Research progress in human serum albumin injections

doi:10.19803/j.1672-8629.2022.02.27

Abstract

Abstract: Human serum albumin (HSA) injections based on the “Guidelines for Comprehensive Evaluation of Chinese Drugs”were evaluated. The guidelines for diagnosis and treatment, pharmacopoeias, drug inserts, literature and official data related to HSA injections were consulted, while the safety, efficacy, compliance, cost, and clinical value of HSA were assessed. HSA injections are widely used in clinical practice and are quite safe, but they are too expensive and have not yet entered the national medical insurance catalogue. HSA injections have been recommended by guidelines in many countries for the treatment of such diseases as liver cirrhosis and hypovolemic shock, but there are still cases of inappropriate medication.

Key words: human serum albumin injection, drug evaluation, rational drug use, adverse drug reaction

CLC Number:

R994.11

LU Song, YANG Ping, YANG Li, DONG Xianzhe, ZHANG Lan. Research progress in human serum albumin injections[J]. Chinese Journal of Pharmacovigilance, 2022, 19(2): 228-232.

References

[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.