硝酸银、红霉素及不进行眼部预防措施预防非淋菌性眼炎高危新生儿结膜炎的随机试验。眼部预防研究组。

Randomized trial of silver nitrate, erythromycin, and no eye prophylaxis for the prevention of conjunctivitis among newborns not at risk for gonococcal ophthalmitis. Eye Prophylaxis Study Group.

作者信息

Bell T A, Grayston J T, Krohn M A, Kronmal R A

机构信息

Department of Biostatistics, University of Washington, Seattle 98195.

出版信息

Pediatrics. 1993 Dec;92(6):755-60.

PMID:8233733

Abstract

OBJECTIVE

To compare the efficacy of commonly used forms of eye prophylaxis for newborns with no prophylaxis in the prevention of nongonococcal conjunctivitis.

DESIGN

Randomized doubly masked clinical trial.

SETTING

University of Washington Hospital and affiliated clinics, Seattle, between 1985 and 1990.

SUBJECTS

The medical records of 8499 women were evaluated for possible participation; 2577 were eligible. Of the 758 enrolled, the infants of 630 were evaluable.

INTERVENTION

Comparison of silver nitrate, erythromycin, and no eye prophylaxis given at birth for the prevention of conjunctivitis.

MAIN OUTCOME MEASURES

Conjunctivitis during the first 60 days of life and nasolacrimal duct patency in the first 2 days of life.

RESULTS

The frequency of impatent tear ducts at the 30- to 48-hour examination did not differ significantly by prophylaxis group. Among the 630 infants randomized and observed, 109 (17%) developed mild conjunctivitis. Sixty-nine (63%) of the cases appeared during the first 2 weeks of life. After 2 months of observation, infants allocated to silver nitrate eye prophylaxis at birth had a 39% lower rate of conjunctivitis (hazard ratio = 0.61, 95% confidence interval = 0.39 to 0.97), and those allocated to erythromycin had a 31% lower rate of conjunctivitis (hazard ratio = 0.69, 95% confidence interval = 0.44 to 1.07), than did those allocated to no prophylaxis.

CONCLUSION

Silver nitrate eye prophylaxis caused no sustained deleterious effects and even provided some benefit to infants born to women without Neisseria gonorrhoeae. However, the effect was modest and against microorganisms of low virulence. The results suggest that parental choice of a prophylaxis agent including no prophylaxis is reasonable for women receiving prenatal care and who are screened for sexually transmitted diseases during pregnancy.

摘要

目的

比较常用的新生儿眼部预防措施与不进行预防措施在预防非淋菌性结膜炎方面的疗效。

设计

随机双盲临床试验。

地点

1985年至1990年期间，西雅图华盛顿大学医院及附属诊所。

研究对象

评估了8499名女性的病历以确定其是否可能参与研究；2577名符合条件。在登记的758名中，630名婴儿的情况可进行评估。

干预措施

比较出生时使用硝酸银、红霉素以及不进行眼部预防措施来预防结膜炎的效果。

主要观察指标

出生后60天内的结膜炎以及出生后前两天鼻泪管通畅情况。

结果

在30至48小时检查时，不同预防措施组间泪道不通畅的频率无显著差异。在随机分组并接受观察的630名婴儿中，109名（17%）患轻度结膜炎。其中69例（63%）出现在出生后的前两周。经过两个月的观察，出生时接受硝酸银眼部预防的婴儿患结膜炎的几率降低了39%（风险比=0.61，95%置信区间=0.39至0.97），接受红霉素预防的婴儿患结膜炎的几率降低了31%（风险比=0.69，95%置信区间=0.44至1.07），均低于未接受预防措施的婴儿。