349例接种甲型H1N1流感病毒裂解疫苗的安全性评价.docVIP

349例接种甲型H1N1流感病毒裂解疫苗的安全性评价 曾友志 李胜前 杨思芸 李光明 谢春花（四川省南充市中心医院，南充，63700） [摘要目的评价接种甲型H1N1流感病毒裂解疫苗的安全性。方法对我院349例接种甲型H1N1流感病毒裂解疫苗者进行临床指标（局部反应、全身反应、生命体征）和实验室指标（血生化、血常规）监测。结果3例接种者发生ADR，发生率为15.2%，共79例次，其中局部反应为20例次，全身反应为59例次，以1级反应为主（81.0%），未发现其他异常反应、偶合反应和任何有临床意义的严重不良事件；不良反应主要发生于接种（67.9%）或第2（24.5%）；不良反应病程主要为12d（%），其中42例不良反应者(79.2%)为自行缓解，11例（20.8%）曾使用药物治疗，所有不良反应发生者均治愈；接种3，接种者的血常规及肝肾功能均无明显异常。结论接种甲型H1N1流感病毒裂解疫苗少数患者发生轻度的不良反应，一般很快自愈，该疫苗有较好的安全性。 关键词甲型H1N1流感病毒裂解疫苗；安全性；不良反应；评价Evaluation on safety of H1N1 Influenza A Vaccine in 349 cases ZENG You-zhi, LI Sheng-qian, Yang Si-yun, LI Guang-ming, XIE Chun-hua (The central Hospital of nanchong, nanchong 637000,China) [Abstract] Objective: To evaluate the safety and immunogenicity of H1N1 Influenza A Vaccine in healthy adults. Methods: Observed Clinical and laboratory indicators of 349 cases who vaccinated H1N1 Influenza A Vaccine in our hospital. Results: 53 cases had adverse reaction, incidence rate was 15.2%, total 79 cases of sub. 20 cases were local reaction times, 59 cases were systemic reaction, majority of adverse reaction Degree was grade 1(81.0%), no abnormal reaction, coupling reaction and any clinical significant serious adverse event was observed. Adverse reactions mainly occurred in the vaccination day (67.9%) or 2 days (24.5%); Most ADR course was in 1～2 day. In all ADR, there were 42 cases to self-healing and 11 cases treated with drugs. All ADR cases were cured. After vaccinated for 3 days, the laboratory results indicated that the vaccine had no effect on blood, liver and kidney functions. Conclusion: The H1N1 Influenza A Vaccine could cause a few people with mild adverse reactions, and the symptoms were quickly self-healing. The vaccine had better security. [Key words] H1N1 Influenza A Vaccine; Safety ; Adverse reaction; Evaluation. 目前甲型H1N1流感在全球范围内流行，人感染甲型H1N1流感后，临床早期症状与流感类似，但病情可能迅速进展，突然高热、肺炎，重者可以出现呼吸衰竭、多器官功能损伤，导致死亡[]。近来，我国甲型H1N1流感的发病人数猛增，为了迅速有效防控甲型H1N1流感疫情，我国研制了甲型H1N1流感病毒裂解疫苗（甲流疫苗），作为新上市的疫苗，其安全性的评价尤为重要，现对我院首批接种该疫苗349