利奈唑胺注射液致血小板减少的主动监测与评价研究

目的：通过计算机辅助主动监测方法，分析评估中国人民解放军总医院住院患者中利奈唑胺注射液致血小板减少的真实世界数据。方法：依托医疗机构药品不良事件主动监测与智能评估警示系统（ADE-ASAS），回顾性调取2008年1月至2020年12月该院使用利奈唑胺注射液患者信息。对系统报警的疑似病例展开双人盲评、逐一甄别，确认利奈唑胺注射液致血小板减少阳性病例。结果：ADE-ASAS提取获得利奈唑胺注射液用药患者9 338例，通过对患者诊疗信息开展主动监测，判别得到阳性病例810例（8.67%），其中ADR组（血小板计数<100×10⁹/L）465例（4.97%），趋势组（血小板降幅>基线值×25%）754例（8.07%）。高龄和入住ICU患者血小板减少发生率较高，高龄、入住ICU、血小板基线值较高、用药时间短、合并抗感染药物品种数少的患者血小板日均降速较大。进一步单因素分析提示，高龄（RR=3.33/3.54，P<0.05）、入住ICU（RR=1.73/1.90，P<0.05）、血小板计数值低/降幅大（RR=2.04/3.33，P<0.05）为ADR组和趋势组患者院内死亡的危险因素。结论：应用ADE-ASAS可以高效、准确地获取利奈唑胺注射液真实世界用药数据，发掘血小板减少发生趋势、规律和院内死亡危险因素，进而早期识别、有效规避高危患者不良反应风险。

Automatic monitoring and evaluation of linezolid induced thrombocytopenia

OBJECTIVE To evaluate the real-world data of linezolid injection-induced thrombocytopenia from inpatients through computer-assisted active monitoring. METHODS From January 2008 to December 2020,clinical data of linezolid injection was retrospectively collected by the Adverse Drug Events Active Surveillance and Assessment System(ADE-ASAS)for adverse drug events at medical institutions.And the suspected cases reported by the system were blindly evaluated and screened one-by-one for confirming the positive cases of thrombocytopenia caused by linezolid injection. RESULTS Among a total of 9 338 patients using linezolid injection,810 positive cases(8.67%)were identified through active monitoring of clinical profiles.There were 465 cases(4.97%)in ADR group(platelet count<100×10⁹/L)and 754 cases(8.07%)in trend group(platelet decline>25% of baseline value).The incidence of thrombocytopenia was higher in elders and intensive care unit(ICU)patients.Advanced age,admission into ICU,higher baseline platelet count,shorter dosing time and fewer types of combined antibiotics exhibited a greater daily decline in platelet count.Further univariate analysis indicated that advanced age(RR=3.33/3.54,P<0.05),admission into ICU(RR=1.73/1.90,P<0.05)and greater thrombocytopenia value/range(RR=2.04/3.33,P<0.05)were risk factors for in-hospital mortality of patients with thrombocytopenia in ADR and trend groups respectively. CONCLUSION Application of ADE-ASAS can efficiently and accurately acquire the real-world medication data of linezolid injection,uncover the regularity of thrombocytopenia and risk factor for in-hospital mortality,identify earlier and avoid effectively adverse effects for high-risk patients.