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肠溶胶囊与Ty21a伤寒疫苗液体制剂在随机对照现场试验中的比较。

Comparison of enteric-coated capsules and liquid formulation of Ty21a typhoid vaccine in randomised controlled field trial.

作者信息

Levine M M, Ferreccio C, Cryz S, Ortiz E

机构信息

Center for Vaccine Development, University of Maryland School of Medicine, Baltimore 21201.

出版信息

Lancet. 1990 Oct 13;336(8720):891-4. doi: 10.1016/0140-6736(90)92266-k.

Abstract

In a randomised, double-blind, controlled field trial in Santiago, Chile, 81,621 schoolchildren aged 5-19 years received three doses, within a week, of attenuated Salmonella typhi oral vaccine Ty21a in enteric-coated capsules or in a new liquid suspension, or placebo. Over 36 months of surveillance, the liquid formulation (76.9% vaccine efficacy) was significantly superior to the enteric-coated capsules (33.2% vaccine efficacy). The liquid formulation protected young children (5-9 years) (efficacy 82.3%) as well as older children (efficacy 69.3%), whereas the capsules significantly protected only older children. The liquid suspension was easy to prepare by mixing lyophilised vaccine with buffer in water and was easily administered, even to the youngest children. Thus, the liquid formulation of Ty21a is preferable to enteric-coated capsules.

摘要

在智利圣地亚哥进行的一项随机、双盲、对照现场试验中,81621名5至19岁的学龄儿童在一周内接受了三剂肠溶胶囊剂型或新型液体悬浮剂型的减毒伤寒沙门氏菌口服疫苗Ty21a,或安慰剂。在36个月的监测期内,液体剂型(疫苗效力为76.9%)显著优于肠溶胶囊剂型(疫苗效力为33.2%)。液体剂型对幼儿(5至9岁)(效力82.3%)和大龄儿童(效力69.3%)均有保护作用,而胶囊剂型仅对大龄儿童有显著保护作用。液体悬浮剂通过将冻干疫苗与水中的缓冲液混合即可轻松制备,且易于给药,即使对最小的儿童也是如此。因此,Ty21a的液体剂型比肠溶胶囊剂型更可取。

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