Evaluation of drug safety among pregnant women with antihypertensive drugs

[研究背景]妊娠高血压综合征（Pregnancy-induced hypertension，PIH）发生率为5-10%，但有关PIH患者抗高血压药物的信息却十分有限。[目的]根据索赔数据，明确孕妇抗高血压药物处方。[方法]我们使用2008年1月1日至2010年5月31日在日本医疗数据中心的健康保险索赔（索赔）数据。孕妇通过健康保险索赔（索赔）数据的信息进行检测。根据妊娠周数、母亲医疗保健开始日期估计每名妇女的妊娠期。妊娠期间药物处方的信息从医疗记录或处方记录中提取。分别在所有孕妇和诊断为高血压相关（ICD-10分类：O 10-O 16）的孕妇中评价妊娠期抗高血压药物处方。[结果]共识别孕妇19,282人 ...更多信息 (mean年龄; 30.5±4.7岁，15.6-49.4岁）。其中，744名妇女（0.04%）在怀孕期间服用了抗高血压药物。在整个妊娠期、妊娠早期、妊娠中期和妊娠晚期最常使用的抗高血压药物分别为“呋塞米”（n=328）、“甲基多巴”（n=13）、"甲基多巴“（n=25）、”呋塞米“（n=299）。在19,282名孕妇中，1101名孕妇被诊断为妊娠期高血压（ICD-10分类：O 10-O 16）。其中，161名妇女（14.6%）在怀孕期间服用了抗高血压药物。在整个妊娠期、妊娠早期、妊娠中期和妊娠晚期最常使用的抗高血压药物分别为“硝苯地平”（n=63）、“肼屈嗪”和“甲基多巴”（n=4）、“肼屈嗪”（n=9）、“硝苯地平”（n=56）。[结论]在基于索赔数据对孕妇抗高血压药物处方进行审查时，无论是否诊断为妊娠期高血压，都应对孕妇的药物处方进行评估。少

[Background] Pregnancy-induced hypertension (PIH) occurs in 5-10% of pregnant women, but information about antihypertensive drugs prescribed to patients with PIH is limited. [Objective] To clarify the prescription of antihypertensive drugs to pregnant women based on claims data. [Methods] We used health insurance claim (claims) data between January 1,2008 and May 31, 2010 at the Japan Medical Data Center. Pregnant women were detected by the information about health insurance claim (claims) data. Pregnancy duration for each woman was estimated by pregnancy week number, start date of medical care in claims for the mothers. Information on drug prescriptions during pregnancy was extracted from medical records or records of dispensed prescriptions. Prescription of antihypertensive drugs during pregnancy was evaluated among all pregnant women and pregnant women with a hypertension-related diagnosis (ICD-10 classification: O10-O16), respectively. [Results] We identified 19,282 pregnant women … More (mean age; 30.5±4.7 years, 15.6-49.4 years) from about 90 million health insurance claim (claims) data. Of these, 744 women (0.04%) had been prescribed an antihypertensive drug during pregnancy. The most frequently prescribed antihypertensive drugs during total pregnancy period, first trimester, second trimester, and third trimester were ‘Furosemide’(n=328), ‘Methyldopa’(n=13), ‘Methyldopa’(n=25), ‘Furosemide’(n=299) , respectively. Among 19,282 pregnant women, 1101 pregnant women were diagnosed as hypertension during pregnancy (ICD-10 classification: O10-O16). Of these, 161 women(14.6％) had been prescribed an antihypertensive drug during pregnancy. The most frequently prescribed antihypertensive drugs during total pregnancy period, first trimester, second trimester, and third trimester were ‘Nifedipine’(n=63),‘Hydralazine’ and ‘Methyldopa’(n=4, respectively), ‘Hydralazine’(n=9), ‘Nifedipine’(n=56), respectively. [Conclusion] We found that prescription of drugs among pregnant women should be evaluated regardless of the presence or absence of the diagnosis as hypertension during pregnancy when we examine the prescription of antihypertensive drugs to pregnant women based on claims data. Less