Ratko T A, Burnett D A, Foulke G E, Matuszewski K A, Sacher R A
Technology Assessment Program, University Hospital Consortium, Oak Brook, Ill 60521-1890, USA.
JAMA. 1995 Jun 21;273(23):1865-70.
To summarize consensus recommendations for off-label uses of standard intravenous immunoglobulin (IVIG), as developed by a University Hospital Consortium (UHC) Expert Panel. These findings are intended to help guide clinicians in the appropriate and efficient use of IVIG.
The UHC-sponsored panel included eight physicians (board certified in critical care, hematology, immunology, neurology, oncology, pediatrics, or rheumatology) and two hospital pharmacists.
MEDLINE and EMBASE were searched to identify all English-language review articles (n = 201) and original reports (n = 1904) on IVIG (human use only, excluding editorials, letters, and comments) published between January 1982 and March 1994. Relevant original reports (250) and review articles (87) were evaluated by the first author (T.A.R.). Extracted data included laboratory and clinical findings, objective measures, or clinical impressions. The evidence quality was graded by study design according to the US Preventive Services Task Force.
Before the panel meeting, a draft literature review and recommendations were produced by one of the authors (T.A.R.). The recommendations herein represent consensus (100% agreement) based on the published evidence.
The UHC Expert Panel made specific recommendations for 53 off-label indications and the following general recommendations: (1) Usually IVIG is indicated only if standard approaches have failed, become intolerable, or are contraindicated; (2) IVIG products should be considered therapeutically equivalent and interchangeable; (3) interproduct pharmaceutical differences should be considered with the patient's clinical and physiological status when selecting an IVIG product; and (4) currently, IVIG manufacturers cannot guarantee freedom from viral contamination in the finished product.
总结大学医院协会（UHC）专家小组制定的关于标准静脉注射免疫球蛋白（IVIG）非标签使用的共识性建议。这些研究结果旨在帮助指导临床医生合理、有效地使用IVIG。
由UHC赞助的专家小组包括8名医生（分别具有重症医学、血液学、免疫学、神经病学、肿瘤学、儿科学或风湿病学的专业认证）和2名医院药剂师。
检索MEDLINE和EMBASE数据库，以识别1982年1月至1994年3月期间发表的所有关于IVIG的英文综述文章（n = 201）和原始报告（n = 1904）（仅涉及人类使用，不包括社论、信件和评论）。第一作者（T.A.R.）对相关原始报告（250篇）和综述文章（87篇）进行了评估。提取的数据包括实验室和临床研究结果、客观测量结果或临床印象。根据美国预防服务工作组的标准，依据研究设计对证据质量进行分级。
在专家小组会议之前，由其中一位作者（T.A.R.）撰写了文献综述和建议草案。本文中的建议代表了基于已发表证据的共识（100%达成一致）。
UHC专家小组针对53种非标签适应症提出了具体建议，并给出以下一般性建议：（1）通常仅在标准方法失败、无法耐受或存在禁忌时才考虑使用IVIG；（2）应将IVIG产品视为治疗等效且可互换的；（3）选择IVIG产品时，应结合患者的临床和生理状况考虑产品间的药学差异；（4）目前，IVIG制造商无法保证成品中无病毒污染。
