辨证论治配合他克莫司治疗白癜风的临床研究

发布时间：2018-07-24 13:45

【摘要】：目的：通过随机对照临床试验,评价白驳方Ⅰ号、白驳方Ⅱ号辨证论治配合外用他克莫司治疗白癜风的临床疗效、安全性,并初步探讨其可能的作用机制。方法：1.选择符合纳入标准的病例,按2：1比例随机分为试验组和对照组,试验组经辨证分为试验Ⅰ组(气滞血瘀型)和试验Ⅱ组(肝肾阴虚型)。2.治疗方法：试验Ⅰ组和试验Ⅱ组分别口服白驳方Ⅰ号(药物组成：当归10g、川芎6g、熟地10g、赤芍10g、桃仁10g、鸡血藤20g、白芷l0g、马齿苋15g)及白驳方Ⅱ号(补骨脂10g,制首乌10g,熟地15g,旱莲草15g,当归6g,白蒺藜30g,丹参20g,红花6g,马齿苋15g,沙苑子30g),每日1剂,水煎400ml,分早晚温服,同时外用0.1%他克莫司软膏,每日2次；对照组患者仅外用0.1%他克莫司软膏,每日2次。3.疗程及观察方法：疗程3个月,分别于治疗前和疗程结束后观察计算皮损面积。4.T细胞亚群检测：试验组及对照组治疗前后均查T细胞亚群,其结果与30例健康成年人组成的健康对照组比较。5.疗效评定方法：参照中国中西医结合皮肤性病学会色素病学组有关白癜风的疗效标准(2003年修订稿)。6.安全性检测：试验组患者治疗前后均查肝肾功能、血尿常规。7.统计方法：采用SPSS12.0统计软件进行统计学分析,P0.05将被认为所检验的差别有统计学意义。结果：1.皮损面积改善情况的比较：试验组与对照组各自治疗前后的皮损面积比较均有显著性差异(P0.05),两组患者治疗后的皮损面积较治疗前有改善；两组治疗后的皮损面积比较也有显著性差异(P0.05)。2.痊愈率及总有效率比较：治疗后两组的痊愈率及总有效率均有显著性差异(P0.05)。3.T细胞亚群检测结果：治疗前,试验组及对照组的稳定期患者的T细胞亚群比较均无显著性差异(P0.05),两组的进展期患者的T细胞亚群比较均无显著性差异(P0.05)；两组的稳定期及进展期患者分别与健康对照组的T细胞亚群比较,两组的稳定期与健康对照组均无显著性差异(P0.05)；但两组的进展期患者与健康对照组相比均有显著性差异(P0.05),其CD3、CD4、CD4/CD8均低于健康对照组,而CD8明显高于健康对照组。治疗结束后,两组的稳定期患者的T细胞亚群比较均无显著性差异(P0.05),两组的进展期患者的T细胞亚群比较均有显著性差异(P0.05),两组的稳定期及进展期患者分别与健康对照组的T细胞亚群比较发现,两组的稳定期患者与健康对照组的T细胞亚群比较均无显著性差异(P0.05)；试验组进展期患者的CD8与健康对照组比较无显著性差异(P0.05),而CD3、CD4、CD4/CD8仍有显著性差异(P0.05),进展期患者与健康对照组的T细胞亚群比较均有显著性差异(P0.05)。试验组进展期患者治疗前后的T细胞亚群比较有显著性差异(P0.05),对照组进展期患者治疗前后的T细胞亚群比较无显著性差异(P0.05)4.安全性比较：两组患者治疗后的肝肾功能、血尿常规均无异常。结论：外用0.1%他克莫司软膏联用中药白驳方Ⅰ号、白驳方Ⅱ号辨证治疗白癜风无明显毒副作用,比较安全,痊愈率及总有效率明显高于仅外用他克莫司的对照组。进展期白癜风患者的T细胞亚群与正常人比较,CD3、CD4、CD4/CD8低于正常人,CD8高于正常人；经过中药治疗,进展期白癜风患者异常的的T细胞亚群均有正常化的趋势,但CD3、CD4、CD4/CD8与正常人比较,仍有显著差异。
[Abstract]:Objective: To evaluate the clinical efficacy, safety and possible mechanism of the treatment of vitiligo by a randomized controlled clinical trial to evaluate the clinical efficacy and safety of the white barge formula No. I, the white barge formula II syndrome differentiation and treatment combined with tacrolimus for the treatment of vitiligo.
Methods: 1. the cases were selected in accordance with the inclusion criteria and were randomly divided into experimental group and control group according to the proportion of 2:1. The experimental group was divided into experimental group I (qi stagnation and blood stasis type) and test group II Group (liver kidney yin deficiency type).2. treatment method: experimental group I and group II group oral white barge No. I (drug composition: Angelica 10g, Ligusticum chuanxiong 6G, cooked 10g, Chek. Peony 10g, peach kernel 10g, Caulis 20g, Angelica dahurica L0g, purslane 15g) and white barge square II (psoralen 10g, made Radix Polygoni multiflorum 10g, Radix Polygoni multiflorum 10g, Radix Rehmanniae 15g, rhizome 15g, Radix Angelicae Sinensis 6G, Tribulus terrestris 30g, Salvia miltiorrhiza 20g, safflower, safflower, and Sha Yuan), 1 doses per day, water fried, 0.1% Tacrolimus Ointment, 2 times a day; and only 2 times a day; control patients only outside 0.1% Tacrolimus Ointment, 2 times a day.3. course and observation method: 3 months of course of treatment, before and after the end of treatment, observe and calculate the.4.T cell subgroup of skin lesion area: the test group and the control group all check the T cell subgroup before and after treatment, and the result is compared with the healthy control group of 30 healthy adults to compare the evaluation method of the curative effect. : referring to the standard of the curative effect of the pigment disease group on the skin venereal disease association of Chinese and Western medicine combined with the skin venereal disease association (2003 revised draft).6. safety test: the liver and kidney function of the patients in the experimental group were examined before and after the treatment, and the routine.7. of hematuria was statistically analyzed by the SPSS12.0 statistical software, and P0.05 would be considered to be tested for the difference. The significance of learning.
Results: the comparison of the area improvement of 1. skin lesions: the skin lesions of the experimental group and the control group were significantly different before and after the treatment (P0.05). The area of skin lesion after treatment in the two groups was better than that before the treatment. The area of skin lesion after the treatment of the two groups was also significantly different (P0.05) the recovery rate of.2. and the total effective rate. After treatment, the recovery rate and total effective rate of the two groups were significantly different (P0.05).3.T cell subgroup detection results: before treatment, there was no significant difference in the T cell subgroup of the patients in the experimental group and the control group (P0.05), and there was no significant difference in the T cell subgroup ratio of the two groups (P0.05); the two groups were stable and advanced. Compared with the T cell subgroup of the healthy control group, there was no significant difference in the stable period between the two groups and the healthy control group (P0.05), but the two groups were significantly different from the healthy control group (P0.05), and their CD3, CD4 and CD4/CD8 were lower than those in the healthy control group, and the CD8 was significantly higher than that in the healthy control group. After the treatment, the treatment was over, There was no significant difference in the T cell subsets in the two groups (P0.05). The T cell subsets of the two groups were significantly different (P0.05). The two groups of stable and progressive patients were compared with the T cell subgroup of the healthy control group, and the two groups of stable patients and the T cell subgroup of the healthy control group There was no significant difference in comparison (P0.05). There was no significant difference between CD8 and healthy control group (P0.05), while CD3, CD4, CD4/CD8 still had significant difference (P0.05). There was a significant difference in T cell subgroups between the progressing patients and the healthy control group (P0.05). The T cell subgroup before and after treatment in the experimental group. There was a significant difference in group comparison (P0.05). There was no significant difference in the T cell subgroup before and after treatment in the control group (P0.05) 4. security comparison: the liver and kidney function of the two groups after treatment and the routine hematuria were not abnormal.
Conclusion: there is no obvious toxic and side effects in the treatment of vitiligo with 0.1% Tacrolimus Ointment combined with Chinese medicine, white barge No. I, and white barge formula II. The recovery rate and total effective rate are significantly higher than those in the control group only external use tacrolimus. The T cell subsets of patients with vitiligo in progressive stage are compared with normal people, CD3, CD4, CD4/CD8 are lower than those of normal people, CD8 It is higher than normal people; after the treatment of Chinese medicine, abnormal T cell subsets in patients with vitiligo have a normal trend, but there are still significant differences in CD3, CD4, and CD4/CD8 compared with normal people.
【学位授予单位】：中国中医科学院
【学位级别】：博士
【学位授予年份】：2012
【分类号】：R758.41

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