Lakatos L, Hatvani I, Oroszlán G, Balla G, Karmazsin L, Alaka O, Kincses E, Szabó I, Lakatos Z
Acta Paediatr Hung. 1986;27(1):47-56.
204 infants with birthweights between 751 and 2000 g and 26-35 weeks gestational age (100 treated and 104 control subjects) were enrolled in a prospective controlled trial of the effectiveness of D-penicillamine (DPA) in the prevention of retinopathy of prematurity (ROP). The two groups did not differ significantly in gestational age, birth weight, Apgar scores, the time of exposure to oxygen and in the incidence of PDA or in the number of exchange transfusions and RBTs. Of the treated infants 29, and of the control infants 34 died before the tenth week of life. These cases were not included in further analysis. Patients were subsequently examined and assessed by two ophthalmologists independently, who did not know which babies were receiving DPA. Six of the 70 surviving control infants and none of the 71 surviving treated infants had ROP stage II or graver. The results suggested that ROP may effectively be prevented with DPA in very low-birth-weight-infants, and that the drug has no serious adverse effects during the neonatal period.
204名出生体重在751至2000克之间、胎龄为26至35周的婴儿（100名接受治疗，104名作为对照）被纳入一项关于青霉胺（DPA）预防早产儿视网膜病变（ROP）有效性的前瞻性对照试验。两组在胎龄、出生体重、阿氏评分、吸氧时间、动脉导管未闭的发生率、换血次数和红细胞输血次数方面无显著差异。在接受治疗的婴儿中，有29名，在对照婴儿中，有34名在出生后第十周前死亡。这些病例未纳入进一步分析。随后由两名眼科医生独立对患者进行检查和评估，他们不知道哪些婴儿接受了DPA治疗。70名存活的对照婴儿中有6名患有II期或更严重的ROP，而71名存活的接受治疗的婴儿中无一例患有。结果表明，DPA可有效预防极低出生体重儿的ROP，且该药物在新生儿期无严重不良反应。
