The Clinical Research Of Differentiation Treatment Of Vitiligo Combined With Tacrolimus

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.