Medical treatment of echinococcosis under the guidance of Good Clinical Practice (GCP/ICH)
Medical treatment of echinococcosis under the guidance of Good Clinical Practice (GCP/ICH)
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DOI：
10.1016/j.parint.2005.11.040
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发表时间：
2006-01-01
影响因子：
1.9
通讯作者：
Kern, P
中科院分区：
文献类型：
--
作者：
Kern, P
化疗是治疗泡状和囊性包虫病的主要组成部分之一。苯并咪唑类药物上市已有30年，根据1996年WHO囊泡型棘球蚴病治疗指南的建议，苯并咪唑类药物被广泛使用[Bull WHO 1996; 74：231 - 242.]。然而，这两种药物（阿苯达唑或甲苯咪唑）中没有一种能够满足相关当局的批准要求，例如欧洲药品评估机构（EMEA）或美国食品药品监督管理局（FDA）。新的驱虫药正在研制中，其中一些已经进行了临床前试验。此外，最近在泡状棘球蚴病临床试验结果的定义方面取得了进展。因此，需要对新活性成分进行III期研究，以评估短期和长期安全性以及治疗价值。药物比较试验的基本要求见《药物临床试验质量管理规范（GCP）指南注释》，并基于国际协调会议（ICH）和欧盟委员会临床试验指令（指令2001/20/EC）的规则和规定。将这些标准应用于棘球蚴病新药检测将有助于提升证据水平。(C)2005爱思唯尔爱尔兰有限公司保留所有权利。
Chemotherapy is one of the main components for the treatment of alveolar and cystic echinococcosis. Benzimidazoles are on the market since 30 years, and are used widely according to the recommendations of the 1996 WHO guidelines for treatment of cystic and alveolar echinococcosis [Bull WHO 1996; 74: 231 -242.]. However, none of the two drugs (Albendazole or Mebendazole) would satisfy today the requirements for an approval by the relevant authorities, such as the European Agency for the Evaluation of Medicinal Products (EMEA) or the Food and Drug Administration (FDA). New anthelmithic drugs are in the pipeline, and some of them have already undergone preclinical testing. In addition, recent advances have been made in the definition of outcomes for clinical trials in alveolar echinococcosis. Thus, phase III studies with new active ingredients are needed to assess short- and long-term safety as well as the therapeutic value. The basic requirements for comparative drug testing are provided in the Note for Guidance on Good Clinical Practice (GCP), and are based upon the rules and regulations by International Conference on Harmonization (ICH) and the Clinical Trial Directive (Directive 2001/20/EC) of the European Commission. The application of these standards to new drug testing for echinococcosis will help to upgrade the level of evidence. (C) 2005 Elsevier Ireland Ltd. All rights reserved.