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眼部使用氯霉素与再生障碍性贫血之间可能存在关联——绝对风险非常低。

Possible association between ocular chloramphenicol and aplastic anaemia--the absolute risk is very low.

作者信息

Laporte J R, Vidal X, Ballarín E, Ibáñez L

机构信息

Institut Català de Farmacologia, Universitat Autònoma de Barcelona, CSU Vall d'Hebron, Spain.

出版信息

Br J Clin Pharmacol. 1998 Aug;46(2):181-4. doi: 10.1046/j.1365-2125.1998.00773.x.

DOI:10.1046/j.1365-2125.1998.00773.x
PMID:9723830
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1873671/
Abstract

AIMS

To determine whether topical ocular chloramphenicol increases the risk of aplastic anaemia and to estimate the magnitude of this risk, if any.

METHODS

Population-based prospective case-control surveillance of aplastic anaemia in a community of 4.2 million inhabitants from 1980 to 1995 (67.2 million person-years) plus case-population estimate of the risk, based on sales figures of ocular chloramphenicol in the study area during the study period.

RESULTS

One hundred and forty-five patients with aplastic anaemia and 1,226 controls were included in the analysis. Three cases (2.1%) and 5 controls (0.4%) had been exposed to ocular chloramphenicol during the relevant etiological period. The adjusted odds ratio was 3.77 (95% confidence interval, 0.84-16.90). Two cases had also been exposed to other known causes of aplastic anaemia. The incidence of aplastic anaemia among users of ocular chloramphenicol was 0.36 cases per million weeks of treatment. The incidence among non users was 0.04 cases per million weeks.

CONCLUSIONS

An association between ocular chloramphenicol and aplastic anaemia cannot be excluded. However, the risk is less than one per million treatment courses.

摘要

目的

确定局部使用氯霉素眼药水是否会增加再生障碍性贫血的风险,并评估该风险(若存在)的程度。

方法

对一个拥有420万居民的社区在1980年至1995年期间进行基于人群的再生障碍性贫血前瞻性病例对照监测(6720万人年),并根据研究期间研究区域内氯霉素眼药水的销售数据对风险进行病例人群估计。

结果

145例再生障碍性贫血患者和1226例对照纳入分析。3例病例(2.1%)和5例对照(0.4%)在相关病因期接触过氯霉素眼药水。调整后的比值比为3.77(95%置信区间,0.84 - 16.90)。2例病例还接触过其他已知的再生障碍性贫血病因。氯霉素眼药水使用者中再生障碍性贫血的发病率为每百万治疗周0.36例。非使用者中的发病率为每百万周0.04例。

结论

不能排除氯霉素眼药水与再生障碍性贫血之间的关联。然而,风险低于每百万治疗疗程1例。

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Br J Clin Pharmacol. 1998 Aug;46(2):181-4. doi: 10.1046/j.1365-2125.1998.00773.x.
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本文引用的文献

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BONE-MARROW HYPOPLASIA FOLLOWING USE OF CHLORAMPHENICOL EYE DROPS.
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Relation of aplastic anaemia to use of chloramphenicol eye drops in two international case-control studies.两项国际病例对照研究中再生障碍性贫血与氯霉素滴眼液使用的关系。
BMJ. 1998 Feb 28;316(7132):666. doi: 10.1136/bmj.316.7132.666.
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Widespread ocular use of topical chloramphenicol: is there justifiable concern regarding idiosyncratic aplastic anaemia?氯霉素眼药水的广泛眼部使用:对于特异性再生障碍性贫血的担忧是否合理?
Br J Ophthalmol. 1996 Feb;80(2):182-4. doi: 10.1136/bjo.80.2.182.
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Ocular chloramphenicol and aplastic anaemia. Is there a link?眼部使用氯霉素与再生障碍性贫血。二者有关联吗?
Drug Saf. 1996 May;14(5):273-6. doi: 10.2165/00002018-199614050-00001.
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Use of chloramphenicol as topical eye medication: time to cry halt?将氯霉素用作局部眼部用药:是时候叫停了吗?
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Is it time to stop using chloramphenicol on the eye? Risk is low in short courses.是时候停止在眼部使用氯霉素了吗?短期使用风险较低。
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Is it time to stop using chloramphenicol on the eye? Safe in patients with no history of blood dyscrasia.是时候停止在眼部使用氯霉素了吗?对无血液系统疾病病史的患者安全。
BMJ. 1995 Aug 12;311(7002):450; author reply 451. doi: 10.1136/bmj.311.7002.450a.
8
Is it time to stop using chloramphenicol on the eye? Fears are based on only six cases.
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Marrow aplasia following topical application of chloramphenicol eye ointment.局部应用氯霉素眼膏后发生的骨髓再生障碍。
Arch Intern Med. 1980 Apr;140(4):576-7.
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Fatal aplastic anemia following topical administration of ophthalmic chloramphenicol.局部应用眼科氯霉素后发生的致命性再生障碍性贫血。
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