Phelps D L, Lakatos L, Watts J L
Pediatrics and Ophthalmology, University of Rochester, Box 651, Pediatrics, 601 Elmwood Ave, Rochester, New York, USA, 14642. dale
Cochrane Database Syst Rev. 2001(1):CD001073. doi: 10.1002/14651858.CD001073.
Retinopathy of prematurity remains a common problem. A low rate of this disorder was unexpectedly observed among infants treated with intravenous d-penicillamine to prevent hyperbilirubinemia. This observation led to the investigation of its use to prevent retinopathy of prematurity.
To answer the question: Among very low birth weight infants, what is the effect of prophylactic administration of d-penicillamine on the incidence of acute ROP or severe ROP, and side effects including death?
Searches were made of multiple electronic databases, previous reviews including cross references, abstracts, conference/symposia proceedings, and expert informants. The search was updated to November 2000.
Randomized or quasi-randomized controlled trials that administered d-penicillamine to infants less than 2000g birth weight within the day following birth were considered relevant to this review. Additional case series were examined for potential side effects.
Data on clinical outcomes were excerpted by 3 reviewers independently, and consensus reached. Data analysis was conducted according to the standards of the Neonatal Cochrane Review Group.
Two randomized trials on the effects on ROP were identified. When combined, they showed a significantly lower incidence of acute ROP in the treated infants, relative risk of 0.09, 95% CI [0.01,0.71]. Severe stages of ROP could not be analyzed. There was no effect on death rates, relative risk 0.99 95% CI [0.70,1.39]. No side effects were reported, and follow up at one year revealed no significant differences in spasticity or developmental delay, although there were more rehospitalizations among the controls. In other reports of using d-penicillamine in over 140 infants for hyperbilirubinemia, skin rashes were reported in 2 infants and one had vomiting that may have been related.
REVIEWER'S CONCLUSIONS: D-penicillamine is unlikely to affect survival, and may reduce the incidence of acute ROP among survivors. Studies to date justify further investigation of this drug in a broader population; careful attention to possible side effects is needed.
早产儿视网膜病变仍是一个常见问题。在接受静脉注射d-青霉胺预防高胆红素血症的婴儿中，意外观察到该疾病的发生率较低。这一观察结果促使人们对其用于预防早产儿视网膜病变进行研究。
回答以下问题：在极低出生体重儿中，预防性给予d-青霉胺对急性早产儿视网膜病变或严重早产儿视网膜病变的发生率以及包括死亡在内的副作用有何影响？
检索了多个电子数据库、先前的综述（包括交叉参考文献）、摘要、会议/研讨会论文集以及专家提供的信息。检索更新至2000年11月。
在出生后一天内对出生体重小于2000g的婴儿给予d-青霉胺的随机或半随机对照试验被认为与本综述相关。对其他病例系列进行了潜在副作用检查。
3名审阅者独立摘录临床结局数据，并达成共识。根据新生儿Cochrane综述小组的标准进行数据分析。
确定了两项关于对早产儿视网膜病变影响的随机试验。合并分析时，结果显示治疗组婴儿急性早产儿视网膜病变的发生率显著降低，相对危险度为0.09，95%可信区间[0.01,0.71]。无法分析早产儿视网膜病变的严重阶段。对死亡率无影响，相对危险度为0.99，95%可信区间[0.70,1.39]。未报告副作用，一年随访显示痉挛或发育迟缓无显著差异，尽管对照组再次住院的情况较多。在其他关于140多名婴儿使用d-青霉胺治疗高胆红素血症的报告中，有2名婴儿出现皮疹，1名婴儿出现可能与之相关的呕吐。
d-青霉胺不太可能影响存活率，可能会降低幸存者中急性早产儿视网膜病变的发生率。迄今为止的研究证明有必要在更广泛的人群中进一步研究这种药物；需要密切关注可能的副作用。
