茱萸丸联合麦灸棒清透点灸治疗寒热错杂型中重度痤疮随机对照研究OA

Objective To observe the clinical efficacy and safety of the combination of Zhuyu Pill and wheat grain moxibustion in the treatment of moderate to severe acne patients with cold-heat complex syndrome.Methods A total of 198 patients with acne were selected.Among them,180 patients met the inclusion criteria and were randomly assigned to the treatment group,the control group 1,and the control group 2,with 60 patients in each group.The treatment group was administered with Zhuyu Pill Granules+wheat grain moxibustion.The control group 1 was administered with Zhuyu Pill Granules,and the control group 2 was administered with Isotretinoin Soft Capsules+wheat grain moxibustion.All three groups received daily care guidance and were treated continuously for 8 weeks.The clinical efficacy was evaluated by comparing the Chinese medicine syndrome scores,the number of skin lesions,the acne comprehensive grading score system(GAGS)score,the facial sebum secretion volume,the quality of life score,the serum inflammatory factors,and the recurrence situation before and after treatment.The safety was evaluated by observing the safety indicators and adverse reactions.Results A total of 11 cases dropped out of this trial(3 cases in the treatment group,5 cases in the control group 1,and 3 cases in the control group 2).A total of 169 cases finally completed and were included in the statistics,among which 57 cases were in the treatment group,55 cases in the control group 1,and 57 cases in the control group 2.The acne improvement rate after treatment of the treatment group,control group 1,and control group 2 were 89.47％(51/57 cases),70.91％(39/55 cases),and 75.44％(43/57 cases),respectively.Comparison of improvement rates among the three groups showed statistically significant differences(x2=6.212,P＜0.05).Compared with baseline,the syndrome scores of traditional Chinese medicine,the number of skin lesions,the GAGS scores,the facial sebum secretion volume,and the serum inflammatory factors[interleukin(IL)-4,IL-1 β,IL-8]in all three groups decreased,while IFN-γ and the quality of life scores increased(P＜0.01).Compared with the control group 1 and control group 2 after treatment,the syndrome scores of traditional Chinese medicine,the number of skin lesions,the GAGS score,the facial sebum secretion volume,and the levels of serum inflammatory factors(IL-4,IL-1 β,IL-8)in the treatment group all decreased,while IFN-γ and the quality of life score increased(P＜0.05,P＜0.01).The adverse reactions in the treatment group,control group 1,and control group 2 were 5.26％(3/57 cases),7.27％(4/55 cases),and 75.44％(43/57 cases),respectively,with statistical difference(x2=86.857,P＜0.05).The recurrence rates in the treatment group,control group 1,and control group 2 were 7.84％(4/51 cases),25.00％(10/40 cases),and 27.91％(12/43 cases),respectively.The differences were also statistically significant(x2=6.442,P＜0.05).Conclusions The combination of Zhuyu Pill and wheat grain moxibustion effectively improved the skin lesions and traditional Chinese medicine syndromes of moderate to severe acne patients with cold-heat complex syndrome,reduced sebum secretion,elevated quality of life with better safety and lower recurrence rate.The mechanism might be related to the regulation of inflammatory factor levels.