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重组生物技术类药物不良反应研究进展

花匠小妙招
2024-08-14 19:33

[1]RAZAGHI A,OWENS L,HEIMANN K.Review of the rec-ombinant human interferon gamma as an immunothe-rapeutic:impacts of production platforms and glycosylation[J].J Biotechnol,2016,240:48-60.

DOI:10.1016/j.jbiotec.2016.10.022 URL

[本文引用:3][2]DONG M X,HU Q C,SHEN P,et al.Recombinant tissue plasminogen activator induces neurological side effects independent on thrombolysis in mechanical animal models of focal cerebral infarction:a systematic review and meta-analysis[J].PLoS One,2016,11(7):e0158848.

DOI:10.1371/journal.pone.0158848 URL

[本文引用:1][3]WATSON S E,ROGOL A D.Recent updates on recombinant human growth hormone outcomes and adverse events[J].Cur Opin Endoc Diab Obes,2013,20(1):39-43.

Purpose of review;To provide up-to-date information on outcomes and adverse events associated with the use of recombinant human growth hormone (rhGH). We will focus on patients with Prader Willi Syndrome and Idiopathic Short Stature. We will also discuss recent reports on long-term adverse events from the European database.Recent findings;Prader Willi Syndrome is associated with hypogonadism, which does not appear to be affected by treatment with rhGH. However, there is new evidence that treatment may improve cognition. For patients with Idiopathic Short Stature, the gain in near adult height with treatment with rhGH appears to be 3-4 cm. Although a recent analysis of this group shows that certain patient characteristics may help identify those most likely to have a good response to treatment. Additionally, the safety and appropriateness of growth hormone treatments in Europe study released preliminary data from patients treated in two separate locations that showed conflicting information on risk of mortality from treatment with rhGH.Summary;lthough we will continue to receive new information regarding the safety and effects of treatment with rhGH, it is important to discuss the risks and benefits with our patients. Additionally, it is incumbent on us to help guide the treatment to those most likely to benefit.

DOI:10.1097/MED.0b013e32835b7ea8 PMID:23183360 URL

[本文引用:1][4]STRYJEWSKA A,KIEPURA K,LIBROWSKI T,et al.Bio-technology and genetic engineering in the new drug development.Part I.DNA technology and recombinant proteins[J].Pharm Rep Pr,2013,65(5):1075-1085.

DOI:10.1016/S1734-1140(13)71466-X URL

[本文引用:1][5]LEVY G,BONNEVALLE M,ROCOURT N,et al.Necroti-zing enterocolitis as an adverse effect of recombinant interleukin-2 and Ch14.18 in maintenance therapy for high-risk neuroblastoma[J].J Pediatr Hematol Oncol,2015,37(4):250-252.

DOI:10.1097/MPH.0000000000000304 URL

[本文引用:1][6]BONGIOVANNI A,MONTI M,FOCA F,et al.Recombinant granulocyte colony-stimulating factor (rG-CSF) in the management of neutropenia induced by anthracyclines and ifosfamide in patients with soft tissue sarcomas (NEUSAR)[J].Sup Care Can,2017,25(1):111-117.

DOI:10.1007/s00520-016-3390-0 URL

[本文引用:1][7]ZHANG Y,AXIAK-BECHTEL S,FRIEDMAN C C,et al.Evaluation of immunomodulatory effect of recombinant human granulocyte-macrophage colony-stimulating factor on polymorphonuclear cell from dogs with cancer in vitro[J].Vet Comp Oncol,2017,15(3):968-979.

DOI:10.1111/vco.2017.15.issue-3 URL

[本文引用:1][8]ZHU L,HUANG L,WEN Q,et al.Recombinant human erythropoietin offers neuroprotection through inducing endogenous erythropoietin receptor and neuroglobin in a neonatal rat model of periventricular white matter damage[J].Neurosci Lett,2017,650:12-17.

DOI:10.1016/j.neulet.2017.03.024 URL

[本文引用:1][9]ZAMANIAN S,MOHAMMADI-YEGANEH S,KIA V,et al.Design and validation of a new method to detect and quantify residual host cell DNA in human recombinant erythropoietin (rEPO)[J].Prep Biochem Biotechnol,2017,47(9):847-851.

DOI:10.1080/10826068.2017.1320292 URL

[本文引用:1][10]ZHOU X,SHEN L,LIU L,et al.Preclinical safety evaluation of recombinant adeno-associated virus 2 vector encoding human tumor necrosis factor receptor-immunoglobulin Fc fusion gene[J].Hum Vaccin Immunother,2016,12(3):732-739.

DOI:10.1080/21645515.2015.1090070 URL

[本文引用:1][11]LI Q,SUN W,YUAN D,et al.Efficacy and safety of recombinant human tumor necrosis factor application for the treatment of malignant pleural effusion caused by lung cancer[J].Thorac Cancer,2016,7(1):136-139.

DOI:10.1111/1759-7714.12296 URL

[本文引用:1][12]RIPAMONTI U,PARAK R,KLAR R M,et al.Cementoge-nesis and osteogenesis in periodontal tissue regeneration by recombinant human transforming growth factor-beta3:a pilot study in papio ursinus[J].J Clin Periodontol,2017,44(1):83-95.

DOI:10.1111/jcpe.12642 URL

[本文引用:1][13]SULISTYOWATI S,BACHNAS M A,ANGGRAINI N D,et al.Recombinant vascular endothelial growth factor 121 injection for the prevention of fetal growth restriction in a preeclampsia mouse model[J].J Perinat Med,2017,45(2):245-251.[本文引用:1][14]VELDKAMP C T,KOPLINSKI C A,JENSEN D R,et al.Production of recombinant chemokines and validation of refolding[J].Methods Enzymol,2016,570:539-365.[本文引用:1][15]LIU R,LUO F,LIU X,et al.Biological response modifier in cancer immunotherapy[J].Adv Exp Med Biol,2016,909:69-138.

DOI:10.1007/978-94-017-7555-7 URL

[本文引用:2][16]GARCIA P V,SEIVA F R,CARNIATO A P,et al.Increased toll-like receptors and p53 levels regulate apoptosis and angiogenesis in non-muscle invasive bladder cancer:mechanism of action of P-MAPA biological response modifier[J].BMC Cancer,2016,16:422.[本文引用:2][17]KORITZINSKY M.Metformin:a novel biological modifier of tumor response to radiation therapy[J].Int J Radiat Oncol Biol Phys,2015,93(2):454-464.

Over the last decade, evidence has emerged to support a role for the antidiabetic drug metformin in the prevention and treatment of cancer. In particular, recent studies demonstrate that metformin enhances tumor response to radiation in experimental models, and retrospective analyses have shown that diabetic cancer patients treated with radiation therapy have improved outcomes if they take metformin to control their diabetes. Metformin may therefore be of utility for nondiabetic cancer patients treated with radiation therapy. The purpose of this review is to examine the data pertaining to an interaction between metformin and radiation, highlighting the essential steps needed to advance our current knowledge. There is also a focus on key biomarkers that should accompany prospective clinical trials in which metformin is being examined as a modifying agent with radiation therapy. Existing evidence supports that the mechanism underlying the ability of metformin to enhance radiation response is multifaceted, and includes direct radiosensitization as well as a reduction in tumor stem cell fraction, proliferation, and tumor hypoxia. Interestingly, metformin may enhance radiation response specifically in certain genetic backgrounds, such as in cells with loss of the tumor suppressors p53 and LKB1, giving rise to a therapeutic ratio and potential predictive biomarkers.

DOI:10.1016/j.ijrobp.2015.06.003 PMID:26383681 URL

[本文引用:2][18]GHONEUM M,AGRAWAL S.Activation of human mono-cytederived dendritic cells in vitro by the biological response modifier arabinoxylan rice bran (MGN-3/Biobran)[J].Int J Immun Pharm,2011,24(4):941-948.

DOI:10.1177/039463201102400412 URL

[本文引用:1][19]韩丹,代菲,储文功.聚乙二醇干扰素α-2a注射液不良反应报告分析[J].药物流行病学杂志,2013,22(4):175-178.

目的:探讨聚乙二醇干扰素α-2a注射液不良反应发生的特点及相关因素,为临床安全用药提供参考。方法:收集某省药品不良反应监测中心2004～2011年自发呈报系统上报的1 606例聚乙二醇干扰素α-2a注射液的不良反应(ADR)报告,对ADR所涉及的患者年龄、性别,以及ADR年份、类型、结果、临床表现等进行统计分析。结果:1606例报告中,男883例,女723例,30～60岁患者最多(72.6%);发生严重不良反应243例,新的严重ADR 86例;临床表现以血液系统损害为主占59.95%,其次为肝胆系统损害占10.76%。结论:临床在运用聚乙二醇干扰素α-2a治疗丙肝的过程中,应密切观察其ADR,制定周密的护理计划,积极干预和防治,以有效减少和防止ADR发生。

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[本文引用:1][20]RACHMAWATI H,MERIKA A,NINGRUM R A,et al.Evaluation of adverse effects of mutein forms of recombinant human interferon alpha-2b in female swiss webster mice[J].Biomed Res Int,2013,2013:943687.[本文引用:1][21]TERAGAWA H,HONDO T,AMANO H,et al.Adverse eff-ects of interferon on the cardiovascular system in patients with chronic hepatitis C[J].Jap Heart J,1996,37(6):905-915.

Abstract The therapeutic effects of interferon in chronic hepatitis C and many of its adverse effects have been well documented. However, there are only a few reports regarding its adverse effects on the cardiovascular system. The aim of this study was to clarify the clinical features of the adverse effects of interferon on the cardiovascular system in patients with chronic hepatitis C. We monitored 295 patients with chronic active hepatitis C during 312 courses of interferon therapy and for 1 year after the end of treatment for the presence of cardiovascular adverse effects. We found 6 patients with cardiovascular adverse effects during interferon therapy and 4 more patients within 1 year after the end of therapy (10/312, 3.2%). The adverse effects of interferon on the cardiovascular system included arrhythmia (n = 4), ischemic heart disease (n = 4) and myocardial disease (n = 2). None of the clinical factors, including history of cardiovascular disease, were related to these cardiovascular adverse effects. In all instances the patient's condition improved after discontinuation of interferon and adequate therapy. The cardiovascular adverse effects of interferon occurred frequently in patients with chronic hepatitis C, even after the end of therapy and they were unpredictable. Thus, all patients undergoing interferon therapy should be monitored not only during but also after the end of treatment.

DOI:10.1536/ihj.37.905 PMID:9057685 URL

[本文引用:2][22]张晓杰,史淑颖,张玉平,等.重组干扰素α-2b治疗急性丙型肝炎46例的护理[J].中国误诊学杂志,2009,9(11):2686-2686.

笔者用重组干扰素α-2b治疗了46例急性丙型肝炎试图阻断其向慢性化的发展，由于于扰素的不良反应，致使大多数患者用药后出现不同程度的临床症状，通过加强临床护理，保证患者在用药期间的治疗效果，护理体会如下。

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[本文引用:1][23]王小虹,雷莹辉,戴亦晖.重组人干扰素α-2b诱发急性左心衰竭1例[J].药物不良反应杂志,2007,9(3):381-381.[本文引用:1][24]张玉秋,黄祥.99例干扰素的不良反应分析[J].药物不良反应杂志,2003,5(5):308-311.

目的:了解干扰素的不良反应。方法:检索1993～2002年间国内医药学期刊有关文献,对干扰素引起的不良反应进行调查分析。结果:99例患者因使用干扰素发生不良反应153例次,用药初期多为流感样症状,反复多次用药后不良反应可累及多个器官/系统。结论:干扰素引起的不良反应大多轻微而可逆,但也有部分为严重的,甚至是致死的反应。提示临床应加强用药监测,以预防和减少不良反应的发生。

DOI:10.3969/j.issn.1008-5734.2003.05.007 Magsci URL

[本文引用:2][25]黄汝刚,姚艳秀,齐国先.干扰素致严重心脏毒性1例及文献分析[J].药物流行病学杂志,2006,15(5):308-309.

正干扰素(interferon,IFN)是细胞对病毒感染和各种合成及生物诱生作用反应而分泌的一类蛋白质,具有抑制病毒复制、免疫调节及抗肿瘤等多种效应。目前应用于临床的干扰素主要有α、β、γ3种,主要用于抗病毒、抗恶性肿瘤、治疗慢

DOI:10.3969/j.issn.1005-0698.2006.05.020 URL

[本文引用:2][26]陈海燕,吕水兰,边彩萍,等.重组人粒细胞刺激因子注射液不良反应及其护理[J].中国美容医学杂志,2011,20(4):195-195.

重组人粒细胞刺激因子注射液(rhG-csF)商品名瑞白,为利用基因重组技术生产的人粒细胞刺激因子.用于预防中性粒细胞减少症的发生,减轻中性粒细胞减少的程度,缩短粒细胞缺乏症的持续时间,加速粒细胞数的恢复.

DOI:10.3969/j.issn.1008-6455.2011.z4.186 URL

[本文引用:1][27]北京市造血干细胞移植协作组.应用重组人粒细胞集落刺激因子的经验与教训专题讨论[J].白血病·淋巴瘤,2007,16(1):1-5.

篇首：主持人:田丁(100053,首都医科大学宣武医院血液科)重组人粒细胞集落刺激因子(recombinant human granulocyte-colony Stimulating factor,rhG-CSF)是一个基因的产品,其商品化产品众多,如格拉诺赛特(Granocyte),惠尔血(Gran)、洁欣、吉赛欣、促粒素、粒升素和特尔津等,已广泛地应用于临床.

DOI:10.3760/cma.j.issn.1009-9921.2007.01.001 Magsci URL

[本文引用:1][28]袭荣刚,弓小雪.重组人粒细胞集落刺激因子致休克1例[J].中国误诊学杂志,2010,10(3):754-755.

篇首： 1 病历摘要男,35岁.因周身乏力6个月余入院.诊断为急性非淋巴细胞白血病M2a型,先后在我院治疗3次.本次住院10 d后患者第1次静脉滴注重组人细胞刺激因子出现明显胸闷、喘憋、躁动不安.

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[本文引用:1][29]刘晓玲,郭颖,张玎.重组人粒细胞集落刺激因子注射液致精神异常1例[J].中国医院药学杂志,2010,30(16):1423-1424.[本文引用:1][30]AKIZUKI S,MIZOROGI F,INOUE T,et al.Pharmacokine-tics and adverse events following 5-day repeated administration of lenograstim,a recombinant human granulocyte colony-stimulating factor,in healthy subjects[J].Bone Marrow Transplant,2000,26(9):939-946.

DOI:10.1038/sj.bmt.1702641 URL

[本文引用:1][31]刘秀香. 重组人白介素-2引起严重心律失常1例报告[J].吉林医学,2011,32(32):6976-6976.

重组人白介素-2为淋巴细胞增殖所需要的调控因子,对B细胞、 NK细胞、抗体依赖性杀伤细胞和LAK细胞等具有促进分化增殖的作用[1].临床广泛应用于各种癌症合并胸腹水患者的治疗.此例患者在首次胸腔积液治疗时,共用此药6次,仅第一次灌注时出现发热,其余次未见异常.4个月后再次用此药胸腔灌注时,两次均出现严重心律失常.

DOI:10.3969/j.issn.1004-0412.2011.32.163 URL

[本文引用:1][32]陈栋晖,吴晴.重组人白介素-11治疗化疗引起的血小板减少症的临床研究[J].中华肿瘤防治杂志,2007,14(19):1506-1507.

为观察国产重组人白介素-11(rhIL-11)对恶性肿瘤患者化疗所致血小板减少的疗效及其不良反应,采用自身对照研究的方法,对16例曾因化疗引起血小板减少的恶性肿瘤患者,给予rhIL-11预防性治疗。结果:在可评价疗效的14例患者中,PLT最低值对照周期为(50.71±14.95)×109L-1,低于治疗周期(68.71±24.91)×109L-1。PLT≤75×109L-1的平均天数对照周期为(8.57±3.13)d,治疗周期为(3.43±3.28)d。PLT≤50×109L-1的平均天数对照周期为(2.00±2.48)d,治疗周期为(0.57±0.94)d。血小板≤75×109L-1天数、≤50×109L-1天数均少于对照周期,血小板恢复至80×109L-1所用天数也快于对照周期。无患者输注血小板。毒副反应以水肿、发热为主。初步研究结果提示,国产rhIL-11能降低血小板减少的幅度,并能减少血小板处于危险期的持续时间。不良反应轻、耐受性好。

DOI:10.3969/j.issn.1673-5269.2007.19.022 URL

[本文引用:1][33]郭代红,李念稚,刘述文,等.重组人促红细胞生成素应用评价及影响因素分析[J].药物流行病学杂志,2010,19(6):333-336.[本文引用:1][34]尹静. 血液透析重组促红细胞生成素应用52例疗效观察及护理[J].基层医学论坛,2008,12(30):957-958.

正为纠正慢性肾功能衰竭(CRF)患者在维持性血液透析中依赖输血的严重贫血,避免输血所诱发的各种疾病与不良反应,改善生活质量,为肾移植创造条件,我科自2005年-2008年4月在CRF血透贫血患者中使用重组促红细胞生成素52例,效果满意。现报告如下。

DOI:10.3969/j.issn.1672-1721.2008.30.087 URL

[本文引用:1][35]STEINBERG H,SARAVAY S M,WADHWA N,et al.Eryth-ropoietin and visual hallucinations in patients on dialysis[J].Psychosomatics,1996,37(6):556-563.

Abstract The authors encountered five patients who first had visual hallucinations while taking erythropoietin. Since this association had not previously been reported, the authors studied a convenience sample of dialysis patients at two institutions to determine the incidence of visual hallucinations in patients on erythropoietin and possible associated risk factors. Eleven percent of the patients had visual hallucinations at one institution with no other factor than erythropoietin as a probable cause and 2% at the other. Significant risk factors for hallucinations included diabetic retinopathy or cataracts (chi 2 = 4.59, df = 1, P = 0.032) and older age (t = 2.24, df = 123, P = 0.27). A multivariate analysis comparing visual hallucinations, eye pathology, and age showed that eye pathology was close to the trend level of significance but that age maintained significance as a risk factor. The visual hallucinations occurred in response to the administration of erythropoietin and appeared to vary in relation to dose. Similarities between the syndrome of visual hallucinations in dialysis patients taking erythropoietin and the syndrome of visual hallucinations in dialysis patients taking erythropoietin and the Charles Bonnet syndrome are discussed.

DOI:10.1016/S0033-3182(96)71519-0 PMID:8942206 URL

[本文引用:1][36]张龙凤,李红,王剑锋.促红细胞生成素引起纯红细胞再生障碍性贫血病例一例报告[J].世界最新医学信息文摘:电子版,2016,16(33):156.[本文引用:1][37]刘瑶,王京华.重组人促红细胞生成素相关纯红细胞再生障碍性贫血的研究进展[J].临床荟萃,2012,27(22):2006-2009.

正自从20世纪80年代以来,重组人促红细胞生成素(recombinant human erythropoietin,rhuEPO)在临床广泛应用治疗肾性或非肾性贫血。它可以使长期透析的肾病患者脱离了长期以来对血制品输注的依赖,同时避免了输血带来的风险,使肾病患者的贫血改善,心肌缺血症状好转,改善生命质量。但近年

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[本文引用:1][38]顾建阳. 重组人干扰素α-1b的纯化工艺研究[D].长春:吉林大学,2011:19-23.[本文引用:1][39]赵利斌. 干扰素治疗慢性丙型肝炎的特殊副作用[J].国际流行病学传染病学杂志,1997,24(3):105-108.

干扰素治疗慢性丙型肝炎时可诱发某些特殊副作用。虽然其发生率并不高,但危害有时是致命的。本文就干扰素治疗丙型肝炎时所诱发的特殊副作用及其发生机理相对策作一综述。

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[本文引用:1][40]崔宝珠. 重组人白介素-2相关的心房纤颤[J].药物不良反应杂志,2009,11(3):214-215.

<P><FONT face=Verdana>1例87岁男性患者因肾癌肺转移合并肺部感染入院治疗。入院后患者心电图示房性期前收缩伴偶发室性期前收缩，予以头孢唑肟和左氧氟沙星治疗。住院第5天给予重组人白介素-22 100万U + 0.9%氯化钠注射液100 ml静脉滴注。次日，患者出现阵发性心房纤颤，2～3次/d，每次持续1～2 min；4 d后心房纤颤频繁发作，发作时间有时10余分钟。给予普罗帕酮100 mg，3次/d口服，效果不佳。考虑可能和重组人白介素-2有关，即刻停药。之后，患者心电图未再出现心房纤颤。</FONT></P>

DOI:10.3969/j.issn.1008-5734.2009.03.024 Magsci URL

[本文引用:1][41]HELMY A,GUILFOYLE M R,CARPENTER K L,et al.Recombinant human interleukin-1 receptor antagonist promotes M1 microglia biased cytokines and chemokines following human traumatic brain injury[J].J Cereb Blood Flow Metab,2016,36(8):1434-1448.

DOI:10.1177/0271678X15620204 URL

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