Chung-Ang University College of Pharmacy, Seoul, Korea.
Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea.
Epidemiol Health. 2024;46:e2024012. doi: 10.4178/epih.e2024012. Epub 2023 Dec 19.
This study developed an algorithm for identifying pregnancy episodes and estimating the last menstrual period (LMP) in an administrative claims database and applied it to investigate the use of pregnancy-incompatible immunosuppressants among pregnant women with systemic lupus erythematosus (SLE).
An algorithm was developed and applied to a nationwide claims database in Korea. Pregnancy episodes were identified using a hierarchy of pregnancy outcomes and clinically plausible periods for subsequent episodes. The LMP was estimated using preterm delivery, sonography, and abortion procedure codes. Otherwise, outcome-specific estimates were applied, assigning a fixed gestational age to the corresponding pregnancy outcome. The algorithm was used to examine the prevalence of pregnancies and utilization of pregnancy-incompatible immunosuppressants (cyclophosphamide [CYC]/mycophenolate mofetil [MMF]/methotrexate [MTX]) and non-steroidal anti-inflammatory drugs (NSAIDs) during pregnancy in SLE patients.
The pregnancy outcomes identified in SLE patients included live births (67%), stillbirths (2%), and abortions (31%). The LMP was mostly estimated with outcome-specific estimates for full-term births (92.3%) and using sonography procedure codes (54.7%) and preterm delivery diagnosis codes (37.9%) for preterm births. The use of CYC/MMF/MTX decreased from 7.6% during preconception to 0.2% at the end of pregnancy. CYC/MMF/MTX use was observed in 3.6% of women within 3 months preconception and 2.5% during 0-7 weeks of pregnancy.
This study presents the first pregnancy algorithm using a Korean administrative claims database. Although further validation is necessary, this study provides a foundation for evaluating the safety of medications during pregnancy using secondary databases in Korea, especially for rare diseases.
本研究开发了一种在医疗理赔数据库中识别妊娠事件并估算末次月经（LMP）的算法，并应用该算法调查系统性红斑狼疮（SLE）孕妇中使用妊娠禁忌免疫抑制剂的情况。
开发了一种算法并应用于韩国全国性的理赔数据库。通过妊娠结局的层次结构和后续妊娠的合理临床时期来识别妊娠事件。通过早产、超声和流产手术代码估算 LMP。否则，将应用特定结局的估计值，为相应的妊娠结局分配固定的妊娠龄。该算法用于检查 SLE 患者妊娠的发生率和妊娠禁忌免疫抑制剂（环磷酰胺[CYC]/霉酚酸酯[MMF]/甲氨蝶呤[MTX]）和非甾体抗炎药（NSAIDs）的使用情况。
SLE 患者的妊娠结局包括活产（67%）、死胎（2%）和流产（31%）。LMP 主要通过足月分娩的特定结局估计（92.3%），并通过超声手术代码（54.7%）和早产诊断代码（37.9%）估算早产。在妊娠期间，CYC/MMF/MTX 的使用从受孕前的 7.6%降至妊娠末期的 0.2%。在受孕前 3 个月内和妊娠 0-7 周内，分别有 3.6%和 2.5%的女性使用 CYC/MMF/MTX。
本研究首次使用韩国医疗理赔数据库提出了一种妊娠算法。尽管需要进一步验证，但本研究为使用韩国二级数据库评估妊娠期间药物安全性提供了基础，特别是对于罕见疾病。
