Scheifele D W, Meekison W, Grace M, Barreto L, Carter A O, Mitchell L, Farley J
Vaccine Evaluation Center, British Columbia's Children's Hospital, Vancouver.
CMAJ. 1991 Sep 15;145(6):641-7.
To quantify accurately the rate of adverse reactions after the preschool (fifth) dose of adsorbed diphtheria toxoid-pertussis vaccine-tetanus toxoid (DPT) vaccine and to test the hypothesis that large local reactions are attributable to the diphtheria toxoid.
Double-blind randomized controlled trial.
Suburban community public health unit.
Healthy children 4 to 5 years of age with a history of having received four doses of adsorbed DPT vaccine.
Subjects were given either the standard DPT vaccine (with 25 Lf units of diphtheria toxoid) or a modified DPT vaccine (with 10 Lf units of diphtheria toxoid). They were assessed 24 hours later by a nurse. Serum samples obtained before vaccination were tested for diphtheria and tetanus antitoxin levels by means of neutralization assay and enzyme-linked immunosorbent assay.
Rates of large local reactions (an area of redness or swelling or both of 5 cm or greater) 24 hours after vaccination in the two groups. Relation between serum antitoxin levels before vaccination and the rate of large local reactions in each group.
Of the 250 subjects enrolled 124 received the standard vaccine and 126 the modified one. Large local reactions occurred in 71% of the subjects receiving the standard vaccine and 52% of those receiving the modified one (p less than 0.01). In the former group large erythematous reactions occurred significantly more often in those with an elevated prevaccination diphtheria antitoxin level than in those without an elevated level; no relation was found between such reactions and the prevaccination tetanus antitoxin level. Reduced arm movement was evident in 45% of the children in the two groups. Few had systemic adverse reactions.
Large local reactions occur frequently after the preschool administration of the DPT vaccine. These reactions are uncomfortable but not serious. They result in part from the large amount of diphtheria toxoid in the standard DPT vaccine.
准确量化学龄前（第五剂）吸附白喉类毒素-百日咳疫苗-破伤风类毒素（DPT）疫苗接种后的不良反应发生率，并检验大的局部反应归因于白喉类毒素这一假设。
双盲随机对照试验。
郊区社区公共卫生单位。
4至5岁、有四剂吸附DPT疫苗接种史的健康儿童。
受试者分别接种标准DPT疫苗（含25Lf单位白喉类毒素）或改良DPT疫苗（含10Lf单位白喉类毒素）。24小时后由护士进行评估。接种疫苗前采集的血清样本通过中和试验和酶联免疫吸附试验检测白喉和破伤风抗毒素水平。
两组接种疫苗24小时后大的局部反应（红肿面积或两者之和为5厘米或更大）发生率。接种疫苗前血清抗毒素水平与每组大的局部反应发生率之间的关系。
250名受试者中，124人接种标准疫苗，126人接种改良疫苗。接种标准疫苗的受试者中有71%出现大的局部反应，接种改良疫苗的受试者中有52%出现大的局部反应（p<0.01）。在前一组中，接种疫苗前白喉抗毒素水平升高者出现大的红斑反应的频率明显高于未升高者；未发现此类反应与接种疫苗前破伤风抗毒素水平之间的关系。两组中有45%的儿童出现手臂活动受限。很少有全身不良反应。
学龄前接种DPT疫苗后经常出现大的局部反应。这些反应令人不适但不严重。部分原因是标准DPT疫苗中白喉类毒素含量高。
