| Objective:The efficacy of milli fire needle combined with drugs and simple drugs in the treatment of vitiligo was compared to observe the difference of efficacy,syndrome type,leukasmus site in the process and modes of pigmentation.As observed by reflectance confocal microscopy.Early pigmentation,to enhance the patient's confidence in the treatment of vitiligo.Methods:The study included patients with vitiligo who met the requirements and were randomly divided into two groups.The treatment group took the " milli fire needle combined with compound glycyrrhizin tablets,traditional Chinese medicine Bushen Huoxue Fang or Baibo pill oral,0.1%tacrolimus for external use".The control group was treated with "Compound glycyrrhizin tablets,traditional Chinese Bushen Huoxue Fang or Baibo Pills,0.1%tacrolimus for external use".Both groups were treated with 3 months as a course of treatment.And treatments were observed at 0,4,8 and 12 weeks,using reflectance confocal microscopy(RCM)and valid of the vitiligo noticeability scale(VNS)scores to observe the process and modes of pigmentation and to record adverse reactions.Later,statisticed the efficacy of the two treatment methods and analyzed the difference of treatment methods,syndrome type,leukasmus site.Besides,all data were analyzed using statistical software SPSS21.0.Results:1.Efficacy1.1 Comparison between treatment group and control group:After 12 weeks of treatment,the effective rate was 65.7%in the treatment group and 44.4%in the control group,with no statistical difference(P<0.05).In the liver and kidney deficiency syndrome type,the effective rate was 35.3%and 58.8%in the 8th and 12th week treatment groups,higher than the control group 5.6%,11.1%(P<0.05);In the qi stagnation and blood stasis syndrome,there was no significant difference in efficacy between the treatment group and the control group(P>0.05).1.2Comparison of different syndromes:In the treatment group,there was no significant difference in efficacy between qi stagnation and blood stasis syndrome and liver and kidney deficiency syndrome(P>0.05).In the control group,at the 4th,8th,and 12th week,the effective rates of qi stagnation and blood stasis syndrome were 27.8%,77.8%,and 77.8%,higher than that of the liver and kidney deficiency syndrome,0.0%,5.6%,and 11.1%(P<0.05).2.Self-assessment of patients based on VNS2.1 Comparison between treatment group and control group:In the liver and kidney deficiency syndrome,the VNS scores of the 4th,8th,and 12th week treatment groups were 18.53,19.18,and 22.00,respectively.The VNS scores in the control group were 17.50,16.89,and 14.22,respectively.And among them,the 12-week treatment group was better than the control group(P<0.05).In the qi stagnation and blood stasis syndrome,there was no significant difference between the treatment group and the control group at the 4th to 12th week(P>0.05).2.2Comparison of different syndromes:In the treatment group,the VNS scores of the liver and kidney deficiency syndrome at the 4th,8th,and 12th weeks were 16.03,14.97,and 14.09,respectively.The VNS scores of qi stagnation and blood stasis were 19.86,20.86,and 21.69,respectively.Among them,the 12th week of qi stagnation and blood stasis syndrome was better than liver and kidney deficiency syndrome(P<0.05);In the control group,the qi stagnation and blood stasis syndrome was better than the liver and kidney deficiency syndrome(P<0.05).3.The process of repigmentation of vitiligo under RCM3.1RCM onset time:After the 8th week of treatment,the onset time of the treatment group under RCM was earlier than that of the control group(P<0.05);The onset time of qi stagnation and blood stasis syndrome was earlier than that of liver and kidney deficiency syndrome,but the difference was not statistically significant(P>0.05).The effection on the face and neck within 4 weeks was the most,accounting for 69.9%.The repigmentation in 4-8weeks in the trunk and limbs was the most,accounting for 46.7%and 61.5%,respectively.After the 12-week treatment,the non-repigmentation was most in the extremities,accounting for 45.0%,and the onset time of RCM was later than the other three sites(P<0.05).By comparing the onset time of the naked eye with the onset time of the RCM,it was found that the RCM onset time was 6.367 2.718 weeks earlier than the naked eye onset time 8.055 3.889 weeks.3.2The codes of repigmentation:The treatment group was dominated by hair follicle-type(51.4%),and the control group was mainly diffuse tupe(27.2%).There was no significant difference in repigmentation between liver and kidney deficiency syndrome and qi stagnation and blood stasis syndrome(P>0.05).In the area of leukasmus site,facial and neck areas were dominated by hair follicle type(52.2%),trunk area was dominated by peripheral type(33.3%),and limbs were mainly diffuse type(46.2%).The extremities were mainly non-reactive(50.0%).And there was a statistically significant difference between the extremities and the neck,limbs.In the treatment group,facial and neck areas were dominated by hair follicle type(90.9%),and the non-repigmentation of the extremities was low(27.3%).In the control group,the face and neck were dominated by diffuse type(75.0%),and the extremities had a high proportion of non-reactive(77.8%).4.Safety observations:Among 35 patients treated by milli fire needle,only 3 cases of erythema did not fade within 48 hours;In 71 patients,there were 3 cases of mildly elevated transaminases.Discontinuing of traditional Chinese medicines,the follow-up review was within the normal range.Overall,the safety of treatment was high.Conclusion:(1)The combination of milli fire needle and drugs in the treatment of vitiligo was effective,and its efficacy was higher than that of simple drug therapy,but there was no statistical difference,and its advantage was not obvious in the self-assessment of patients.This might be because the sample size was too small,the observation time was short,the repigmentation by eyes was subtle,and the patient cannot detect it.So the sample size should be increased to extend treatment and observation time.(2)Regardless of efficacy or self-assessment of patients,qi stagnation and blood stasis syndrome were better than liver and kidney deficiency syndrome,which indicates that the condition of qi stagnation and blood stasis syndrome was milder than that of liver and kidney deficiency syndrome.(3)The combination therapy of milli fire needle combined with drug therapy was earlier than the simple drug treatment in the RCM onset time,and the onset time of the RCM on the extremities was the latest.(4)The repigmentation codes of treatment of vitiligo with milli fire needle was mainly hair follicle-type.Compared with the control group,the milli fire needle could increase the repigmentatin rate of the hair follicle and promoted the repigmentation of the stubborn acromic site.(5)RCM could dynamically and non-invasively observe the process of repigmentation of vitiligo,which can reflect the repigmentation codes of vitiligo treated by different drugs.The early repigmentation observed by RCM gives patients confidence in the treatment. |
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