紫杉醇制剂超敏反应预处理指导意见
摘要
<正>紫杉醇是一种作用于微管的细胞毒类抗肿瘤药物,广泛应用于乳腺癌、卵巢癌、非小细胞肺癌、食管癌及胃癌等恶性肿瘤的治疗。紫杉醇常见的不良反应之一是超敏反应,这使紫衫醇的临床应用受到限制,患者的用药机会减少,严重超敏反应甚至危及患者的生命。大剂量糖皮质激素
引文
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[3]SCHWARTZ J R.Dexamethasone premedication for prophylaxis of taxane toxicities:can the doses be reduced when paclitaxel or docetaxel are given weekly[J].J Oncol Pharm Pract,2012,18(2):250-256.
[4]CASTELLS M C,TENNANT N M,SLOANE D E,et al.Hypersensitivity reactions to chemotherapy:outcomes and safety of rapid desensitization in 413 cases[J].J Allergy Clin Immunol,2008,122(3):574-580.
[5]WEISS R B,DONEHOWER R C,WIERNIK P H,et al.Hypersensitivity reactions from taxol[J].J Clin Oncol,1990,8(7):1263-1268.
[6]A fatal anaphylactic reaction to paclitaxel is described,which was preceded by a possible delayed reaction to the initial infusion[J].Allergy Asthma Proc,2011,32(1):79.
[7]MARKMAN M,KENNEDY A,WEBSTER K,et al.Paclitaxel-associated hypersensitivity reactions:experience of the gynecologic oncology program of the cleveland clinic cancer center[J].J Clin Oncol,2000,18(1):102-105.
[8]WEISS R B.Hypersensitivity reactions[J].Semin Oncol,1992,19(5):458-477.
[9]BANERJI A,LAX T,GUYER A,et al.Management of hypersensitivity reactions to Carboplatin and Paclitaxel in an outpatient oncology infusion center:a 5-year review[J].JAllergy Clin Immunol Pract,2014,2(4):428-433.
[10]ROBINSON J B,SINGH D,BODURKA-BEVERS D C,et al.Hypersensitivity reactions and the utility of oral and intravenous desensitization in patients with gynecologic malignancies[J].Gynecol Oncol,2001,82(3):550-558.
[11]SZEBENI J,MUGGIA F M,ALVING C R.Complement activation by Cremophor EL as a possible contributor to hypersensitivity to paclitaxel:an in vitro study[J].J Natl Cancer Inst,1998,90(4):300-306.
[12]EBO D G,PIEL G C,CONRAADS V,et al.IgE-mediated anaphylaxis after first intravenous infusion of cyclosporine[J].Ann Allergy Asthma Immunol,2001,87(3):243-245.
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[15]ESSAYAN D M,KAGEY-SOBOTKA A,COLARUSSO P J,et al.Successful parenteral desensitization to paclitaxel[J].JAllergy Clin Immunol,1996,97(1 Pt 1):42-46.
[16]PRIETO GARCIA A,PINEDA DE LA LOSA F.Immunoglobulin E-mediated severe anaphylaxis to paclitaxel[J].J Investig Allergol Clin Immunol,2010,20(2):170-171.
[17]PICARD M,CASTELLS M C.Re-visiting hypersensitivity reactions to taxanes:a comprehensive review[J].Clin Rev Allergy Immunol,2015,49(2):177-191.
[18]MADRIGAL-BURGALETA R,BERGES-GIMENO M P,ANGEL-PEREIRA D,et al.Hypersensitivity and desensitization to antineoplastic agents:outcomes of 189procedures with a new short protocol and novel diagnostic tools assessment[J].Allergy,2013,68(7):853-861.
[19]GASTAMINZA G,DE LA BORBOLLA J M,GOIKOETXEA M J,et al.A new rapid desensitization protocol for chemotherapy agents[J].J Investig Allergol Clin Immunol,2011,21(2):108-112.
[20]Italian Association of Aerobiology.An epidemiological survey of Cupressaceae pollenosis in Italy[J].J Investig Allergol Clin Immunol,2002,12(4):287-292.
[21]ZIDAN J,HUSSEIN O,ABZAH A,et al.Oral premedication for the prevention of hypersensitivity reactions to paclitaxel[J].Med Oncol,2008,25(3):274-278.
[22]TSAVARIS N B,KOSMAS C.Risk of severe acute hypersensitivity reactions after rapid paclitaxel infusion of less than 1-h duration[J].Cancer Chemother Pharmacol,1998,42(6):509-511.
[23]KWON J S,ELIT L,FINN M,et al.A comparison of two prophylactic regimens for hypersensitivity reactions to paclitaxel[J].Gynecol Oncol,2002,84(3):420-425.
[24]O'CATHAIL S M,SHABOODIEN R,MAHMOUD S,et al.Intravenous versus oral dexamethasone premedication in preventing paclitaxel infusion hypersensitivity reactions in gynecological malignancies[J].Int J Gynecol Cancer,2013,23(7):1318-1325.
[25]CHEN F C,WANG L H,ZHENG X Y,et al.Meta-analysis of the effects of oral and intravenous dexamethasone premedication in the prevention of paclitaxel-induced allergic reactions[J].Oncotarget,2017,8(12):19236-19243.
[26]KLOOVER J S,DEN BAKKER M A,GELDERBLOM H,et al.Fatal outcome of a hypersensitivity reaction to paclitaxel:a critical review of premedication regimens[J].Br J Cancer,2004,90(2):304-305.
[27]BRAVERMAN A S,RAO S,SALVATTI M E,et al.Tapering and discontinuation of glucocorticoid prophylaxis during prolonged weekly to biweekly paclitaxel administration[J].Chemotherapy,2005,51(2/3):116-119.
[28]NOKIHARA H,YAMAMOTO N,OHE Y,et al.Pharmacokinetics of weekly paclitaxel and feasibility of dexamethasone taper in Japanese patients with advanced non-small cell lung cancer[J].Clin Ther,2016,38(2):338-347.
[29]TANPIPATTANAKUL W,POOVORAWAN N,RATTANA-NUPONG T,et al.Feasibility of withholding dexamethasone premedication for hypersensitivity reactions associated with paclitaxel administration[J].2017,10(4):371-377.
[30]BERGER M J,DUNLEA L J,RETTIG A E,et al.Feasibility of stopping paclitaxel premedication after two doses in patients not experiencing a previous infusion hypersensitivity reaction[J].Support Care Cancer,2012,20(9):1991-1997.
[31]QUOCK J,DEA G,TANAKA M,et al.Premedication strategy for weekly paclitaxel[J].Cancer Invest,2002,20(5-6):666-672.
[32]CHEN Q,ZHANG Q Z,LIU J,et al.[Multi-center prospective randomized trial on paclitaxel liposome and traditional taxol in the treatment of breast cancer and non-small-cell lung cancer][J].Chin J Oncol(中华肿瘤杂志),2003,25(2):190-192.
[33]XU X,WANG L,XU H Q,et al.Clinical comparison between paclitaxel liposome(Lipusu(R)and paclitaxel for treatment of patients with metastatic gastric cancer[J].Asian Pac J Cancer Prev,2013,14(4):2591-2594.
[34]WANG H,CHENG G,DU Y,et al.Hypersensitivity reaction studies of a polyethoxylated castor oil-free,liposome-based alternative paclitaxel formulation[J].Mol Med Rep,2013,7(3):947-952.
[35]注射用紫杉醇脂质体说明书(力朴素)[K].
[36]KRATZ F.Albumin as a drug carrier:design of prodrugs,drug conjugates and nanoparticles[J].J Control Release,2008,132(3):171-183.
[37]DESAI N,TRIEU V,YAO Z,et al.Increased antitumor activity,intratumor paclitaxel concentrations,and endothelial cell transport of cremophor-free,albumin-bound paclitaxel,ABI-007,compared with cremophor-based paclitaxel[J].Clin Cancer Res,2006,12(4):1317-1324.
[38]IBRAHIM N K,DESAI N,LEGHA S,et al.Phase I and pharmacokinetic study of ABI-007,a Cremophor-free,protein-stabilized,nanoparticle formulation of paclitaxel[J].Clin Cancer Res,2002,8(5):1038-1044.
[39]IBRAHIM N K,SAMUELS B,PAGE R,et al.Multicenter phase II trial of ABI-007,an albumin-bound paclitaxel,in women with metastatic breast cancer[J].J Clin Oncol,2005,23(25):6019-6026.
[40]GRADISHAR W J,TJULANDIN S,DAVIDSON N,et al.Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer[J].J Clin Oncol,2005,23(31):7794-7803.
[41]FADER A N,ROSE P G.Abraxane for the treatment of gynecologic cancer patients with severe hypersensitivity reactions to paclitaxel[J].Int J Gynecol Cancer,2009,19(7):1281-1283.
[42]FELDWEG A M,LEE C W,MATULONIS U A,et al.Rapid desensitization for hypersensitivity reactions to paclitaxel and docetaxel:a new standard protocol used in 77 successful treatments[J].Gynecol Oncol,2005,96(3):824-829.
[43]FISHMAN A,GOLD T,GOLDBERG A,et al.Effective desensitization protocol to paclitaxel following hypersensitivity reaction[J].Int J Gynecol Cancer,1999,9(2):156-159.
[44]浙江省医院药事管理质控中心,浙江省微生物与免疫学会,浙江省护理质控中心.浙江省头孢菌素类抗菌药物皮肤过敏试验指导意见[J].中国现代应用药学,2018,35(12):1906-1909.
[45]LIEBERMAN P,NICKLAS R A,RANDOLPH C,et al.Anaphylaxis-a practice parameter update 2015[J].Ann Allergy Asthma Immunol,2015,115(5):341-384.
[46]ROSELLO S,BLASCO I,GARCIA FABREGAT L,et al.Management of infusion reactions to systemic anticancer therapy:ESMO Clinical Practice Guidelines[J].Ann Oncol,2017,28(Suppl 4):4100-4118.
[2]BOOKMAN M A,KLOTH D D,KOVER P E,et al.Intravenous prophylaxis for paclitaxel-related hypersensitivity reactions[J].Semin Oncol,1997,24(6 Suppl 19):13-15.
[3]SCHWARTZ J R.Dexamethasone premedication for prophylaxis of taxane toxicities:can the doses be reduced when paclitaxel or docetaxel are given weekly[J].J Oncol Pharm Pract,2012,18(2):250-256.
[4]CASTELLS M C,TENNANT N M,SLOANE D E,et al.Hypersensitivity reactions to chemotherapy:outcomes and safety of rapid desensitization in 413 cases[J].J Allergy Clin Immunol,2008,122(3):574-580.
[5]WEISS R B,DONEHOWER R C,WIERNIK P H,et al.Hypersensitivity reactions from taxol[J].J Clin Oncol,1990,8(7):1263-1268.
[6]A fatal anaphylactic reaction to paclitaxel is described,which was preceded by a possible delayed reaction to the initial infusion[J].Allergy Asthma Proc,2011,32(1):79.
[7]MARKMAN M,KENNEDY A,WEBSTER K,et al.Paclitaxel-associated hypersensitivity reactions:experience of the gynecologic oncology program of the cleveland clinic cancer center[J].J Clin Oncol,2000,18(1):102-105.
[8]WEISS R B.Hypersensitivity reactions[J].Semin Oncol,1992,19(5):458-477.
[9]BANERJI A,LAX T,GUYER A,et al.Management of hypersensitivity reactions to Carboplatin and Paclitaxel in an outpatient oncology infusion center:a 5-year review[J].JAllergy Clin Immunol Pract,2014,2(4):428-433.
[10]ROBINSON J B,SINGH D,BODURKA-BEVERS D C,et al.Hypersensitivity reactions and the utility of oral and intravenous desensitization in patients with gynecologic malignancies[J].Gynecol Oncol,2001,82(3):550-558.
[11]SZEBENI J,MUGGIA F M,ALVING C R.Complement activation by Cremophor EL as a possible contributor to hypersensitivity to paclitaxel:an in vitro study[J].J Natl Cancer Inst,1998,90(4):300-306.
[12]EBO D G,PIEL G C,CONRAADS V,et al.IgE-mediated anaphylaxis after first intravenous infusion of cyclosporine[J].Ann Allergy Asthma Immunol,2001,87(3):243-245.
[13]LIAU-CHU M,THEIS J G,KOREN G.Mechanism of anaphylactoid reactions:improper preparation of high-dose intravenous cyclosporine leads to bolus infusion of Cremophor EL and cyclosporine[J].Ann Pharmacother,1997,31(11):1287-1291.
[14]O'DWYER P J,KING S A,FORTNER C L,et al.Hypersensitivity reactions to teniposide(VM-26):an analysis[J].J Clin Oncol,1986,4(8):1262-1269.
[15]ESSAYAN D M,KAGEY-SOBOTKA A,COLARUSSO P J,et al.Successful parenteral desensitization to paclitaxel[J].JAllergy Clin Immunol,1996,97(1 Pt 1):42-46.
[16]PRIETO GARCIA A,PINEDA DE LA LOSA F.Immunoglobulin E-mediated severe anaphylaxis to paclitaxel[J].J Investig Allergol Clin Immunol,2010,20(2):170-171.
[17]PICARD M,CASTELLS M C.Re-visiting hypersensitivity reactions to taxanes:a comprehensive review[J].Clin Rev Allergy Immunol,2015,49(2):177-191.
[18]MADRIGAL-BURGALETA R,BERGES-GIMENO M P,ANGEL-PEREIRA D,et al.Hypersensitivity and desensitization to antineoplastic agents:outcomes of 189procedures with a new short protocol and novel diagnostic tools assessment[J].Allergy,2013,68(7):853-861.
[19]GASTAMINZA G,DE LA BORBOLLA J M,GOIKOETXEA M J,et al.A new rapid desensitization protocol for chemotherapy agents[J].J Investig Allergol Clin Immunol,2011,21(2):108-112.
[20]Italian Association of Aerobiology.An epidemiological survey of Cupressaceae pollenosis in Italy[J].J Investig Allergol Clin Immunol,2002,12(4):287-292.
[21]ZIDAN J,HUSSEIN O,ABZAH A,et al.Oral premedication for the prevention of hypersensitivity reactions to paclitaxel[J].Med Oncol,2008,25(3):274-278.
[22]TSAVARIS N B,KOSMAS C.Risk of severe acute hypersensitivity reactions after rapid paclitaxel infusion of less than 1-h duration[J].Cancer Chemother Pharmacol,1998,42(6):509-511.
[23]KWON J S,ELIT L,FINN M,et al.A comparison of two prophylactic regimens for hypersensitivity reactions to paclitaxel[J].Gynecol Oncol,2002,84(3):420-425.
[24]O'CATHAIL S M,SHABOODIEN R,MAHMOUD S,et al.Intravenous versus oral dexamethasone premedication in preventing paclitaxel infusion hypersensitivity reactions in gynecological malignancies[J].Int J Gynecol Cancer,2013,23(7):1318-1325.
[25]CHEN F C,WANG L H,ZHENG X Y,et al.Meta-analysis of the effects of oral and intravenous dexamethasone premedication in the prevention of paclitaxel-induced allergic reactions[J].Oncotarget,2017,8(12):19236-19243.
[26]KLOOVER J S,DEN BAKKER M A,GELDERBLOM H,et al.Fatal outcome of a hypersensitivity reaction to paclitaxel:a critical review of premedication regimens[J].Br J Cancer,2004,90(2):304-305.
[27]BRAVERMAN A S,RAO S,SALVATTI M E,et al.Tapering and discontinuation of glucocorticoid prophylaxis during prolonged weekly to biweekly paclitaxel administration[J].Chemotherapy,2005,51(2/3):116-119.
[28]NOKIHARA H,YAMAMOTO N,OHE Y,et al.Pharmacokinetics of weekly paclitaxel and feasibility of dexamethasone taper in Japanese patients with advanced non-small cell lung cancer[J].Clin Ther,2016,38(2):338-347.
[29]TANPIPATTANAKUL W,POOVORAWAN N,RATTANA-NUPONG T,et al.Feasibility of withholding dexamethasone premedication for hypersensitivity reactions associated with paclitaxel administration[J].2017,10(4):371-377.
[30]BERGER M J,DUNLEA L J,RETTIG A E,et al.Feasibility of stopping paclitaxel premedication after two doses in patients not experiencing a previous infusion hypersensitivity reaction[J].Support Care Cancer,2012,20(9):1991-1997.
[31]QUOCK J,DEA G,TANAKA M,et al.Premedication strategy for weekly paclitaxel[J].Cancer Invest,2002,20(5-6):666-672.
[32]CHEN Q,ZHANG Q Z,LIU J,et al.[Multi-center prospective randomized trial on paclitaxel liposome and traditional taxol in the treatment of breast cancer and non-small-cell lung cancer][J].Chin J Oncol(中华肿瘤杂志),2003,25(2):190-192.
[33]XU X,WANG L,XU H Q,et al.Clinical comparison between paclitaxel liposome(Lipusu(R)and paclitaxel for treatment of patients with metastatic gastric cancer[J].Asian Pac J Cancer Prev,2013,14(4):2591-2594.
[34]WANG H,CHENG G,DU Y,et al.Hypersensitivity reaction studies of a polyethoxylated castor oil-free,liposome-based alternative paclitaxel formulation[J].Mol Med Rep,2013,7(3):947-952.
[35]注射用紫杉醇脂质体说明书(力朴素)[K].
[36]KRATZ F.Albumin as a drug carrier:design of prodrugs,drug conjugates and nanoparticles[J].J Control Release,2008,132(3):171-183.
[37]DESAI N,TRIEU V,YAO Z,et al.Increased antitumor activity,intratumor paclitaxel concentrations,and endothelial cell transport of cremophor-free,albumin-bound paclitaxel,ABI-007,compared with cremophor-based paclitaxel[J].Clin Cancer Res,2006,12(4):1317-1324.
[38]IBRAHIM N K,DESAI N,LEGHA S,et al.Phase I and pharmacokinetic study of ABI-007,a Cremophor-free,protein-stabilized,nanoparticle formulation of paclitaxel[J].Clin Cancer Res,2002,8(5):1038-1044.
[39]IBRAHIM N K,SAMUELS B,PAGE R,et al.Multicenter phase II trial of ABI-007,an albumin-bound paclitaxel,in women with metastatic breast cancer[J].J Clin Oncol,2005,23(25):6019-6026.
[40]GRADISHAR W J,TJULANDIN S,DAVIDSON N,et al.Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer[J].J Clin Oncol,2005,23(31):7794-7803.
[41]FADER A N,ROSE P G.Abraxane for the treatment of gynecologic cancer patients with severe hypersensitivity reactions to paclitaxel[J].Int J Gynecol Cancer,2009,19(7):1281-1283.
[42]FELDWEG A M,LEE C W,MATULONIS U A,et al.Rapid desensitization for hypersensitivity reactions to paclitaxel and docetaxel:a new standard protocol used in 77 successful treatments[J].Gynecol Oncol,2005,96(3):824-829.
[43]FISHMAN A,GOLD T,GOLDBERG A,et al.Effective desensitization protocol to paclitaxel following hypersensitivity reaction[J].Int J Gynecol Cancer,1999,9(2):156-159.
[44]浙江省医院药事管理质控中心,浙江省微生物与免疫学会,浙江省护理质控中心.浙江省头孢菌素类抗菌药物皮肤过敏试验指导意见[J].中国现代应用药学,2018,35(12):1906-1909.
[45]LIEBERMAN P,NICKLAS R A,RANDOLPH C,et al.Anaphylaxis-a practice parameter update 2015[J].Ann Allergy Asthma Immunol,2015,115(5):341-384.
[46]ROSELLO S,BLASCO I,GARCIA FABREGAT L,et al.Management of infusion reactions to systemic anticancer therapy:ESMO Clinical Practice Guidelines[J].Ann Oncol,2017,28(Suppl 4):4100-4118.