怀孕期间口服抗霉菌药会增加流产风险


  【24drs.com】丹麦的研究者表示,孕妇口服抗霉菌药物fluconazole (商品名Diflucan [辉瑞/Pfizer]或其它学名药)治疗阴道念珠菌病,流产风险显著增加。
  
  在妊娠7-22周期间口服fluconazole的3,315名妇女中,147人发生自然流产,相对的,13,246名对照组中(没有服用fluconazole的孕妇)中,563人发生自然流产,差异值换算成风险比(HR)为1.48 (95%信赖区间[CI]为1.23 - 1.77)。
  
  丹麦哥本哈根Statens Serum Institut 流行病学研究部Ditte Molgaard-Nielsen等人指出,相较于没有服用fluconazole的对照组或者没有服用的非配对孕妇,口服fluconazole之孕妇的死胎风险也倾向比较高,但是这些差异未达统计上的显著程度。
  
  研究者在JAMA写道,等到有更多关于这项关联的资料,即可对孕妇处方口服fluconazole提出警告。虽然死胎风险没有显著增加,应对此进行后续研究。
  
  作者们指出,怀孕期间,性荷尔蒙分泌增加,增加了阴道念珠菌的风险,估计美国约有十分之一孕妇会发生这项感染。虽然一般是使用外用的azole类抗霉菌剂治疗此一感染,对于严重或反覆感染者会处方口服fluconazole,而此一药物之致畸胎可能性的资料相当有限。
  
  为了探讨怀孕期间口服fluconazole是否与自然流产及死胎的风险有关,研究者搜集了丹麦的全国综合出生、病历资料、以及制药登记,以建立他们的研究世代,他们选择妊娠第7周作为研究起点,因为发生在更初期孕期的自然流产是无法确认的。
  
  透过倾向得分配对、母亲年龄每5岁为一组、怀孕时的日历年、第一次使用fluconazole时的妊娠年龄,将每位有服用fluconazole的妇女配对最多4名没有服用fluconazole的孕妇,控制配对组的怀孕存活到相同妊娠年龄,最后,研究世代共有1,405,663名孕妇。
  
  除了刚才提到的,口服fluconazole者自然流产风险比对照组增加,研究者也发现,使用fluconazole者的风险也比没有使用的未配对孕妇增加(HR, 1.49;95% CI, 1.27 - 1.75)。
  
  此外,敏感性分析中,使用口服fluconazole者的自然流产风险,高于使用外用azole类制剂(HR, 1.62;95% CI, 1.26 - 2.07)或抗生素pivmecillinam (美国未核准此药)者。
  
  资料来源:http://www.24drs.com/
  
  Native link:Oral Antifungal in Pregnancy Increases Miscarriage Risk

Oral Antifungal in Pregnancy Increases Miscarriage Risk

By Neil Osterweil
Medscape Medical News

Pregnant women who take the oral antifungal drug fluconazole (Diflucan [Pfizer] and generics) for vaginal candidiasis have a significantly increased risk for miscarriage, say Danish investigators.

Of 3315 women who took oral fluconazole during the 7th through 22nd weeks of gestation, 147 had a spontaneous abortion. In contrast, of 13,246 matched controls (pregnant women with no fluconazole exposure), 563 had spontaneous abortions, a difference that translated into a hazard ratio (HR) of 1.48 (95% confidence interval [CI], 1.23 - 1.77).

There was also a trend toward a higher risk for stillbirths among women who took oral fluconazole compared with unexposed matched controls or unexposed unmatched pregnant women, but these differences were not statistically significant, report Ditte Molgaard-Nielsen, MSc, and colleagues from the Department of Epidemiology Research at Statens Serum Institut in Copenhagen, Denmark.

"Until more data on the association are available, cautious prescribing of oral fluconazole in pregnancy may be advisable. Although the risk of stillbirth was not significantly increased, this outcome should be investigated further," the investigators write in JAMA.

Increased secretion of sex hormones during pregnancy increases the risk for vaginal candidiasis, and it's estimated that 1 in 10 pregnant women in the United States will develop the infection, the authors note. Although the infection is typically treated with topical azole antifungals, oral fluconazole may be prescribed for severe or recurrent infections, despite limited data about the teratogenic potential of this agent.

Danish Data Trove

To see whether oral fluconazole use in pregnancy could be associated with risk for spontaneous abortions and stillbirths, the investigators drew on Denmark's comprehensive nationwide birth, patient data, and pharmaceutical registries to create their cohort. They chose week 7 as the starting point for measuring pregnancy because many spontaneous abortions occurring during very early gestation go unrecognized.

Each woman exposed to fluconazole was matched with up to 4 pregnant women with no fluconazole exposure by using propensity score matching, maternal age in 5-year groups, calendar year of pregnancy, and gestational age at the time of first fluconazole exposure, with controls matched for pregnancies surviving to the same gestational age. The final cohort consisted of 1,405,663 pregnancies.

In addition to the increased risk for spontaneous abortion with oral fluconazole exposure vs matched controls noted before, the investigators saw an increased risk for fluconazole use compared with unexposed unmatched pregnancies (HR, 1.49; 95% CI, 1.27 - 1.75).

Additionally, in sensitivity analyses, the risk for spontaneous abortion was higher in women who used oral fluconazole than in those who used a topical azole (HR, 1.62; 95% CI, 1.26 - 2.07) or the antibiotic pivmecillinam (not approved in the United States).

The study was supported by the Danish Medical Research Council. The authors have disclosed no relevant financial relationships.

JAMA. 2016;315:58-67.

    
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