ABSTRACT
Objective:To analyze the off-label use and adverse reactions of lobaplatin for injection to provide reference for the rational use in clinic. Methods:A retrospective review was conducted on the inpatient medical records (201 cases) with lobaplatin for injection from November 2016 to July 2017 in a hospital and analyzed the characteristics of adverse drug reactions/events (ADR/ADE) with the help of SPSS software. The ADRs were performed correlation factor analysis.Results:The off-label ratio of the indication,administration route and solvent for lobaplatin was 89.55%,18.41% and 47.26%,respectively. The rate of adverse events was 63.18%. The main adverse reactions were blood and lymphatic system disorders and hepatobiliary system damage,and the manifestations were lymphocyte decrease(40.80%),hemoglobin(23.88%),white blood cell decrease (19.90%) and platelet decrease (15.92%) and AST increase (10.45%). No grade 5 adverse event happened, however, new adverse reactions,such as palpitation, dyspnea, harshness, etc were shown. The use of 0.9% sodium chloride injection as the solvent for lobaplatin may be a risk factor for ADRs. Conclusion:Most of the medical orders with lobaplatin for injection contain off-label use,and the rate of adverse events is as high as 63.18%. The use of 0.9% sodium chloride injection as the solvent for lobaplatin may be a risk factor for ADRs.
ABSTRACT
OBJECTIVE:To explore the characteristics and regularities of cardiac damage induced by metranidazole,and pro-vide reference for clinical safe application. METHODS:In retrospective study,58 cases of cardiac damage caused by metranidazole in Henan ADR Monitoring Center for Drug from Jan. 2010 to Dec. 2015 were analyzed statistically. RESULTS:In 58 cases of cardiac damage induced by metranidazole,25 cases were male,33 were female,the ratio of male to female was 0.76∶1,the patients with ADR/ADE aged 15-64 years (74.14%),most were intravenous administration (79.31%) and happened within 30 min (70.69%), cardiac damage mainly manifested as palpitation,severe cases can cause tachycardia and arrhythmia,the ADR improved or cured af-ter withdrawal or symptomatic treatment. CONCLUSIONS:Clinic should strengthen observation of ADR/ADE caused by metranida-zole,especially the monitoring of cardiac toxicity reactions;pharmaceutical manufacturers should improve the drug instructions to in-sure the safety of clinical medication.