PDF(Pubmed)
Abstract：
At present, safety of letrozole administration as an ovulation-inducing drug still remains controversial. Investigation of the safety of letrozole use for the induction of ovulation in the Chinese population is scant. The present study aimed to fill this gap. Data concerning mothers using letrozole and birth outcomes of their singleton offspring were collected as the letrozole group (n=194), equivalent data from mothers using non-letrozole drugs and their singleton offspring were included as the non-letrozole group (control, n=154). Birth outcomes, congenital anomalies and neonatal complications were compared and analyzed between the two groups. Univariate analysis, Spearman\'s rank correlation analysis and the logistic regression model were utilized. For birth outcomes, the percentage of caesarean section deliveries in the letrozole group was lower than the non-letrozole group (43.8 vs. 56.4%, P=0.019). For congenital anomalies, no significant difference was found between the two groups (all P>0.05). The statistical P-value for the correlation between the maternal use of letrozole and neonatal complications was marginal (P=0.051). Results from the logistic regression analysis confirmed that maternal use of letrozole was not a significant contributor for neonatal complications, independent of statistical adjustment [crude odds ratio (OR), 1.436; 95% confidence interval (CI), 0.803-2.569; P=0.223 vs. adjusted OR, 1.406; 95% CI, 0.748-2.643; P=0.290). The results of the present study suggested that maternal use of letrozole for ovulation induction does not associate with poorer birth outcomes or increased risk of congenital anomalies and neonatal complications.
摘要：
目前,来曲唑作为促排卵药物的安全性仍存在争议.在中国人群中使用来曲唑诱导排卵的安全性调查很少。本研究旨在填补这一空白。有关使用来曲唑的母亲和其单胎后代的出生结局的数据收集作为来曲唑组（n=194），来自使用非来曲唑药物的母亲及其单胎后代的等效数据被纳入非来曲唑组(对照，n=154）。出生结果,比较分析两组患儿的先天性畸形和新生儿并发症。单变量分析,采用Spearman秩相关分析和logistic回归模型。对于出生结果，来曲唑组的剖宫产率低于非来曲唑组（43.8vs.56.4%,P=0.019)。对于先天性异常，两组间差异无统计学意义(均P>0.05)。母亲使用来曲唑与新生儿并发症之间相关性的统计学P值是边缘的（P=0.051）。Logistic回归分析的结果证实，母亲使用来曲唑并不是新生儿并发症的重要原因。独立于统计调整[粗比值比(OR)，1.436；95%置信区间(CI)，0.803-2.569；P=0.223vs.调整或,1.406；95%CI，0.748-2.643；P=0.290）。本研究的结果表明，母体使用来曲唑进行排卵诱导与较差的出生结局或先天性异常和新生儿并发症的风险增加无关。
