现代医药卫生2016，Vol.32Issue(17)：2644-2646,3.DOI:10.3969/j.issn.1009-5519.2016.17.008
国产派格宾治疗慢性乙型肝炎Ⅲ期临床试验严重不良事件观察
Observation on serious adverse events of phase 3 clinical trial in domestic Paigebin treatment of chronic hepatitis B
摘要
Abstract
Objective To analyze the serious adverse events (SAE) occurred in the clinical trial of domestic polyethylene glycol human recombinant interferonα-2b (Paigebin) to provide a reference for the safe medication in the future. Methods The phaseⅢclinical trial of multicenter,prospective,central randomization and positive drug control was performed from December 2013 to June 2015,the study group used the domestic Paigebin and the control group used polyethylene glycol interferon α-2a injection(Pegsys). The safety of domestic Paigebin use was investigated by analyzing the SAE occurrence situation during the clinical trial process. Results A total of 47 cases were screened in the phase Ⅲclinical trial,33 cases were included,5 cases (6 case-times) of SAE occurred,the SAE occurrence rate was 15.15%(5/33). The SAE occurrence had no relation with domestic Paigebin and Pegsys. Conclusion Using domestic Paigebin and Pegsys had no SAE occurrence during the clinical trial. Using the domestic Paigebin in clinic should pay close attention to the symptom occurrence of patients for reducing the SAE occurrence.关键词
肝炎,乙型,慢性/药物疗法/干扰素类/治疗应用/聚西托醇/治疗应用/严重不良事件Key words
Hepatitis B,chronic/drug therapy/Interferons/therapeutic use/Cetomacrogol/therapeutic use/Serious adverse events引用本文复制引用
刘振宇,袁劲松,彭雁忠..国产派格宾治疗慢性乙型肝炎Ⅲ期临床试验严重不良事件观察[J].现代医药卫生,2016,32(17):2644-2646,3.基金项目
广东省深圳市科技项目（201213）。 （）
