CAJ | 학술논문

目的：探讨聚乙二醇化重组人粒细胞刺激因子（ PEG-rhG-CSF）对同期放化疗所致Ⅲ度粒细胞缺乏患者挽救性治疗的疗效及不良反应，为其在临床中合理应用提供依据。方法对105例同期放化疗所致Ⅲ度粒细胞缺乏的恶性肿瘤患者进行分析，试验组包括：PEG-50组38例、PEG-100组26例、 PEG-R组21例，给药方式依次为PEG-rhG-CSF 50μg／kg 单次皮下注射，100μg／kg 单次皮下注射， PEG-rhG-CSF 50μg／kg 单次皮下注射＋rhG-CSF 5μg· kg -1· d -1皮下注射，外周血中性粒细胞绝对计数（ ANC）≥2珑．0×109／L后停用rhG-CSF；对照组为R组20例，即rhG-CSF 5μg· kg-1· d-1皮下注射，ANC≥2．0×109／L后停用。对上述4组患者的时间-中性粒细胞增殖率、时间-ANC值、粒细胞缺乏所致不良症状的缓解时间、药物不良反应发生率进行统计学分析。结果试验组中性粒细胞增殖率和中性粒细胞绝对值均较对照组显著增高（ P ＜0．05），各试验亚组的临床效应发挥均始于用药12～24 h，于24 h左右达到改善粒细胞缺乏的治疗目的， P-50组与P＋R组的时间中-性粒细胞增殖率和时间-ANC值无明显差异（ P ＞0．05）；试验组与对照组缓解因粒细胞缺乏所致临床症状所需的时间无明显差异（ P ＞0．05）。结论 PEG-rhG-CSF对于同期放化疗所致Ⅲ度粒细胞缺乏患者的挽救性治疗推荐剂量为单次50μg／kg皮下注射，其效应发挥时间始于12～24 h之后，如果在此期间ANC值无明显提高，无需加用rhG-CSF。
목적：탐토취을이순화중조인립세포자격인자（ PEG-rhG-CSF）대동기방화료소치Ⅲ도립세포결핍환자만구성치료적료효급불량반응，위기재림상중합리응용제공의거。방법대105례동기방화료소치Ⅲ도립세포결핍적악성종류환자진행분석，시험조포괄：PEG-50조38례、PEG-100조26례、 PEG-R조21례，급약방식의차위PEG-rhG-CSF 50μg／kg 단차피하주사，100μg／kg 단차피하주사， PEG-rhG-CSF 50μg／kg 단차피하주사＋rhG-CSF 5μg· kg -1· d -1피하주사，외주혈중성립세포절대계수（ ANC）≥2롱．0×109／L후정용rhG-CSF；대조조위R조20례，즉rhG-CSF 5μg· kg-1· d-1피하주사，ANC≥2．0×109／L후정용。대상술4조환자적시간-중성립세포증식솔、시간-ANC치、립세포결핍소치불량증상적완해시간、약물불량반응발생솔진행통계학분석。결과시험조중성립세포증식솔화중성립세포절대치균교대조조현저증고（ P ＜0．05），각시험아조적림상효응발휘균시우용약12～24 h，우24 h좌우체도개선립세포결핍적치료목적， P-50조여P＋R조적시간중-성립세포증식솔화시간-ANC치무명현차이（ P ＞0．05）；시험조여대조조완해인립세포결핍소치림상증상소수적시간무명현차이（ P ＞0．05）。결론 PEG-rhG-CSF대우동기방화료소치Ⅲ도립세포결핍환자적만구성치료추천제량위단차50μg／kg피하주사，기효응발휘시간시우12～24 h지후，여과재차기간ANC치무명현제고，무수가용rhG-CSF。
Objective To investigate the therapeutic effect and adverse reaction of salvage therapy of pegylated recombinant human granulocyte colony stimulating factor( PEG-rhG-CSF) on degree Ⅲ neutropenia induced by radiotherapy and chemotherapy in synchronism in order to provide basis for reasonable application of PEG-rhG-CSF in clinic.Methods The data about 105 patients with degree Ⅲ neutropenia caused by radiotherapy and chemotherapy in synchronism were analyzed.The experimental groups included group PEG50 ( n=38),group PEG100 ( n =26),group PEG+R ( n =21). The patients in the three groups were given respectively with a single injection of PEG -rhG-CSF 50μg/kg,a single injection of PEG-rhG-CSF 100μg/kg,a single injection of PEG-rhG-CSF 50μg/kg plus multiple injections of rhG-CSF 5μg· kg-1 · d-1 , until the absolute neutrophil count ( ANC) ≥2.0 ×109/L.The 20 patients in control group received multiple injections of rhG-CSF 5μg· kg-1 · d-1 ,untill ANC≥2.0 ×109/L.The time-neutrophil proliferation rate,time-ANC,the time of symptom relief,the incidence of drug adverse reaction were statistically analyzed .Rseults The time-neutrophil proliferation rate , time-ANC in experimental group were significantly increased, as compared with those in control group ( P <0.05 ) .The starting time of clinical effect in experimental groups began during 12 ~24 hours, and the symptoms of neutropenia were improved about 24 hours.There were no significant differences in the time-neutrophil proliferation rate and time-ANC between the PEG50 group and PEG+R group ( P >0.05).There was no significant difference in the time of symptom relief between experimental group and control group ( P >0.05 ) .Conclusion The recommended dose of PEG-rhG-CSF in salvage treatment of degreeⅢneutropenia is single subcutaneous injection of 50μg/kg,its clinical effects start after 12~24 hours,and it need not to reinforce rhG-CSF if ANC has no obvious enhancement during this period .