DISCONTINUING PENICILLIN PROPHYLAXIS IN CHILDREN WITH SICKLE-CELL-ANEMIA
DISCONTINUING PENICILLIN PROPHYLAXIS IN CHILDREN WITH SICKLE-CELL-ANEMIA
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DOI：
10.1016/s0022-3476(95)70154-0
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发表时间：
1995-11-01
影响因子：
5.1
通讯作者：
REID, C
中科院分区：
文献类型：
--
作者：
FALLETTA, JM;WOODS, GM;REID, C
目的：评估一生中大部分时间接受预防性青霉素治疗的镰状细胞性贫血儿童在 5 岁时停止青霉素预防的后果。设计：随机、双盲、安慰剂对照试验。在美国各地设置 18 家教学医院。患者：接受预防性青霉素治疗的镰状细胞性贫血（血红蛋白 SS 或血红蛋白 S β(0)-地中海贫血）儿童在 5 岁生日前接受了至少 2 年青霉素治疗，并在 2 至 3 岁之间接种了 23 价肺炎球菌疫苗，并在随机分组时再次接种。在 599 名潜在候选人中，随机选择了 400 名，并平均随访 3.2 年。 干预措施：随机分组后，患者每天接受两次研究药物——青霉素 V 钾 250 毫克，或相同的安慰剂片剂。患者要么到诊所就诊，要么此后每 3 个月联系一次，了解间隔病史和研究药物的配药情况。每 6 个月安排一次体检。主要结局指标：主要终点是对继续接受青霉素预防的儿童与接受安慰剂的儿童中肺炎链球菌引起的菌血症或脑膜炎的发生率进行比较。结果：6 名儿童出现由肺炎链球菌引起的全身感染，其中安慰剂组有 4 名（2.0%；95% 置信区间 0.5%、5.0%），继续青霉素组有 2 名儿童预防组（1.0%；95%置信区间0.1%、3.6%），相对风险为0.5（95%置信区间0.1、2.7）。所有侵袭性分离株均为血清型 6（A 或 B）或血清型 23F。其中四种分离株对青霉素敏感，两种（每个治疗组各一种）对青霉素和多种抗生素具有耐药性。研究药物对三名患者报告了不良反应（恶心、呕吐或两者兼而有之），其中一名属于安慰剂组。 结论：患有镰状细胞性贫血的儿童，如果既往没有严重肺炎球菌感染或脾切除术，并且正在接受全面护理，可以在 5 岁时安全地停止预防性青霉素治疗。必须积极建议父母就镰状细胞性贫血儿童的所有发热事件寻求医疗救助。
Objective: To evaluate the consequences of discontinuing penicillin prophylaxis at 5 years of age in children with sickle cell anemia who had received prophylactic penicillin for much of their lives.Design: Randomized, double-blind, placebo-controlled trial.Setting Eighteen teaching hospitals throughout the United States.Patients: Children with sickle cell anemia (hemoglobin SS or hemoglobin S beta(0)-thalassemia) who had received prophylactic penicillin therapy for at least 2 years immediately before their fifth birthday and had received the 23-valent pneumococcal vaccine between 2 and 3 years of age and again at the time of randomization. Of 599 potential candidates, 400 were randomly selected and followed for an average of 3.2 years.Interventions: After randomization, patients received the study medication twice daily-either penicillin V potassium, 250 mg, or an identical placebo tablet. Patients were either seen in the clinic or contacted every 3 months thereafter for an interval history and dispensing of the study drug. A physical examination was scheduled every 6 months.Main outcome measures: The primary end point was a comparison of the incidence of bacteremia or meningitis caused by Streptococcus pneumoniae in children continuing penicillin prophylaxis versus those receiving the placebo.Results: Six children had a systemic infection caused by 5. pneumoniae, four in the placebo group (2.0%; 95% confidence interval 0.5%, 5.0%) and two in the continued penicillin prophylaxis group (1.0%; 95% confidence interval 0.1%, 3.6%), with a relative risk of 0.5 (95% confidence interval 0.1, 2.7). All invasive isolates were either serotype 6(A or B) or serotype 23F. Four of the isolates were penicillin susceptible, and two (one from each treatment group) were penicillin and multiply antibiotic resistant. Adverse effects of the study drug were reported for three patients (nausea, vomiting, or both), one of whom was in the placebo group.Conclusion: Children with sickle cell anemia who have not had a prior severe pneumococcal infection or a splenectomy and are receiving comprehensive care may safely stop prophylactic penicillin therapy at 5 years of age. Parents must be aggressively counseled to seek medical attention for all febrile events in children with sickle cell anemia.