[1] SUGIO S, KASHIMA A, MOCHIZUKI S, et al.Crystal structure of human serum albumin at 2.5 a resolution[J]. Protein Eng, 1999, 12(6): 439-446. [2] EVANS TW.Review article: albumin as a drug-biological effects of albumin unrelated to oncotic pressure[J]. Aliment Pharmacol Ther, 2002, 16( Suppl 5): 6-11. [3] FANALI G, DI MASI A, TREZZA V, et al.Human serum albumin: from bench to bedside[J]. Mol Aspects Med, 2012, 33(3): 209-290. [4] NICHOLSON JP, WOLMARANS MR, PARK GR.The role of albumin in critical illness[J]. Br J Anaesth, 2000, 85(4): 599-610. [5] GARCIA MR, CARACENI P, BERNARDI M, et al.Albumin: pathophysiologic basis of its role in the treatment of cirrhosis and its complications[J]. Hepatology, 2013, 58(5): 1836-1846. [6] OETTL K, STAUBER RE.Physiological and pathological changes in the redox state of human serum albumin critically influence its binding properties[J].Br J Pharmacol, 2007, 151(5): 580-590. [7] CHEN TA, TSAO YC, CHEN A, et al.Effect of intravenous albumin on endotoxin removal, cytokines, and nitric oxide production in patients with cirrhosis and spontaneous bacterial peritonitis[J]. Scand J Gastroenterol, 2009, 44(5): 619-625. [8] QIAO R, SIFLINGER-BIRNBOIM A, LUM H, et al.Albumin and Ricinus communis agglutinin decrease endothelial permeability via interactions with matrix[J]. Am J Physiol, 1993, 265(2 Pt 1): C439-C446. [9] SONG ZH, LI L, WANG X.Study on clinical application and rational application strategy of human serum albumin injection[J].Chin Pharm Aff(中国药事), 2018, 32(5): 687-693. [10] Guideline for comprehensive evaluation of medicine in China(2nd Edition)[J]. Drug Eval(药品评价), 2015, 12(8): 6. [11] PALUMBO R, SOTTOTETTI F, BERNARDO A.Targeted chemotherapy with nanoparticle albumin-bound paclitaxel (nab-paclitaxel) in metastatic breast cancer: which benefit for which patients?[J]. Ther Adv Med Oncol. 2016, 8(3): 209-229. [12] ISHTIKHAR M, RABBANI G, KHAN RH.Interaction of 5-fluoro-5'-deoxyuridine with human serum albumin under physiological and non-physiological condition: a biophysical investigation[J]. Colloids Surf B Biointerfaces, 2014, 123: 469-477. [13] MELIEF CJM.Transmission of retroviruses through blood transfusions and blood preparations[J]. Foreign Med Sci (Biol Prod Prophylaxis Diag Ther)(国外医学·预防·诊断·治疗用生物制品分册), 1987(5): 213-215. [14] TROURIN JH.Le concept de sécurité virale: application à la transfusion sanguine et aux médicaments dérivés du sang[Viral safety concept: application to blood and blood products][J]. Rev Prat, 2005, 55(18): 2033-2038. [15] VON HI, WALLER C.Safety of human albumin based on spontaneously reported serious adverse events[J]. Crit Care Med, 2001, 29(5): 994-6. [16] VINCENT JL, WILKES MM, NAVICKIS RJ.Safety of human albumin-serious adverse events reported worldwide in 1998-2000[J]. Br J Anaesth, 2003, 91(5): 625-630. [17] LIAO LL.One case of allergic reaction caused by intravenous infusion of human serum albumin[J]. Chin J Clin Rational Drug Use(临床合理用药杂志), 2017, 10(16): 13-15. [18] NIU YH, LEI ZB.25 cases analysis of anaphylactic shock induced by human albumin injection[J]. World Clinical Drugs(世界临床药物), 2014, 35(12): 752-755. [19] YU M.A case of severe allergic reaction caused by human serum albumin.[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2011, 8(5): 320. [20] WNAG MY.Two deaths caused by allergic reaction of human albumin injection[J]. China Pharmaceuticals(中国药业), 2011, 20(20): 83-84. [21] BAI WJ, AN J, QIU ZH, et al.A case of allergic asthma caused by human albumin injection[J]. Chinese Journal of Modern Applied Pharmacy(中国现代应用药学), 2015, 32(9): 1143-1146. [22] ZHANG F, LIU X, TAN Z, et al.Effect of postoperative hypoal-buminemia and supplement of human serum albumin on the development of surgical site infection following spinal fusion surgery: a retrospective study[J]. Eur Spine J, 2020, 29(7): 1483-1489. [23] COOPER DJ, MYBURGH J, HERITIER S, et al.Albumin resuscitation for traumatic brain injury: is intracranial hypertension the cause of increased mortality?[J]. J Neurotrauma, 2013, 30(7): 512-518. [24] University Hospital Consortium. Guidelines for use of albumin.(Revised-2005&2010)[EB/OL].(2019-04-28)[2021-02-25]. https://www.universityhealthsystem.com/~/media/files/clinical-pathways/albumin-guidelines-0410. [25] SATOSHI Y, SHIGEYOSHI M, MASANORI M, et al. Evidence-based guidelines for the use of albumin products[EB/OL].(2017-03-25)[2021-02-25]. http://www.jstage.jst.go.jp/artical/jjtc/63/5/5/63 641/ pdf/-char/ja. [26] ALDERSON P, BUNN F, LI W, et al. Human albumin solution for resuscitation and volume expansion in critically ill patients[J]. Cochrane Database Syst Rev, 2011(10): CD001208. [27] PATEL A, LAFFAN MA, WAHEED U, et al.Randomised trials of human albumin for adults with sepsis: systematic review and meta-analysis with trial sequential analysis of all-cause mortality[J]. BMJ, 2014, 349: g4561. [28] GUO YC, JIANG CM, SU WB.Meta-analysis of the efficacy of recombinant human growth hormone and human serum albumin in the treatment of hypoproteinemia in cirrhosis[J]. Chinese Journal of Primary Medicine and Pharmacy(中国基层医药), 2020, 27(23): 2825-2829. [29] YANG J, NING QQ, WU J, et al.Clinical effect of human serum albumin versus artificial colloidal fluid in patients with cirrhotic: a meta-analysis[J]. Journal of Clinical Hepatology(临床肝胆病杂志), 2019, 35(1): 82-86. [30] LI YY, LI JW, JIANG C, et al.Efficacy and safety of human serum albumin in the treatment of acute ischemic stroke: a systematic review[J]. Chinese Journal of Practical Nervous Diseases(中国实用神经疾病杂志), 2018, 21(22): 2487-2493. [31] ZHAN HQ, LIU H, SUN N.Efficacy and safety of human serum albumin treatment in pafients with ascites due to cirrhosis:a meta-analysis[J]. Adverse Drug Reactions Journal(药物不良反应杂志), 2014, 16(2): 100-106. [32] MIKKAT S, DOMINIK A, STANGE J, et al.Comparison of accompanying proteins in different therapeutic human serum albumin preparations[J]. Biologicals, 2020, 64: 41-48. [33] FANG L, PARTI R, HU P.Characterization of N-acetyltryptophan degradation products in concentrated human serum albumin solutions and development of an automated high performance liquid chromatography-mass spectrometry method for their quantitation[J]. J Chromatogr A, 2011, 1218(41): 7316-7324. [34] KHLYBOVA EV, KORMSHCHIKOVA ES, DROBKOVA AV, et al.A chromatographic method for assay of sodium caprylate in the formulation“albumin, solution for infusions”[J]. Pharmaceutical Chemistry Journal, 2017, 51(3): 235-238. [35] WANG ML,YANG PY, XU M, et al.Establishment of a method for determination of molecular-size distribution of human serum albumin by ultra performance liquid chromatography[J]. Chinese Pharmaceutical Journal(中国药学杂志), 2018, 53(13): 1110-1116. [36] ZHAO MF, WANG X, LI RZ, et al.Determination of sodium caprilate in the human albumin semi-finished product by gas chromatography[J]. Drug Stand China(中国药品标准), 2017, 18(1): 37-40. [37] LI RZ, ZHAO J, LI QY, et al.Study on two methods of sodium caprilate assay determination in human serum albumin[J]. Qilu Pharm Aff(齐鲁药事), 2014, 33(2): 85-86. [38] TANAKA K, SAWATANI E, SHIGUEOKA EM, et al.Isolation of bovine plasma albumin by liquid chromatography and its polymerization for use in immunohematology[J]. Braz J Med Biol Res, 2001, 34(8): 977-983. [39] HUANG JH, HOU M, QIU L, et al.Flame atomic absorption spectrometry determination of kalium and sodium in human serum albumin[J]. Journal of Guilin University of Technology(桂林工学院学报). 2009, 29(4): 528-530. [40] SFDA. Notice on Severely Investigating and Punishing Guangdong Danxia Bio-Pharmaceutical Co. Ltd. for Tampering with Human Albumin Stability Data (2017-81)[EB/OL].(2017-06-01)(2018-06-30). https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20170601173901851.html. [41] GUO JH, XIE YY, KE BB.Quality evaluation and research of human albumin[J]. Chin Pharm J(中国药学杂志), 2019, 54(9): 734-740. [42] FDA. Code of Federal Regulations Title 21 (Food and Drugs) Part 640[EB/OL]. (2008-04-01)[2018-06-30].http://www.acce-ssdata.Fda.gov /scripts/ cdrh/cfcfr/cfrseareh.cfm. [43] FDA. Guide to inspections of source plasma establishments[EB/OL].(1997-09)[2018-06-30]. http://www.fda.Gov/ora/inspectref/igs/Source Plasma/default.htm. [44] EMEA. Note for guidance on plasma-derived medicinal products[EB/OL]. (2001-07-23)[2018-06-30]. http://www.emea.europa.Eu/pdfs/human/bwp/45208107en.pdf. [45] TOLEDO LAK, NOBLAT ACB, NASCIMENTO HFD, et al.Economic evaluation of human albumin use in patients with nephrotic syndrome in four Brazilian public hospitals: pharmacoeconomic study[J]. Sao Paulo Med J, 2017, 135(2): 92-99. [46] LIU XL, ZHENG LY.Economic evaluation of closed human blood albumin infusion based on the risk of nosocomial acquired infection[J]. Adverse Drug Reactions Journal(药物不良反应杂志). 2019(6): 425-430. |