口服中药复方PSORI-CM01联合外用序贯疗法治疗中重度寻常型银屑病：一项双盲、随机、安慰剂对照试验的初步研究

Oral PSORI-CM01, a Chinese herbal formula, plus topical sequential therapy for moderate-to-severe psoriasis vulgaris: pilot study for a double-blind, randomized, placebo-controlled trial.

作者信息

Yao Dan-Ni, Lu Chuan-Jian, Wen Ze-Huai, Yan Yu-Hong, Xuan Mei-Ling, Li Xiao-Yan, Li Geng, He Ze-Hui, Xie Xiu-Li, Deng Jing-Wen, Guo Xin-Feng, Ou Ai-Hua

机构信息

Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, No. 111 Dade Road, Guangzhou, 510120, China.

Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, 510120, China.

出版信息

Trials. 2016 Mar 16;17(1):140. doi: 10.1186/s13063-016-1272-x.

DOI:10.1186/s13063-016-1272-x

PMID:26983642

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4793560/

Abstract

BACKGROUND

To provide evidence that the Chinese herbal medicine (CHM) PSORI-CM01 combined with Western medicine reduces the relapse rate of psoriasis vulgaris (PV), we plan to conduct a large-scale randomized control trial (RCT). In order to improve and perfect the RCT, this pilot study was designed to determine the feasibility and the potential of a modified protocol for the full-scale RCT.

METHODS

Eligible patients with psoriasis vulgaris (PV) were enrolled into a randomized comparison in which all subjects received topical sequential therapy and PSORI-CM01 or placebo for 12 weeks. The primary outcome measure was the relapse rate. Treatment response was computed from Psoriasis Area and Severity Index (PASI), body surface area (BSA), and Dermatology Life Quality Index (DLQI). The secondary outcome measures included time to relapse, time to onset, rebound rate, PASI score, pruritus scores on the Visual Analog Scale (VAS), BSA, DLQI and SF-36 (short form health survey), and incidence of serious adverse events (SAEs).

RESULTS

Six of 7 (86 %) subjects reached the PASI-50 in the CHM group compared with nine of 10 (90 %) in the placebo group during the treatment period. Among the subjects who reached PASI-50, one out of six subjects (17 %) relapsed in the CHM group during the treatment period compared with six out of nine patients in the placebo group (67 %). No subjects met the rebound criteria. Changes to baseline in the PASI scores were not significantly different between the two groups (t = 1.764, P = 0.098).

CONCLUSION

Oral PSORI-CM01 combined with topical sequential treatment showed a smaller recurrence rate (P = 0.118) than placebo combined with the same topical therapy for moderate-to-severe PV in this pilot study.

TRIAL REGISTRATION

Chinese Clinical Trial Registry ( http://www.chictr.org.cn/searchproj.aspx ) ChiCTR-TRC-13003233 ; date of registration: 15 April 2013.

摘要

背景

为了提供证据证明中药PSORI-CM01联合西药可降低寻常型银屑病（PV）的复发率，我们计划开展一项大规模随机对照试验（RCT）。为了改进和完善该RCT，本预试验旨在确定全面RCT改良方案的可行性和潜力。

方法

符合条件的寻常型银屑病（PV）患者被纳入随机对照试验，所有受试者均接受外用序贯治疗，并服用PSORI-CM01或安慰剂，为期12周。主要结局指标为复发率。治疗反应通过银屑病面积和严重程度指数（PASI）、体表面积（BSA）以及皮肤病生活质量指数（DLQI）计算得出。次要结局指标包括复发时间、发病时间、反弹率、PASI评分、视觉模拟量表（VAS）瘙痒评分、BSA、DLQI和SF-36（简明健康调查）以及严重不良事件（SAE）的发生率。

结果

在治疗期间，中药组7名受试者中有6名（86%）达到PASI-50，而安慰剂组10名受试者中有9名（90%）达到。在达到PASI-50的受试者中，中药组6名受试者中有1名（17%）在治疗期间复发，而安慰剂组9名患者中有6名（67%）复发。没有受试者符合反弹标准。两组PASI评分相对于基线的变化无显著差异（t = 1.764，P = 0.098）。