Li X X, Zhuo L, Yang Y H, Zhan S Y, Zhai S D
Department of Pharmacy, Third Hospital, Peking University, Beijing 100191, China.
School of Public Health, Peking University, Beijing 100191, China.
Zhonghua Liu Xing Bing Xue Za Zhi. 2017 Feb 10;38(2):248-252. doi: 10.3760/cma.j.issn.0254-6450.2017.02.023.
To evaluate the safety of injection among children in the real world. A multicenter, large sample, ambispective cohort study, with registration-type clinical safety monitoring. A total of 6 188 inpatients and patients from the emergency units, aged ≤ 14 years who all had been using injection in 59 secondary and tertiary hospitals in China, were recruited between January, 2014 and May, 2015. The main outcomes would include incidence and severity of adverse drug reaction (ADR)/adverse drug event (ADE) of injection. Univariate analysis was used to explain the risk factors of ADR. The overall incidence of ADE was 4.20‰ (26 cases), including 4 serious ones. The incidence of ADR was 3.07‰ (19 cases), including 17 cases of general ADR and 2 cases of new ADR. All the ADR cases were mild or moderate, mostly showing damages in skin and appendages. The onset of disease happened in 24 hours after the injection but all the ADR cases got improved or cured. Having histories of allergies to drugs or foods would increase the incidence of ADR. injection caused low incidence of ADR in children. Progams as stratifying high-risk patients and improving administrative management could further increase the safety level of injection.
评估现实世界中儿童使用注射剂的安全性。一项多中心、大样本、双向队列研究，采用注册型临床安全性监测。2014年1月至2015年5月期间，在中国59家二级和三级医院招募了6188名年龄≤14岁的住院患者和急诊科患者，他们均使用了注射剂。主要结局将包括注射剂药物不良反应（ADR）/药物不良事件（ADE）的发生率和严重程度。采用单因素分析来解释ADR的危险因素。ADE的总体发生率为4.20‰（26例），其中4例为严重病例。ADR的发生率为3.07‰（19例），包括17例一般ADR和2例新的ADR。所有ADR病例均为轻度或中度，主要表现为皮肤和附属器损害。疾病在注射后24小时内发生，但所有ADR病例均得到改善或治愈。有药物或食物过敏史会增加ADR的发生率。注射剂在儿童中引起的ADR发生率较低。对高危患者进行分层和改进行政管理等方案可进一步提高注射剂的安全水平。
