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| 研究生： |
姜幸呂 Jiang, Xing-Lu |
|---|---|
| 論文名稱： |
評估乳癌病患使用G-CSF處理化學治療期間嗜中性白血球低下之研究 Utilization of the Granulocyte Colony-stimulating Factors (G-CSF) for Managing Chemotherapy-induced Neutropenia in Breast Cancer Patients |
| 指導教授： |
高雅慧
Yang, Yea-Huei Kao 林嘉音 Lin, Chia-Yin |
| 學位類別： |
碩士 Master |
| 系所名稱： |
醫學院 - 臨床藥學研究所 Institute of Clinical Pharmacy |
| 論文出版年： | 2011 |
| 畢業學年度： | 99 |
| 語文別： | 中文 |
| 論文頁數： | 108 |
| 中文關鍵詞： | 乳癌 、化療引起之嗜中性白血球減少 、嗜中性白血球低下合併發燒 、顆粒性白血球群落刺激因子 |
| 外文關鍵詞： | Breast cancer, chemotherapy-induced neutropenia (CIN), febrile neutropenia (FN), granulocyte colony-stimulating factor (G-CSF) |
| 相關次數： | 點閱：125 下載：9 |
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研究背景：
嗜中性白血球低下合併發燒 (febrile neutropenia，FN) 為接受化療的患者最常見的毒性，併發症包含嚴重感染、導致住院、增加醫療資源的支出及死亡率。顆粒性白血球聚落刺激因子 (granulocyte colony-stimulating factor，G-CSF) 被證實可預防或治療FN。
G-CSF為高價藥品，因此限制了在臨床上的使用。國外治療指引建議初級預防G-CSF使用於化療後，預期發生FN風險大於20%的癌症患者；而目前國內於固體腫瘤的初級預防G-CSF並不在給付範圍內。針對前次化療曾發生嚴重嗜中性白血球低下，國外治療指引建議於必須維持化療強度之癌症患者才得以使用次級預防G-CSF；目前國內給付該適應症。針對治療性G-CSF的適應症，國內外規範與指引一致性的建議使用在發生FN並且合併其他相關高風險危險因子的患者。
研究目的：
了解乳癌病人於化學治療期間使用G-CSF的處方形態，與國外治療指引或國內藥品給付規定比較其遵從性以進行藥物使用評估，了解預防性使用G-CSF之預後並分析是否有影響G-CSF使用的因子。
研究方法：
本研究為橫斷性研究，以2009年至2010年於成大附設醫院新診斷之乳癌患者合併使用化療者為研究對象，進行病歷回顧。
研究結果：
共納入275位乳癌患者，包含1986次化療療程。其中化療併用G-CSF為139 (51%) 人。G-CSF處方型態在施打時機及使用劑量大致與治療指引相符合，惟預防性G-CSF平均治療期間 (初級預防為5.75天、次級預防為5天) 較國外的使用經驗 (通常為7天以上) 稍短。治療性G-CSF有44.7%在G-CSF停藥之際未追蹤WBC值。
預防性G-CSF療程中，有144筆 (26.5%) 初級預防不在國內健保給付範圍內，比照國外治療指引，扣除TEC ( docetaxel, epirubicin, cyclophosphamide) 化療組合，有32%為FN risk >20%屬需接受初級預防G-CSF，另外68%為FN risk 10-20%，屬於需考慮使用初級預防G-CSF者。而404筆 (73.5%) 次級預防G-CSF的使用，符合國內藥品給付規範。
在179筆治療性G-CSF的療程中，與國內外治療指引的遵從性為31.8%。大部分不符合使用規範的原因在於僅出現嗜中性白血球低下未併有發燒症狀即開始使用G-CSF (56.3%)。化療組合的型態為決定使用G-CSF得顯著影響因子， anthracycline與taxanes併用的化療組合為使用G-CSF中所佔的比例最大。
結論：
預防性G-CSF處方型態大致與治療指引相符合，惟平均治療期間稍短。治療性G-CSF的遵從性則相對偏低，大部分不符規定的適應症，為單獨嗜中性白血球低下時即處方G-CSF，有賴後續研究以探討該適應症之臨床效益評估。本研究結果發現化療組合的選擇，為主要影響使用G-CSF與否的因子。
Background：Febrile neutropenia (FN) is a major complications in patients treated with chemotherapy, leading to life-threatening infections, hospitalization, and escalation of costs and mortality risk. Granulocyte colony-stimulating factor (G-CSF) has been shown to prevent FN or improve the outcome while FN occurs.
However, the use of G-CSF was restricted due to its considerable expense. In current international guidelines, cancer patients with more than 20% risk of FN during the chemotherapy are recommended to receive primary prophylactic G-CSF, but it is not reimbursed for solid cancer patients in Taiwan’s regulations. The secondary prophylactic G-CSF is recommended only for supporting does-dense and dose-intense chemotherapy in the international guidelines, but it is reimbursed by the regulations in Taiwan.
Objectives：To analyse G-CSF prescribing pattern, to identify the determinants of compliance with the international guidelines or reimbursement criteria in Taiwan, to identify the outcome of the prophylactic G-CSF use and to evaluate the factors influence G-CSF prescribed by physician.
Methods：The study was conducted by a retrospective chart review of new breast cancer patients who received chemotherapy at the National Cheng-Kung University Hospital (NCKUH) during year 2009-2010.
Results：275 patients who received a total of 1986 chemotherapy cycles were recruited in this study. 139 patients (51%) had used G-CSF. G-CSF prescribing patterns in the timing and dose generally in compliance with guidelines, but the average prophylactic G-CSF duration (primary prophylaxis : 5.75 days , secondary prophylaxis : 5 days) was shorter than the use of foreign experience (usually above 7 days). A concering number (44.7%) of therapeutic G-CSF courses did not follow the WBC at the G-CSF discontiniation. The 144 primary prophylactic G-CSF courses were not reimbursed in Taiwan. In contrast, compared to the guidelines [except the TEC (T, docetaxel; E, epirubicin; C, cyclophosphamide) regimen], there were 32% belonging to FN risk >20%. Further, primary prophylactic G-CSF was recommended and others (68%) belongs to FN risk 10-20% and primary prophylactic G-CSF was considered.Additionally, there were 404 courses of secondary prophylactic G-CSF were reimbursed in Taiwan.In the 179 therapeutic G-CSF courses, 31.8% (FN) met the guidelines and reimbursement regulations in Taiwan, highest proportion of inadequate therapeutic G-CSF application (56.3%) was afebrile neutropenia. The results showed the chemotherapy regimen type containing anthracyclines and taxanes were associated with highest proportion of G-CSF used.
Conclusions：Prophylactic G-CSF prescribing patterns generally in compliance with guidelines, but average duration was slightly shorter. Prophylactic G-CSF prescription was mainly in compliance with guidelines and reimbursement regulations in Taiwan, expect the primary prophylactic G-CSF. Therapeutic G-CSF prescription compliance is relative low, most of the irregularities is indicated for the afebrile neutropenia. Therefore, further study would focus on the assessment of the clinical benefit. The results showed the chemotherapy regimen type affect the use of G-CSF.
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