Epidemiological investigation of emergency infusion adverse drug reactions in Nanjing, China: a prospective cross-sectional study.

OBJECTIVE: Little is known about the morbidity and mortality of infusion Adverse drug reactions (ADRs) in the emergency department. We sought to evaluate the epidemiology of emergency infusion ADRs. MATERIALS AND METHODS: This was a prospective study of infusion ADRs in the emergency infusion unit (EIU) of a tertiary hospital from 1 January 20201 January 2020, to 31 December 2021w31 December 2021. Emergency infusion ADRs were identified as intravenous drug-related ADRs that the causality was determined using the Naranjo algorithm. The incidence, severity and preventability of these ADRs were assessed using other standard criteria. RESULTS: A total of 327 ADRs were recorded for 320 participants, antibiotics were the class of drugs most commonly involved, and 76.15% of ADRs occurred within the first hour. The most common symptoms observed were skin manifestations, accounting for 46.04% of ADRs. Mild reactions accounted for 85.32% based on the Hartwig and Siegel scale. In 89.30% of the reports, the ADRs were evaluated as not preventable based on the modified Schumock and Thornton scale. The causality and severity of ADRs were related to Charlson Comorbidity Index score and age (P < 0.05). CONCLUSION: This epidemiological study described the pattern of emergency infusion ADRs in East China in detail. These findings may be useful to compare patterns among different centers.

Pharmacokinetics of ginkgolides A, B and K after single and multiple intravenous infusions and their interactions with midazolam in healthy Chinese male subjects.

PURPOSE: Ginkgo terpene lactones meglumine injection (GMI) is a novel preparation of traditional Chinese medicine that contains ginkgolides A, B and K (GA, GB, GK, respectively) as its primary components. In this study we evaluated the safety, tolerability and pharmacokinetics of these three ginkgolides after single and multiple intravenous infusions of GMI. We also investigated the effect of GMI on cytochrome P450 3A4 (CYP3A4) in healthy Chinese volunteers. METHODS: In this open-label, placebo-controlled study 15 subjects were randomly assigned to receive GMI or matched placebo (4:1 ratio). All subjects first received midazolam (MDZ) on day 1, followed by a 6-day washout. On Day 8, the subjects were started on once-daily dosing of either GMI or placebo for 14 days. Lastly, on Day 22 the subjects were given second dose of MDZ + GMI or MDZ + placebo. Plasma concentrations of ginkgolides, MDZ and its metabolite 1-hydroxy midazolam were quantified. RESULTS: The steady-state conditions of GA, GB and GK were achieved after 6 days of daily dosing. Following a single dose of GMI (Day 8) the area under the concentration-timecurve from zero to 24 h after administration (AUC0-24h) of GA, GB and GK (arithmetic ± standard deviation) was 4.10 ± 1.06, 4.61 ± 1.31 and 0.127 ± 0.102 h µg/mL, respectively; the corresponding values following multiple doses of GMI (Day 19) were 3.94 ± 1.16, 5.00 ± 1.55 and 0.118 ± 0.096 h µg/mL, respectively. The mean accumulation ratios were 0.95, 1.08 and 0.89 for GA, GB and GK, respectively. Additionally, the geometric mean [peak concentration (Cmax) and AUC0-24h] ratios of MDZ and 1-hydroxy midazolam were all within the specified acceptance ranges in the MDZ + placebo treatment and MDZ + GMI treatment. CONCLUSIONS: Our results show that GMI was well tolerated during the entire study. There was no systemic accumulation and no significant effects on the pharmacokinetics of MDZ in healthy Chinese male subjects after repeated dosing of GMI.