Analysis on 201 Cases of Off-label Use and Related Factors for Adverse Reactions of Lobaplatin for Injection in a Hospital
- VernacularTitle:某院201例注射用洛铂超说明书用药及其不良反应相关因素分析
- Author:
Haiyan ZHAN
1
,
2
;
Jian YANG
Author Information
1. 武汉大学人民医院药学部 武汉430060
2. 武汉大学药学院
- Keywords:
Lobaplatin for injection;
Adverse drug reaction/event;
Off-label drug use;
Related factors
- From:
China Pharmacist
2018;21(5):870-874
- CountryChina
- Language:Chinese
-
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.
