以臺灣全民健保資料庫分析門診孕婦抗生素處方型態及其對生產之影響

The Association between Child Labor and the Prescription Patterns of Antibiotics in Pregnant Women from Outpatient Clinic in Taiwan

侯乃華(Nai-Hua Hou)

指導教授 ： 簡淑真

共同指導教授 ： 曾頌惠(Sung-Hui Tseng)

臺北醫學大學/藥學院/生技製藥產業碩士專班/碩士(2014年)

摘要

研究目的：已知國外許多研究顯示懷孕期間服用抗生素可能與孕婦生產情況或胎兒健康有關，又臺灣目前並無專門討論孕婦服用抗生素情形的相關研究，因此本研究欲利用臺灣全民健保資料庫分析門診孕婦抗生素的處方型態及其對生產之影響。

研究方法：本研究採敘述統計（Descriptive Statistics）的方式，以國家衛生研究院全民健康保險資料庫2010承保抽樣歸人檔為樣本，篩選自1999年至2010年期間之20歲以上門診懷孕婦女為研究對象，並且分析其抗生素處方型態，接著再以卡方檢定（Chi-square test）及邏輯回歸（Logistic regression model）進行推論統計（Inferential Statistics），分析抗生素的使用是否與生產結果有關係。

研究結果：本研究共納入88,533位孕婦（以人次計），其中有53,549位（60.48%）曾於懷孕期間接受抗生素處方，另有34,984位（39.52%）未接受過抗生素之處方，其中孕婦年齡以20−29為主（共47,523位）。生產結果屬於流產者共2,939 （3.32%）人次，而順產者共85,594 （96.68%）人次。1999年至2010年間，門診孕婦之抗生素總處方次數為167,902筆，且結果顯示，抗生素之總處方量自2000年之28,820下降至2004年之5,330筆。每年平均有60.48%孕婦會暴露到抗生素。所有抗生素之平均單次療程處方天數以3至7天為主。孕婦懷孕期間最常使用之抗生素種類為Beta-lactam (penicillins)類之抗生素，佔所有處方量的25.61%。而孕婦最常使用之抗生素成份為口服劑型之amoxicillin。孕婦最常使用之前十大抗生素中，以口服與陰道栓劑等劑型之抗生素為主，其相對應之診斷以上呼吸道感染症及婦科感染症為主。孕婦用藥安全分析結果顯示，不論是哪種生產結果之孕婦，皆以FDA孕婦用藥安全等級B級之抗生素之處方為主。而邏輯回歸分析顯示，相較於孕婦懷孕期間未使用抗生素之孕婦，服用抗生素者發生流產的勝算較低（OR 0.66, 95CI:0.61−0.71）。然而孕婦以得知懷孕後接受抗生素處方者較多，僅接受D級抗生素者於得知懷孕前接受抗生素治療之情形較多。

結論：本研究驗証了孕婦族群之抗生素使用量自2001年健保局進行「抗微生物製劑」健保給付規定條文之增修後，確實有明顯下降的趨勢。且本研究也間接反應2003年SARS對孕婦看診次數之影響。另外，由抗生素之安全性使用可得知，國內對孕婦之抗生素使用有相當程度的注意，對於孕婦所患之感染症，醫師絕大多數皆給予較保守的治療。

關鍵字

孕婦 ； 抗生素 ； 全民健保資料庫 ； 處方型態

並列摘要

Objective: Several studies had shown that use of antibiotics might be associated with the adverse outcome of pregnancy, while similar researches on antibiotic use during pregnancy in Taiwan remains inadequate. In this study, we would like to evaluate the association between child labor and the prescription patterns of antibiotics in pregnant women from outpatient clinic in Taiwan.

Methods: Data set of a randomly sampled cohort registry in Taiwan, provided by the National Health Research Institutes was used. Pregnant women over 20 years old during 1999 to 2010 were included in this study. The prescription patterns of antibiotics in these women from outpatient clinic were described, and the association between child labor and the use of antibiotics was further evaluated with Chi-square test and Logistic regression model.

Results: 88,533 pregnancies were identified. 53,549 (60.48%) were exposed to antibiotics, and 34,984 (39.52%) of them were not. Most pregnant women (n=47,523) were between 20 to 29 years old. 2,939 (3.32%) pregnant women had miscarriage, while 85,594 (96.68%) delivered their babies successfully. A total of 167,902 antibioitcs prescriptions were observed during 1999-2010 among these pregnant women. We found that the number of antibiotics prescriptions decreased from 28,820 to 5,330 during 2000-2004. The antibiotics exposure rate of these pregnant women was 60.48% per year during 1999-2010. The most frequent length of each antibiotic treatment was between 3 to 7 days per treatment in average. Beta-lactam (penicillins) was the most commonly prescribed antibiotics class with 25.61% prescriptions among all, and amoxicillin was the most-dispensed antibiotics. Upper respiratory infections amd inflammatory disease of cervix, vagina, and vilva are the major diagnosis among the top 10 antibiotics treatments. The most frequently used FDA pregnancy risk categorized-antibiotics were category B antibiotics. We found that use of antibiotics during pregnancy significantly decreased the odds (OR 0.66, 95CI:0.61−0.71) of miscarriage compared to the unexposed group. Antibiotics were more likely to be prescribed after the first prenatal exams, while pregnancy category D antibiotics were mosly prescribed before the first prenatal exams.

Conclusion: We found that the use of antibiotics in pregnant women decreased after the drug guideline of antimicrobials changed in 2001. Also, we suspected that there is an impact on the number change of antibiotics prescriptions during 2003-2004 by the incident of SARS in 2003. Finally, we conclude that the antibiotics treatments were well controlled with the physicians’ careful selection of antibiotics’ FDA pregnancy risk category. Since infections are risk factors for adverse pregnancy outcomes, treatments with antibiotics may decrease the risk of miscarriage.

並列關鍵字

pregnancy ； antibiotics ； National Health Insurance Research Database ； prescription pattern

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