PROPHYLAXIS WITH ORAL PENICILLIN IN CHILDREN WITH SICKLE-CELL-ANEMIA - A RANDOMIZED TRIAL
PROPHYLAXIS WITH ORAL PENICILLIN IN CHILDREN WITH SICKLE-CELL-ANEMIA - A RANDOMIZED TRIAL
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DOI：
10.1056/nejm198606193142501
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发表时间：
1986-06-19
影响因子：
158.5
通讯作者：
FALLETTA, JM
中科院分区：
文献类型：
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作者：
GASTON, MH;VERTER, JI;FALLETTA, JM
患有镰状细胞性贫血的儿童对细菌感染的易感性增加，特别是对肺炎链球菌引起的细菌感染。因此，我们进行了一项多中心、随机、双盲、安慰剂对照的临床试验，以测试定期、每日口服青霉素是否会降低由S.在入选时年龄小于3岁的镰状细胞性贫血儿童中，这些儿童被随机分配接受125 mg青霉素V钾（105名儿童）或安慰剂（110名儿童），每日两次。在平均15个月的随访后，当观察到青霉素治疗组的感染发生率比安慰剂组降低84%时，试验提前8个月终止（110例患者中的13例对105例患者中的2例; P = 0.0025），青霉素组没有肺炎球菌败血症死亡，但安慰剂组有3例感染死亡。根据这些结果，我们得出结论，儿童应在新生儿期筛查镰状细胞血红蛋白病，镰状细胞贫血应在4个月大时接受口服青霉素预防性治疗，以降低与肺炎球菌败血症相关的发病率和死亡率。
Children with sickle cell anemia have an increased susceptibility to bacterial infections, especially to those caused by Streptococcus pneumoniae. We therefore conducted a multicenter, randomized, double-blind, placebo-controlled clinical trial to test whether the regular, daily administration of oral penicilin would reduce the incidence of documented septicemia due to S. pneumoniae in children with sickle cell anemia who were under the age of three years at the time of entry. The children were randomly assigned to receive either 125 mg of penicillin V potassium (105 children) or placebo (110 children) twice daily. The trial was terminated 8 months early, after an average of 15 months of follow-up, when an 84 percent reduction in the incidence of infection was observed in the group treated with penicilin, as compared with the group given placebo (13 of 110 patients vs. 2 of 105; P = 0.0025), with no deaths from pneumonococcal septicemia occurring in the penicilin group but three deaths from the infection occuring in the placebo group. On the basis of these results, we conclude that children should be screened in the neonatal period for sickle cell hemoglobinopathy and that those with sickle cell anemia should receive prophylactic therapy with oral penicillin by four months of age to decrease the morbidity and mortality associated with pneumococcal septicemia.