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目的通过与重组人红细胞生成素(rhEPO 10000 IU)给药进行对照比较,评价使用重组人红细胞生成素注射液(36000 IU/支)每周一次给药治疗肿瘤化疗相关贫血的疗效和安全性。方法多中心、随机开放、剂量平行对照,将206例非髓性恶性肿瘤化疗合并贫血的患者随机分为两组,试验组rhEPO 36 000 IU,每周给药1次。对照组rhEPO 10 000 IU,每周给药三次,疗程均为8周。结果共入组患者206例,其中对照组102例,试验组104例,8周内对照组和试验组血红蛋白上升的显效率分别为52.0%和51.9%。两组总有效率(显效+有效)分别为73.5%和67.3%,经CMH检验两组差异无显著性(P>0.05)。两组血红蛋白上升的最大值分别为112 g/L和113 g/L,最大值与基线的差值分别为22 g/L和23 g/L,两组比较差异均无显著性。两组血红蛋白较基线值上升≥10 g/L的中位天数分别为18 d和16 d(P>0.05);两组血红蛋白较基线值上升≥20 g/L的中位天数分别为31d和32 d(P>0.05)。两组治疗期间输血比例分别为2.9%和8.7%,两组间输血次数和输血总量差异均无显著性(P>0.05)。对照组全部不良事件发生率为21.6%,试验组18.3%。对照组不良反应发生率为2.9%,试验组为1.9%。对照组严重不良事件发生率为3.9%,试验组为1.0%。结论在治疗8周内,rhEPO(36 000 IU)每周一次给药纠正贫血的总有效率(显效+有效)与常规剂量(10 000IU)每周三次给药的作用相当,可明显减少给药的注射频率,减轻患者痛苦;不增加不良事件的发生率,不良反应轻微,持续时间短,多可自行缓解。
Objective To compare the efficacy and safety of once weekly administration of recombinant human erythropoietin injection (36,000 IU / cartridge) in the treatment of chemotherapy-related anemia by comparison with recombinant human erythropoietin (rhEPO 10000 IU). Methods A total of 206 patients with nonmyelogenous malignant neoplasm associated with chemotherapy and anemia were randomly divided into two groups randomly. The experimental group received rhEPO 36 000 IU once a week. The control group rhEPO 10 000 IU, administered three times a week, the course of treatment were 8 weeks. Results A total of 206 patients were enrolled in the study, including 102 patients in the control group and 104 patients in the test group. The effective rates of hemoglobin rise in the control and experimental groups were 52.0% and 51.9% respectively within 8 weeks. The total effective rate (effective and markedly effective) was 73.5% and 67.3% respectively in the two groups. There was no significant difference between the two groups (P> 0.05) by CMH test. The maximum values of hemoglobin rise were 112 g / L and 113 g / L, respectively. The difference between maximum and baseline values was 22 g / L and 23 g / L, respectively. There was no significant difference between the two groups. The mean number of days when hemoglobin was increased ≥10 g / L in both groups was 18 d and 16 d, respectively (P> 0.05). The median days for hemoglobin rise ≥20 g / L in both groups were 31 d and 32 d d (P> 0.05). The blood transfusion rates during the two groups were 2.9% and 8.7%, respectively. There was no significant difference between the two groups in the number of transfusions and total transfusion (P> 0.05). The incidence of all adverse events in the control group was 21.6% and in the experimental group 18.3%. The incidence of adverse reactions in the control group was 2.9%, 1.9% in the experimental group. The incidence of serious adverse events was 3.9% in the control group and 1.0% in the experimental group. Conclusions The total effective rate (effective and effective) of rhEPO (36 000 IU) to correct anemia once a week is equivalent to that of the conventional dose (10 000 IU) three times a week for 8 weeks of treatment, which can significantly reduce the dosage Of the injection frequency, reduce patient pain; do not increase the incidence of adverse events, minor adverse reactions, short duration, and more self-remission.