痰热清注射液儿童应用安全性再评价的真实世界研究

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

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。

Objective To evaluate the safety of Tanreqing injection among children in the real world. Methods 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 Tanreqing 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 Tanreqing injection. Univariate analysis was used to explain the risk factors of ADR. Results 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 Tanreqing injection but all the ADR cases got improved or cured. Having histories of allergies to drugs or foods would increase the incidence of ADR. Conclusion Tanreqing 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 Tanreqing injection.