Li Xiao-Xiao, Zhuo Lin, Zhang Yan, Yang Yi-Heng, Zhang Hong, Zhan Si-Yan, Zhai Suo-Di
Department of Pharmacy, Peking University Third Hospital, Beijing, China.
Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Beijing, China.
Front Pharmacol. 2020 Jan 9;10:1523. doi: 10.3389/fphar.2019.01523. eCollection 2019.
Tanreqing injection (TRQ) is a traditional Chinese medicine commonly used in China to treat pulmonary diseases presenting as phlegm-heat syndrome. Robust data on the safety of TRQ from real-world observational cohorts are currently lacking. To evaluate as the incidence, type, and predictors of adverse events (AEs) and adverse drug reactions (ADRs) of TRQ in clinical practice in China. We conducted a population-based cohort, multicenter study to evaluate the incidence, manifestation, outcomes, and risk factors of AEs and ADRs following TRQ use in China. Between April 2014 and May 2015 a total of 30,322 consecutive inpatients/emergency attendance patients from 90 hospitals across China administrated TRQ were followed-up for 7 days. Odds ratios (ORs) with 95% confidence intervals (CIs) were estimated using logistic regression to identify predictors of ADRs. The incidence of AEs and ADRs was 1.4 and 0.3%, respectively. Skin and subcutaneous tissue disorders were the most common ADRs. All ADRs were mild or moderate in severity, except for one serious case of anaphylactic reaction. The majority of ADRs (72.8%) occurred in the first 2 h after TRQ administration. Two-thirds of patients (66.1%) in the study were prescribed TRQ off-label, including infants aged ≤24 months. A history of food allergy (OR 4.50, 95% CI: 1.35-15.00), drug allergy (OR 2.77, 95% CI: 1.56-4.94), and fast infusion speed (off-label use) (OR 2.10, 95% CI: 1.27-3.50) were associated with an increased risk of ADRs. TRQ is well tolerated in the general population, yet off-label use is prevalent. Efforts are required to educate prescribers to adhere to the drug label in order to minimize potential patient harm.
痰热清注射液（TRQ）是中国常用的一种治疗表现为痰热证的肺部疾病的中药。目前缺乏来自真实世界观察队列的关于TRQ安全性的有力数据。为了评估TRQ在中国临床实践中不良事件（AE）和药物不良反应（ADR）的发生率、类型及预测因素。我们开展了一项基于人群的队列、多中心研究，以评估在中国使用TRQ后AE和ADR的发生率、表现、结局及危险因素。在2014年4月至2015年5月期间，对中国90家医院连续使用TRQ的30322例住院患者/急诊患者进行了7天的随访。使用逻辑回归估计比值比（OR）及95%置信区间（CI），以确定ADR的预测因素。AE和ADR的发生率分别为1.4%和0.3%。皮肤及皮下组织疾病是最常见的ADR。除1例严重过敏反应病例外，所有ADR的严重程度均为轻度或中度。大多数ADR（72.8%）发生在TRQ给药后的前2小时内。研究中三分之二的患者（66.1%）使用TRQ属于超说明书用药，包括年龄≤24个月的婴儿。食物过敏史（OR 4.50，95% CI：1.35 - 15.00）、药物过敏史（OR 2.77，95% CI：1.56 - 4.94）以及快速输注速度（超说明书用药）（OR 2.10，95% CI：1.27 - 3.50）与ADR风险增加相关。TRQ在普通人群中耐受性良好，但超说明书用药很普遍。需要努力教育开处方者遵守药品说明书，以尽量减少对患者的潜在伤害。
