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題 名 | The Effect of Subcutaneous r-HuEPO in Cancer Patients Receiving Chemotherapy with Anemia: A Preliminary Report=皮下注射基因工程合成人類紅血球生長素對於惡性腫瘤病人化學治療所併發續發性貧血療效之初步評估 |
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作 者 | 邱宗傑; 金詠興; 韋至信; 謝瑞坤; 陳博明; | 書刊名 | 中華醫學雜誌 |
卷 期 | 60:5 1997.11[民86.11] |
頁 次 | 頁229-235 |
分類號 | 415.6 |
關鍵詞 | 晚期癌症; 化療引起貧血; 基因工程合成人類紅血球生長素; Advanced cancer; Chemotherapyrelated anemia; Recombinant human erythropoietin; r-HuEPO; |
語 文 | 英文(English) |
中文摘要 | 背景:癌症病人化學治療後導致貧血會降低病人對化療的意願和接受度而減少療效,貧血可因血清內紅血球生長素減少或化療導致對紅血球生長素反應的減少所致。以外源性紅血還應生長素補充治療在早期文獻已被指出可改善此種情形。本研究即是探討基因工程合成的人 類紅血球素在國人發生惡性腫瘤化療後產生貧血的療效和使用後的安全性。 方法:十六例惡性腫瘤病人接受週期性化療後發生貧血(血色素<10.5 g/dl)且無合併其他器官異常、腦轉移、和不可控制性高血壓或其他原因的貧血參與本研究,病人接受每週三次共十六週的紅血球生長素150單位/公斤體重皮下注射,療效的評估則藉助于每週檢驗病人的血液常規、病人生活品質評估、及醫師的整體評估、而藥物使用安全評估則藉助于血液生化檢驗。病人生命相記錄以及注射後不良反應發生比率和嚴重度的記錄。 結果:十二例病人完成全程研究,在研究的第4、8、12、16週病人的紅血球、血小板數目並無變化,平均血紅素在第0、4、8、12、16週分別為9.2 ± 1.0 g/dl、11.4 ± 0.9 g/dl、11.6 ± 1.8 g/dl、11.8 ± 1.8 g/d1、和12.2 ± 2.3 g/d1 (p<0.0001),平均血容比在第0、4、8、12、16週分別為28.3 ± 3.4%、36.0 ± 2.8%、36.3 ± 5.7%、37.8 ± 6.0%、40.1 ± 7.1% (p < 0.0005)。紅血球生長素的使用對增加病人的體能和活動在本研究發現僅有邊際性的效用,除了二例病人和另一例病人在注射的第4週發生收縮壓性高血壓和舒張壓性高血壓外無其他特殊併發症發生。 結論:以150單位/公斤的紅血球生長素每週三次皮下注射可有效增加病人紅血球量、血比容以及減少病人的輸血量且無特殊併發症,但是否目前的使用劑量對化療引起的貧血是最適當的劑量仍有待進一步的研究探討。 |
英文摘要 | Background: Chemotherapy-related anemia in cancer patients is often encountered in clinical practice. It can reduce patient's compliance and tolerance to continuing chemotherapy. The mechanism of anemia may be ascribed to either decreasing serum EPO concentration or reducing sensitivity of EPO. Exogenous supply of EPO has shown to be effective in control of cancer-related anemia in early reports. This study preliminarily explored the efficacy and safety of r-HuEPO for cancer patients with anemia during the cytotoxic chemotherapy period in Taiwan. Methods: Sixteen cancer patients receiving cyclic chemotherapy with anemia (Hgb <= 10.5 g/dl) and without other systemic organ dysfunction, cerebral metastasis, uncontrolled hypertension, or presence of anemia attributable to causes other than cancer and chemotherapy entered the study. All patients received r-HuEPO 150 u/kg subcutaneous injection tiw for a total of 16 weeks. The efficacy determinations was based on the effect of r-HuEPO on hematological parameters, transfusion requirements, quality of life assessment, and physician's global assessment. Safety was assessed based on clinical laboratory tests, vital sign measurements and the incidence and severity of adverse experiences. Results: There were no changes of WBC and platelet count in 4, 8, 12 and 16 weeks of r-HuEPO therapy. The mean hemoglobin values at baseline, week 4, 8, 12, and 16 were 9.2 ± 1.0 g/dl, 11.4 ± 0.9 g/dl, 11.6 ± 1.8 g/dl, 11.8 ± 1.8 g/dl, and 12.2 ± 2.3 g/dl, respectively (p < 0.001). The mean hematocrit values at baseline, week 4, 8, 12, and 16 were 28.3 ± 3.4%, 36.0 ± 2.8%, 36.3 ± 5.7%, 37.8 ± 6.0%, and 40.1 ± 7.1%, respectively (p < 0.0005). The use of r-HuEPO had the marginal effect on the increase of patient's energy and activity. No adverse impacts on patient's vital signs were noted except 2 incidences of systolic hypertension and one episode of diastolic hypertension in the week 4. Conclusions: Subcutaneous injection of r-HuEPO at the dose of 150 u/kg tiw was safe and effective in increasing patient's hematocrit and RBC mass, and decreasing their blood transfusion requirement. Whether the current dosage of 150 u/kg tiw is the optimal treatment for chemotherapy-related anemia still needs further study. |
本系統中英文摘要資訊取自各篇刊載內容。