Do the Usage of Di (2-ethylhexyl) Phthalate-Containing Medical Devices Promote Development of Allergic Symptoms?

接觸含DEHP醫療器材是否會導致發生過敏症狀的機會增加？

顏志瑋(Chih-Wei Yen) ； 張玉坤(Yue-Cune Chang) ； 李孟蓉(Meng-Rung Lee)

《輔仁醫學期刊》 8卷1期 (2010/03) Pp. 17-32

摘要

鄰苯二甲酸二（2-乙基已基）酯(DEHP)是一個FDA核准醫療器材製程中使用的增塑劑，過去研究可能對人體有害。雖然FDA指出含DEHP醫療器材已用於新生兒很多年而沒有明顯負面效應。但接觸含DEHP器材的治療後，發現DEHP的確可於新生兒的尿液樣本中檢測到。本項研究，我們將研究含DEHP醫療器材對於新生兒是否有任何負面效應。我們假設：在新生兒重症加護病房治療後的嬰兒其發生過敏性症狀的風險較新生兒中心的嬰兒高。方法：從一所區域教學醫院共收集202位新生兒病患，其中新生兒加護病房29位而新生兒中心173位。出院後追蹤一年，收集與嬰兒健康相關資料，包括住院史、家族史、家庭環境條件和四個常見的過敏症狀：異位性皮膚炎、下呼吸道過敏（氣喘）、過敏性鼻炎和胃腸道過敏。統計用卡方測試、動力分析和多項邏輯迴歸模型來分析資料。結果：四分之三的比率曾在重症加護病房治療過的新生兒過敏症狀較新生兒中心高，雖然不到統計上顯著意義（除了胃腸道過敏外）。證據顯示新生兒住在醫院時間越長，得到過敏性症狀風險就越大。結論：我們發現證據顯示含DEHP醫療設備對新生嬰兒可能有影響。更確鑿的結果需要進一步研究。建議至少有1800位新生兒的樣本量與3年追蹤研究。

關鍵字

鄰苯二甲酸二2-乙基已基酯 ； 增塑劑 ； 醫療器材 ； 新生兒重症加護病房 ； 過敏症狀

並列摘要

Background and Purpose: Di (2-ethylhexyl) phthalate (DEHP) is a FDA approved plasticizer used in medical devices and may be toxic to humans. Although, FDA has pointed out that ”DEHP containing devices have been used on newborn babies for many years without apparent ill effect”. Through medical care procedures, DEHP is detectable in neonates' urine samples. In this study we examined whether or not the DEHP containing devices have any ill effect on newborn babies. We tested the hypotheses that the risks of allergic symptoms of infants who had been cared in NICU are higher than those in newborn center. Methods: We studied a convenience sample of 202 infants enrolled from NICU (n=29) and NBC (n=173) at a teaching hospital. We collected all information about infants' health related data, medical devices used during hospitalization, family history, household conditions, and the occurrence of four patterns of allergic symptoms, named atopic dermatitis, lower airway allergy (asthma), allergic rhinitis, and Gastro-intestinal (G-I) tract allergy. We used chi-square tests, power analyses, and multiple logistic regression models to analyze the data. Results: Three out of four incidence rates of the allergic symptoms in NICU were higher, although not statistically significantly, than those incidence rates in NBC (except G-I Tract Allergy). There were some evidences showed that the longer the neonates stayed in the hospital the greater the risks of getting some allergic symptoms would be. Conclusions: We found some evidence about the ill effects of DEHP-containing medical devices to newborn babies. Further investigation is needed to get amore conclusive result. A study with sample size of at least 1800 newborn babies and more than 3 years follow-up is recommended.

並列關鍵字

DEHP ； plasticizer ； medical devices ； NICU ； allergic symptoms