Safety Signal Mining for 7 Kinds of Fluid Therapy Drug Based on FAERS Database / 中国药房

ABSTRACT

OBJECTIVE：To mine t he data of adverse even ts of 7 kinds of commonly used fluid therapy drugs （normal Ringer ’ s solution ，Ringer’s lactate solution ，Ringer’s acetate solution ，hydroxyethyl starch ，succinylated gelatin ，dextran and human albumin） based on FAERS database of FDA ，in order to provide reference for carrying out fluid therapy in clinic safely. METHODS：Data from the first quarter of 2004 to the fourth quarter of 2019（64 quarters）in FAERS database were downloaded. After data cleaning ，adverse drug event report cases related to 7 kinds of fluid therapy drug as the primary and secondary suspected drugs were extracted ，and ADR signal was mined by using the reporting odds ratio method （ROR）and the proportional reporting ratio method （PRR）. RESULTS ：A total of 2 383 adverse event reports were extracted ，including 26 reports（1.09％）of normal Ringer’s solution ，479 reports（20.10％）of Ringer ’s lactate solution ，65 reports（2.73％）of Ringer ’s acetate solution ，256 reports （10.74％）of hydroxyethyl starch ，79 reports（3.32％）of succinylated gelatin ，154 reports（6.46％）of dextran ，1 324 reports （55.56％）of human albumin. Totally 879 cases（36.89％）were male and 985 cases（41.33％）were female ，the rest were unknown. The main age was 18-64 years old （950 cases，39.87％）；most of the reporters were doctors （634 cases，26.60％）. Totally 382 cases（16.03％）died. Among the adverse event reports of fluid therapy drugs ，70 cases（14.61％）administered Ringer ’s lactated solution and 259 cases（19.56％）administered human albumin died. Among them ，the top three adverse events in the number of reports were immune system diseases ，heart organ diseases ，vascular and lymphatic diseases. CONCLUSIONS ：ADRs of fluid therapy drugs are mainly related to immune system and heart organ. In the process of them ，especially for patients with allergic history and heart disease ，patients’volume indicators should be closely monitored ；during fluid therapy ，especially during the use of colloids ， great importance should be attached to renal and urinary system related adverse events ， and renal function should be closely monitored .