Jaiiaroensup W, Lang J, Thipkong P, Wimalaratne O, Samranwataya P, Saikasem A, Chareonwai S, Yenmuang W, Prakongsri S, Sitprija V, Wilde H
Queen Saovabha Memorial Institute, (WHO Collaborating Center for Research in Rabies), Chulalongkorn University, Bangkok, Thailand.
Vaccine. 1998 Oct;16(16):1559-62. doi: 10.1016/s0264-410x(98)00045-0.
To determine adverse reactions as a result of pre- and post-exposure rabies vaccination, using the conventional intramuscular, and reduced dose intradermal regimens and purified Vero cell rabies vaccine.
A prospective and randomized study of patients exposed to rabies and of subjects in need of pre-exposure rabies vaccination.
A metropolitan rabies control center in a canine rabies endemic country.
1198 subjects were recruited between May, 1994 and March, 1996. They were divided into four groups. Patients with suspected or proven rabies exposures were given the vaccine intramuscularly using the conventional regimen, or intradermally using the World Health Organization approved Thai Red Cross schedule. Human or equine rabies immune globulin was administered where indicated. Pre-exposure and post-exposure vaccine recipients were divided randomly into two groups each and given the vaccine either by the intramuscular or intradermal schedules.
All local and systemic adverse reactions were recorded and statistically analyzed.
Pruritus at injection sites was the only significant local reaction. It was more common in the intradermal groups. Low-grade fever, the only significant adverse systemic event, was more common in the intramuscular groups and was noted in 8% of all subjects. Eighty-four patients bitten by proven rabid animals were found to be alive and well 3 years later. Forty-four of these had received the intramuscular and 40 the intradermal postexposure regimens with human or equine immune globulin injected into wounds on the first day of treatment.
Purified Vero cell rabies vaccine is safe, carries a very low adverse reaction rate and is effective in preventing rabies in severely exposed subjects when used with human or equine rabies immune globulin.
使用传统肌内注射、减量皮内注射方案以及纯化的Vero细胞狂犬病疫苗，确定暴露前和暴露后狂犬病疫苗接种的不良反应。
对暴露于狂犬病的患者和需要进行暴露前狂犬病疫苗接种的受试者进行一项前瞻性随机研究。
一个犬类狂犬病流行国家的大都市狂犬病控制中心。
1994年5月至1996年3月招募了1198名受试者。他们被分为四组。疑似或确诊狂犬病暴露的患者按照传统方案进行肌内注射疫苗，或按照世界卫生组织批准的泰国红十字会方案进行皮内注射疫苗。在需要时给予人或马狂犬病免疫球蛋白。暴露前和暴露后疫苗接种者各随机分为两组，分别按照肌内注射或皮内注射方案接种疫苗。
记录所有局部和全身不良反应并进行统计分析。
注射部位瘙痒是唯一显著的局部反应。在皮内注射组中更常见。低热是唯一显著的不良全身事件，在肌内注射组中更常见，所有受试者中有8%出现该症状。84名被确诊患有狂犬病的动物咬伤的患者在3年后被发现存活且状况良好。其中44人接受了肌内注射，40人接受了皮内注射暴露后方案，并在治疗第一天将人或马免疫球蛋白注射到伤口中。
纯化的Vero细胞狂犬病疫苗安全，不良反应率极低，与人类或马狂犬病免疫球蛋白联合使用时，对严重暴露的受试者预防狂犬病有效。
