聚乙二醇化重组人粒细胞集落刺激因子在妇科肿瘤中药物利用评价的建立与应用
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摘要
目的了解聚乙二醇化重组人粒细胞集落刺激因子(PEG-rhG-CSF)在本院妇科肿瘤患者中的使用情况,为合理使用PEG-rhG-CSF提供参考。方法参考国内外指南、药品说明书并结合专家咨询,建立妇科肿瘤放/化疗过程中PEG-rhG-CSF的药物利用评价(DUE)标准。用回顾性分析方法,通过医院病例检索系统随机抽取2018年6月至2018年12月入住我院妇科病房的200例患者,共计965例次使用PEG-rhG-CSF的病历。结果 PEG-rhG-CSF的DUE标准包括用药适应证、用药过程和用药结果 3部分,结果发现,本院PEGrhG-CSF应用的不合理现象主要为用法用量不合理(97. 29%)和用药适应证不合理(39. 90%)。结论 PEG-rhG-CSF在妇科肿瘤中DUE标准的建立,可为临床医师和临床药师合理应用该药提供参考。
Objective To understand the use of PEG-rhG-CSF( pegylated recombinant human granulocyte-colony stimulating factor) in patients with gynecologic tumors in our hospital,and to provide reference for the rational use of PEG-rhG-CSF. Methods Based on the domestic and foreign guidelines,package inserts and expert consultation,a drug use evaluation( DUE) criteria for the use of PEG-rhG-CSF in gynecology during the chemoradiotherapy was established. A retrospective analysis method was used to randomly select 200 patients who were treated with PEG-rhG-CSF in the gynecological ward of our hospital from June to December 2018 and 965 cases of medical records were collected.Results The DUE criterion for PEG-rhG-CSF consisted of medication indication,medication course and medication results. The results showed that the irrational use of PEG-rhG-CSF mainly manifested in unreasonable usage or dosage( 97. 29%),and indicative use of drugs( 39. 90%). Conclusion The establishment of DUE criteria for PEG-rhG-CSF can provide a reference for physicians and clinical pharmacists to rationally apply for this drug.
Objective To understand the use of PEG-rhG-CSF( pegylated recombinant human granulocyte-colony stimulating factor) in patients with gynecologic tumors in our hospital,and to provide reference for the rational use of PEG-rhG-CSF. Methods Based on the domestic and foreign guidelines,package inserts and expert consultation,a drug use evaluation( DUE) criteria for the use of PEG-rhG-CSF in gynecology during the chemoradiotherapy was established. A retrospective analysis method was used to randomly select 200 patients who were treated with PEG-rhG-CSF in the gynecological ward of our hospital from June to December 2018 and 965 cases of medical records were collected.Results The DUE criterion for PEG-rhG-CSF consisted of medication indication,medication course and medication results. The results showed that the irrational use of PEG-rhG-CSF mainly manifested in unreasonable usage or dosage( 97. 29%),and indicative use of drugs( 39. 90%). Conclusion The establishment of DUE criteria for PEG-rhG-CSF can provide a reference for physicians and clinical pharmacists to rationally apply for this drug.
引文
[1]石远凯,孙燕.临床肿瘤内科手册[M]. 6版.北京:人民卫生出版社,2015:489-559.
[2] KUDERER N M,DALE D C,CRAWFORD J,et al. Impact of primary prophylaxis with granulocyte colony-stimulating factor on febrile neutropenia and mortality in adult cancer patients receiving chemotherapy:A systematic review[J]. J Clin Oncol,2007,25(21):3158-3167.
[3]刘浩,任浩洋,孙纯广,等.重组人粒细胞集落刺激因子(rhGCSF)对小细胞肺癌化疗后骨髓抑制的有效性和安全性分析[J].中国临床药理学杂志,2009,25(6):501-504.
[4] GREEN M D,KOELBL H,BASELGA J,et al. A randomized double-blind multicenter phaseⅢstudy of fixed-dose singleadministration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy[J]. Ann Oncol,2003,14(1):29-35.
[5] HOLMES F A,O’SHAUGHNESSY J A,VUKELJA S,et al. Blinded,randomized,multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stageⅡor stageⅢ/Ⅳbreast cancer[J]. J Clin Oncol,2002,20(3):727-731.
[6] KUDERER N M,DALE D C,CRAWFORD J,et al. Mortality,morbidity,and cost associated with febrile neutropenia in adult cancer patients[J]. Cancer,2006,106(10):2258-2266.
[7] NATIONAL COMPREHENSIVE CANCER NETWORK(NCCN).Myeloid growth factors V2. 2018[EB/OL]. Philadelphia:NCCN,2018-12-31[2019-01-10]. http://www. nccn. org.
[8] SMITH T J,KHATCHERESSIAN J,LYMAN G H,et al. 2006 update of recommendations for the use of white blood cell growth factors:An evidence-based clinical practice guideline[J]. J Clin Oncol,2006,24(19):3187-3205.
[9]中国临床肿瘤学会指南工作委员会.肿瘤放化疗相关中性粒细胞减少症规范化管理指南[J].中华肿瘤杂志,2017,39(11):868-878.
[10]晏妮,吴胜林,杜霞,等.肿瘤患者使用重组人粒细胞集落刺激因子DUE标准的建立与应用[J].中国药房,2016,27(29):4050-4053.
[11]刘茂柏,林碧娟,杨菁,等.骨髓生长因子药物利用评价标准的建立及应用[J].中国医院药学杂志,2015,35(17):1597-1601.
[12]中国医师协会肿瘤医师分会,中国抗癌协会肿瘤临床化疗专业委员会,《中华医学杂志》编辑委员会.中国重组人粒细胞集落刺激因子在肿瘤化疗中的临床应用专家共识(2015年版)[J].中华医学杂志,2015,95(37):3001-3003.
[13]马军,朱军,徐兵河,等.聚乙二醇化重组人粒细胞刺激因子(PEG-rhG-CSF)临床应用中国专家共识[J].中国肿瘤临床,2016,43(7):271-274.
[14] COLEMAN R L,BRADY M F,HERZOG T J,et al. Bevacizumab and paclitaxel–carboplatin chemotherapy and secondary cytoreduction in recurrent,platinum-sensitive ovarian cancer(NRG Oncology/Gynecologic Oncology Group study GOG-0213):a multicentre,open-label,randomised,phase 3 trial[J]. Lancet Oncol,2017,18(6):779-791.
[15] PUJADELAURAINE E,WAGNER U,AAVALLLUNDQVIST E,et al. Pegylated liposomal doxorubicin and carboplatin compared with paclitaxel and carboplatin for patients with platinum-sensitive ovarian cancer in late relapse[J]. J Clin Oncol,2010,28(20):3323-3329.
[16] JOLY F,RAY-COQUARD I,FABBRO M,et al. Decreased hypersensitivity reactions with carboplatin-pegylated liposomal doxorubicin compared to carboplatin-paclitaxel combination:Analysis from the GCIG CALYPSO relapsing ovarian cancer trial[J].Gynecol Oncol,2011,122(2):226-232.
[17] ELSHEBEINY M, ALMORSY W. Gemcitabine-oxaliplatin(GEMOX)for epithelial ovarian cancer patients resistant to platinum-based chemotherapy[J]. J Egypt Natl Canc Inst,2016,28(3):183-189.
[18] HUDDART R A,GABE R,CAFFERTY F H,et al. A Randomised phase 2 trial of intensive induction chemotherapy(CBOP/BEP)and standard bep in poor-prognosis germ cell tumours(MRC TE23,CRUK 05/014,ISRCTN 53643604)[J]. Eur Urol,2015,67(3):534-543.
[19] FERREIRA A R,OTTO M F,SARMENTO R M B,et al. Neoadjuvant Treatment of StageⅡB/ⅢTriple Negative Breast Cancer with Cyclophosphamide,Doxorubicin,and Cisplatin(CAP Regimen):A Single Arm,Single Center PhaseⅡStudy(GBECAM2008/02)[J/OL]. Front Oncol,2018,7:329. 2018-01-24[2019-02-01]. https://www. ncbi. nlm. nih. gov/pmc/articles/pmid/29416986/.
[20] VOGEL C L. First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer:A multicenter,double-blind,placebo-controlled phaseⅢstudy[J]. J Clin Oncol,2005,23(6):1178-1184.
[21] PFEIL A M,ALLCOTT K,PETTENGELL R,et al. Efficacy,effectiveness and safety of long-acting granulocyte colony-stimulating factors for prophylaxis of chemotherapy-induced neutropenia in patients with cancer:A systematic review[J]. Support Care Cancer,2015,23(2):525-545.
[22] PEDERSEN C A,SCHNEIDER P J,SCHECKELHOFF D J. ASHP national survey of pharmacy practice in hospital settings:Prescribing and transcribing-2016[J]. Am J Health Syst Pharm,2017,74(17):1336-1352.
[23]黄艳芳,吴柳婷,罗洁丽,等.亚胺培南药物利用评价标准的建立及应用[J].中国药房,2016,27(2):271-273.
[24]莫红楠,石远凯,孙燕.重组人粒细胞集落刺激因子在肿瘤化疗中应用20年回顾[J].中国新药杂志,2013,22(17):2027-2032.
[2] KUDERER N M,DALE D C,CRAWFORD J,et al. Impact of primary prophylaxis with granulocyte colony-stimulating factor on febrile neutropenia and mortality in adult cancer patients receiving chemotherapy:A systematic review[J]. J Clin Oncol,2007,25(21):3158-3167.
[3]刘浩,任浩洋,孙纯广,等.重组人粒细胞集落刺激因子(rhGCSF)对小细胞肺癌化疗后骨髓抑制的有效性和安全性分析[J].中国临床药理学杂志,2009,25(6):501-504.
[4] GREEN M D,KOELBL H,BASELGA J,et al. A randomized double-blind multicenter phaseⅢstudy of fixed-dose singleadministration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy[J]. Ann Oncol,2003,14(1):29-35.
[5] HOLMES F A,O’SHAUGHNESSY J A,VUKELJA S,et al. Blinded,randomized,multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stageⅡor stageⅢ/Ⅳbreast cancer[J]. J Clin Oncol,2002,20(3):727-731.
[6] KUDERER N M,DALE D C,CRAWFORD J,et al. Mortality,morbidity,and cost associated with febrile neutropenia in adult cancer patients[J]. Cancer,2006,106(10):2258-2266.
[7] NATIONAL COMPREHENSIVE CANCER NETWORK(NCCN).Myeloid growth factors V2. 2018[EB/OL]. Philadelphia:NCCN,2018-12-31[2019-01-10]. http://www. nccn. org.
[8] SMITH T J,KHATCHERESSIAN J,LYMAN G H,et al. 2006 update of recommendations for the use of white blood cell growth factors:An evidence-based clinical practice guideline[J]. J Clin Oncol,2006,24(19):3187-3205.
[9]中国临床肿瘤学会指南工作委员会.肿瘤放化疗相关中性粒细胞减少症规范化管理指南[J].中华肿瘤杂志,2017,39(11):868-878.
[10]晏妮,吴胜林,杜霞,等.肿瘤患者使用重组人粒细胞集落刺激因子DUE标准的建立与应用[J].中国药房,2016,27(29):4050-4053.
[11]刘茂柏,林碧娟,杨菁,等.骨髓生长因子药物利用评价标准的建立及应用[J].中国医院药学杂志,2015,35(17):1597-1601.
[12]中国医师协会肿瘤医师分会,中国抗癌协会肿瘤临床化疗专业委员会,《中华医学杂志》编辑委员会.中国重组人粒细胞集落刺激因子在肿瘤化疗中的临床应用专家共识(2015年版)[J].中华医学杂志,2015,95(37):3001-3003.
[13]马军,朱军,徐兵河,等.聚乙二醇化重组人粒细胞刺激因子(PEG-rhG-CSF)临床应用中国专家共识[J].中国肿瘤临床,2016,43(7):271-274.
[14] COLEMAN R L,BRADY M F,HERZOG T J,et al. Bevacizumab and paclitaxel–carboplatin chemotherapy and secondary cytoreduction in recurrent,platinum-sensitive ovarian cancer(NRG Oncology/Gynecologic Oncology Group study GOG-0213):a multicentre,open-label,randomised,phase 3 trial[J]. Lancet Oncol,2017,18(6):779-791.
[15] PUJADELAURAINE E,WAGNER U,AAVALLLUNDQVIST E,et al. Pegylated liposomal doxorubicin and carboplatin compared with paclitaxel and carboplatin for patients with platinum-sensitive ovarian cancer in late relapse[J]. J Clin Oncol,2010,28(20):3323-3329.
[16] JOLY F,RAY-COQUARD I,FABBRO M,et al. Decreased hypersensitivity reactions with carboplatin-pegylated liposomal doxorubicin compared to carboplatin-paclitaxel combination:Analysis from the GCIG CALYPSO relapsing ovarian cancer trial[J].Gynecol Oncol,2011,122(2):226-232.
[17] ELSHEBEINY M, ALMORSY W. Gemcitabine-oxaliplatin(GEMOX)for epithelial ovarian cancer patients resistant to platinum-based chemotherapy[J]. J Egypt Natl Canc Inst,2016,28(3):183-189.
[18] HUDDART R A,GABE R,CAFFERTY F H,et al. A Randomised phase 2 trial of intensive induction chemotherapy(CBOP/BEP)and standard bep in poor-prognosis germ cell tumours(MRC TE23,CRUK 05/014,ISRCTN 53643604)[J]. Eur Urol,2015,67(3):534-543.
[19] FERREIRA A R,OTTO M F,SARMENTO R M B,et al. Neoadjuvant Treatment of StageⅡB/ⅢTriple Negative Breast Cancer with Cyclophosphamide,Doxorubicin,and Cisplatin(CAP Regimen):A Single Arm,Single Center PhaseⅡStudy(GBECAM2008/02)[J/OL]. Front Oncol,2018,7:329. 2018-01-24[2019-02-01]. https://www. ncbi. nlm. nih. gov/pmc/articles/pmid/29416986/.
[20] VOGEL C L. First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer:A multicenter,double-blind,placebo-controlled phaseⅢstudy[J]. J Clin Oncol,2005,23(6):1178-1184.
[21] PFEIL A M,ALLCOTT K,PETTENGELL R,et al. Efficacy,effectiveness and safety of long-acting granulocyte colony-stimulating factors for prophylaxis of chemotherapy-induced neutropenia in patients with cancer:A systematic review[J]. Support Care Cancer,2015,23(2):525-545.
[22] PEDERSEN C A,SCHNEIDER P J,SCHECKELHOFF D J. ASHP national survey of pharmacy practice in hospital settings:Prescribing and transcribing-2016[J]. Am J Health Syst Pharm,2017,74(17):1336-1352.
[23]黄艳芳,吴柳婷,罗洁丽,等.亚胺培南药物利用评价标准的建立及应用[J].中国药房,2016,27(2):271-273.
[24]莫红楠,石远凯,孙燕.重组人粒细胞集落刺激因子在肿瘤化疗中应用20年回顾[J].中国新药杂志,2013,22(17):2027-2032.