辨证论治配合他克莫司治疗白癜风的临床研究
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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,P<0.05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(P<0.05),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(P<0.05)。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(P<0.05)。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(P>0.05),两组的进展期患者的T细胞亚群比较均无显著性差异(P>0.05)；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(P>0.05)；但两组的进展期患者与健康对照组相比均有显著性差异(P<0.05),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(P>0.05),两组的进展期患者的T细胞亚群比较均有显著性差异(P<0.05),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(P>0.05)；试验组进展期患者的CD8与健康对照组比较无显著性差异(P>0.05),而CD3、CD4、CD4/CD8仍有显著性差异(P<0.05),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(P<0.05)。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(P<0.05),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(P>0.05)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。
Objective:To evaluate clinical efficacy and safety of using vitiligo prescription Ⅱ, vitiligo prescription Ⅱ and tacrolimus in the treatment of vitiligo by randomized controlled clinical trial, and to explore its possible mechanism.
Methods:
1.Selected patients were randomly divided into experimental group and control group by the ratio of2:1. The experimental group were then further divided into Experimental Group Ⅰ(syndrome of Qi-Stagnation and Blood Stasis) and Ⅱ(syndrome of Yin Deficiency of the Liver and Kidney).
2.Treatments:Experimental Group Ⅰ and Ⅱ were treated with vitiligo prescription I and vitiligo prescription Ⅱ respectively. And meanwhile use topical0.1%tacrolimus ointment twice a day; control group only use topical0.1%tacrolimus ointment, twice daily.
3.Treatment and observation methods:observing and calculating the skin lesions area before and after the treatment.
4.T cell subsets detection:check T-cell subsets before and after treatment and compare the results with30cases of healthy adults.
5.efficacy evaluation method:refer to the efficacy standard of vitiligo by Chinese Medicine Institute of Dermatology and Venereology pigment Disease Study Group (2003revised).
6.Safety testing:test group before and after treatment to check liver and kidney functions, urine routine.
7.Statistical Methods:to adopt SPSS12.0statistical software for statistical analysis, P <0.05would be considered the test of the difference was statistically significant.
Results:
1.Comparison of the improvement of lesions area:both the experimental group and control group showed significant difference(improved) of lesions area before and after treatment (P<0.05). the difference between the experimental group and control group were also significant (P<0.05).
2..Comparison of cure rate and total efficacy:the differences of cure rate and total efficiency between experimental group and control group were significant (P<0.05)
3.Results of T cell subsets test:There were no significant difference between patients in the experimental group and control group in both stable stage and advanced stage before treatment (P>0.05); there were no difference between both groups that were in stable stage and the healthy group (P>0.05); the CD8of the experimental group that were in advance stage showed no significant difference comparing to healthy control group (P>0.05), but the difference of CD3, CD4, CD4/CD8are significant(P<0.05), the comparison of T cell subsets of patients in advance stage and healthy group showed significant difference(P<0.05). there are no significant difference in control group that are in advance stage in comparison of T cell subsets before and after treatment(P>0.05).
4. security:liver and kidney function, urinalysis showed no abnormality after treatment.
Conclusion:Using0.1%tacrolimus ointment topically combined with vitiligo prescription Ⅰ and vitiligo prescription Ⅱ treating vitiligo have no significant side effects, and are relatively safe. The recovery rate and the total efficiency are significantly higher than control group that only using tacrolimusthe topically. Compare to normal people, vitiligo patients in advance stage have lower CD3and CD4and CD4/CD8and higher CD8. After treated with Traditional Chinese Medicine, the T cell subset of vitiligo patients in advance stage showed a progress to normal, but there are significant differences of CD3, CD4, CD4/CD8comparing to normal people.
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,P<0.05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(P<0.05),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(P<0.05)。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(P<0.05)。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(P>0.05),两组的进展期患者的T细胞亚群比较均无显著性差异(P>0.05)；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(P>0.05)；但两组的进展期患者与健康对照组相比均有显著性差异(P<0.05),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(P>0.05),两组的进展期患者的T细胞亚群比较均有显著性差异(P<0.05),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(P>0.05)；试验组进展期患者的CD8与健康对照组比较无显著性差异(P>0.05),而CD3、CD4、CD4/CD8仍有显著性差异(P<0.05),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(P<0.05)。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(P<0.05),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(P>0.05)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。
Objective:To evaluate clinical efficacy and safety of using vitiligo prescription Ⅱ, vitiligo prescription Ⅱ and tacrolimus in the treatment of vitiligo by randomized controlled clinical trial, and to explore its possible mechanism.
Methods:
1.Selected patients were randomly divided into experimental group and control group by the ratio of2:1. The experimental group were then further divided into Experimental Group Ⅰ(syndrome of Qi-Stagnation and Blood Stasis) and Ⅱ(syndrome of Yin Deficiency of the Liver and Kidney).
2.Treatments:Experimental Group Ⅰ and Ⅱ were treated with vitiligo prescription I and vitiligo prescription Ⅱ respectively. And meanwhile use topical0.1%tacrolimus ointment twice a day; control group only use topical0.1%tacrolimus ointment, twice daily.
3.Treatment and observation methods:observing and calculating the skin lesions area before and after the treatment.
4.T cell subsets detection:check T-cell subsets before and after treatment and compare the results with30cases of healthy adults.
5.efficacy evaluation method:refer to the efficacy standard of vitiligo by Chinese Medicine Institute of Dermatology and Venereology pigment Disease Study Group (2003revised).
6.Safety testing:test group before and after treatment to check liver and kidney functions, urine routine.
7.Statistical Methods:to adopt SPSS12.0statistical software for statistical analysis, P <0.05would be considered the test of the difference was statistically significant.
Results:
1.Comparison of the improvement of lesions area:both the experimental group and control group showed significant difference(improved) of lesions area before and after treatment (P<0.05). the difference between the experimental group and control group were also significant (P<0.05).
2..Comparison of cure rate and total efficacy:the differences of cure rate and total efficiency between experimental group and control group were significant (P<0.05)
3.Results of T cell subsets test:There were no significant difference between patients in the experimental group and control group in both stable stage and advanced stage before treatment (P>0.05); there were no difference between both groups that were in stable stage and the healthy group (P>0.05); the CD8of the experimental group that were in advance stage showed no significant difference comparing to healthy control group (P>0.05), but the difference of CD3, CD4, CD4/CD8are significant(P<0.05), the comparison of T cell subsets of patients in advance stage and healthy group showed significant difference(P<0.05). there are no significant difference in control group that are in advance stage in comparison of T cell subsets before and after treatment(P>0.05).
4. security:liver and kidney function, urinalysis showed no abnormality after treatment.
Conclusion:Using0.1%tacrolimus ointment topically combined with vitiligo prescription Ⅰ and vitiligo prescription Ⅱ treating vitiligo have no significant side effects, and are relatively safe. The recovery rate and the total efficiency are significantly higher than control group that only using tacrolimusthe topically. Compare to normal people, vitiligo patients in advance stage have lower CD3and CD4and CD4/CD8and higher CD8. After treated with Traditional Chinese Medicine, the T cell subset of vitiligo patients in advance stage showed a progress to normal, but there are significant differences of CD3, CD4, CD4/CD8comparing to normal people.
引文
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