目的 初步評(píng)價(jià)中藥外用治療小兒濕疹濕熱證的有效性及安全性，為小兒濕疹外用藥的臨床研究設(shè)計(jì)提供范例。方法 采用區(qū)組隨機(jī)、雙盲、安慰劑平行對(duì)照、多中心臨床研究的方法，將240例亞急性濕疹濕熱證患兒以1∶1的比例分為試驗(yàn)組和對(duì)照組，分別應(yīng)用小兒濕疹凈軟膏或安慰劑軟膏治療，療程4周。以靶皮損形態(tài)計(jì)分和靶皮損面積為主要有效性評(píng)價(jià)指標(biāo)，全身瘙癢單項(xiàng)療效、全身皮損面積、中醫(yī)證候療效、單項(xiàng)中醫(yī)癥狀療效以及隨訪4周內(nèi)的皮損復(fù)發(fā)率為次要指標(biāo)；以不良事件/反應(yīng)發(fā)生率為主要安全性評(píng)價(jià)指標(biāo)。結(jié)果 建立了用于靶皮損形態(tài)和中醫(yī)證候評(píng)價(jià)的癥狀分級(jí)量化標(biāo)準(zhǔn)，制定了病例的納入、排除、脫落和剔除標(biāo)準(zhǔn)，提出了保證濕疹外用藥臨床試驗(yàn)質(zhì)量的辦法。

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.

國(guó)家科技重大專項(xiàng)十二五“重大新藥創(chuàng)制”（2011ZX09302-006-03）