Chinese herbal medicine granules (PTQX) for children with moderate to severe atopic eczema: study protocol for a randomised controlled trial.
Chinese herbal medicine granules (PTQX) for children with moderate to severe atopic eczema: study protocol for a randomised controlled trial.
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DOI：
10.1186/s13063-015-0806-y
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发表时间：
2015-07-07
期刊：
影响因子：
2.5
通讯作者：
Xue CC
中科院分区：
文献类型：
--
作者：
Gu SX;Zhang AL;Coyle ME;Mo X;Lenon GB;Cranswick NE;Chen D;Xue CC
特应性湿疹或特应性皮炎是一种慢性炎症性皮肤病。目前对于中度和重度特应性湿疹的常规治疗效果并不令人满意。随机临床试验提供了有希望的证据支持临床使用中草药治疗特应性湿疹。然而，现有证据因大多数纳入试验相关的高偏倚风险而受到损害。因此，需要精心设计和充分有力的随机临床试验。本试验的主要目的是评估口服中药配方（培土清心颗粒；PTQX）对 6 至 16 岁中度至重度特应性湿疹儿童口服的有效性和安全性。我们设计了一项随机、双盲、安慰剂对照、双组平行临床试验，为期 12 周的治疗和 4 周的随访期。澳大利亚皇家墨尔本理工大学将进行一项有 30 名参与者参与的试点研究，以确定全面随机临床试验（N = 124）的可行性。湿疹面积和严重程度指数评分将是主要结果。次要结果指标包括使用以患者为导向的湿疹指标、儿童皮肤病生活质量指数以及伴随药物的使用来改变症状。安全性参数包括试验期间的不良事件报告和病理学测试。本方案已解决进行高质量随机临床试验的关键要素。拟议试验的结果将为中草药治疗特应性湿疹提供关键证据。澳大利亚新西兰临床试验注册标识符：ACTRN12614001172695。注册日期：2014 年 11 月 7 日。
Atopic eczema or atopic dermatitis is a chronic inflammatory skin disease. Current conventional medical treatment for moderate and severe atopic eczema is not satisfactory. There is promising evidence derived from randomised clinical trials to support the clinical use of Chinese herbal medicine in the management of atopic eczema. However, the available evidence is compromised by the high risk of bias associated with most of the included trials. Therefore, well-designed and adequately powered randomised clinical trials are needed. The primary aim of this trial is to evaluate the efficacy and safety of oral ingestion of an oral Chinese herbal formula (Pei Tu Qing Xin granules; PTQX) in children aged between 6 and 16 years with moderate to severe atopic eczema. We have designed a randomised, double-blind, placebo-controlled, two-arm, parallel clinical trial with 12 weeks of treatment and a 4-week follow-up period. A pilot study with 30 participants will be conducted at the RMIT University in Australia to determine the feasibility of the full-scale randomised clinical trial (N = 124). Eczema Area and Severity Index score will be the primary outcome. Secondary outcome measures include change in symptoms using the Patient-Oriented Eczema Measure, the Children’s Dermatology Life Quality Index and the use of concomitant medicines. Safety parameters include report of adverse events and pathology tests during the trial period. Key elements for conducting a high-quality randomised clinical trial have been addressed in this protocol. Findings from the proposed trial will provide critical evidence regarding Chinese herbal medicine treatment for atopic eczema. Australian New Zealand Clinical Trials Registry Identifier: ACTRN12614001172695. Date of Registration: 7 November 2014.
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