Objective: By observing the change of leukasmus area before and after, evaluating the effectiveness and safeness of treating vitiligo with herbal fomentation combined with NB-UVB and tacrolimus ointment. From both syndrome differentiation and treatment theory of Chinese medicine and modern medicine perspective, exploring the mechanism and synergistic effect of the combined treatments, designed to provide clinical and preliminary theoretical basis to a clinical effective treatment of vitiligo with minor adverse reaction.Methods:1 In long-term clinical practice and research, herbal fomentation combined with NB-UVB and tacrolimus ointment showed preferred clinical effect. By following the randomized controlled experimental methods, 66 vitiligo patients were selected after excluding the ones which are not suitable for this study, from all patients of dermatological department of Chinese Medicine Hospital of Hebei Province, starting from December 2013, ending with July 2015. Patients were randomly divided into control group(n=32) and treatment group(n=34). There have no statistical difference between the two groups in gender, age, illness duration, stage, types and area of leukasmus distribution(P>0.05), which ensured the accuracy and comparability of the experiment result.2 The patients in the control group expose leukasmus under NB-UVB, three times a week, adjusting irradiation dose by the result. External usage of 0.1% tacrolimus ointment, twice a day. The patients in the treatment group receive the same treatment as the control group, combined with herbal fomentation treatment(the tutor’s own prescription, keep the temperature of fomentation at 42℃) before NB-UVB irradiation, on a daily basis, 30 mins each time. Each group was treated for 1 course which is 6 months per course.3 Measuring and comparing the area of leukasmus before and after the treatment, classifying the patients into cured, markedly effective, effective and ineffective cases referred to The Clinical Types and Criteria of Therapeutic Effect of Vitiligo(2003 revised), calculated the markedly effective rate and the total effective rate. Documented the adverse reactions of both groups(e.g burning sensation, itching, redness, blisters etc.) to evaluate the safety of the two treatment methods. All data were analyzed by using SPSS(P>0.05 which is not statistical difference, P≤0.05 which is statistical difference, P≤0.01 which is significant difference).Results: During 6 months of treatment for the 66 patients, a small number of patients were dropped out of the study, which resulted in 64 completed cases, 33 in the treatment group and 31 in control group. Clinical Comparison: 1 After treatment, the average area of leukasmus of the control group is 41.48±16.77, which is less than the before treatment average of 53.78±24.67. The after treatment average area of leukasmus of the treatment group is 22.58±11.07, which is less than the before treatment average of 46.48±21.98. After statistical analysis, both group have statistical difference before and after treatment(P<0.01), which means both treatment is curative; 2 The treatment group after treatment the average area of leukasmus(22.58±11.07) is significantly lower than the control group(41.48±16.77), and the difference is statistical(P<0.01),which showed a much better therapeutic effect in the treatment group comparing to the control group; 3 Among the 31 cases in the control group, 1 was cured, 4 were markedly effective, 17 were effective, 9 were ineffective, the markedly effective rate is 16.13% and the total effective rate is 70.94%. Among the 33 patients in the treatment group, 3 were cured, 11 were markedly effective, 17 were effective, 2 were ineffective, resulting the markedly effective rate of 42.42% and the total effective rate of 93.94%. The difference is statistical(P<0.05), which showed the treatment group is superior in the markedly effective rate and the total effective rate; 4 In the treatment process, 1 in control group and 2 in treatment group developed minor adverse reaction, all reaction were self-cured without special treatment. The difference in adverse reaction is not statistical(P >0.05), which shows no difference between the two groups in term of safety.Conclusion: By following the randomized controlled experimental methods, measuring and comparing the area of leukasmus before and after the treatment, herbal fomentation combined with NB-UVB and tacrolimus ointment showed preferred clinical effect. It can effectively reduce the area of leukasmus, improving the quality of life of the patients without causing adverse reaction. This method can improve clinical efficacy and worth further promotion in the clinical. |