中国肿瘤临床
中國腫瘤臨床
중국종류림상
CHINESE JOURNAL OF CLINICAL ONCOLOGY
2015年
12期
626-631
,共6页
杨晟%何小慧%刘鹏%周生余%董梅%秦燕%杨建良%张长弓%韩晓红%石远凯
楊晟%何小慧%劉鵬%週生餘%董梅%秦燕%楊建良%張長弓%韓曉紅%石遠凱
양성%하소혜%류붕%주생여%동매%진연%양건량%장장궁%한효홍%석원개
聚乙二醇化重组人粒细胞集落刺激因子%化疗%中性粒细胞减少%粒细胞集落刺激因子%不良反应
聚乙二醇化重組人粒細胞集落刺激因子%化療%中性粒細胞減少%粒細胞集落刺激因子%不良反應
취을이순화중조인립세포집락자격인자%화료%중성립세포감소%립세포집락자격인자%불량반응
pegylated filgrastim%chemotherapy%neutropenia%filgrastim%adverse effect
目的：比较每周期1剂聚乙二醇化重组人粒细胞集落刺激因子（PEG-rhG-CSF）与每日1剂重组人粒细胞集落刺激因子（rhG-CSF）预防癌症患者化疗后中性粒细胞减少的有效性。方法：合并分析PEG-rhG-CSF的2期和3期临床研究中的单中心数据，比较疗效与安全性指标。两项研究均为随机、自身交叉对照试验。56例初治恶性肿瘤患者接受2个周期常用化疗方案治疗，且化疗方案相同，其中试验周期给予PEG-rhG-CSF 100μg/kg皮下注射，每个周期1次；对照周期皮下注射rhG-CSF 5μg/kg，每日1次。结果：2个研究单中心共纳入56例患者，其中53例可进行疗效评价，PEG-rhG-CSF和rhG-CSF各使用53个周期。在使用PEG-rhG-CSF的周期和使用rhG-CSF的周期中，4度外周血中性粒细胞绝对值（ANC）减少未发生率均为94.3%（50/53），均未出现中性粒细胞减少性发热，抗生素使用率分别为7.5%（4/53）和3.8%（2/53，P=0.678）。全组患者中位应用rhG-CSF天数为10（3～14）天。此两种药物的不良反应均为骨痛、注射部位疼痛、心悸、发热和乏力等。结论：1剂聚乙二醇化重组人粒细胞集落刺激因子预防化疗后中性粒细胞减少的有效性与连续10剂常规重组人粒细胞集落刺激因子相似。
目的：比較每週期1劑聚乙二醇化重組人粒細胞集落刺激因子（PEG-rhG-CSF）與每日1劑重組人粒細胞集落刺激因子（rhG-CSF）預防癌癥患者化療後中性粒細胞減少的有效性。方法：閤併分析PEG-rhG-CSF的2期和3期臨床研究中的單中心數據，比較療效與安全性指標。兩項研究均為隨機、自身交扠對照試驗。56例初治噁性腫瘤患者接受2箇週期常用化療方案治療，且化療方案相同，其中試驗週期給予PEG-rhG-CSF 100μg/kg皮下註射，每箇週期1次；對照週期皮下註射rhG-CSF 5μg/kg，每日1次。結果：2箇研究單中心共納入56例患者，其中53例可進行療效評價，PEG-rhG-CSF和rhG-CSF各使用53箇週期。在使用PEG-rhG-CSF的週期和使用rhG-CSF的週期中，4度外週血中性粒細胞絕對值（ANC）減少未髮生率均為94.3%（50/53），均未齣現中性粒細胞減少性髮熱，抗生素使用率分彆為7.5%（4/53）和3.8%（2/53，P=0.678）。全組患者中位應用rhG-CSF天數為10（3～14）天。此兩種藥物的不良反應均為骨痛、註射部位疼痛、心悸、髮熱和乏力等。結論：1劑聚乙二醇化重組人粒細胞集落刺激因子預防化療後中性粒細胞減少的有效性與連續10劑常規重組人粒細胞集落刺激因子相似。
목적：비교매주기1제취을이순화중조인립세포집락자격인자（PEG-rhG-CSF）여매일1제중조인립세포집락자격인자（rhG-CSF）예방암증환자화료후중성립세포감소적유효성。방법：합병분석PEG-rhG-CSF적2기화3기림상연구중적단중심수거，비교료효여안전성지표。량항연구균위수궤、자신교차대조시험。56례초치악성종류환자접수2개주기상용화료방안치료，차화료방안상동，기중시험주기급여PEG-rhG-CSF 100μg/kg피하주사，매개주기1차；대조주기피하주사rhG-CSF 5μg/kg，매일1차。결과：2개연구단중심공납입56례환자，기중53례가진행료효평개，PEG-rhG-CSF화rhG-CSF각사용53개주기。재사용PEG-rhG-CSF적주기화사용rhG-CSF적주기중，4도외주혈중성립세포절대치（ANC）감소미발생솔균위94.3%（50/53），균미출현중성립세포감소성발열，항생소사용솔분별위7.5%（4/53）화3.8%（2/53，P=0.678）。전조환자중위응용rhG-CSF천수위10（3～14）천。차량충약물적불량반응균위골통、주사부위동통、심계、발열화핍력등。결론：1제취을이순화중조인립세포집락자격인자예방화료후중성립세포감소적유효성여련속10제상규중조인립세포집락자격인자상사。
Objective:To compare the efficacy of a single injection of pegylated filgrastim with daily doses of filgrastim as pro-phylaxis for chemotherapy-induced neutropenia in Chinese cancer patients. Methods:Single-institution data from a phase 2 study and a phase 3 trial on pegylated filgrastim were combined to analyze the efficacy and safety parameters. In the two randomized crossover tri-als, patients with previously untreated cancers received two cycles of chemotherapy with identical regimen. In the study cycle, the pa-tients received a single subcutaneous injection of pegylated filgrastim (100 μg/kg), whereas those in the control cycle received daily subcutaneous injections of filgrastim (5μg/kg). Results:Among the 56 patients enrolled, 53 were evaluable for efficacy. These patients received one cycle with pegylated filgrastim prophylaxis and one cycle with filgrastim support each. Results indicated that 94.3%(50/53) of the cycles with pegylated filgrastim or filgrastim support did not develop grade 4 neutropenia. Moreover, febrile neutropenia did not occur in the cycles. The incidence rates of antibiotic administration were 7.5%(4/53) and 3.8%(2/53) in the pegylated filgrastim and filgrastim cycles, respectively (P=0.678). The median duration of filgrastim administration was 10 days (3-14 days). Generally, the safety profile of pegylated filgrastim is similar to that of filgrastim, including skeletal pain, pain at the injection site, palpitation, fever, and fatigue. Conclusion:A single dose of pegylated filgrastim demonstrated comparable efficacy with 10 consecutive doses of filgras-tim as prophylaxis for chemotherapy-induced neutropenia.
