CAJ | 학술논문

目的研究雾化粒细胞-巨噬细胞集落刺激因子(GM-CSF)作用于原发于肺部肿瘤肺转移癌的药物毒性和治疗的可行性.方法采用GM-CSF三个剂量递增水平的试验设计,每日2次雾化连续7 d休息7 d的方案.若未观察到药物的毒性反应,休息7 d后再进行下一个剂量水平的试验.结果 7例患者中的6例完成60、120和240 μg3个剂量水平的雾化试验.雾化GM-CSF前后白细胞数和粒细胞百分比数差异无统计学意义.另外9例患者接受240μg GM-CSF的7 d雾化方案治疗2～6个月,无一例患者观察到药物的毒性反应.2例肺腺癌舣肺转移和1例小细胞肺癌双肺转移,病情进展,其余6例患者病情稳定2～6个月,全部患者未发生药物的不良反应.结论雾化GM-CSF治疗原发性肺癌的肺转移.是一种耐受性较好的生物治疗,也显示出一定的抗肿瘤作用.
목적 연구무화립세포-거서세포집락자격인자(GM-CSF)작용우원발우폐부종류폐전이암적약물독성화치료적가행성.방법 채용GM-CSF삼개제량체증수평적시험설계,매일2차무화련속7 d휴식7 d적방안.약미관찰도약물적독성반응,휴식7 d후재진행하일개제량수평적시험.결과 7례환자중적6례완성60、120화240 μg3개제량수평적무화시험.무화GM-CSF전후백세포수화립세포백분비수차이무통계학의의.령외9례환자접수240μg GM-CSF적7 d무화방안치료2～6개월,무일례환자관찰도약물적독성반응.2례폐선암의폐전이화1례소세포폐암쌍폐전이,병정진전,기여6례환자병정은정2～6개월,전부환자미발생약물적불량반응.결론 무화GM-CSF치료원발성폐암적폐전이.시일충내수성교호적생물치료,야현시출일정적항종류작용.
Objective To evaluate the feasibility of granulocyte macrophage-colony stimulating factor (GM-CSF)delivery to the lung using an aerosol in patients with metastatic lung cancer to the lungs.Methods A Phase I dose escalation study inhaled GM-CSF at three dose levels as twice-a-dayx7 days schedule.Blood counts were checked at the beginning and end of each week of GM-CSF nebulization. If no toxicity was encountered,in-patients rested for 7 days and then were inhaled at the next dose level.Results Six of sevenpatients were all dose escalated from 60 μg/dose twice-a-dayx7 days,to 120μ g/dose twice-a-dayx7 days,then 240μg/dose twice-a-dayx7 days,one of the patients with cerebral hemorrhage was removed from the clinical trials,and no toxicity was seen.Comparison of inhaled GM-CSF of day 0 and day 7 blood leukocyte counts and percentage of neutrophils,it showed no significant difference in analysis of blood count data at the beginning and end of nebulization used paired t tests for each dose level.The other 9 patients received an additional 2-6 months of intermittent aerosol GM-CSF at 240 μg dose level without side effect.Two patients with bilateral lung metastases of lung adenocarcinoma had a progress disease after 2-2.5 months of aerosol GM-CSF.One patient with lung metastasis of SCLC had a progressive disease after 2 months of aerosol GM-CSF,the other 6 patients had stabilization of pulmonary metastases for 2-6 months. Conclusion Aerosol delivery of GM-CSF may achieve effective immunological antitumor action in the metastases tumor to lungs,and this therapy is feasible and possibly effective and worthy of further study.