中国寻常型银屑病的特征：一项前瞻性队列研究方案。
Characteristics of psoriasis vulgaris in China: a prospective cohort study protocol.
作者信息
Luo Ying, Ru Yi, Sun Xiaoying, Zhou Yaqiong, Yang Yingyao, Ma Tian, Xu Rong, Chen Jie, Zhou Mi, Ze Kan, Ju Li, Wang Yanjiao, Yin Qingfeng, Wang Ruiping, Li Bin, Li Xin
机构信息
Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China.
Institute of Dermatology, Shanghai Academy of Traditional Chinese Medicine, Shanghai 201203, China.
出版信息
Ann Transl Med. 2019 Nov;7(22):694. doi: 10.21037/atm.2019.10.46.
BACKGROUND
Psoriasis is an incurable, chronic skin disorder with considerable impact on the quality of life. No drugs are available for treating the disease. Clarifying the progression, exploring the risk factors affecting progression, and finding effective treatments with few side-effects and low recurrence rates is critical. This protocol describes a future study that will analyze psoriasis vulgaris progression risk factors and trends, establish a multicenter clinical registration platform, evaluate clinical evidence for Chinese Medicine (CM) intervention for psoriasis, and evaluate therapeutic effectiveness and recurrence rate advantages of CM.
METHODS
The study is a prospective cohort clinical trial planned for October 2019 to September 2021 involving 20 clinics. The trial will enroll 1,500 participants in a psoriasis vulgaris group, and 500 healthy participants in a control group (no intervention). The psoriasis vulgaris group will be divided into three equal-sized subgroups: blood heat syndrome group (BHS), blood stasis syndrome group (BSS), and non-blood heat nor blood stasis syndrome group (NHS) group. Participants will be grouped according to CM syndrome classification and receive oral CM herbal medication (according to the CM syndrome classification, and tailored to the participant's disease progression). Medication will be administered twice every day during the intervention phase (eight weeks of intervention, and eight weeks of follow-up). Exposure measures include demographic variables, risk factors, and intervention factors.
DISCUSSION
The primary outcome measures include improvement in both the psoriasis and severity index scores after eight weeks of intervention. Secondary outcome measures include body surface area affected, Physician Global Assessment scores, Dermatology Life Quality Index, pain-relat ed quality of life, pain on visual analog scale, CM syndromes, and recurrence. Other outcome measures include CM physical scale, personal history, medical expenses, and patient satisfaction. The number, nature, and severity of adverse events will be carefully recorded.
TRIAL REGISTRATION
The trial has been registered at (ID: NCT03942185).
背景
银屑病是一种无法治愈的慢性皮肤疾病，对生活质量有相当大的影响。目前尚无治疗该疾病的药物。阐明疾病进展情况，探索影响进展的风险因素，并找到副作用少、复发率低的有效治疗方法至关重要。本方案描述了一项未来的研究，该研究将分析寻常型银屑病的进展风险因素和趋势，建立多中心临床注册平台，评估中医干预银屑病的临床证据，并评估中医的治疗效果和复发率优势。
方法
该研究是一项前瞻性队列临床试验，计划于2019年10月至2021年9月进行，涉及20家诊所。试验将招募1500名寻常型银屑病组参与者和500名健康对照组参与者（不进行干预）。寻常型银屑病组将被分为三个规模相等的亚组：血热证组（BHS）、血瘀证组（BSS）和非血热非血瘀证组（NHS）。参与者将根据中医证候分类进行分组，并接受口服中药（根据中医证候分类，并根据参与者的疾病进展进行调整）。在干预阶段（八周干预和八周随访），药物每天服用两次。暴露测量包括人口统计学变量、风险因素和干预因素。
讨论
主要结局指标包括干预八周后银屑病和严重程度指数评分的改善情况。次要结局指标包括受累体表面积、医生整体评估评分、皮肤病生活质量指数、疼痛相关生活质量、视觉模拟量表上的疼痛、中医证候和复发情况。其他结局指标包括中医体质量表、个人病史、医疗费用和患者满意度。将仔细记录不良事件的数量、性质和严重程度。
试验注册
该试验已在 （ID：NCT03942185）注册。
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