中华预防医学杂志
中華預防醫學雜誌
중화예방의학잡지
CHINESE JOURNAL OF
2008年
z1期
135-137
,共3页
尤尔科%熊翔%彭晋岳%刘富英%南玮秋%马礼萍%彭茂林%刘研%王旭
尤爾科%熊翔%彭晉嶽%劉富英%南瑋鞦%馬禮萍%彭茂林%劉研%王旭
우이과%웅상%팽진악%류부영%남위추%마례평%팽무림%류연%왕욱
流感疫苗%安全%评价研究
流感疫苗%安全%評價研究
류감역묘%안전%평개연구
Influenza vaccine%Safety%Evaluation studies
目的 评价流行性感冒(简称流感)感裂解疫苗安尔来福的安全性.方法 在十堰市东风集团进行开放式临床观察,受试者为97名18～60岁成人和101名≥61岁老年人,其中28例有慢性病史,全部受试者健康状态稳定.在受试者签署知情同意书后接种0.5 ml/支流感裂解疫苗安尔来福,接种后观察7 d,直至不良反应消失.结果 共发生不良反应17例,不良反应发生率为8.6%,其中成人组和老年组不良反应发生率分别为13.4%(13/97)和4.0%(4/101),差异有统计学意义(x2=5.620,P=0.018).局部不良反应发生率为5.5%(11/198),主要为接种部位疼痛;全身不良反应发生率为3.5%(7/198),以发热最多.有慢性病史受试者未观察到不良反应.结论 本次观察未见由疫苗引起新的不良反应,亦未见严重不良事件及罕见不良反应,流感裂解疫苗安全性良好.
目的 評價流行性感冒(簡稱流感)感裂解疫苗安爾來福的安全性.方法 在十堰市東風集糰進行開放式臨床觀察,受試者為97名18～60歲成人和101名≥61歲老年人,其中28例有慢性病史,全部受試者健康狀態穩定.在受試者籤署知情同意書後接種0.5 ml/支流感裂解疫苗安爾來福,接種後觀察7 d,直至不良反應消失.結果 共髮生不良反應17例,不良反應髮生率為8.6%,其中成人組和老年組不良反應髮生率分彆為13.4%(13/97)和4.0%(4/101),差異有統計學意義(x2=5.620,P=0.018).跼部不良反應髮生率為5.5%(11/198),主要為接種部位疼痛;全身不良反應髮生率為3.5%(7/198),以髮熱最多.有慢性病史受試者未觀察到不良反應.結論 本次觀察未見由疫苗引起新的不良反應,亦未見嚴重不良事件及罕見不良反應,流感裂解疫苗安全性良好.
목적 평개류행성감모(간칭류감)감렬해역묘안이래복적안전성.방법 재십언시동풍집단진행개방식림상관찰,수시자위97명18～60세성인화101명≥61세노년인,기중28례유만성병사,전부수시자건강상태은정.재수시자첨서지정동의서후접충0.5 ml/지류감렬해역묘안이래복,접충후관찰7 d,직지불량반응소실.결과 공발생불량반응17례,불량반응발생솔위8.6%,기중성인조화노년조불량반응발생솔분별위13.4%(13/97)화4.0%(4/101),차이유통계학의의(x2=5.620,P=0.018).국부불량반응발생솔위5.5%(11/198),주요위접충부위동통;전신불량반응발생솔위3.5%(7/198),이발열최다.유만성병사수시자미관찰도불량반응.결론 본차관찰미견유역묘인기신적불량반응,역미견엄중불량사건급한견불량반응,류감렬해역묘안전성량호.
Objective To evaluate the safety of the split influenza vaccine Anflu.Methods A total of 198 subjects were enrolled in this open clinical trial.Of which,97 aged 18-60 years old and 101 aged 61 years old.28 of the subjects had history of chronic disease,while all the subjects were under stable health condition.After being infoma consented,each subject was vaccinated with one dose of split influeza vaccine and observed for 7 days for adverse reactions.Results A total of 17 subjects reported adverse reactions and the adverse reactions occurrence rate was 8.6%.The adverse reactions occurrence rate was 13.4%in the adult group and 4.0%in the elderly group(x2=5.620,P=0.018).Local adverse reactions occurrence rate was 5.5%and pain at the iniection site was the major symptom.System adverse reactions rate was 3.5% and fever was the most frequently reported symptom.None of the subjects with chronic disease history reported adverse reactions.Conclusion The results showed that the vaccine did not cause new adverse reaction,serious adverse event or rare adverse reaction.The split influenza vaccine was safe.
