长短效粒细胞集落刺激因子用于乳癌化疗后骨髓保护的临床研究

Clinical trial of long and short acting granulocyte colony stimulating factor in bone marrow protection after chemotherapy for breast cancer

目的 评估长效或短效重组人粒细胞集落刺激因子(rhG-CSFs)用于乳腺癌患者新辅助或辅助化疗后的临床疗效和安全性。方法 将乳腺癌患者根据治疗方案分为对照组和试验组。2组患者化疗方案均以含紫杉和蒽环为基础的联合或续贯方案。在此基础上,对照组于每周期化疗后72 h给予rhG-CSF每次300μg,皮下注射8~10 d;试验组于每周期化疗后24~48 h给予聚乙二醇重组人粒细胞集落刺激因子(PEG-rhG-CSF)每次6 mg,皮下注射1次。2组患者一个化疗周期均为21 d,至少保证进行4个周期。比较2组患者的骨髓保护疗效和药物不良反应的发生情况。结果 最终试验组和对照组均各入组60例。治疗后,试验组和对照组的生活质量评分分别为(82.2±4.8)和(70.6±7.3)分,差异有统计学意义(P<0.05)。试验组和对照组的Ⅲ度骨髓抑制率分别为15.00%(9例/60例)和16.67%(10例/60例),Ⅳ度骨髓抑制率分别为15.00%(9例/60例)和18.33%(11例/60例),粒缺伴发热发生率分别为6.67%(4例/60例)和10.00%(6例/60例),因骨髓抑制导致延迟化疗>3 d的发生率分别为8.33%(5例/60例)和13.33%(8例/60例),因骨髓抑制导致下调剂量15%的发生率分别为3.33%(2例/60例)和10.00%(6例/60例),差异均无统计学意义(均P>0.05)。试验组和对照组的骨痛发生率分别为66.67%和68.33%,疲乏发生率分别为10.00%和15.00%,注射部位淤血/硬结发生率分别为11.67%和16.67%,差异均无统计学意义(均P>0.05)。结论 长效或短效重组人粒细胞集落刺激因子在乳腺癌化疗后均具有骨髓保护功能,药物不良反应相似且可耐受,但接受长效重组人粒细胞集落刺激因子患者的生活质量更佳。

Objective To evaluate the bone marrow protection effect and safety of long-effecting or short-effecting recombinant granulocyte colony-stimulating factors(rhG-CSFs) after neoadjuvant or adjuvant chemotherapy in patients with breast cancer. Methods The patients with breast cancer were divided into control group and treatment group according to the different disposals. The chemotherapy regimens of both groups were combination or continous regimens containing taxanes and anthracyclines. Control group received rhG-CSF 300 μg hypodermic injection at 72 h after each cycle of chemotherapy, subcutaneous injection for 8-10 days. Treatment group received PEG-rhG-CSF 6 mg hypodermic injection subcutaneously once 24-48 hours after each cycle of chemotherapy. Each chemotherapy cycle was 21 days, and every patient received at least 4 cycles. The bonemarrow protection effect and safety were compared between two groups.Results Finally, the treatment and controlgroups were enrolled 60 cases per group. The scores of life quality of treatment and the control group were(82. 2 ± 4. 8)and( 70. 6 ± 7. 3) with significant difference(P< 0. 05). The incidences of grade 3 granulocytopenia afterchemotherapy in treatment group and control group were 15. 00%(9 cases/60 cases) and 16. 67%(10 cases/60cases), the incidences of grade 4 granulocytopenia after chemotherapy in treatment group and control group were15. 00%(9 cases/60 cases) and 18. 33%(11 cases/60 cases), the incidences of febrile neutropenia in treatmentgroup and control group were 6. 67%(4 cases/60 cases) and 10. 00%(6 cases/60 cases), the incidences ofdelayed chemotherapy > 3 d due to myelosuppression in treatment group and control group were 8. 33%(5 cases/60cases) and 13. 33%(8 cases/60 cases), the incidences of 15% downdose due to myelosuppression in treatmentgroup and control group were 3. 33%(2 cases/60 cases) and 10. 00%(6 cases/60 cases), the above differenceswere not statistically significant(allP> 0. 05). The incidences of bone pain in treatment group and control group were66. 67% and 68. 33%, the incidences of fatigue were 10. 00% and 15. 00%, the incidences of congestion/indurationat the injection site were 11. 67% and 16. 67%;all the incidences of adverse drug reactions were similar withoutsignificant statistical differences( allP> 0. 05).Conclusion Both the long-effecting and short-effectingrecombinant human granulocyte colony-stimulating factors can protect bone marrow after chemotherapy for breastcancer, and the adverse drug reactions are similar and tolerable, but the quality of life was better in patients receivinglong-effecting recombinant human granulocyte colony-stimulating factor.