Carvajal A, Caro-Patón T, Martín de Diego I, Martín Arias L H, Alvarez Requejo A, Lobato A
Centro Regional de Farmacovigilancia de Castilla y León, Facultad de Medicina, Universidad de Valladolid.
Med Clin (Barc). 1996 May 4;106(17):649-52.
At the beginning of 1994, five cases of sudden infant death syndrome after DTP immunization appeared in Spain. In order to study a causal relationship a meta-analysis of the different studies that assess this possibility has been conducted.
The selection criteria was epidemiological study, case-control or cohort, assessing risk of sudden infant death syndrome in immunized versus non-immunized infants or risk of sudden infant death syndrome in recently immunized infants versus immunized infants beyond 30 days. Pooled risk ratios were calculated from adjusted risk ratios, when available, of the different studies, by a meta-analysis according the method described by Greenland.
One cohort and four case-control studies were selected. Pooled risk ratio for immunized versus non-immunized infants was 0.67 (95% CI = 0.60-0.75). When comparing risk of sudden death syndrome in up to 30 days immunized infants versus more than 30 days immunized infants, the pooled risk ratio was 1.00 (95% CI = 0.84-1.20).
DTP-immunization does not seem to increase the risk of sudden infant death syndrome. The risk of sudden infant death syndrome is not greater in the first thirty days following immunization. These data indicate a lack of association between DTP immunization and sudden infant death syndrome.
1994年初,西班牙出现了5例接种百白破疫苗后发生婴儿猝死综合征的病例。为研究因果关系,对评估这种可能性的不同研究进行了荟萃分析。
选择标准为流行病学研究,病例对照或队列研究,评估接种疫苗婴儿与未接种疫苗婴儿的婴儿猝死综合征风险,或近期接种疫苗婴儿与接种疫苗超过30天婴儿的婴儿猝死综合征风险。当不同研究有调整后的风险比时,根据格林兰描述的方法通过荟萃分析计算合并风险比。
选择了1项队列研究和4项病例对照研究。接种疫苗婴儿与未接种疫苗婴儿的合并风险比为0.67(95%CI = 0.60 - 0.75)。比较接种疫苗30天内婴儿与接种疫苗超过30天婴儿的猝死综合征风险时,合并风险比为1.00(95%CI = 0.84 - 1.20)。
接种百白破疫苗似乎不会增加婴儿猝死综合征的风险。接种疫苗后的头三十天内,婴儿猝死综合征的风险并不更高。这些数据表明百白破疫苗接种与婴儿猝死综合征之间缺乏关联。