光动力疗法联合加味附子理中汤治疗中重度寻常性痤疮的有效性和安全性研究

Study on the Efficacy and Safety of Photodynamic Therapy Combined with Jiawei Fuzi Lizhong Decoction in the Treatment of Moderate and Severe Acne Vulgaris

目的:探讨光动力疗法(photodynamic therapy,PDT)联合加味附子理中汤治疗中重度寻常性痤疮的有效性和安全性。方法:选取2016年6月-2019年6月在笔者医院皮肤科门诊接受治疗的95例中重度面部痤疮患者,所有患者的研究者总体评价(Investigator Global Assessment,IGA)评分3~4分。将所有患者随机分为观察组(n=48)和对照组(n=47)。观察组接受PDT联合加味附子理中汤治疗,PDT每2次间隔1周,共4次,加味附子理中汤每天口服1次,共8周;对照组接受PDT治疗,每2次间隔1周,共4次。在治疗前和治疗开始后的2、4、6和8周评估患者的IGA评分、皮损个数和安全性。结果:两组患者治疗前的IGA评分、皮损个数比较无显著差异。与对照组比较,8周时观察组在炎症性病变和非炎症性病变的皮损个数的下降百分比(74.4% vs 53.3%,P<0.001)和非炎症性病变(61.7% vs 42.4%,P<0.001)均明显增加。8周时观察组中IGA评分<2的比例明显高于对照组(30/48 vs 20/47,P<0.05)。中医证候疗效方面,观察组有效率明显高于对照组(P<0.05)。两组患者的不良反应发生率无明显差异。结论:与单用PDT相比,PDT联合加味附子理中汤治疗中重度面部痤疮患者安全、有效。

Objective The purpose of this study was to investigate the efficacy and safety of photodynamic therapy(PDT)combined with Jiawei Fuzi Lizhong Decoction for moderate to severe acne vulgaris,and its quality of life.The impact of (QOL).Methods This study included 95 patients with moderate to severe facial acne who were treated in our dermatology clinic from June 2016 to June 2019.The Investigator Global Assessment(IGA)scored 3-4 points for all patients.All patients were randomized into observation group(n=48)and control group(n=47).The observation group received PDT combined with Jiawei Fuzi Lizhong Decoction.PDT was treated every 2 times for 1 week,a total of 4 times.Jiawei Fuzi Lizhong Decoction was taken once a day for 8 weeks.The control group received PDT treatment,every 2 intervals for 1 week.,a total of 4 times.Patients'IGA scores,lesions,Dermatology Life Quality-index(DLQI)and safety were assessed before treatment and at 2,4,6 and 8 weeks after treatment initiation.Results There were no statistically significant differences in pretreatment IGA scores,lesions,and DLQI between the 2 groups.Compared with the control group,the percentage of lesions in the inflammatory lesions and non-inflammatory lesions was significantly increased in the observation group at 8 weeks(74.4%vs 53.3%,P<0.001)and non-inflammatory lesions(61.7%).Vs 42.4%,(P<0.001).At 8 weeks,the proportion of IGA score<2 in the observation group was significantly higher than that in the control group(30/48 vs 20/47,P<0.05).In addition,the DLQI of the observation group was significantly lower than that of the control group at 8 weeks(4.4 vs 6.3,P<0.001).In terms of TCM syndrome efficacy,the effective rate of the observation group was significantly higher than that of the control group(P<0.05).Conclusion Compared with PDT alone,PDT combined with Jiawei Fuzi Lizhong Decoction significantly improved the clinical efficacy and QOL of patients with moderate to severe facial acne.