早產兒藥物治療開放性動脈導管之研究—比較靜脈注射Ibuprofen, 口服Ibuprofen及口服Paracetamol的成效與安全性

Outcome and Safety of Patent Ductus Arteriosus Closure- Results of intravenous Ibuprofen, oral Ibuprofen and oral Paracetamol Administration in Preterm Infants

王杏安(Xing-An Wang)

指導教授 ： 楊順發

共同指導教授 ： 蘇本華(Pen-Hua Su)

中山醫學大學/醫學院/醫學研究所/碩士(2022年)

https://doi.org/10.6834/csmu202200161

摘要

研究背景與目的：開放性動脈導管（Patent ductus arteriosis, PDA）是新生兒加護病房中造成併發症或死亡的常見原因，因此在早產兒照護中，治療PDA是重要的。目前PDA的標準治療包含藥物、手術及導管栓塞等方法，其中藥物治療為第一線的標準治療，使用的藥物包含非類固醇類抗發炎藥（Non-steroidal anti-inflammatory drugs, NSAIDs）和Paracetamol等。因此，本研究將過去在新生兒加護病房內使用過藥物治療方式治療PDA的早產兒病歷資料做收集，比較並討論靜脈注射Ibuprofen，口服Ibuprofen和口服Paracetamol的成效與安全性。
研究方法：本研究為一單一中心回溯性病歷資料研究。我們將2013年6月至2016年12月曾入住中山醫學大學附設醫院新生兒加護病房，診斷為Hemodynamic significant PDA（心臟超音波顯示PDA size>1.5mm，LA: AO ratio> 1.5合併左至右的分流）並接受過開放性動脈導管治療的病人之病歷做一回顧。依目前的標準治療，視病人使用之藥物分為三組（Group 1：靜脈注射Ibuprofen；Group 2:口服Ibuprofen; Group 3:口服 Paracetamol），將此三組的病人資料、治療療程長短、相關併發症及成功率分別作相關的統計。
研究結果：此三組病人治療PDA的成功率無顯著差異（Group 1= 80.0%; Group 2= 65%; Group 3= 61.5%, P=0.756），且用藥安全性即肝腎功能等三組亦無顯著差異。另外，探討各項因子與PDA治療成功的相關性，僅起始治療的時間（P=0.012）與治療的總天數（P<0.001）在治療成功與失敗兩組中有顯著相關性。
結論與建議：三組不同藥物治療方法在治療PDA有相近的療效，且安全性亦是相當的，而治療成功與否與開始治療的時間和治療總天數有其相關性。因此，臨床上可以根據臨床經驗及病人狀況作藥物治療的選擇。

關鍵字

開放性動脈導管 ； 早產兒 ； 非類固醇類抗發炎藥物

並列摘要

Objectives: Patent ductus arteriosus (PDA) is a common cause leading morbidity and mortality in neonatal intensive care unit (NICU). Medical treatment is the first line therapy for closure of PDA, including Nonsteroidal anti-inflammatory drugs (NSAIDs) and Paracetamol use. Thus, the aims of this study are to compare the outcomes and safety of these common three medical therapies (intravenous Ibuprofen, oral Ibuprofen and oral Paracetamol) for preterm infants.
Methods: This is a single-center retrospective study. Data were collected from charts review of the patients who were hospitalized at the NICU in Chung Shan Medical University Hospital (CSMUH) between June, 2013 and December, 2016. Patients who were diagnosed of hemodynamic significant PDA (PDA size> 0.15cm, left atrium:aorta ratio> 1.5, and left to right shunt through PDA on echocardiogram) were included. Patients were separated into three groups based on the medical treatment of hemodynamic significant PDA (Group 1: Intravenous ibuprofen; Group 2: Oral ibuprofen; Group 3: Oral paracetamol) according to 3 different medical therapies. The patients’ characteristics, treatment courses, complications and ductal closure rates were all be analyzed among the three groups.
Results: There were 53 patients (Group 1= 20 patients; Group 2= 20 patients; Group 3= 13 patients) diagnosed of hemodynamic significant PDA with medical treatment between June, 2013 and December, 2016 included in this study. There were no significant difference in PDA closure rate among intravenous ibuprofen, oral ibuprofen or oral Paracetamol groups (Group 1= 80.0%; Group 2= 65.0%; Group 3= 61.5%, P=0.756). Comparison of factors between PDA close and non-closure groups, the time of initial treatment (P=0.012) and total treatment days (P<0.001) have significant difference between two groups.
Conclusion: Among three common medical therapies for treatment of hemodynamic significant PDA, PDA closure rate was similar with intravenous ibuprofen, oral ibuprofen and oral paracetamol groups. Regardless of which method of treatment is used, earlier initiation of treatment is a major factor in PDA closure.

並列關鍵字

Patent ductus arteriosus ； Preterm infants ； Non-steroidal anti-inflammatory drugs

參考文獻

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