[Post-marketing surveillance of Tanreqing injection in children: a real world study].

• DOI: 10.3760/cma.j.issn.0254-6450.2017.02.023
• Publication Date: 2017-02-10
• Authors: Xiaoxiao Li; Lin Zhuo; Yiheng Yang; Siyan Zhan; Suodi Zhai
• Keywords: Postmarketing surveillance; Adverse drug reaction

Objective: To evaluate the safety of Tanreqing injection among children in real world. Methods: A multicenter, large sample, ambispective cohort study, with registration-type clinical monitoring. total 6 188 inpatients and patients from emergency units, aged ≤ 14 years who all had been using 59 secondary tertiary hospitals China, were recruited between January, 2014 May, 2015. The main outcomes would include incidence severity adverse drug reaction (ADR)/adverse event (ADE) injection. Univariate analysis was used to explain risk factors ADR. Results: overall ADE 4.20‰ (26 cases), including 4 serious ones. ADR 3.07‰ (19 17 cases general 2 new All mild or moderate, mostly showing damages skin appendages. onset disease happened 24 hours after but got improved cured. Having histories allergies drugs foods increase Conclusion:Tanreqing caused low children. Progams as stratifying high-risk improving administrative management could further level injection.目的：评价真实世界中儿童应用痰热清注射液的安全性。 方法：采用多中心、大样本、双向队列、注册登记式临床安全性监测方法，在全国59家二级以上医院纳入2014年1月至2015年5月连续处方使用痰热清注射液的6 188例年龄≤14岁住院、急诊留观患儿。主要评价指标为不良反应／事件的发生率、严重程度以及转归。对不良反应可能的危险因素进行单因素分析。 结果：儿童痰热清注射液药品不良事件发生率为4.20‰（26例，包含严重不良事件4例）。不良反应发生率为3.07‰（19例），其中一般不良反应17例、新的不良反应2例。所有不良反应的程度均为轻中度，以皮肤及其附件损害最常见。所有不良反应在用药24 h内出现，转归均为痊愈或好转。有食物或药物过敏史者不良反应发生率显著增加。 结论：儿童痰热清注射液的不良反应发生率较低。对高危人群进行分层，并进一步规范临床使用，可提高痰热清注射液的用药安全性。.