541例马来酸桂哌齐特药品不良反应报告及风险因素分析

Analysis of 541 ADR reports associated with cinepazide maleate

目的:通过自发ADR报告分析,探索马来酸桂哌齐特的临床用药风险相关因素,为进一步开展临床安全性评价研究提供依据。方法:采用回顾性研究方法,提取解放军ADR监测中心数据库中所有马来酸桂哌齐特ADR报告数据,并对患者年龄、用法用量、ADR累及系统/器官及主要临床表现等进行统计分析。结果:541例ADR报告中,严重ADR及新的ADR报告构成比分别为3.32%、9.24%;发生ADR的患者中,以50岁以上人群居多(79.48%);马来酸桂哌齐特日剂量320 mg使用最多(73.01%)。最常见ADR的临床表现为中枢及周围神经系统损害(38.01%);8例血液系统ADR均为白细胞减少(1.21%),白细胞低值为(1.76~3.70)×10~9·L^(-1),严重程度与用药时间可能存在相关性。结论:马来酸桂哌齐特所致ADR相对较轻,通过强化血压、血象监测可有效防止出现严重ADR。该药所致血液系统ADR与用药时间的相关性仍需通过大样本研究获取安全性再评价证据。

Objective: To research the possible risk factors of cinepazide maleate by analysing the spontaneous ADR reports and provide references for advanced clinical safety evaluation. Methods: With the retrospective method, all the ADR reports of cinepazide maleate were extracted in the database of PLA ADR monitoring center. The data in respect of patients' age, dosage and administration, systems and organs involved in ADR and clinical manifestations were analyzed statistically. Results: Among the 541 ADR reports, the severe and the new ADRs accounted for 3.32% and 9.24% respectively, beyond 50 years old was 79.48%, the used daily dose of 320 mg(73.01%) and the impairment of central and peripheral nervous system(38.01%) was the commonest. All of the 8 hematological system ADRs was leucopenia(1.21%), WBC range from 1.76 × 10~9·L^(-1) to 3.70 × 10~9·L^(-1), and a close correlation between the severity and the time of medication could be indicated. Conclusion: ADRs caused by cinepazide maleate is slight, severe ADRs can be prevented effectively by strengthening the monitoring of blood pressure and hemogram. To validate the correlation between the severity and the time of medication still need wider study.