臺灣博碩士論文加值系統

RU486 (Mifepristone) (美服培酮) 合併使用口服前列腺素 Cytotec (Misoprostol,PGE1) 對於早期懷孕之藥物人工流產的治療成效
研究目的 :
過去對於早期懷孕的孕婦，若想要終止妊娠，絕大多數都是採用子宮內膜搔刮術 (D&C)，但是自從RU486 (Mifeprostone) (美服培酮) 在西元2001年於台灣合法上市以來，提供了這類病人另一種選擇。本實驗是將各種不同條件之早期懷孕的孕婦，想要藉由藥物來人工終止懷孕的病人，給予口服RU486(Mifepristone)及Cytotec(Misoprostol)，期望能將其結果做為日後臨床應用的基準。
研究方法與材料 :
本實驗為一個 回顧性描述型研究 ( Retrospective Descriptive study )，於西元2001年7月1日至2002年4月30日間，收集中山醫學大學附設醫院婦產科，兩個院區門診單位的就診病人，由病史、妊娠週數、經腹部或陰道超音波檢查有子宮內妊娠囊 (IUGS)，確定診斷為早期子宮內懷孕，並且要求使用藥物人工流產的患者，在符合RU486及Cytotec的使用標準之下，解釋過RU486藥物人工流產及子宮內膜搔刮術 (D&C) 人工流產的差異，並簽署藥物人工流產同意書之後，才收入此實驗之中。
本實驗要先排除下列有禁忌症的患者 : (1)慢性腎上腺衰竭者、肝臟衰竭或營養不良者。(2)已知對RU486 (Mifepristone)或其他內含物會產生過敏者。(3)長期併用類固醇治療者。(4)罹患出血性疾病或併用抗凝血劑治療者。(5)尚未經由超音波掃描或血液尿液等生化檢測確認懷孕者。(6)懷孕日數超過七週者。(7)疑似子宮外孕者。(8)因前列腺素藥物而產生的禁忌者(如已知對前列腺素過敏)、現有或曾有心血管疾病的人(如心絞痛、雷諾氏症候群、心律不整、心臟衰竭、嚴重高血壓)。(9)遺傳性咯紫質沉著症患者。(10)年紀超過35歲及一天抽煙超過10支。
在繳費領藥後，於門診醫護人員面前，先服下3顆 Mifepristone ( 保諾錠Apano 200 mg ) 共600毫克 (mg) ;然後在36到48小時之後回診，在門診醫護人員面前再服下3顆 前列腺素Misoprostol ( Cytotec 200 mcg ) 共600 微克 (mcg) ;在服用前列腺素Cytotec及服用後3小時內，病人應留在醫療院所內觀察，因為妊娠組織有可能在幾個小時內或接下來的幾天內排出。通常出血會持續到下一次的回診，因此病人應有隨時就醫的準備，患者應在2週內回門診追蹤超音波，或其他血液、尿液檢查，已確定藥物人工流產之完全。在所有的就診過程當中，詳實的記錄患者的年齡、妊娠週數、超音波掃瞄結果、嘔吐及陰道出血之合併症，以作為影響治療效果的因子評估。
研究的測量方法 :
完成整個Mifepristone及Misoprostol的治療過程之後，兩週內回門診檢查，以〝 超音波檢查未再發現有子宮內妊娠囊(IUGS) 〞，視為藥物人工流產成功。
研究結果 :
實驗期間總計收入了156個孕婦，她們各有不同年齡、孕次、產次、妊娠週數、超音波掃瞄結果及治療過程合併症 ( Table 2 )。她們的平均年齡是29.60 ± 6.69歲 ( Table 4 )，其中有85個孕婦 ( 85 / 156 = 54.49 % ) 未生育過。然而有12個孕婦 ( 12 / 156 = 7.69 % )，因為有持續性陰道出血 或 持續懷孕 ( ongoing pregnancy ) 有子宮內妊娠囊IUGS(+) ( 2 / 156 = 1.28 % )，因而施以子宮內膜搔刮術 ( D&C )，來達到完全人工流產的結果，所以藥物人工流產成功率為98.72 % ( 154 / 156 )，完全未接受外科手術流產處理的為92.31 % ( 144 / 156 )。此外，有一個患者因服用Cytotec時發生嚴重嘔吐，將Cytotec全部吐出來，故再服用重覆劑量的Cytotec 600 微克。另有一個患者因為嚴重貧血 ( Hb = 6.8 )，而住院輸血治療三天。
此外，將這12個接受 子宮內膜搔刮術 ( D&C ) 的孕婦之 各項資料，以〝邏輯式迴歸 (logistic regression) 〞來分析，發現孕婦 的 年齡、孕次、產次 及 人工流產的次數，皆無統計上的顯著意義， ( P 值 分別為 0.26 , 0.81 , 0.79 , 0.83 , 0.84 ) ( Table 6 )， 故可推論 這些因子 應與造成藥物流產之失敗無關。
討論 :
想藉由藥物來人工終止懷孕的病人，給予口服Apano (保諾錠) ( Mifepristone ) 600 毫克 及Cytotec ( Misoprostol ) 600 微克 來做藥物人工流產，其效果是相當另人滿意的 ( 98.72 % )。然而，此研究中有12個孕婦 ( 7.69 %) 後來以 子宮內膜搔刮術 (D&C) 來完成人工流產，因為患者在服用RU486與Cytotec之後仍持續有陰道出血，但是為了人工流產能完全成功，故放棄繼續追蹤，而施以子宮內膜搔刮術處理;在這12個接受子宮內膜搔刮術的個案當中，只有2個孕婦是追蹤超過14天仍有陰道出血 ( vaginal bleeding ) ( 2 / 156 = 1.28 % )，有2個孕婦是持續性懷孕 ( ongoing pregnancy ) ( 2 / 156 = 1.28 % )。所以，若在服藥後能有2週的追蹤，以Mifepristone併用Misoprostol來做藥物流產，其效果將會更令人滿意 (154 / 156 = 98.72 %)。
此研究中有49個孕婦 ( 31.41 % = 49 / 156 )是小於25歲的，顯見生育控制與避孕仍是需要加以注意的課題，若能加強避孕措施，當可減少因不慎懷孕而需要做人工流產 ( artificial abortion ) 的機會。
此外，本研究中有 54.49 % ( 85 / 156 ) 是 未經產的 ( nulliparous )，RU486的上市，提供了婦女們另一種 非侵襲性 ( non-invasive ) 的方式 來進行人工流產，除了可以避免 手術中與手術後的併發症 及 麻醉的風險，同時也可以減少因 子宮內膜搔刮術 造成子宮內膜傷害 所導致的無月經、月經量過少 或 次發性不孕症 的機會。

RU486 (Mifepristone) combined with oral Cytotec (Misoprostol) for medical abortion in first-trimester pregnant women
Objective :
Evaluation of the effectiveness of RU486 (Misipristone) combined with oral Cytotec (Misoprostol) for medical abortion in first-trimester pregnant women .
Methods and Materials :
A retrospective descriptive study of the patients visited to the outpatient departments of OB / GYN , Chung Shan Medical University Hospital between 1 July 2001 and 30 April 2002 . The patients were diagnosed as intrauterine pregnancy in first-trimester by their past history , last menstrual period , present illness , gestational age , transabdominal sonography or transvaginal sonographic findings . The maternal age , gestational age , complications and sonographic findings were recorded for prognostic evaluation . All patients were included in this study when first-trimester intrauterine pregnancy was diagnosed , then oral mifepristone 600 mg and oral cytotec (misoprostol) 600 micrograms were taken . The patients followed-up in Chang-Shan Medical University Hospital OPD of OB / GYN by transabdominal or transvaginal sonography within 2 weeks . Review the successful rate of medical abortion by oral mifepristone 600 mg and oral cytotec (misoprostol) 600 micrograms .
Main Outcome Measurement :
No intrauterine gestational sac was found by ultrasonographic finding means successful medical abortion , and complete medical abortion of first-trimester pregnancy without surgical intervention (D&C) was measured .
Results :
One hundred and fifty-six patients with different age , gestational age , parity , gravidity , sonographic findings and complications . Mean age of patients is 29.60±6.69 years old ; and 54.49 % of the cases were nulliparous . ( Table 4 ) Because patients asked for complete artificial abortion and unsatisfactory vaginal bleeding was persistent , 12 patients ( 12 / 156 = 7.69 % ) were received D&C procedure under the impression of incomplete abortion ( 10 / 156 = 6.41 % ) or ongoing pregnancy ( 2 / 156 = 1.28 % ) . The successful rate of oral Apano ( mifepristone ) 600 mg and oral cytotec ( misoprostol ) 600 micrograms is 98.72 % ( 154 / 156 ) , and the complete abortion rate without surgical intervention is 92.31% ( 144 / 156 ) . One patient was admitted for 3 days due to severe anemia ( Hb = 6.8 ) , and blood transfusion with 4 units pack-RBC was performed . Severe vomiting occurred in one patient after cytotec taken and then this patient took cytotec 600 mcg repeatedly .
Discussion :
Oral Apano ( mifepristone ) 600 mg combined with oral cytotec ( misoprostol ) 600 micrograms for medical abortion is effective in first-trimester pregnant women ( successful rate : 98.72 % ) . However , patients ask for complete artificial abortion and unsatisfactory vaginal bleeding is persistent or ongoing pregnancy would result in medical abortion failure . The complete abortion rate without surgical intervention is 92.31% ( 144 / 156 ) . If 8 patients were excluded due to the induction to abortion interval is less than 2 weeks , the complete abortion rate of medical abortion without surgical intervention would increase to 97.44 % ( 152 / 156 ) . Oral Apano ( mifepristone ) 600 mg and oral cytotec ( misoprostol ) 600 micrograms could be an alternative method for medical abortion in first-trimester pregnancy because of non-invasive and less complication .

目 錄
中文摘要 p.2
第一章 緒 論 .…. 研究動機與重要性 p.8
第二章 文獻回顧 p.12
第一節 Mifepristone的藥理作用 p.13
第二節 Mifepristone與Misoprostol的臨床應用 p.18
第三節 Mifepristone合併Misoprostol使用之合併症 p.45
第三章 研究設計與實施 p.49
第一節 研究架構與對象 p.49
第二節 研究的方法與程序 p.50
第三節 研究的測量與資料說明 p.52
第四節 資料統計分析 p.53
第四章 研究結果 p.54
第五章 研究結論與建議 p.57
第六章 參考文獻 p.61
附錄一 臨床試驗審查申請書 p.71
附錄二 藥物流產患者同意書 p.80
附錄三 圖表 ( Figure & Table ) p.82
英文摘要 p.91

第六章 參考文獻
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