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    Title: 臺灣先天性巨細胞病毒感染之產前篩檢、 照護實務與法律政策改進方案研究
    Research on prenatal screening, care practices, and legal policy improvement suggestions for congenital cytomegalovirus infection in Taiwan
    Authors: 周昱青
    CHOU, YU-CHING
    Contributors: 醫療暨生物科技法律研究所碩士班
    何建志
    Keywords: 巨細胞病毒;先天性巨細胞病毒感染;產前檢查;巨細胞病毒抗體篩檢;IgG 親和力;抗?疹病毒藥物;袪疹易錠;優生保健法;晚期終止妊娠
    cytomegalovirus (CMV);congenital cytomegalovirus infecrtion (cCMV);prenatal exams;cytomegalovirus antibody screening;IgG avidity;antiherpetic drugs;valacyclovir;Genetic Health Act;late termination of pregnancy
    Date: 2024-06-19
    Issue Date: 2025-01-06
    Abstract: 巨細胞病毒普遍存在人群中,對健康人無害,但對子宮內胎兒或免疫低下族群,卻有極大危害。孕婦若感染巨細胞病毒,並垂直傳染給胎兒,稱為先天性巨細胞病毒感染。新生兒先天性巨細胞病毒感染的發生率約為 1/100,其中五分之一、即 1/500 新生兒, 會有神經發展障礙或聽損後遺症,帶給家庭龐大的醫療支出和身心壓力,也帶來難以估計的無形社會成本。發生率 1/100 遠高於目前多數公費和自費產檢項目所要預防的疾病,如著名的唐氏症, 發生率為 1/800, 且一旦胎兒被檢出罹病,幾乎都會終止妊娠。目前許多醫學實證,認為先天性巨細胞病毒感染,可藉由母血抗體篩檢,檢出對胎兒危害最大的第一孕期、初次感染的孕婦;並以羊水 PCR 診斷已感染胎兒。也能以抗病毒藥物 valacyclovir 預防和治療胎兒感染,更有超音波和磁振造影可追蹤胎兒病程和評估預後。這樣一個發生率高、危害大、可檢出、可預防的先天性感染,卻不是公費產檢項目,也缺乏篩檢共識和照護準則。
    本文認為,孕婦巨細胞病毒抗體檢驗,應列入第一孕期公費產檢項目,全面為孕婦篩檢,並且制定標準化的報告判讀和三級防護架構。第一級為全面衛教,預防孕婦感染。第二級為預防胎兒感染:針對第一孕期母血抗體 IgM、IgG 陽性且 IgG 親和力低,屬近期感染的孕婦,給予抗病毒藥物,可減少七成胎兒感染,並於妊娠 20 週以 PCR 檢測羊水是否有病毒,以診斷胎兒感染。第三級為治療胎兒感染:胎兒已感染的孕婦,繼續服藥,有機會減少 胎兒後遺症,並於 27~ 32 週以磁振造影評估胎兒預後。胎兒嚴重感染且預後不佳的孕婦家庭,應給予合法且安全的終止妊娠選項。
    優生保健法及施行細則,規定 12 週以上的人工流產必須於醫院中住院施行,並且對於 24 週以上人工流產的規範模糊。本文認為,應修正原法規「人工流產應於妊娠二十四週內施行。但屬於醫療行為者,不在此限。」中「醫療行為」之用字為「醫學上理由」,較為恰當。並應設置倫理委員會,個案討論是否准許各種樣態、 24 週以上的晚期終止妊娠。也應開放診所可執行 12 週以上的人工流產,給有此需求的家庭更多選擇。
    少子化的臺灣,應善加利用並優化公費產檢政策及照護實務,方能保護幼小生命,不受先天性巨細胞病毒感染及其後遺症危害。
    Cytomegalovirus (CMV) is prevalent among the population and harmless to healthy people, but it poses a significant risk to fetuses in utero and immunocompromised individuals. If a pregnant woman contracts cytomegalovirus and transmits it vertically to the fetus, it is called congenital cytomegalovirus infection (cCMV). The incidence of congenital cytomegalovirus infection in newborns is about 1/100, and one-fifth of them, or 1/500 newborns, will have neurodevelopmental disorders or hearing loss sequelae. This imposes substantial medical expenses and psychological stress on families, along with incalculable intangible social costs. An incidence rate of 1/100 is much higher than that of most diseases targeted by government-funded and private prenatal exams, such as the well-known Down syndrome, which has an incidence rate of 1/800, and once detected in a fetus, pregnancy is almost always terminated. Many medical studies currently believe that congenital cytomegalovirus infection can be detected through maternal antibody screening, identifying those at greatest risk to the fetus during the first trimester of primary infection; fetal infection can be diagnosed using amniotic fluid PCR. Antiviral medication, such as valacyclovir, can also prevent and treat fetal infection, and ultrasound and MRI can be used to track the fetal disease progression and predict prognosis. Despite its high incidence, significant harm, detectability, and preventability, congenital cytomegalovirus infection screening is not included in government-funded prenatal exams and lacks consensus on screening and care guidelines.
    This article advocates that cytomegalovirus antibody testing for pregnant women should be included in government-funded prenatal exams in the first trimester, with comprehensive screening for all pregnant women. As well as the establishment of standardized report analysis and a three-level prevention framework. The first level, primary prevention, is comprehensive education to prevent maternal infection. The second level, secondary prevention, is to prevent fetal infection: for pregnant women in the first trimester who test positive for maternal antibodies IgM, IgG, and have low IgG avidity, indicating recent infection, antiviral drugs should be administered, which can reduce fetal
    infection by 70%. Amniotic fluid should be tested for the virus using PCR at 20 weeks of gestation to diagnose fetal infection. The third level, tertiary prevention, is to treat fetal infection: pregnant women with infected fetuses should continue medication to reduce fetal sequelae, and fetal prognosis should be evaluated with MRI at 27 to 32 weeks of gestation. Families of pregnant women with severe fetal infection and poor prognosis should be given legal and safe termination options.
    The Genetic Health Act and its enforcement rules stipulate that abortions after 12 weeks must be performed in hospitals with inpatient care, and regulations for abortions after 24 weeks are vague. This article considers that the wording "medical behavior" in the original regulation "abortion should be performed within 24 weeks of pregnancy, except for medical behavior" should be revised to "medical reasons" for appropriateness. An ethics committee should be established to discuss on a case-by-case basis whether to permit late-term terminations of pregnancy after 24 weeks in various circumstances. Clinics should also be allowed to perform abortions after 12 weeks, giving the families in need more options.
    In Taiwan, with its declining birth rate, government-funded prenatal exam policies and care practices should be optimized to protect young lives from the harms and sequelae of congenital cytomegalovirus infection.
    Description: 碩士
    指導教授:何建志
    口試委員:何建志
    口試委員:李崇僖
    口試委員:陳怡仁
    Note: 論文公開日期:2026-07-01
    Data Type: thesis
    Appears in Collections:[Graduate Institute of Health and Biotechnology Law] Dissertations/Theses

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