懷孕期間口服抗黴菌藥會增加流產風險


  【24drs.com】丹麥的研究者表示,孕婦口服抗黴菌藥物fluconazole (商品名Diflucan [輝瑞/Pfizer]或其他學名藥)治療陰道念珠菌病,流產風險顯著增加。
  
  在妊娠7-22週期間口服fluconazole的3,315名婦女中,147人發生自然流產,相對的,13,246名對照組中(沒有服用fluconazole的孕婦)中,563人發生自然流產,差異值換算成風險比(HR)為1.48 (95%信賴區間[CI]為1.23 - 1.77)。
  
  丹麥哥本哈根Statens Serum Institut 流行病學研究部Ditte Molgaard-Nielsen等人指出,相較於沒有服用fluconazole的對照組或者沒有服用的非配對孕婦,口服fluconazole之孕婦的死胎風險也傾向比較高,但是這些差異未達統計上的顯著程度。
  
  研究者在JAMA寫道,等到有更多關於這項關聯的資料,即可對孕婦處方口服fluconazole提出警告。雖然死胎風險沒有顯著增加,應對此進行後續研究。
  
  作者們指出,懷孕期間,性荷爾蒙分泌增加,增加了陰道念珠菌的風險,估計美國約有十分之一孕婦會發生這項感染。雖然一般是使用外用的azole類抗黴菌劑治療此一感染,對於嚴重或反覆感染者會處方口服fluconazole,而此一藥物之致畸胎可能性的資料相當有限。
  
  為了探討懷孕期間口服fluconazole是否與自然流產及死胎的風險有關,研究者蒐集了丹麥的全國綜合出生、病歷資料、以及製藥登記,以建立他們的研究世代,他們選擇妊娠第7週作為研究起點,因為發生在更初期孕期的自然流產是無法確認的。
  
  透過傾向得分配對、母親年齡每5歲為一組、懷孕時的日曆年、第一次使用fluconazole時的妊娠年齡,將每位有服用fluconazole的婦女配對最多4名沒有服用fluconazole的孕婦,控制配對組的懷孕存活到相同妊娠年齡,最後,研究世代共有1,405,663名孕婦。
  
  除了剛才提到的,口服fluconazole者自然流產風險比對照組增加,研究者也發現,使用fluconazole者的風險也比沒有使用的未配對孕婦增加(HR, 1.49;95% CI, 1.27 - 1.75)。
  
  此外,敏感性分析中,使用口服fluconazole者的自然流產風險,高於使用外用azole類製劑(HR, 1.62;95% CI, 1.26 - 2.07)或抗生素pivmecillinam (美國未核准此藥)者。
  
  資料來源: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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