Corso D M, Pucino F, DeLeo J M, Calis K A, Gallelli J F
Department of Pharmacy, Memorial Sloan-Kettering Cancer Center, New York, NY.
Ann Pharmacother. 1992 Jul-Aug;26(7-8):890-6. doi: 10.1177/106002809202600704.
To develop a comprehensive list of symptoms categorized by body system as part of a questionnaire for detecting potential adverse drug reactions.
A preliminary list of symptoms in lay terminology was extracted from the "Side Effects" section of all drug monographs contained in the United States Pharmacopeia Dispensing Information (USP DI) computerized database (Volume II, Advice for the Patient) using natural language processing software. The list was sorted alphabetically and duplicate terms were eliminated. Symptoms were then categorized by body system or anatomic region. A preferred term for each symptom was selected when multiple synonyms and related words were listed. Finally, all of the symptom terms were incorporated into a thesaurus from which the questionnaire was derived.
The questionnaire will be used as part of a computer-assisted interview, developed to solicit information from patients regarding their medication regimens and to systematically query them regarding the presence of salient symptoms or complaints. The computer system will eventually interface with the USP DI database to identify drugs from a patient's regimen that may be associated with adverse symptoms. The symptom thesaurus will provide the link to the USP DI database. Preliminary experience with the questionnaire in a limited number of patients has been encouraging.
The questionnaire can assist clinicians in identifying drug-related symptoms including unreported adverse clinical effects of newly marketed or investigational therapeutic agents. When the questionnaire is computerized and linked to a comprehensive database, it can be more widely used to alert healthcare providers of potential adverse drug reactions that may otherwise go undetected.
制定一份按身体系统分类的综合症状清单，作为检测潜在药物不良反应问卷的一部分。
使用自然语言处理软件，从《美国药典药物信息》（USP DI）计算机数据库（第二卷，患者建议）中所有药品说明书的“副作用”部分提取一份用通俗易懂术语表述的初步症状清单。该清单按字母顺序排序并删除重复项。然后按身体系统或解剖区域对症状进行分类。当列出多个同义词和相关词汇时，为每个症状选择一个首选术语。最后，所有症状术语都被纳入一个词库，问卷即由此而来。
该问卷将作为计算机辅助访谈的一部分使用，该访谈旨在从患者那里获取有关其用药方案的信息，并系统地询问他们是否存在明显症状或不适。计算机系统最终将与USP DI数据库连接，以识别患者用药方案中可能与不良症状相关的药物。症状词库将提供与USP DI数据库的链接。在少数患者中对该问卷的初步试用情况令人鼓舞。
该问卷可帮助临床医生识别与药物相关的症状，包括新上市或正在研究的治疗药物未报告的不良临床效应。当问卷实现计算机化并与综合数据库链接时，它可更广泛地用于提醒医疗保健人员注意可能未被发现的潜在药物不良反应。
