiNimethod). Calculation method of score reduction index: fall index = (total integral after treatment-total score after treatment)/ total score before treatment. 1. 5 Method of evaluation of safety: There is a patient in the trial blood routine and urine routine are respectively detected before and after the test, Liver function, renal function, record two groups of adverse event rates, Pro whole-course observation of the bed. Experimental part 2. 1 Study object: In the second part, 40 patients in the test group were treated with "Chinese medicine oral administration and external facial mask", and 10 cases of healthy control group. centrifuging (2000r/ min, 10min) sucking the upper layer serum into the EP tube, capping, placing in-87 鈩，
本文编号：2253755
[Abstract]:Purpose: To observe the clinical curative effect of traditional Chinese medicine oral and anti-plaque membrane combined with the traditional Chinese medicine pressed bean for the treatment of melalma; observe the effect of its influence on the serum SOD and MDA of the patients, discuss its possible treatment mechanism; observe the possible adverse events, and make it safe to the patients. Evaluation. Through the above research, it provides a safe and effective treatment for the clinical treatment of melmelia. Programme. METHODOLOGY: 1 Clinical part 1. 1 Study set The method adopts a randomized controlled method. With closed envelope method, the reference to the random number table is 2: 1. The randomization schedule for the test group and the control group was generated. The corresponding treatment was assigned The letterhead is sealed into the envelope to form a random letter. The order in which the case is incorporated will Patients were randomized to either the test group or the control group. Finally, 165 patients were enrolled in the study, of which 112 cases of test group In the control group, there were 112 cases of control group, 1. 2 treatment method test group, 1 prescription of traditional Chinese medicine Xiaoyan No.1 and the traditional Chinese medicine spot removing film No. 1 for external use. Prescription and traditional Chinese medicine spot removing film No. 2 for external use in combination with pressed bean treatment. In control group, 53 cases, vitamin C tablets and vitamin E gel pill were taken orally, 0. 1% dimensional A Application of acid cream for external use After 12 weeks of treatment, after 12 weeks of treatment, all patients were treated for the first week, the 4th week, the 8th week and the 12th week, and the lesion area, the color of the lesions, the severity of the lesions were recorded and other observation indexes were recorded. At the end of 12 weeks of treatment, blood urine routine, liver and kidney function, etc. were performed. Safety index detection. Query Medication compliance, record of concomitant medications and adverse reactions. 1. 4 Methods of evaluation of efficacy determination methods and criteria for the change of skin lesions: According to the Chinese traditional Chinese and western medicine combined with the dermatology of dermatology, the branch of the disease branch 200 The standard developed in 3 years. Evaluation criteria for clinical efficacy: assessed by four levels of efficacy criteria (NiNimethod). Calculation method of score reduction index: fall index = (total integral after treatment-total score after treatment)/ total score before treatment. 1. 5 Method of evaluation of safety: There is a patient in the trial blood routine and urine routine are respectively detected before and after the test, Liver function, renal function, record two groups of adverse event rates, Pro whole-course observation of the bed. Experimental part 2. 1 Study object: In the second part, 40 patients in the test group were treated with "Chinese medicine oral administration and external facial mask", and 10 cases of healthy control group. centrifuging (2000r/ min, 10min) sucking the upper layer serum into the EP tube, capping, placing in-87 鈩，
本文编号：2253755
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