108 年 國立臺灣大學護理學系碩士班乙組《臨床研究護理學》
第 1 題
一、就您對「臨床研究護理師」的認識與了解,闡述其角色功能(10%)與專業職責(10%)
登入後即可作答並保存紀錄。
此題主要在探討臨床研究護理師的角色與職責。臨床研究護理師是結合臨床護理專業與研究執行能力的專職人員，在臨床試驗中扮演至關重要的角色。
角色功能：
- 執行臨床試驗計畫： 根據研究計畫書（Protocol）的要求，確保試驗程序的準確執行，包括病患收案、給藥、訪視、檢體採集與處理、資料記錄等。
- 病患照護與安全監測： 負責受試者在臨床試驗過程中的照護，監測其生理及心理狀況，並識別、記錄及通報不良事件（Adverse Events, AE）及嚴重不良事件（Serious Adverse Events, SAE），確保受試者安全。
- 研究資料品質管理： 確保研究資料的準確性、完整性、一致性與及時性，負責病歷紀錄、數據登錄（Case Report Form, CRF）及相關文件管理，以維持資料的可靠性。
- 與研究團隊溝通協調： 作為研究者、病患、藥商、稽核人員及醫護團隊之間的溝通橋樑，確保所有相關人員對研究計畫有共同的理解與配合。
- 教育與宣導： 向受試者及其家屬解釋研究計畫、權利與義務，提供相關衛教；同時也向研究團隊成員及其他醫護人員宣導研究的執行細節與重要性。
- 符合法規與倫理要求： 確保臨床試驗的執行符合國際與當地法規（如 ICH-GCP, FDA, TFDA 等）及倫理委員會（IRB/EC）的規範，保護受試者權益。
第 2 題
二、請將下列這段英文敘述翻譯成中文,以忠實呈現其意涵。(30%)
【摘錄自Taylor等,2019年發表於Int」 Gynecol Cancer, 29(1):147-152.的文章: Phase I study of intravenous oxaliplatin
and intraperitoneal docetaxel in recurrent ovarian cancer.】
Introduction: Intraperitoneal (IP) chemotherapy improves survival in ovarian cancer but its use has been limited by toxicity
with cisplatin-based regimens. The primary objective of this study was to define the maximum tolerated dose and dose-
limiting toxicity of intravenous (IV) oxaliplatin and IP docetaxel in women with recurrent ovarian, fallopian tube or peritoneal
cancer. Secondary objectives were response rate, time to progression, symptom interference with quality of life, and
pharmacokinetics.
Methods: Patients received a constant dose of oxaliplatin 75 mg/m2 IV on day 1 and docetaxel escalating from 50 mg/m2 IP
on day 2 every 3 weeks using a 3 + 3 design. Treatment continued until disease progression, remission, or intolerable toxicity
occurred. Plasma and IP samples were taken to determine drug concentrations. Patients completed the MD Anderson
Symptom Inventory weekly.
Results: Twelve patients were included. The median number of cycles was 4 (range 2-6) with a median time to progression of
4.5 months. Among eight patients with measurable disease, the best responses were partial response in two patients, stable
disease in five, and progressive disease in one. A total of 14 grade 3-4 toxicities were noted, most commonly hematologic.
Four patients, all dose level 3, had six dose-limiting toxicities: two with prolonged neutropenia, one with infection, one with
hyponatremia, and two with abdominal pain. Dose level 3 was therefore considered intolerable. The mean±SD ratio of
docetaxel area under the curve (AUC) in IP fluid to AUC in plasma was 229±111. Symptom interference with life activities
steadily decreased from cycle 1 to 5.
Conclusions: Oxaliplatin 75 mg/m2 IV on day 1 and docetaxel 75 mg/m2 IP on day 2 was the maximum tolerated dose. Most
patients had partial response or stable disease, even in a heavily pre-treated population. At this dose level, patient-reported
outcomes demonstrate temporary but tolerable decrements in quality of life.
登入後即可作答並保存紀錄。
此題為翻譯題，要求將英文摘要忠實翻譯成中文。翻譯時需注意醫學術語的精確性、語句的流暢性以及原文的語意。
翻譯內容：
標題： 靜脈注射奧沙利鉑與腹腔注射太平洋紫杉醇於復發性卵巢癌之第一期研究。
出處： 摘錄自 Taylor 等人，2019 年發表於 International Journal of Gynecol Cancer, 29(1):147-152。
前言： 腹腔內（IP）化學治療可改善卵巢癌的存活率，但其使用因含順鉑（cisplatin-based）療法的毒性而受限。本研究的主要目標是定義靜脈注射（IV）奧沙利鉑（oxaliplatin）與腹腔內注射太平洋紫杉醇（docetaxel）在復發性卵巢癌、輸卵管癌或腹膜癌女性患者中的最大耐受劑量（maximum tolerated dose, MTD）及劑量限制性毒性（dose-limiting toxicity, DLT）。次要目標包括反應率（response rate）、無疾病進展時間（time to progression）、症狀對生活品質的干擾（symptom interference with quality of life）及藥物動力學（pharmacokinetics）。
方法： 患者每三週於第一天接受恆定劑量的靜脈注射奧沙利鉑 75 mg/m²，並於第二天開始接受劑量逐級遞增（escalating）的腹腔內注射太平洋紫杉醇（起始劑量為 50 mg/m²），
第 3 題
三、請閱讀下列英文摘要,依序回答以下問題。
【摘錄自 Vienterie等,2016年發表於 Eur J Cancer, 58, 62-72.的文章: Outcome of chemotherapy in advanced synovial
sarcoma patients: Review of 15 clinical trials from the European Organisation for Research and Treatment of Cancer Soft
Tissue and Bone Sarcoma Group; setting a new landmark for studies in this entity】
(一)請問本研究設計類型為何?(5%)
(二)請簡述本研究中有關於 synovial sarcoma 病人,與其他STS 病人相較之下,其年齡層分布狀況(5%)、對化學治療
的反應(5%)以及存活率(5%)的相關陳述為何?
Abstract Introduction: Previous studies in metastatic soft tissue sarcomas (STS) showed that synovial sarcomas tend to have
better survival rates and a higher chemosensitivity than other STS subtypes. However, data are derived from relatively small
subgroups and statistical significance of these observations is lacking. Larger cohorts are necessary to define and confirm the
specific characteristics of this subtype.
Patients and methods: Patient data were retrieved from 15 European Organisation for Research and Treatment of Cancer
advanced first-line STS trials. Patient characteristics, survival and treatment response of synovial sarcoma patients were
compared to other STS patients. Univariable and multivariable analyses were performed to evaluate prognostic factors.
Results: In total, 3330 advanced STS patients were retrieved, of whom 313 had a synovial sarcoma. Synovial sarcoma patients
were significantly younger (median 40 versus 52 years), more often had extremity primary tumours and had a better performance
status (PS 0: 50.2 versus 43.4%) compared to other STS patients. Additionally, synovial sarcoma patients had a significantly better
response to chemotherapy (responders: 27.8 versus 18.8%) and better survival rates (progression free survival [PFS]: 6.3 versus
3.7 months; Overall survival [OS]: 15.0 versus 11.7 months). Age, PS, and presence of metastatic disease were defined as
prognostic factors for PFS and OS in the univariable analysis. The last two factors were confirmed in the multivariable analysis for
OS.
Discussion: Advanced synovial sarcomas are a distinct subgroup of STS, with a better response to systemic chemotherapy and
longer PFS and OS. These results should be taken into account in the design of future synovial sarcoma specific studies.
登入後即可作答並保存紀錄。
此題主要考驗閱讀英文摘要並回答特定問題的能力，包含研究設計、特定族群特徵比較等。
(一) 本研究設計類型為何？
本研究的「方法」（Patients and methods）段落中提到：「Patient data were retrieved from 15 European Organisation for Research and Treatment of Cancer advanced first-line STS trials. Patient characteristics, survival and treatment response of synovial sarcoma patients were compared to other STS patients. Univariable and multivariable analyses were performed to evaluate prognostic factors.」
這表示研究團隊從既有的 15 項臨床試驗資料中回溯性地收集並分析病患數據，並進行比較與統計分析。因此，這是一項回溯性世代研究（Retrospective Cohort Study），更精確地說，由於是從已完成的臨床試驗中提取資料，也可稱為次級資料分析（Secondary Data Analysis）或系統性回顧（Systematic Review），因為它匯集了多項臨床試驗的結果。
【答案】回溯性世代研究（Retrospective Cohort Study）／次級資料分析／系統性回顧。