Plaque psoriasis is a refractory inflammatory skin disease. The common therapies used to treat plaque psoriasis in traditional Chinese medicine (TCM) and western medicine (WM) have distinct characteristics and advantages. Although a combination of TCM and WM therapies, adjusted to the clinical situation, is widely used, there are no systematic studies on the hierarchical selection of this treatment combination based on the severity of skin lesions. We therefore designed a randomized clinical trial to focus on the sequence of internal and external treatments of TCM in patients with mild-to-moderate plaque psoriasis and to optimize the integration of Chinese and western medicine for the treatment of patients with severe plaque psoriasis, thereby achieving high-level clinical evidence and establish treatment norms for the integrated use of Chinese and western medicines. In this proposed multicenter, single-blinded, randomized controlled trial, 108 patients with mild-to-moderate plaque psoriasis will be randomly assigned to two groups in a 1:1 ratio to receive either internal or external TCM treatment, and 270 patients with severe plaque psoriasis will be randomly assigned to three groups in a 1:1:1 ratio to receive treatment with TCM or WM, or TCM + WM. All enrolled patients will receive 8 weeks of treatment. Follow-up assessments will be done 8 weeks after the treatment. The primary outcome of this study is the evaluation of efficacy and relapse rate, based on the Psoriasis Area and Severity Index, and the secondary outcome measures include determination of the affected body surface area, physician’s global assessment, pruritus scores (determined using a visual analog scale), TCM symptom score, Dermatology Life Quality Index, patient-reported quality of life score and incidence of serious adverse events. This study will provide high-level clinical evidence for internal and external TCM treatment optimization and will contribute to establishing norms for the integration of Chinese and western Medicines. ClinicalTrials.gov, NCT03941431. Registered on 8 May 2019.

中文翻译：

---

我们的选择：一项针对中西医结合治疗牛皮癣最佳实施方案的随机对照试验研究方案

斑块状牛皮癣是难治性炎性皮肤病。中药（TCM）和西药（WM）用于治疗斑块状牛皮癣的常用疗法具有明显的特点和优势。尽管已根据临床情况调整了中医和西医的结合治疗方法，但根据皮肤病变的严重程度，对该治疗方法的分层选择尚无系统的研究。因此，我们设计了一项随机临床试验，重点研究轻度至中度斑块状牛皮癣患者的中医内外治疗顺序，并优化中西医结合治疗重度斑块状牛皮癣的患者，从而获得高水平的临床证据并建立中西医结合使用的治疗规范。在这项拟议的多中心，单盲，随机对照试验中，将108例轻度至中度斑块型牛皮癣患者按1：1比例随机分为两组，分别接受内部或外部中医治疗，另外270例重症患者斑块状牛皮癣将以1：1：1的比例随机分为三组，以接受中医或西医治疗，或中医+西医治疗。所有登记的患者将接受8周的治疗。治疗后8周将进行随访评估。这项研究的主要结果是根据银屑病面积和严重程度指数评估疗效和复发率，次要结果指标包括确定受影响的身体表面积，医生的整体评估，瘙痒评分（使用视觉模拟量表确定），中医症状评分，皮肤病生活质量指数，患者报告的生活质量评分和严重不良反应的发生率事件。这项研究将为内部和外部中药治疗的优化提供高水平的临床证据，并将有助于建立中西医结合的规范。ClinicalTrials.gov，NCT03941431。于2019年5月8日注册。这项研究将为内部和外部中药治疗的优化提供高水平的临床证据，并将有助于建立中西医结合的规范。ClinicalTrials.gov，NCT03941431。于2019年5月8日注册。这项研究将为内部和外部中药治疗的优化提供高水平的临床证据，并将有助于建立中西医结合的规范。ClinicalTrials.gov，NCT03941431。于2019年5月8日注册。