自然人群口服重组B亚单位／菌体霍乱疫苗现场安全性评价

目的观察自然人群口服重组B亚单位／菌体（Recombinant B—subunit／Inactivoted Whole Cell，rBS／WC）霍乱疫苗的安全性。方法采用随机、双盲、对照的方法，将3041名5～60岁知情同意的健康者随机分为3组，其中2组服用疫苗，1组服用安慰剂，服用程序0、7、28d。每次口服后连续3d观察不良反应，全程服后1、2、3个月内随访观察。结果未发现严重不良反应，不良反应总发生率服疫苗组为1．70％，服安慰剂组1．74％，差异无显著的统计学意义（x^2=0．013，P=0．909）。不良反应主要为腹痛、腹泻，也出现了过敏反应；其他反应为头晕、疲劳、乏力等主观不适，均在短时间内自愈，不能排除心因性反应的可能。结论口服rBS／WC霍乱疫苗在自然人群中安全性良好。

A Safety Assessment on Adverse Reaction of Recombinant B-subunit/Inactivated Whole Cell Oral Cholera Vaccine Among Non-infected Population

Objective To observe the safety of recombinant B-subunit/inactivated whole cell （rBS/WC） oral cholera vaccine among non-infected population. Method A method of double-blind and case control was conducted randomly. 3041 non-infected persons who aged from 5 to 60 years old were divided randomly into 3 groups, including 2 vaccine groups and 1 placebo group. The vaccine and placebo were taken respectively by vaccine groups and placebo group on the 1 st, 7th and 28th day in every months of sequential 3 months. The adverse reaction was observed in sequential 3 days after intaking orally. The follow-up interviews were conducted in 1,2,3 months. Results No severe adverse reaction was occurred. The rate of adverse reaction was 1.70% in vaccine groups, 1.74% in placebo group. There was no statistically significant difference between two groups （x^2=0.013, P=0.909）. The adverse reaction were mainly abdominal pain, diarrhea, partly anaphylaxis, and the others of dizziness, fatigue, weakness. Most people recovered within short time without any medical treatment. The adverse reactions might be related to psychogenic reaction. Conclusion The safety of oral rBS/WC cholera vaccine among non-infected population was pretty good.