祛风润面散（）治疗湿瘀证寻常痤疮的疗效：一项多中心、随机、双盲、安慰剂对照临床试验。

Efficacy of Modified Qufeng Runmian Powder () on Acne Vulgaris with Syndromes of Dampness and Blood Stasis: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

机构信息

Beijing University of Chinese Medicine, Beijing, 100029, China.

Department of Dermatology and Venereology, China-Japan Friendship Hospital, Beijing, 100029, China.

出版信息

Chin J Integr Med. 2020 Jul;26(7):490-496. doi: 10.1007/s11655-020-3214-4. Epub 2020 Feb 11.

DOI:10.1007/s11655-020-3214-4

PMID:32048170

Abstract

OBJECTIVE

To evaluate the efficacy and safety of a Chinese medicine (CM) Modified Qufeng Runmian Powder (, MQFRMP) for the treatment of acne vulgaris with CM syndromes of dampness and blood stasis.

METHODS

In this multicenter, randomized, double-blind, placebo-controlled clinical trial, 220 acne vulgaris patients with CM syndrome of dampness and blood stasis were included and randomly assigned using a central area group random design to receive either MQFRMP or the placebo, with 110 cases in each group. MQFRMP or a placebo at 145 g/bag were administered once daily for 4 weeks, respectively. The primary index of efficacy was the effective rate according to the acne severity score (ASS). The secondary indices of efficacy included the changes in the dermatology life quality index (DLQI) score, VISIA scores (spots, pores, brown spots, porphyrins and red areas) and skin assessment (skin pH, sebum amount and hydration) according to a SOFT skin multianalyzer.

RESULTS

(1) Follow-up: a total of 204 patients completed the follow-up, with 103 in the treatment group and 101 in the control group. (2) Effective rate: the total effective rate of the treatment group was significantly higher than the control group [83.5% (86/103) vs. 31.7% (32/101), P<0.01)] with 95% confidence interval of 39.3%-66.4%. (3) DLQI: DLQI scores were significantly decreased the treatment and control groups (both P<0.01), but the treatment group was more obvious than the placebo group (P<0.01). (4) VISIA scores: the scores of spots, brown spots and red areas in the treatment group decreased compared with baseline (P<0.05). In the control group, the scores of brown spots and pores decreased compared with baseline (P<0.05). The improvement was more obvious in the treatment group than in the control group for all items (P<0.05). (5) Skin assessment: the pH and sebum score in the both groups decreased drastically compared with the baseline (all P<0.01), however, the improvement was more obvious in the treatment group than in the control group (P<0.01). The hydration amount in the two groups showed no statistically significant difference compared with the baseline (both P>0.05). (6) Safety: two cases of mild drug allergy were observed in the treatment group.

CONCLUSION

MQFRMP was effective and safe for the treatment of acne vulgaris with syndromes of dampness and blood stasis. (No. ChiCTR1900020479).

摘要

目的

评价中药祛风润面散（MQFRMP）治疗湿瘀证寻常痤疮的疗效和安全性。

方法

采用多中心、随机、双盲、安慰剂对照临床试验设计，纳入 220 例湿瘀证寻常痤疮患者，采用中央区组随机设计，按 1∶1 比例随机分为治疗组和安慰剂组，每组 110 例。治疗组给予 MQFRMP 冲服，每次 145 g，每日 1 次，共 4 周；安慰剂组给予安慰剂冲服，用法用量同治疗组。主要疗效指标为痤疮严重程度评分（ASS）的有效率。次要疗效指标包括皮肤病生活质量指数（DLQI）评分、VISIA 评分（斑点、毛孔、棕色斑点、卟啉和红色区域）和 SOFT 皮肤多参数分析仪评估的皮肤状况（皮肤 pH 值、皮脂量和水分含量）的变化。

结果

（1）随访：共 204 例患者完成随访，治疗组 103 例，对照组 101 例。（2）有效率：治疗组总有效率显著高于对照组[83.5%（86/103）比 31.7%（32/101），P<0.01]，95%置信区间为 39.3%~66.4%。（3）DLQI：两组治疗后 DLQI 评分均显著降低（均 P<0.01），但治疗组较安慰剂组降低更明显（P<0.01）。（4）VISIA 评分：治疗组治疗后斑点、棕色斑点和红色区域评分较基线降低（均 P<0.05），对照组治疗后棕色斑点和毛孔评分较基线降低（均 P<0.05），各指标治疗组改善程度均优于对照组（均 P<0.05）。（5）皮肤评估：两组治疗后 pH 值和皮脂评分均较基线明显降低（均 P<0.01），但治疗组改善程度优于对照组（均 P<0.01），两组治疗后水分含量与基线比较，差异均无统计学意义（均 P>0.05）。（6）安全性：治疗组出现 2 例轻度药物过敏。