多潘立酮片门诊用药评价及智能化知识库的作用

背景　多潘立酮为胃肠促动力药,自2012年起连续载入《国家基本药物》。鉴于2012-2014年加拿大、美国、英国等指出多潘立酮有导致心源性猝死及突发室性心律失常的风险,特别是年龄超过60岁、每天用药超过30 mg的患者。2016年9月,我国原国家食品药品监督管理总局（CFDA）发布了《关于修订多潘立酮制剂说明书的公告》,提出对多潘立酮说明书内容进行重新修订的要求。此后,多潘立酮生产厂家对多潘立酮说明书“不良反应、禁忌、注意事项、用法用量”等项进行修订,更新后的药品说明书载入了相关警示及风险提示内容。目的　了解多潘立酮片门诊治疗各种疾病的情况,为临床安全、合理用药提供参考。方法　选取2019年3-8月上海市闵行区吴泾社区卫生服务中心门诊医师开具的单一诊断,使用多潘立酮片的处方515张,统计患者的性别、年龄、临床诊断、用法用量等。构建契合社区医疗卫生机构用药特点的知识库智能管理系统。结果　515例使用多潘立酮片患者中,男197例（38.3%）,女318例（61.7%）;年龄26~98岁,平均年龄（72.0±12.4）岁,以60 岁及以上的老年患者为主〔86.0%（443/515）〕。单一诊断涉及的疾病有19种,其中消化不良、消化性溃疡、慢性胃炎、胃食管反流病居前4位,占81.4%（419/515）。所有患者的每日剂量符合药品说明书规定。结论　门诊多潘立酮片使用基本合理。借助知识库利用信息技术能为患者用药“保驾护航”。

Outpatient Use of Domperidone Tablets and the Contributive Role of Intelligent Knowledge Base

Background　Domperidone is a gastrointestinal prokinetic drug that has been on the National Essential Drugs List since 2012. In 2012—2014,reports from Canada,the United States and the United Kingdom put forward that domperidone may be associated with increased risk of sudden cardiac death and sudden ventricular arrhythmia,especially in those older than 60 years and those using domperidone greater than 30 mg as a total daily dose. In view of this,in September 2016,the former China Food and Drug Administration issued the Notice on the Revision of the Instructions for Use of Domperidone Preparations,requiring the revision of the package insert for domperidone preparations. Since then,domperidone manufacturers have revised the contents of "adverse reactions,contraindications,precautions,usage and dosage",and the updated package insert includes relevant warnings and risk warnings. Objective　To explore outpatient use of domperidone tablets in the treatment of various diseases,to provide a reference for safe and appropriate use of medicines in clinical practice. Methods　A total of 515 patients with a diagnosis of single illness who were prescribed Domperidone Tablets at Wujing Community Health Center,Minhang District of Shanghai,between March and August 2019,were selected. Data concerning gender,age,clinical diagnosis,and usage and dosage were collected. A drug use management system using the intelligent knowledge base was developed in accordance with the characteristics of drug use in community hospitals. Results　The 515 patients consisted of 197（38.3%） men and 318（61.7%） women,ranging in age from 26 to 98（mean 72.0±12.4） years,and those aged 60 or over accounted for the largest proportion〔86.0%（443/515）〕. The diagnoses involved 19 illnesses,with dyspepsia,peptic ulcer,chronic gastritis,and gastroesophageal reflux disease as the 4 top-ranked,accounting for 81.4%（419/515） of all diagnoses. The daily dose of all patients conformed with the package insert information. Conclusion　Current outpatient use of domperidone tablets is appropriate generally. With the help of knowledge base,information technology can be used to "escort" patients with medication.