一种复合胶态硫乳液对寻常型痤疮疗效的随机对照非劣效性研究

Treatment Effectiveness of a Compound Colloidal Sulfur Emulsion for Acne Vulgaris:a Randomized Controlled Noninferiority Trial

目的:评估一种复合胶态硫乳液对寻常型痤疮的治疗效果是否不低于过氧苯甲酰凝胶。方法:于2022年8月1日至2022年11月20日在深圳市罗湖区中医院皮肤科门诊招募120例寻常型痤疮炎性丘疹患者作为研究对象,随机分为对照组(5%过氧苯甲酰凝胶,59例)和观察组(复合胶态硫乳液,61例)。两组患者均连续用药28 d,用药后第1、2、3、4周随访复诊,比较两组患者的治疗效果、皮损数量和面积变化、对药物刺激的主观感受程度。结果:经4周治疗,两组患者间的有效率差值为1.07%,95%CI为(–3.38,5.24),差值的95%CI下限–3.38%>非劣效阈值–5%。除随访2周时,对照组患者皮损面积显著小于观察组,差异具有统计学意义(P <0.05)以外,其余各周两组患者皮损数量和皮损面积差异均无统计学意义(P> 0.05)。在不同的随访时间下,两组患者对所用药物感受刺激程度分布差异均具有统计学意义(P <0.001)。结论:在寻常型痤疮炎性丘疹的治疗中,复合胶态硫乳液的治疗效果不低于过氧苯甲酰凝胶,且刺激性较小。

Objective To evaluate whether a compound colloidal sulfur emulsion is as effective as peroxybenzoyl gel in treating acne vulgaris.Methods A total of 120 patients with acne vulgaris were recruited from the dermatology clinic of Shenzhen Luohu Hospital of Traditional Chinese Medicine from August 1,2022 to November 20,2022,and were randomly divided into a control group(5% oxybenzoyl gel,59 cases) and an observation group(61 cases).Patients in both groups were treated continuously for 28days,and were followed up at 1,2,3 and 4 weeks after medication.The therapeutic effect,the changes in the number and area of skin lesions,and the degree of subjective feeling to drug stimulation were compared between the two groups.Results After 4 weeks of treatment,the difference in response rate between the two groups was 1.07%,95% CI was(-3.38,5.24),and the lower 95% CI of the difference was(3.38%) > the non-inferiority threshold was(5%).In addition to 2 weeks of follow-up,the skin area of the control group was significantly smaller than that of the observation group,the difference was statistically significant(P < 0.05),and there was no statistically significant difference in the number and area of skin lesions between the two groups in other weeks(P > 0.05).At different follow-up times,there were statistically significant differences between the two groups in the degree of sensory stimulation of the drugs used(P < 0.001).Conclusion In the treatment of acne vulgaris inflammatory papules,the therapeutic effect of compound colloidal sulfur emulsion is not inferior to that of peroxybenzoyl gel,and it is less irritating.