摘要目的 比较b型流感嗜血杆菌(Hib)结合疫苗在婴儿股外侧肌与上臂三角肌预防接种后的安全性.方法 于2014年在北京市选择408名3～4月龄婴儿作为观察对象,通过抽取随机数字分为股外侧肌组(204名)和上臂三角肌组(204名).分别按程序接种3剂次Hib结合疫苗,观察接种后全身和局部不良反应发生情况,计算不良反应发生率.结果 研究中途退出61名婴儿,共观察1 132人次.股外侧肌组和上臂三角肌组总不良反应发生率分别为33.0％(186/564)和27.6％(157/568) (x2=3.818,P=0.059).两组均为接种后第0天不良反应发生率最高,分别为23.2％(131/564)和20.6％(117/568),而后随时间呈下降趋势(线性趋势检验,股外侧肌组:x2=36.600,P＜0.001;上臂三角肌组:x2=29.947,P＜0.001),第1天分别为20.4％(115/564)和17.6％(100/568),第2天分别为16.0％(90/564)和13.4％ (76/568),第3天分别为10.3％(58/564)和10.6％(60/568),第4～7天分别为11.2％(63/564)和11.3％(64/568).没有与接种疫苗有关的严重不良事件报告.两组局部不良反应发生率分别为7.1％ (40/564)和7.7％ (44/568) (x2=0.176,P=0.675).全身不良反应发生率分别为25.9％(146/564)和20.6％(117/568) (x2=4.437,P=0.035).股外侧肌组(11.5％,65/564)发热发生率高于上臂三角肌组(4.4％,25/568) (x2=4.868,P=0.027).第1剂次接种后,股外侧肌组发热和异常哭闹的发生率[分别为11.3％ (23/204)、19.1％(39/204)]高于上臂三角肌组[分别为4.4％ (9/204)、11.8％ (24/204)](x2值分别为15.288、4.224,P值分别为＜0.001、0.040);第2剂次接种后,上臂三角肌组腹泻的发生率[11.6％(22/190)]高于股外侧肌组[5.9％(11/187)](x2=3.829,P=0.046).结论 婴儿股外侧肌组和上臂三角肌组疫苗接种后不良反应发生率均较低,未见与预防接种有关的严重不良事件,表明婴儿股外侧肌较上臂三角肌接种同样具有较好的安全性.

abstractsObjective To compare the safety of haemophilus influenzae type b (Hib) vaccine vaccination on vastus lateralis muscle and deltoid muscle of infant.Methods A total of 408 3-4 months old infants were divided into vastus lateralis muscle group and deltoid muscle group in Beijing,2014.They were divided into the vastus lateralis muscle group (204) and deltoid muscle group (204) by extracting random number.Each observation object was given 3 doses of Hib vaccine according to the program.Collected systemic and local reactions after vaccination and calculated the incidence of adverse reactions.Results A total of 61 infants were quitted during the study,1 132 doses were observed.The total reactions incidence of Vastus lateralis muscle group and Deltoid muscle group were 33.0％ (186/564) and 27.6％ (157/568) with no statistical differences (x2=3.818,P=0.059).The two groups incidence at the same day of vaccination (day 0) which the highest were 23.2％ (131/564) and 20.6％ (117/568),then declined with time (linear trend test vastus lateralis muscle group x2=36.600,P＜0.001,deltoid muscle group x2=29.947,P＜0.001),day 1 were 20.4％(115/564) and 17.6％(100/568),day 2 were 16.0％(90/564) and 13.4％(76/568),day 3 were 10.3％(58/564) and 10.6％(60/568),day 4-7 were 11.2％(63/564) and 11.3％(64/568).No serious adverse events (SAE) were reported during the study.The local reactions incidence of two groups were 7.1％(40/564)and 7.7％ (44/568)with no statistical differences (x2=0.176,P=0.675).The systemic reactions incidence of two groups were 25.9％ (146/564) and 20.6％ (117/568) with obvious statistical differences (x2=4.437,P=0.035).The fever incidence of vastus lateralis muscle group (11.5％ (65/564)) was higher than Deltoid muscle group (4.4％(25/568)) with obvious statistical differences (x2=4.868,P=-0.027).The 1st dose incidence of fever and abnormal crying of vastus lateralis muscle group (fever 11.3％ (23/204),abnormal crying 19.1％(39/204)) was higher than deltoid muscle group (fever 4.4％(9/204),abnormal crying 11.8％ (24/204)) and the 2nd dose of diarrhea of deltoid muscle group (11.6％(22/190)) was higher than vastus lateralis muscle group (5.9％ (11/187)) with obvious statistical differences (fever x2=15.288,P＜0.001,abnormal crying x2=4.224,P=0.040,diarrhea x2=3.829,P=0.046).Conclusion Both vastus lateralis muscle group and deltoid muscle group had lower incidence of adverse reactions after vaccination.No serious adverse events were associated with vaccination.Vastus lateralis muscle vaccination as well as deltoid muscle vaccination demonstrated safe.