| Purposes:This research aims to comprehensively evaluate the efficacy and safety of nano-microneedles in combination with Plant Essence Germinal Shampoo(hereinaflter referred to as plant shampoo)and Gufa Decoction in the treatment of AGA with damp-heat syndrome,which provides a reference for clinical treatment of androgenetic alopecia patients.Methods:Forty two patients who had been suffering from androgenetic alopecia with damp-heat syndrome were randomly divided into two groups,21 patients in each group.Patients in the treatment group were treated with Gufa decoction(200ml/time,2 times/day)add with combination of nano-micro needles and plant shampoo(1 time/week),and the patients in the control group were only given Gufa decoction(200ml/time,2 times/day).The course of treatment is 12 weeks.Before and after the treatment,we counted the total number of hair in every field of vision and record dermoscopic signs of scalp and the scalp symptom scores of the patient.We also took the photographs of patients’ hair from the front,bevel,and vertical planes.Thereby,we can comprehensively evaluate the therapeutic effect.At the same time,attention should be paid to the adverse reactions during the treatment.Results:1.General data evaluation:There was no significant difference between the two groups in the general data of age,sex and course of disease(P>0.05),which was comparable.2.Evaluation of overall e:fficacy:We evaluated the efficacy of alopecia based on the《Guidelines for Clinical Research of New Drugs in Traditional Chinese Medicine》.Through comparison of photos before and after,it was concluded that the efficiency of treatment group was 71.43%and the the efficiency of controlled group was 57.14%.There was no significant difference between the treatment group and the control group(P>0.05).3.Total number of hairs:The total number of hairs in the forehead,Baihui and Houding increased significantly both in the treatment group and the control group,and the difference was statistically significant(P<0.05).4.Hair growth rate:We compared the hair growth rate between the two groups.The hair growth rate of the treatment group in the forehead and posterior apex was significantly higher than that of the control group(P<0.01)and the hair growth rate of the treatment group in the baihui was obviously higher than that of the control group(P<0.05),the difference was statistically significant.5.The treatment group and the the control group have no significant improvement on the microscopic signs and hairy signs before and after treatment(P>0.05),and the difference was not statistically significant.6.Scalp symptom scores:Compared with the treatment group,the oil secretion symptoms were significantly improved(P<0.01),folliculitis and pruritus were significantly improved(P<0.05).The difference was statistically significant,The improvement of dandruff and scalp numbness was not obvious(P>0.05),and the difference was not statistically significant.In the control group,the symptoms of oil secretion and itching were significantly improved after treatment(P<0.01),the difference was statistically significant;The symptom of folliculitis was significantly improved(P<0.05)and the difference was statistically significant;The symptom of dandruff was not improved obviously(P>0.05),and there was no statistical significance;The symptom of scalp numbness had no improvement.Conclusions:1.Drinking Gufa decoction add with combination of nano-microneedles and plant shampoo and drinking Gufa decoction only are both effective for the treatment of androgenetic alopecia.However,there was no significant difference in the effect of the two regimens after 3 months of treatment.Compared with drinking Gufa decoction only,the treatment of drinking Gufa decoction add with combination of nano-microneedles can increase the growth rate of hair,and the effect is exact.2.Drinking Gufa decoction add with combination of nano-micro needles and plant shampoo and drinking Gufa decoction only can effectively improve the symptoms of scalp,such as oil secretion,folliculitis and itching.Our shampoo shows no obvious effect for the symptom of yellow spot sign and hair circumference sign in both groups.3.Treatments above have fewer adverse reactions and the adverse reactions can be controlled.In all,the operation is safe and reliable. |