60微克乙肝疫苗成人免疫效果评价及全科医师在乙肝预防控制工作中的作用研究
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摘要
目的：
作为“十一五”国家科技重大专项的研究成果之一,60微克乙肝疫苗用于成人免疫失败人群能取得较好的免疫效果,但在初免人群中的应用目前在国内乃至国际上尚无人群研究先例。本研究率先探讨普通成人初免人群接种1针剂和2针剂60微克乙肝疫苗的免疫效果,并观察1针剂60微克乙肝疫苗对免疫失败人群进行加强免疫的免疫效果。
方法：
将研究对象共分为四个组：
1、初免人群Ⅰ组：选择HBsAg、anti-HBs、乙肝核心抗体(anti-HBc)全阴者2000人接种1针60微克乙肝疫苗,接种后1个月再次采血,检测anti-HBs。
2、初免人群Ⅱ组：选择HBsAg、anti-HBs、乙肝核心抗体(anti-HBc)全阴者1000人接种2针60微克乙肝疫苗,免疫程序为0、1月。接种第二针后1个月再次采血,检测anti-HBs。
3、初免人群对照组：选择HBsAg、anti-HBs、乙肝核心抗体(anti-HBc)全阴者1400人接种3针10微克乙肝疫苗,免疫程序为0、1、6月。接种第三针后1个月再次采血,检测anti-HBs。
4、免疫失败人群组：选择1000人于2010年接种过乙肝疫苗,但anti-HBs滴度低于10mIU/ml的成人,接种1针60微克乙肝疫苗,接种后1个月再次采血,检测anti-HBs.
由于现场工作的不确定因素较多,人群失访率不确定,因此实际样本数大于此处计划样本数。
结果：
1、初免人群Ⅰ组乙肝表面抗体阳转率为19.73%,几何平均滴度(GMT)为1.53mIU/ml (95%CI1.35-1.74).但15～岁这一年龄段的人群的乙肝表面抗体阳转率为80%,GMT为147.64mIU/ml (95%CI56.10-388.60).
2、初免人群Ⅱ组的乙肝表面抗体阳转率为78.97%，GMT为51.61mIU/ml (95%CI43.96-60.56).
3、初免人群对照组的乙肝表面抗体阳转率为89.50%,GMT为197.24mlU/ml (95%CI176.47-220.46).
4、初免人群Ⅱ组的乙肝表面抗体阳转率和GMT均明显高于初免人群Ⅰ组,其中乙肝表面抗体阳转率比较(χ2=707.243,P<0.001),两者之间的差异有显著统计学意义；初免人群Ⅰ组与初免人群Ⅱ组GMT比较(t=33.777,P<0.001),两者之间的差异有显著统计学意义。
5、初免人群对照组的乙肝表面抗体阳转率和GMT均高于初免人群Ⅰ组(χ2=1751.78,P<0.001；t=56.633,P<0.001),两者之间的差异有显著统计学意义。
6、初免人群对照组的乙肝表面抗体阳转率和GMT均高于初免人群Ⅱ组(x2=46.182,P<0.001；t=13.498,P<0.001),两者之间的差异有显著统计学意义。
7、免疫失败组的乙肝表面抗体阳转率为86.91%,GMT为231.80mIU/ml(95%CI177.83-263.03)。
结论：
1、60微克乙肝疫苗1针剂免疫程序,除15～岁组外,其他年龄组乙肝表面抗体阳转率和GMT水平均不理想。
2、60微克乙肝疫苗2针剂免疫程序,可以取得较好的乙肝表面抗体阳转率,但GMT水平较低,长期效果尚待观察。
3、对免疫失败人群,60微克乙肝疫苗能取得较好的免疫效果。
4、乙肝疫苗的免疫程序,三针程序优于单针和两针,两针程序优于一针。单纯提高剂量减少针次尚不能取得很好的免疫效果。
目的
本研究旨在了解当前乙肝预防控制工作的现状,并从乙肝预防控制宣传教育及患者管理等多方面入手,通过分析短期培训对提升全科医师乙肝防制知识掌握情况的作用,及其对所管辖居民乙肝防治知识知晓率和乙肝疫苗全程接种率的加强作用,从而进一步研究探讨全科医师在乙肝预防控制工作中的作用。
方法
1、通过文献研究和访谈工作了解当前乙肝预防控制工作的现状和全科医师对乙肝预防控制工作的认识。
2、对研究组的全科医师开展短期培训,培训前后,对全科医师分别进行问卷调查,了解全科医师在接受短期培训后乙肝预防控制知识掌握情况的提升程度。
3、研究组的全科医师根据培训要求开展乙肝预防控制工作；对照组保持现有的工作方式工作。半年后,进行两组全科医师所管辖居民乙肝防治知晓率和乙肝疫苗全程接种率调查,并进行组间比较。
结果
1、定性研究结果
(1)基层卫生服务工作者的访谈结果：
1)全科医师在乙肝患者的发现、治疗和预防乙肝传播中起着关键的角色,但当前乙肝预防控制工作的主要承担者是公卫医师。
2)全科医师参与乙肝预防控制工作是非常有必要的,但是如何参与,具体参与的环节尚需进一步探讨。
3)全科医师参与乙肝预防控制工作存在的困难主要为：工作量大、人员不足,缺乏乙肝预防控制方面的知识。
(2)经过短期的培训,全科医师乙肝防制知识的掌握情况得到了较大提升
(3)全科医师认为影响乙肝疫苗全程接种率的因素包括：接种时间、地点、次数,人群流动性、宣传力度等。
2、定量研究结果
(1研究组的居民在干预后的乙肝防治知晓率为94.79%,明显高于干预前34.79%,χ2=1169.562,P<0.05,两者之间有显著性差异。
(2)研究组全科医师所辖居民的乙肝疫苗全程接种率为74.62%,明显优于对照组的26.99%,χ2=512.2,P<0.05,两者之间有显著性差异。
结论
1、当前全科医师的乙肝防制知识较匮乏,乙肝预防控制工作模式也制约着全科医师作用的发挥；
2、短期培训对全科医师乙肝防制知识的掌握情况有明显提升作用
3、全科医师积极参与的乙肝预防控制工作模式能够在一定程度上提高居民乙肝防治知识知晓率和乙肝疫苗的全程接种率。
Objectives:
To evaluate the immunological effects of one or two doses of60μg/dose hepatitis B vaccines (HepB) in adults and to investigate the effects of revaccination of one dose of60ug HepB vaccine among non-responders after the primary course of HepB vaccination.
Methods:
Subjects who tested negative for HBsAg, anti-HBs, and anti-HBc were selected in our study and then divided into four groups.
Group Ⅰ:primary vaccination Group I,2000subjects were selected for one dose of60μg/dose HepB vaccine. Anti-HBs levels were assessed using a chemiluminescence immunoassay one month after the vaccination.
Group Ⅱ:primary vaccination Group Ⅱ,1000subjects were selected for two doses of60μg/dose HepB vaccines with the first dose administered immediately and subsequent doses1month later. Anti-HBs levels were assessed one month after the second vaccination
Group Ⅲ:primary vaccination control Group,1400subjects were selected and received3doses of lOug/dose hepatitis B vaccines with the first dose administered immediately and subsequent doses1and6months later. Anti-HBs levels were assessed one month after the third vaccination.
Group Ⅳ:people who failed to respond after a course of3vaccinations in2010.1000non-responders with an anti-HBs titer level being less than lOmlU/ml were selected. They were given one dose of60ug/dose HepB vaccine and the Anti-HBs levels were assessed one month after the vaccination.
Results:
1、Group I:The seroconversion rate of anti-HBs after the primary vaccination course was19.73%, and the geometric mean titer (GMT) of anti-HBs was1.53mIU/ml (95%CI1.35-1.74). But the seroconversion rate of anti-HBs among those aged between14-24years old was80%, and the GMT was147.64mIU/ml (95%CI56.10-388.60).
2、Group Ⅱ:The seroconversion rate of anti-HBs was78.97%, and the GMT was51.61mIU/ml (95%CI43.96-60.56).
3、Group Ⅲ:The seroconversion rate of anti-HBs was89.50%, and the GMT was197.24mlU/ml (95%CI176.47-220.46).
4、The seroconversion rate of anti-HBs and GMT of anti-HBs in Group Ⅱ were significantly higher than those in Group Ⅰ (χ2=707.243, P<0.001; t=33.777, P<0.001).
5、The seroconversion rate of anti-HBs and GMT of anti-HBs in control Group were significantly higher than those in Group Ⅰ (χ2=1751.78, P<0.001; t=56.633, P<0.001).
6、The seroconversion rate of anti-HBs and GMT of control Group were significantly higher than those of Group Ⅱ(χ2=46.182, P<0.001; t=13.498, P<0.001).
7. The seroconversion rate of anti-HBs in non-responder Group was86.91%after receiving one dose of60ug/dose HepB vaccine,and the GMT was213.80mIU/ml (95%CI177.83-263.03)
Conclusions:
1、Except for those aged between15-24years, the immunological effects of one dose of60μg/dose hepatitis B vaccines were not very good.
2、The immunological effects of two doses of60μg/dose hepatitis B vaccines can elicit high seroconversion rate of anti-HBs, but the level of GMT was low, which needs further study.
3、Among those non-responders,60μg/dose hepatitis B vaccines can exert good immunological effects.
4、Among the different schedules of hepatitis B vaccination, the three-dose course was better than one or two-dose series and two doses were better than one. Simply increasing the dose and reduce the doses course of hepatitis B vaccine could not achieve good immunological effects.
Objectives
1. To find out the current status of prevention and control of Hepatitis B.
2. To explore the effects of general practitioners (GPs) on the prevention and control of Hepatitis B through comparing the differences in awareness among residents of Hepatitis B control and rate of complete immunization schedule of Hepatitis B vaccine between residents in study group who were educated and managed by the general practitioners shortly trained in expertise in control of Hepatitis B and those in control group.
Methodology
1. A literature review has been done on the current status of prevention and control of Hepatitis B and interviews about GPs'knowledge of prevention and control of Hepatitis B
2. Self-complete questionnaires were administered to GPs in study group before and after a short training course
3. GPs in study group carried out their work according to the training requirements for half a year, meanwhile the control group managed their residents in the old way. Comparisons of awareness rate of control of Hepatitis B and rate of complete immunization schedule of Hepatitis B between study group and control group have been done after the plan.
Research outcomes
1. Qualitative study results
(1) Interviews with primary health service staff
1) GPs played a key role in the detection, treatment and prevention of Hepatitis B, but the prevention and control of Hepatitis B was mainly done by public health workers now.
2) It was highly necessary for GPs to take part in the prevention and control of Hepatitis B; however how they participate need further research.
3) Major difficulties GPs experienced in the prevention and control of Hepatitis B were heavy workload, staff shortage and lack of expertise in control of Hepatitis B.
(2) After the short training course, GPs'knowledge of control of Hepatitis B significantly improved.
(3) GPs thought that factors influencing the rate of complete immunization schedule were vaccination time, vaccination sites, vaccination frequency, flow of population and health education.
2. Quantitative study results
(1) Awareness among residents of Hepatitis B control after the intervention in study group was higher than that before intervention and there was significant difference between the two groups.
(2) Rate of complete immunization schedule of Hepatitis B in study group was significantly higher than that in control group (74.62%and26.99%respectively).χ2=512.2, P<0.05, there was significant difference between the two groups.
Conclusions
1. There is a real lack of knowledge in control of Hepatitis B among general practitioners; meanwhile, the current system exerts a negative impact on the GPs' role in Hepatitis B control.
2. Short training course can remarkably enhance the knowledge of control of Hepatitis B among GPs.
3. The model of Hepatitis B control involving GPs can raise resident awareness of Hepatitis B control and rate of complete immunization schedule of Hepatitis B to some extent.
作为“十一五”国家科技重大专项的研究成果之一,60微克乙肝疫苗用于成人免疫失败人群能取得较好的免疫效果,但在初免人群中的应用目前在国内乃至国际上尚无人群研究先例。本研究率先探讨普通成人初免人群接种1针剂和2针剂60微克乙肝疫苗的免疫效果,并观察1针剂60微克乙肝疫苗对免疫失败人群进行加强免疫的免疫效果。
方法：
将研究对象共分为四个组：
1、初免人群Ⅰ组：选择HBsAg、anti-HBs、乙肝核心抗体(anti-HBc)全阴者2000人接种1针60微克乙肝疫苗,接种后1个月再次采血,检测anti-HBs。
2、初免人群Ⅱ组：选择HBsAg、anti-HBs、乙肝核心抗体(anti-HBc)全阴者1000人接种2针60微克乙肝疫苗,免疫程序为0、1月。接种第二针后1个月再次采血,检测anti-HBs。
3、初免人群对照组：选择HBsAg、anti-HBs、乙肝核心抗体(anti-HBc)全阴者1400人接种3针10微克乙肝疫苗,免疫程序为0、1、6月。接种第三针后1个月再次采血,检测anti-HBs。
4、免疫失败人群组：选择1000人于2010年接种过乙肝疫苗,但anti-HBs滴度低于10mIU/ml的成人,接种1针60微克乙肝疫苗,接种后1个月再次采血,检测anti-HBs.
由于现场工作的不确定因素较多,人群失访率不确定,因此实际样本数大于此处计划样本数。
结果：
1、初免人群Ⅰ组乙肝表面抗体阳转率为19.73%,几何平均滴度(GMT)为1.53mIU/ml (95%CI1.35-1.74).但15～岁这一年龄段的人群的乙肝表面抗体阳转率为80%,GMT为147.64mIU/ml (95%CI56.10-388.60).
2、初免人群Ⅱ组的乙肝表面抗体阳转率为78.97%，GMT为51.61mIU/ml (95%CI43.96-60.56).
3、初免人群对照组的乙肝表面抗体阳转率为89.50%,GMT为197.24mlU/ml (95%CI176.47-220.46).
4、初免人群Ⅱ组的乙肝表面抗体阳转率和GMT均明显高于初免人群Ⅰ组,其中乙肝表面抗体阳转率比较(χ2=707.243,P<0.001),两者之间的差异有显著统计学意义；初免人群Ⅰ组与初免人群Ⅱ组GMT比较(t=33.777,P<0.001),两者之间的差异有显著统计学意义。
5、初免人群对照组的乙肝表面抗体阳转率和GMT均高于初免人群Ⅰ组(χ2=1751.78,P<0.001；t=56.633,P<0.001),两者之间的差异有显著统计学意义。
6、初免人群对照组的乙肝表面抗体阳转率和GMT均高于初免人群Ⅱ组(x2=46.182,P<0.001；t=13.498,P<0.001),两者之间的差异有显著统计学意义。
7、免疫失败组的乙肝表面抗体阳转率为86.91%,GMT为231.80mIU/ml(95%CI177.83-263.03)。
结论：
1、60微克乙肝疫苗1针剂免疫程序,除15～岁组外,其他年龄组乙肝表面抗体阳转率和GMT水平均不理想。
2、60微克乙肝疫苗2针剂免疫程序,可以取得较好的乙肝表面抗体阳转率,但GMT水平较低,长期效果尚待观察。
3、对免疫失败人群,60微克乙肝疫苗能取得较好的免疫效果。
4、乙肝疫苗的免疫程序,三针程序优于单针和两针,两针程序优于一针。单纯提高剂量减少针次尚不能取得很好的免疫效果。
目的
本研究旨在了解当前乙肝预防控制工作的现状,并从乙肝预防控制宣传教育及患者管理等多方面入手,通过分析短期培训对提升全科医师乙肝防制知识掌握情况的作用,及其对所管辖居民乙肝防治知识知晓率和乙肝疫苗全程接种率的加强作用,从而进一步研究探讨全科医师在乙肝预防控制工作中的作用。
方法
1、通过文献研究和访谈工作了解当前乙肝预防控制工作的现状和全科医师对乙肝预防控制工作的认识。
2、对研究组的全科医师开展短期培训,培训前后,对全科医师分别进行问卷调查,了解全科医师在接受短期培训后乙肝预防控制知识掌握情况的提升程度。
3、研究组的全科医师根据培训要求开展乙肝预防控制工作；对照组保持现有的工作方式工作。半年后,进行两组全科医师所管辖居民乙肝防治知晓率和乙肝疫苗全程接种率调查,并进行组间比较。
结果
1、定性研究结果
(1)基层卫生服务工作者的访谈结果：
1)全科医师在乙肝患者的发现、治疗和预防乙肝传播中起着关键的角色,但当前乙肝预防控制工作的主要承担者是公卫医师。
2)全科医师参与乙肝预防控制工作是非常有必要的,但是如何参与,具体参与的环节尚需进一步探讨。
3)全科医师参与乙肝预防控制工作存在的困难主要为：工作量大、人员不足,缺乏乙肝预防控制方面的知识。
(2)经过短期的培训,全科医师乙肝防制知识的掌握情况得到了较大提升
(3)全科医师认为影响乙肝疫苗全程接种率的因素包括：接种时间、地点、次数,人群流动性、宣传力度等。
2、定量研究结果
(1研究组的居民在干预后的乙肝防治知晓率为94.79%,明显高于干预前34.79%,χ2=1169.562,P<0.05,两者之间有显著性差异。
(2)研究组全科医师所辖居民的乙肝疫苗全程接种率为74.62%,明显优于对照组的26.99%,χ2=512.2,P<0.05,两者之间有显著性差异。
结论
1、当前全科医师的乙肝防制知识较匮乏,乙肝预防控制工作模式也制约着全科医师作用的发挥；
2、短期培训对全科医师乙肝防制知识的掌握情况有明显提升作用
3、全科医师积极参与的乙肝预防控制工作模式能够在一定程度上提高居民乙肝防治知识知晓率和乙肝疫苗的全程接种率。
Objectives:
To evaluate the immunological effects of one or two doses of60μg/dose hepatitis B vaccines (HepB) in adults and to investigate the effects of revaccination of one dose of60ug HepB vaccine among non-responders after the primary course of HepB vaccination.
Methods:
Subjects who tested negative for HBsAg, anti-HBs, and anti-HBc were selected in our study and then divided into four groups.
Group Ⅰ:primary vaccination Group I,2000subjects were selected for one dose of60μg/dose HepB vaccine. Anti-HBs levels were assessed using a chemiluminescence immunoassay one month after the vaccination.
Group Ⅱ:primary vaccination Group Ⅱ,1000subjects were selected for two doses of60μg/dose HepB vaccines with the first dose administered immediately and subsequent doses1month later. Anti-HBs levels were assessed one month after the second vaccination
Group Ⅲ:primary vaccination control Group,1400subjects were selected and received3doses of lOug/dose hepatitis B vaccines with the first dose administered immediately and subsequent doses1and6months later. Anti-HBs levels were assessed one month after the third vaccination.
Group Ⅳ:people who failed to respond after a course of3vaccinations in2010.1000non-responders with an anti-HBs titer level being less than lOmlU/ml were selected. They were given one dose of60ug/dose HepB vaccine and the Anti-HBs levels were assessed one month after the vaccination.
Results:
1、Group I:The seroconversion rate of anti-HBs after the primary vaccination course was19.73%, and the geometric mean titer (GMT) of anti-HBs was1.53mIU/ml (95%CI1.35-1.74). But the seroconversion rate of anti-HBs among those aged between14-24years old was80%, and the GMT was147.64mIU/ml (95%CI56.10-388.60).
2、Group Ⅱ:The seroconversion rate of anti-HBs was78.97%, and the GMT was51.61mIU/ml (95%CI43.96-60.56).
3、Group Ⅲ:The seroconversion rate of anti-HBs was89.50%, and the GMT was197.24mlU/ml (95%CI176.47-220.46).
4、The seroconversion rate of anti-HBs and GMT of anti-HBs in Group Ⅱ were significantly higher than those in Group Ⅰ (χ2=707.243, P<0.001; t=33.777, P<0.001).
5、The seroconversion rate of anti-HBs and GMT of anti-HBs in control Group were significantly higher than those in Group Ⅰ (χ2=1751.78, P<0.001; t=56.633, P<0.001).
6、The seroconversion rate of anti-HBs and GMT of control Group were significantly higher than those of Group Ⅱ(χ2=46.182, P<0.001; t=13.498, P<0.001).
7. The seroconversion rate of anti-HBs in non-responder Group was86.91%after receiving one dose of60ug/dose HepB vaccine,and the GMT was213.80mIU/ml (95%CI177.83-263.03)
Conclusions:
1、Except for those aged between15-24years, the immunological effects of one dose of60μg/dose hepatitis B vaccines were not very good.
2、The immunological effects of two doses of60μg/dose hepatitis B vaccines can elicit high seroconversion rate of anti-HBs, but the level of GMT was low, which needs further study.
3、Among those non-responders,60μg/dose hepatitis B vaccines can exert good immunological effects.
4、Among the different schedules of hepatitis B vaccination, the three-dose course was better than one or two-dose series and two doses were better than one. Simply increasing the dose and reduce the doses course of hepatitis B vaccine could not achieve good immunological effects.
Objectives
1. To find out the current status of prevention and control of Hepatitis B.
2. To explore the effects of general practitioners (GPs) on the prevention and control of Hepatitis B through comparing the differences in awareness among residents of Hepatitis B control and rate of complete immunization schedule of Hepatitis B vaccine between residents in study group who were educated and managed by the general practitioners shortly trained in expertise in control of Hepatitis B and those in control group.
Methodology
1. A literature review has been done on the current status of prevention and control of Hepatitis B and interviews about GPs'knowledge of prevention and control of Hepatitis B
2. Self-complete questionnaires were administered to GPs in study group before and after a short training course
3. GPs in study group carried out their work according to the training requirements for half a year, meanwhile the control group managed their residents in the old way. Comparisons of awareness rate of control of Hepatitis B and rate of complete immunization schedule of Hepatitis B between study group and control group have been done after the plan.
Research outcomes
1. Qualitative study results
(1) Interviews with primary health service staff
1) GPs played a key role in the detection, treatment and prevention of Hepatitis B, but the prevention and control of Hepatitis B was mainly done by public health workers now.
2) It was highly necessary for GPs to take part in the prevention and control of Hepatitis B; however how they participate need further research.
3) Major difficulties GPs experienced in the prevention and control of Hepatitis B were heavy workload, staff shortage and lack of expertise in control of Hepatitis B.
(2) After the short training course, GPs'knowledge of control of Hepatitis B significantly improved.
(3) GPs thought that factors influencing the rate of complete immunization schedule were vaccination time, vaccination sites, vaccination frequency, flow of population and health education.
2. Quantitative study results
(1) Awareness among residents of Hepatitis B control after the intervention in study group was higher than that before intervention and there was significant difference between the two groups.
(2) Rate of complete immunization schedule of Hepatitis B in study group was significantly higher than that in control group (74.62%and26.99%respectively).χ2=512.2, P<0.05, there was significant difference between the two groups.
Conclusions
1. There is a real lack of knowledge in control of Hepatitis B among general practitioners; meanwhile, the current system exerts a negative impact on the GPs' role in Hepatitis B control.
2. Short training course can remarkably enhance the knowledge of control of Hepatitis B among GPs.
3. The model of Hepatitis B control involving GPs can raise resident awareness of Hepatitis B control and rate of complete immunization schedule of Hepatitis B to some extent.
引文
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