论文部分内容阅读
日经医学82年8期报道,日本厚生省的乙型肝炎疫苗开发协议会统计了与这一疫苗安全性和有效性有关的第二阶段试验结果:在疫苗接种后第20周有70%接种者出现抗病毒抗体,且没有严重的副作用,说明该疫苗有高度的安全性和有效性。按照这个结果该协议会自7月下旬又以3,000多名自愿者为对象,开始了第3阶段试验,以期使该疫苗尽早投入临床使用。第二阶段试验是1981年以全国15所医院的医师、护士等感染机会多的约200人为对象进行的。在初次接种后,分别于第4周、第24周各继续接种40μg。从接种后8周以上的211例(男101例,女110例)看,
According to Nikkei Medical’s 82-year-8 report, Japan’s Ministry of Health, Labor and Welfare’s Hepatitis B Vaccine Development Council conducted a Phase II trial on the safety and efficacy of this vaccine: 70% of those vaccinated at week 20 after vaccination Anti-virus antibodies appear, and no serious side effects, indicating that the vaccine is highly safe and effective. According to this result, the protocol started with Phase III trial targeting more than 3,000 volunteers in late July in order to put the vaccine into clinical use as soon as possible. The second phase of the trial was conducted in 1981 on the basis of about 200 people with more opportunistic infections such as doctors and nurses in 15 hospitals across the country. After the first inoculation, 40 μg were inoculated on the 4th week and the 24th week respectively. From 211 weeks after inoculation more than 8 weeks (101 males and 110 females)