医学理论与实践
醫學理論與實踐
의학이론여실천
The Journal of Medical Theory and Practice
2015年
2期
141-142,158
,共3页
杨海云%陈乐锋%黄金凤%梁小媚%陈雪玲
楊海雲%陳樂鋒%黃金鳳%樑小媚%陳雪玲
양해운%진악봉%황금봉%량소미%진설령
国产%进口%重组乙型肝炎疫苗%安全性
國產%進口%重組乙型肝炎疫苗%安全性
국산%진구%중조을형간염역묘%안전성
Domestic%Import Recombinant hepatitis B vaccine%Safety
目的：了解国产和进口两种乙肝疫苗安全性的差异，促进乙肝疫苗接种，提高免疫覆盖率。方法：在茂名市市区内选择0～1岁的健康儿童共300例，以自愿为原则分为国产疫苗组与进口疫苗组，分别接种国产重组乙型肝炎疫苗和进口重组乙型肝炎疫苗，在接种后的7d内追踪观察全身反应和局部反应。结果：国产重组乙型肝炎疫苗与进口重组乙型肝炎疫苗相比具有相似的安全性。300例接种者中均无局部反应发生，全身反应的发生率分别为在4.67％、3．33％，两者在安全性方面差异没有统计学意义（χ2＝0．35，P值＞0．05）。在发生的12例不良反应中，83.33％（10／12）发生于接种后1d内，16．67％（2／12）发生于接种后2～3d；男女比例为1．40∶1。25.00％（3／12）发生在接种第1剂时，41．67％（5／12）发生在接种第2剂时，33．33％（4／12）发生在接种第3剂时。国产疫苗组与进口疫苗组发生的不良反应在时间分布、人群分布、接种针次分布上的趋势一致。结论：无论国产乙肝疫苗还是进口乙肝疫苗接种后均有部分儿童发生不良反应，可能与儿童个体差异因素有关，经干预后无严重后果发生，安全性较高，而国产疫苗为国家免疫规划疫苗，儿童免费接种3剂次，与价格偏高的进口疫苗相比，更适用于我国乙型肝炎防控工作。
目的：瞭解國產和進口兩種乙肝疫苗安全性的差異，促進乙肝疫苗接種，提高免疫覆蓋率。方法：在茂名市市區內選擇0～1歲的健康兒童共300例，以自願為原則分為國產疫苗組與進口疫苗組，分彆接種國產重組乙型肝炎疫苗和進口重組乙型肝炎疫苗，在接種後的7d內追蹤觀察全身反應和跼部反應。結果：國產重組乙型肝炎疫苗與進口重組乙型肝炎疫苗相比具有相似的安全性。300例接種者中均無跼部反應髮生，全身反應的髮生率分彆為在4.67％、3．33％，兩者在安全性方麵差異沒有統計學意義（χ2＝0．35，P值＞0．05）。在髮生的12例不良反應中，83.33％（10／12）髮生于接種後1d內，16．67％（2／12）髮生于接種後2～3d；男女比例為1．40∶1。25.00％（3／12）髮生在接種第1劑時，41．67％（5／12）髮生在接種第2劑時，33．33％（4／12）髮生在接種第3劑時。國產疫苗組與進口疫苗組髮生的不良反應在時間分佈、人群分佈、接種針次分佈上的趨勢一緻。結論：無論國產乙肝疫苗還是進口乙肝疫苗接種後均有部分兒童髮生不良反應，可能與兒童箇體差異因素有關，經榦預後無嚴重後果髮生，安全性較高，而國產疫苗為國傢免疫規劃疫苗，兒童免費接種3劑次，與價格偏高的進口疫苗相比，更適用于我國乙型肝炎防控工作。
목적：료해국산화진구량충을간역묘안전성적차이，촉진을간역묘접충，제고면역복개솔。방법：재무명시시구내선택0～1세적건강인동공300례，이자원위원칙분위국산역묘조여진구역묘조，분별접충국산중조을형간염역묘화진구중조을형간염역묘，재접충후적7d내추종관찰전신반응화국부반응。결과：국산중조을형간염역묘여진구중조을형간염역묘상비구유상사적안전성。300례접충자중균무국부반응발생，전신반응적발생솔분별위재4.67％、3．33％，량자재안전성방면차이몰유통계학의의（χ2＝0．35，P치＞0．05）。재발생적12례불량반응중，83.33％（10／12）발생우접충후1d내，16．67％（2／12）발생우접충후2～3d；남녀비례위1．40∶1。25.00％（3／12）발생재접충제1제시，41．67％（5／12）발생재접충제2제시，33．33％（4／12）발생재접충제3제시。국산역묘조여진구역묘조발생적불량반응재시간분포、인군분포、접충침차분포상적추세일치。결론：무론국산을간역묘환시진구을간역묘접충후균유부분인동발생불량반응，가능여인동개체차이인소유관，경간예후무엄중후과발생，안전성교고，이국산역묘위국가면역규화역묘，인동면비접충3제차，여개격편고적진구역묘상비，경괄용우아국을형간염방공공작。
Objective:Understand the difference between domestic and imported vaccines the safety of both the two hepatitis B ,hepatitis Bvaccination to promote and improve immunization coverage .Methods:In Maoming City area choose healthy children aged 0~1 total 300 ,a voluntary set of principles into domestic and imported vaccines vaccine group were vaccinated with a recombinant hepatitis B vaccine and recombinant hepatitis B vaccine imported in vaccina‐tion 7 days after the follow‐up observation of systemic reactions and local swelling reactions .Results:Compared with domestic recombinant vaccine and imported recombinant hepatitis B vaccine has a similar safety profile .300 cases of re‐cipients had no local reaction ,the incidence was 3 .33% in 4 .67% ,systemic reaction ,the difference in the aspect of safety was not statistically significant (χ2 =0 .35 ,P>0 .05) .In 12 cases of adverse reactions occurred in 83 .33% (10/12) ,occurs within 1 days after inoculation ,16 .67% (2/12) occurred in 2~3 days after inoculation;the male to female ratio was 1 .40∶1 25.00% (3/12) ,occurred in inoculated first agents ,41 .67% (5/12) occurred within second agents , 33 .33% (4/12) occurred in third when the inoculation agent .Domestic vaccine group and imported vaccines group had adverse reactions in the time distribution ,population distribution ,the distribution of the inoculating needle on the same trend .Conclusion:Whether domestic or imported hepatitis B vaccine hepatitis B vaccination are part of the children after the occurrence of adverse reactions may be related to factors related to children's individual differences ,without serious consequences occur after the intervention ,the security is high ,while the domestic vaccine vaccines for national immu‐nization programs ,children free vaccinated three times ,compared with the high price of imported vaccines ,more suit‐able for the prevention and control of hepatitis .
