Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.
Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.
Curr Med Sci. 2018 Dec;38(6):1103-1108. doi: 10.1007/s11596-018-1990-2. Epub 2018 Dec 7.
Qingkailing (QKL) is a modern preparation exploited according to the traditional Chinese medicine theory. It becomes the second leading cause of adverse drug events (ADEs) in all traditional Chinese medicine injections. The safety evaluation and rational use of QKL are of special importance. This retrospective study used data from Adverse Drug Reaction Monitoring Center of Hubei Province in China from January 2012 to December 2014. ADE cases induced by QKL were collected and analyzed according to patients' demographics, characteristics of drugs involved, characteristics of ADEs, causality, and outcomes. A total of 1330 qualified ADEs were included. Most ADEs occurred within 30 min after administration and the 0-10 years old age group had the highest number of ADEs. The common ADEs included anaphylactic reaction, dyspnea and nausea. Serious reactions accounted for 5.19%. Combination with cephalosporin (74/146, 50.69%) caused more ADEs than other drugs did. Serious attention should be paid when QKL is used for children, and combination with cephalosporin should be avoided.
清开灵（QKL）是一种根据中医理论开发的现代制剂，它已成为所有中药注射剂中导致不良药物事件（ADE）的第二大原因。QKL 的安全性评估和合理使用尤为重要。本回顾性研究使用了中国湖北省药品不良反应监测中心 2012 年 1 月至 2014 年 12 月的数据。根据患者人口统计学、涉及药物的特点、ADE 特点、因果关系和结果，收集并分析了由 QKL 引起的 ADE 病例。共纳入 1330 例合格 ADE。大多数 ADE 发生在给药后 30 分钟内，0-10 岁年龄组的 ADE 数量最多。常见的 ADE 包括过敏反应、呼吸困难和恶心。严重反应占 5.19%。与头孢菌素（74/146，50.69%）联合使用比其他药物引起更多的 ADE。在儿童中使用 QKL 时应特别注意，应避免与头孢菌素联合使用。
