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评估美国肿瘤学网络针对初治患者以及从促红细胞生成素α转换而来的患者每2周使用200微克达贝泊汀α进行治疗替代的推荐指南。

Evaluation of the US Oncology Network's recommended guidelines for therapeutic substitution with darbepoetin alfa 200 microg every 2 weeks in both naïve patients and patients switched from epoetin alfa.

作者信息

Thames William A, Smith Sandra L, Scheifele Andrew C, Yao Bin, Giffin Suzana A, Alley Julie L

机构信息

Department of Pharmacy Services, US Oncology, Houston, Texas, USA.

出版信息

Pharmacotherapy. 2004 Mar;24(3):313-23. doi: 10.1592/phco.24.4.313.33180.

Abstract

STUDY OBJECTIVE

To evaluate the efficacy of darbepoetin alfa 200 microg subcutaneously every 2 weeks after therapeutic substitution for epoetin alfa.

DESIGN

Retrospective multicenter chart review.

SETTING

Three US Oncology-affiliated outpatient sites.

PATIENTS

Three hundred thirty anemic patients with nonmyeloid malignancies, of whom 174 had been treated previously with epoetin alfa (switched group) and 156 had not been treated recently with epoetin alfa (naive group).

INTERVENTIONS

Therapeutic substitution with darbepoetin alfa was started according to the US Oncology Pharmacy and Therapeutics Committee's recommended dosing guidelines: anemic patients with cancer received a starting dosage of darbepoetin alfa 200 microg every 2 weeks regardless of whether or not they had previously received epoetin alfa. Hematologic and darbepoetin alfa usage data were abstracted from consecutive medical records dated from May 2002-March 2003.

MEASUREMENTS AND MAIN RESULTS

Median exposure to darbepoetin alfa was 10 weeks (25th quartile 6 wks, 75th quartile 17 wks) and 10 weeks (25th quartile 5 wks, 75th quartile 18 wks) for the naive and switched groups, respectively. The week before the switch to darbepoetin alfa, the 174 patients receiving epoetin alfa were administered the following weekly doses: less than 40,000 U (9%), 40,000 U (50%), or 45,000-90,000 U (41%). Mean hemoglobin level increased from baseline (wk 0) in both the naive and switched groups. The proportion of patients receiving a red blood cell transfusion in the darbepoetin alfa treatment phase was low (15% in each group). No variation in transfusion rates was observed across weight categories in patients who received a fixed dosage of darbepoetin alfa. Darbepoetin alfa was well tolerated. A detailed usage algorithm was validated by these results and is being used in these three US Oncology-affiliated practices.

CONCLUSION

A darbepoetin alfa starting dosage of 200 microg subcutaneously every 2 weeks administered according to US Oncology-recommended dosing guidelines is effective in treating chemotherapy-induced anemia in both epoetin alfa-naive patients and those switched from epoetin alfa.

摘要

研究目的

评估在将促红细胞生成素α进行治疗性替换后,每2周皮下注射200微克的阿法达贝泊汀的疗效。

设计

回顾性多中心病历审查。

地点

美国肿瘤学会下属的三个门诊点。

患者

330例非髓系恶性肿瘤贫血患者,其中174例先前接受过促红细胞生成素α治疗(转换组),156例近期未接受过促红细胞生成素α治疗(初治组)。

干预措施

根据美国肿瘤学会药学与治疗学委员会推荐的给药指南开始用阿法达贝泊汀进行治疗性替换:癌症贫血患者无论之前是否接受过促红细胞生成素α治疗,均接受起始剂量为每2周200微克的阿法达贝泊汀。从2002年5月至2003年3月的连续病历中提取血液学和阿法达贝泊汀使用数据。

测量指标及主要结果

初治组和转换组阿法达贝泊汀的中位暴露时间分别为10周(第25百分位数为6周,第75百分位数为17周)和10周(第25百分位数为5周,第75百分位数为18周)。在转换为阿法达贝泊汀前一周,174例接受促红细胞生成素α治疗的患者接受的每周剂量如下:低于40,000单位(9%)、40,000单位(50%)或45,000 - 90,000单位(41%)。初治组和转换组的平均血红蛋白水平均较基线(第0周)有所升高。在阿法达贝泊汀治疗阶段接受红细胞输血的患者比例较低(每组均为15%)。在接受固定剂量阿法达贝泊汀的患者中,未观察到不同体重类别之间输血率的差异。阿法达贝泊汀耐受性良好。这些结果验证了一个详细的使用算法,该算法正在美国肿瘤学会下属的这三个医疗机构中使用。

结论

按照美国肿瘤学会推荐的给药指南,每2周皮下注射200微克阿法达贝泊汀的起始剂量,对于治疗初治的促红细胞生成素α患者以及从促红细胞生成素α转换而来的患者的化疗所致贫血是有效的。

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