中华预防医学杂志
中華預防醫學雜誌
중화예방의학잡지
CHINESE JOURNAL OF
2009年
10期
903-906
,共4页
付清培%何惠%李丽%陈海平%曾义学%刘青恋%方刚%董春明%郭绍红%李汉刚%王怀远%何崇松%周仕昭%李力%古思宁%张正芳%代敏
付清培%何惠%李麗%陳海平%曾義學%劉青戀%方剛%董春明%郭紹紅%李漢剛%王懷遠%何崇鬆%週仕昭%李力%古思寧%張正芳%代敏
부청배%하혜%리려%진해평%증의학%류청련%방강%동춘명%곽소홍%리한강%왕부원%하숭송%주사소%리력%고사저%장정방%대민
肝炎疫苗%乙型%剂型%抗原%肝炎抗体%乙型
肝炎疫苗%乙型%劑型%抗原%肝炎抗體%乙型
간염역묘%을형%제형%항원%간염항체%을형
Hepatitis B vaccines%Dosage forms%Antigens%Hepatitis B antibodies
目的 评价10μg重组乙型肝炎疫苗(酵母)扩大适用人群至5～18岁的可行性.方法 筛选乙肝表面抗原(HBsAg)及表面抗体(抗-HBs)均阴性者,进行两个阶段的临床试验,对安全性和免疫原性观察分析.对925名受试者进行了安全性观察;在免疫原性观察中共检测568名受试者,包括观察组(5～18岁)493名、对照组(>18岁)75名,观察组又分为3个亚组:儿童组(5～6岁)141名、少年组(12～13岁)177名、青年组(16～18岁)175名.使用10μg重组乙型肝炎疫苗(酵母)按0、1、6个月程序接种3针,分时段连续观察4周并记录其接种反应以评价疫苗安全性,全程接种后4～6周时用固相放射免疫(RIA)法共检测568份有效血清,比较两组抗-HBs阳转率、几何平均滴度(GMT)和达到保护水平率以评价疫苗免疫原性.结果 观察组和对照组在接种疫苗后0.5、6、24、48、72 h及1周、2周、3周、4周均未观察到局部或全身的异常反应.免疫后儿童组、少年组、青年组和对照组抗-HBs阳转率分别为100.00%(141/141)、97.18%(172/177)、98.29%(172/175)和89.33%(67/75),GMT分别为440.28、875.38、467.80、131.06 U/L,达到保护水平率分别为100.00%(141/141)、97.18%(172/177/)、97.14%(170/175)和86.67%(65/75).观察组的3个亚组抗-HBs阳转率、GMT、达到保护水平率均高于对照组(x_(阳转率)~2=12.77、5.12、7.99;t_(GMT)=3.89、4.13、5.91;x_(保护率)~2=16.81、8.60、8.44;P值均<0.05).结论 试验疫苗在5～18岁人群接种安全有效,抗-HBs阳转率和保护率高于18岁以上人群.
目的 評價10μg重組乙型肝炎疫苗(酵母)擴大適用人群至5～18歲的可行性.方法 篩選乙肝錶麵抗原(HBsAg)及錶麵抗體(抗-HBs)均陰性者,進行兩箇階段的臨床試驗,對安全性和免疫原性觀察分析.對925名受試者進行瞭安全性觀察;在免疫原性觀察中共檢測568名受試者,包括觀察組(5～18歲)493名、對照組(>18歲)75名,觀察組又分為3箇亞組:兒童組(5～6歲)141名、少年組(12～13歲)177名、青年組(16～18歲)175名.使用10μg重組乙型肝炎疫苗(酵母)按0、1、6箇月程序接種3針,分時段連續觀察4週併記錄其接種反應以評價疫苗安全性,全程接種後4～6週時用固相放射免疫(RIA)法共檢測568份有效血清,比較兩組抗-HBs暘轉率、幾何平均滴度(GMT)和達到保護水平率以評價疫苗免疫原性.結果 觀察組和對照組在接種疫苗後0.5、6、24、48、72 h及1週、2週、3週、4週均未觀察到跼部或全身的異常反應.免疫後兒童組、少年組、青年組和對照組抗-HBs暘轉率分彆為100.00%(141/141)、97.18%(172/177)、98.29%(172/175)和89.33%(67/75),GMT分彆為440.28、875.38、467.80、131.06 U/L,達到保護水平率分彆為100.00%(141/141)、97.18%(172/177/)、97.14%(170/175)和86.67%(65/75).觀察組的3箇亞組抗-HBs暘轉率、GMT、達到保護水平率均高于對照組(x_(暘轉率)~2=12.77、5.12、7.99;t_(GMT)=3.89、4.13、5.91;x_(保護率)~2=16.81、8.60、8.44;P值均<0.05).結論 試驗疫苗在5～18歲人群接種安全有效,抗-HBs暘轉率和保護率高于18歲以上人群.
목적 평개10μg중조을형간염역묘(효모)확대괄용인군지5～18세적가행성.방법 사선을간표면항원(HBsAg)급표면항체(항-HBs)균음성자,진행량개계단적림상시험,대안전성화면역원성관찰분석.대925명수시자진행료안전성관찰;재면역원성관찰중공검측568명수시자,포괄관찰조(5～18세)493명、대조조(>18세)75명,관찰조우분위3개아조:인동조(5～6세)141명、소년조(12～13세)177명、청년조(16～18세)175명.사용10μg중조을형간염역묘(효모)안0、1、6개월정서접충3침,분시단련속관찰4주병기록기접충반응이평개역묘안전성,전정접충후4～6주시용고상방사면역(RIA)법공검측568빈유효혈청,비교량조항-HBs양전솔、궤하평균적도(GMT)화체도보호수평솔이평개역묘면역원성.결과 관찰조화대조조재접충역묘후0.5、6、24、48、72 h급1주、2주、3주、4주균미관찰도국부혹전신적이상반응.면역후인동조、소년조、청년조화대조조항-HBs양전솔분별위100.00%(141/141)、97.18%(172/177)、98.29%(172/175)화89.33%(67/75),GMT분별위440.28、875.38、467.80、131.06 U/L,체도보호수평솔분별위100.00%(141/141)、97.18%(172/177/)、97.14%(170/175)화86.67%(65/75).관찰조적3개아조항-HBs양전솔、GMT、체도보호수평솔균고우대조조(x_(양전솔)~2=12.77、5.12、7.99;t_(GMT)=3.89、4.13、5.91;x_(보호솔)~2=16.81、8.60、8.44;P치균<0.05).결론 시험역묘재5～18세인군접충안전유효,항-HBs양전솔화보호솔고우18세이상인군.
Objective To assess the feasibility of the 10 μg recombination yeast hepatitis B vaccine in the expanded applicable population group aged 5-18. Methods People with both HBsAg and anti-HBs negative were selected to take two-stage clinical experiment and the safety and immunogenicity were observed. Safety observation was conducted in 925 subjects, while 568 for immunogenicity. The observation group (aged 5-18) included 493 subjects, and (age>18) 75 enrolled in control group. For the observation group,there were three sub-groups including a child group (141, aged 5-6), early youth group(177, aged 12-13), and youth group (175, aged 16-18). Both groups were administered with 10 μg recombination yeast hepatitis B vaccines with 3 doses at 0 month, 1st month,6th month. To assess the immunogenicity,the vaccination reactions were observed during the following 4 weeks in order to assess the vaccine safety. The blood samples were taken during 4-6 weeks after fully vaccinated, and then anti-HBs were tested with RIA and analyzed by comparing the positive rate of anti-HBs,the geometric mean titer(GMT) and the protective rate between the two groups. Results Both observation and control group didn't show any general reactions,adverse events following immunization(AEFI) or coincidental cases when observed at 0. 5 h,6 h,24 h,48 h, 72 h, 1 week,2 weeks,3 weeks,4 weeks after being vaccinated. The result of serum test showed, the positive rates of child group, early youth group, youth group and control group were respectively 100. 00% (141/ 141),97.18% (172/177), 98. 29% (172/175) and 89. 33% (67/75); the GMTs of anti-HBs were respectively 440. 28,875.38,467.80,131.06 U/L; the protective rates were respectively 100. 00% (141/ 141), 97.18%(172/177), 97.14% (170/175) and 86. 67% (65/75). The positive rate, GMT and protective rate of the experimental group were all higher than that of control group(x_(positive rate)~2=12.77,5.12, 7.99; t_(GMT)=3.89,4.13,5.91;x_(protective rate)~2=16. 81,8.60,8.44;P< 0.05). Conclusion This vaccine could be expanded to 5-18 year-old population with safety and effectiveness, the positive rate and protective rate of anti-HBs were both higher than that of control group.
