Prescrire Int. 2012 Jul;21(129):186-7, 190.
When a pregnant woman suffers from mild to moderate pain, and when simple non-drug measures are ineffective, paracetamol is the drug of first choice. Data from epidemiological and animal studies are reassuring regarding the risk of malformations. In late 2010, a link was suggested between paracetamol exposure in utero and the occurrence of cryptorchidism, a common male urogenital birth defect that usually resolves during the first year of life. Does paracetamol exposure in utero increase the risk of birth defects, particularly cryptorchidism persisting beyond one year of age? To answer this question, we conducted a review of the literature using the standard Prescrire methodology. The results of about 10 animal teratogenicity studies are reassuring. Some studies yielded conflicting results for testicular abnormalities. Two cohort studies including a total of nearly 49 000 boys showed no increase in the risk of persistent cryptorchidism after paracetamol exposure in utero. A case-control study showed a link with cryptorchidism in a subgroup of boys exposed to paracetamol in utero for more than 15 days; the analysis was not performed in boys with persistent cryptorchidism. Six cohort studies and 11 case-control studies including approximately 38 000 women showed no increase in malformations among children exposed to paracetamol in utero compared to unexposed children. Available data show no conclusive link between paracetamol exposure in utero and the risk of childhood asthma. Overall, data available in early 2012, especially those from epidemiological studies, are reassuring on the use of paracetamol during pregnancy. Paracetamol remains the analgesic and antipyretic medication of first choice for pregnant women when nondrug measures are ineffective.
当孕妇遭受轻至中度疼痛,且简单的非药物措施无效时,对乙酰氨基酚是首选药物。流行病学和动物研究的数据表明其致畸风险令人安心。2010年末,有人提出子宫内接触对乙酰氨基酚与隐睾症的发生之间存在关联,隐睾症是一种常见的男性泌尿生殖系统出生缺陷,通常在出生后第一年自行缓解。子宫内接触对乙酰氨基酚会增加出生缺陷的风险吗,尤其是持续超过一岁的隐睾症?为回答这个问题,我们使用标准的《处方》方法对文献进行了综述。约10项动物致畸性研究的结果令人安心。一些研究在睾丸异常方面得出了相互矛盾的结果。两项队列研究共纳入了近49000名男孩,结果显示子宫内接触对乙酰氨基酚后,持续性隐睾症的风险并未增加。一项病例对照研究表明,在子宫内接触对乙酰氨基酚超过15天的男孩亚组中,与隐睾症存在关联;该分析未在持续性隐睾症男孩中进行。六项队列研究和11项病例对照研究共纳入了约38000名女性,结果显示,与未接触对乙酰氨基酚的儿童相比,子宫内接触对乙酰氨基酚的儿童中畸形发生率并未增加。现有数据表明,子宫内接触对乙酰氨基酚与儿童哮喘风险之间没有确凿的关联。总体而言,2012年初可得的数据,尤其是来自流行病学研究的数据,对于孕期使用对乙酰氨基酚是令人安心的。当非药物措施无效时,对乙酰氨基酚仍然是孕妇首选的止痛和解热药物。