探索中药外治小儿亚急性湿疹湿热证的有效性与安全性——小儿湿疹净软膏Ⅱ期临床试验方案设计

Efficacy and safety of external treatment with Chinese materia medica on pediatric subacute eczema——Protocol of phase II clinical trials by External-applied Chrisma for Infantile Eczematization

目的初步评价中药外用治疗小儿湿疹湿热证的有效性及安全性,为小儿湿疹外用药的临床研究设计提供范例。方法采用区组随机、双盲、安慰剂平行对照、多中心临床研究的方法,将240例亚急性湿疹湿热证患儿以1∶1的比例分为试验组和对照组,分别应用小儿湿疹净软膏或安慰剂软膏治疗,疗程4周。以靶皮损形态计分和靶皮损面积为主要有效性评价指标,全身瘙痒单项疗效、全身皮损面积、中医证候疗效、单项中医症状疗效以及随访4周内的皮损复发率为次要指标;以不良事件/反应发生率为主要安全性评价指标。结果建立了用于靶皮损形态和中医证候评价的症状分级量化标准,制定了病例的纳入、排除、脱落和剔除标准,提出了保证湿疹外用药临床试验质量的办法。

Objective To evaluate the effectiveness and safety of Chinese materia medica （CMM） in the external treatment of pediatric subacute eczema, and to provide an example for the clinical study design of ECIE. Methods Using block parallel randomized, double blind, placebo controlled, and multi-center clinical research method, 240 cases of children with pediatric subacute eczema were divided into trial and control groups （1：1）, respectively, and treated with ECIE and placebot for 4 weeks as a course. The target lesion form and effectiveness and target lesion area were used as the main evaluation indexes; The whole body itch individual curative effect, whole body skin area, syndrome curative effect in traditional Chinese medicine （TCM）, and single Chinese medicine symptom curative effect, and followed up for 4 weeks of recurrence were detected as secondary indexes; Incidence of adverse events/reaction was used as the main security evaluation index. Results The target lesion shape and symptoms of TCM syndrome evaluation hierarchical quantification standard were established, the standards for cases including, excluding, and falling off were established, and the measures to ensure the quality of clinical trials for external treatment of eczema were provided.