Preparation and application of a novel monoclonal antibody specific for the heat shock protein 60 of Lawsonia intracellularis

Porcine proliferative enteropathy(PPE),an important infectious disease in pig production caused by an obligate intracellular bacterium Lawsonia intracellularis,is commonly associated with diarrhea and reduced weight gain in growing pigs widespread.An accurate method for detecting L.intracellularis is particularly important for preventing and controlling PPE.Heat shock protein 60(Hsp60)is an immunodominant bacterial antigen found in all eukaryotic and prokaryotic organisms.Thus,the purpose of the current investigation was to produce a novel L.intracellularis Hsp60 monoclonal antibody(mAb)useful for immunodiagnostics.Three hybridomas secreted anti-Hsp60 termed 3E5,4E2,and 9G6 were generated,and the titers of ascitic fluids of 3E5,4E2,9G6 were 1:1024000,1:2048000 and 1:2048000,respectively.The Western blotting analysis demonstrated that recombinant Hsp60(rHsp60)was recognized by mAbs 3E5,4E2 and 9G6.Subsequently,analyses of specificity showed all the mAbs were highly specific to L.intracellularis while could not significantly react with other enteric bacteria commonly found in the ileum of pigs,such as Escherichia coli,Salmonella Choleraesuis,Salmonella Typhimurium,and Brachyspira hyodysenteriae.Furthermore,the mAbs were useful for detecting L.intracellularis in the infected monolayer cells and histological sections of the ileum from PPE-affected pigs.Our research will provide a foundation for the development of immunological diagnostic tests.

Monoclonal antibody targeting mu-opioid receptor attenuates morphine tolerance via enhancing morphine-induced receptor endocytosis

Morphine is a frequently used analgesic that activates the mu-opioid receptor(MOR),which has prominent side effects of tolerance.Although the inefficiency of morphine in inducing the endocytosis of MOR underlies the development of morphine tolerance,currently,there is no effective therapy to treat morphine tolerance.In the current study,we aimed to develop a monoclonal antibody(mAb)precisely targeting MOR and to determine its therapeutic efficacy on morphine tolerance and the underlying molecular mechanisms.We successfully prepared a mAb targeting MOR,named 3A5C7,by hybridoma technique using a strategy of deoxyribonucleic acid immunization combined with cell immunization,and identified it as an immunoglobulin G mAb with high specificity and affinity for MOR and binding ability to antigens with spatial conformation.Treatment of two cell lines,HEK293T and SH-SY5Y,with 3A5C7 enhanced morphine-induced MOR endocytosis via a G protein-coupled receptor kinase 2(GRK2)/b-arrestin2-dependent mechanism,as demonstrated by immunofluorescence staining,flow cytometry,Western blotting,coimmunoprecipitation,and small interfering ribonucleic acid(siRNA)-based knockdown.This mAb also allowed MOR recycling from cytoplasm to plasma membrane and attenuated morphine-induced phosphorylation of MOR.We established an in vitro morphine tolerance model using differentiated SH-SY5Y cells induced by retinoic acid.Western blot,enzyme-linked immunosorbent assays,and siRNA-based knockdown revealed that 3A5C7 mAb diminished hyperactivation of adenylate cyclase,the in vitro biomarker of morphine tolerance,via the GRK2/b-arrestin2 pathway.Furthermore,in vivo hotplate test demonstrated that chronic intrathecal administration of 3A5C7 significantly alleviated morphine tolerance in mice,and withdrawal jumping test revealed that both chronic and acute 3A5C7 intrathecal administration attenuated morphine dependence.Finally,intrathecal electroporation of silencing short hairpin RNA illustrated that the in vivo anti-tolerance and anti-dependence efficacy of 3A5C7 was mediated by enhanced morphine-induced MOR endocytosis via GRK2/b-arrestin2 pathway.Collectively,our study provided a therapeutic mAb,3A5C7,targeting MOR to treat morphine tolerance,mediated by enhancing morphine-induced MOR endocytosis.The mAb 3A5C7 demonstrates promising translational value to treat clinical morphine tolerance.

Clinical application of SARS-CoV-2 antibody detection and monoclonal antibody therapies against COVID-19

The purpose of this study was to investigate the clinical application of severe acute respiratory distress syndrome coronavirus-2(SARS-CoV-2)specific antibody detection and anti-SARS-CoV-2 specific monoclonal antibodies(mAbs)in the treatment of coronavirus infectious disease 2019(COVID-19).The dynamic changes of SARS-CoV-2 specific antibodies during COVID-19 were studied.Immunoglobulin M(IgM)appeared earlier and lasted for a short time,while immunoglobulin G(IgG)appeared later and lasted longer.IgM tests can be used for early diagnosis of COVID-19,and IgG tests can be used for late diagnosis of COVID-19 and identification of asymptomatic infected persons.The combination of antibody testing and nucleic acid testing,which complement each other,can improve the diagnosis rate of COVID-19.Monoclonal anti-SARS-CoV-2 specific antibodies can be used to treat hospitalized severe and critically ill patients and non-hospitalized mild to moderate COVID-19 patients.COVID-19 convalescent plasma,highly concentrated immunoglobulin,and anti-SARS-CoV-2 specific mAbs are examples of anti-SARS-CoV-2 antibody products.Due to the continuous emergence of mutated strains of the novel coronavirus,especially omicron,its immune escape ability and infectivity are enhanced,making the effects of authorized products reduced or invalid.Therefore,the optimal application of anti-SARS-CoV-2 antibody products(especially anti-SARS-CoV-2 specific mAbs)is more effective in the treatment of COVID-19 and more conducive to patient recovery.

UV/Vis-based process analytical technology to improve monoclonal antibody and host cell protein separation

Process analytical technology(PAT) is gaining more interest in the biomanufacturing industry because of its potential to improve operational control and compliance through real-time quality assurance.Currently, biopharmaceutical producers mainly monitor chromatographic processes with ultraviolet/visible(UV/Vis) absorbance. However, this measurement has a very limited correlation with purity and quantity. The current study aims to determine the concentration of monoclonal antibody(mAb) and host cell proteins(HCPs) using a build-in UV/Vis monitoring during Protein A affinity chromatography and to optimize the separation conditions for high purity of mAb and minimizing the HCPs content. The eluate was analyzed through in-line UV/Vis at 280 and 410 nm, representing mAb and HCPs concentration,respectively. Each 0.1 column volume(CV) fraction of UV/Vis chromatogram peak area were calculated,and different separation conditions were then compared. The optimum conditions of mAb separation were found as 12 CV loading, elution at pH 3.5, and starting the collection at 0.5 CV point, resulting in high m Ab recovery of 95.92% and additional removal of 49.98% of HCP comparing with whole elution pool. This study concluded that UV/Vis-based in-line monitoring at 280 and 410 nm showed a high potential to optimize and real-time control Protein A affinity chromatography for mAb purification from HCPs.

Therapeutic Implications of Monoclonal Antibody

Background: The coronavirus disease 2019 (COVID-19) pandemic is a distinct public health issue that calls for the quick development of novel treatments and viral detection. Due to their high specificity and reliability, monoclonal antibodies (mAbs) have emerged as useful diagnostic and therapeutic tools for a variety of diseases. As a result, several scientists have jumped right into developing Ab-based assays for the identification of SARS-CoV-2 and Ab drugs for use as COVID-19 therapy agents. Since the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein is essential for viral infection and has a known precise structure, it has become a key target for the creation of therapeutic antibodies. The use of Ab cocktails is anticipated to be a key component of an efficient COVID-19 treatment plan since SARS-CoV-2 is an RNA virus with a high mutation rate, particularly when subjected to the selection pressure of aggressively applied preventive vaccinations and neutralizing Abs. Furthermore, SARS-CoV-2 infection could provoke an overzealous immune response, leading to a cytokine storm that accelerates the onset of a severe disease. Abs to counteract cytokine storms are also actively being researched as COVID-19 therapies. Abs are now used in SARS-CoV-2 detection assays, including immunoglobulin and antigen tests, in addition to their use as medicines. In order to stop the spread of COVID-19, such Ab-based detection tests are essential surveillance tools. In this article, we’ll go over several important ideas related to mAb-based COVID-19 pandemic detection tests and treatments. Objective: To understand the role of hybridoma technology in therapeutic implications. 1) To study the basic concepts and options in hybridoma technology;2) To study the applications of hybridoma technology;3) To explore how hybridoma technology is applied in diagnostic histopathology. Method: For this method generally there is use of mouse or mammals are transfect with the Ags to find out the formation of antibody afterwards isolate the antibody which has been formed after injecting the antigens for a number of weeks. Following are the steps for mAbs: Step 1: In this step immunization of mouse is done;Step 2: Spleen is used for the isolation of B cells;Step 3: Cultivation of cancerous cells;Step 4: Merging of B cells with Myeloma cells;Step 5: This step cell lines are separated;Step 6: in the next step screening the suitable cell lines;Step 7: observation of multiplication in vitro as well as in vivo;Step 8: Harvesting. Discussion: Now a day there are many diseases which has been cured easily at the mean time it’s very difficult to diagnose and get the treatment. Due to advancement of monoclonal antibodies are used in the diagnosis and treatments such as COVID-19, SARS and SARS COV-2. Therefore important part of the monoclonal antibodies are its used in the diagnosis as well as in the treatment tools.

抗IgE单克隆抗体联合变应原特异性免疫治疗的应用进展

抗IgE单克隆抗体目前已被批准用于治疗哮喘和慢性荨麻疹,同时抗IgE单克隆抗体联合变应原特异性免疫治疗(AIT)作为过敏性疾病的辅助治疗已引起普遍关注。研究表明,在AIT治疗中或治疗前添加抗IgE单克隆抗体可显著减少AIT不良反应的发生频率和严重程度,明显改善症状评分,缩短达到维持剂量所需的时间。目前仍需要更大规模的高质量对照试验更好地识别抗IgE单克隆抗体联合AIT的获益人群,以及治疗最佳剂量和持续时间,并评估长期效益、进行成本-效益分析。本文就抗IgE单克隆抗体在AIT中作为辅助治疗的应用进展进行综述。

PD-1单抗后线辅助治疗晚期结直肠癌患者对胃肠功能、肿瘤标志物的影响

目的分析程序性死亡受体-1(PD-1)单抗后线辅助治疗晚期结直肠癌患者对胃肠功能、肿瘤标志物的影响。方法前瞻性选取2020年1月至2023年1月海口市人民医院收治的105例晚期结直肠癌患者为研究对象,按照随机数字表法将患者分为对照组(n=50)、研究组(n=55)。对照组采用阿帕替尼治疗,研究组在对照组的基础上联合PD-1单抗后线治疗,3周为1个疗程,共治疗4个疗程。比较两组的临床疗效、胃肠功能改善时间,治疗前、治疗12周后的肿瘤标志物[癌胚抗原、糖类抗原(CA)72-4、CA199]、免疫功能(CD4^(+)、CD8^(+)、CD4^(+)/CD8^(+))指标以及不良反应发生情况。结果治疗12周后,研究组的客观缓解率(ORR)、病情控制率(DCR)分别为78.33%、90.91%,均高于对照组(58.00%、70.00%),差异均有统计学意义(P<0.05)。研究组患者的首次排便时间、首次排气时间、肠鸣音消退时间分别为(51.50±5.02)、(35.52±4.25)、(44.28±4.80)d,均短于对照组[(69.37±6.40)、(50.63±5.10)、(53.50±6.15)d],差异均有统计学意义(P<0.05)。治疗12周后,研究组癌胚抗原、CA72-4、CA199水平分别为(12.57±1.64)ng/mL、(17.60±3.45)U/mL、(58.29±8.70)kU/L,均低于对照组[(17.24±2.50)ng/mL、(27.59±4.67)U/mL、(82.65±12.29)kU/L],差异均有统计学意义(P<0.05)。治疗12周后,研究组CD4^(+)、CD4^(+)/CD8^(+)水平分别为(21.42±3.54)%、0.73±0.30,均低于对照组[(28.39±4.38)%、1.12±0.41],CD8^(+)水平为(30.36±4.52)%,高于对照组[(25.71±3.30)%],差异均有统计学意义(P<0.05)。研究组的不良反应发生率为9.09%,稍低于对照组(16.00%),但两组比较差异无统计学意义(P>0.05)。结论通过PD-1单抗后线辅助治疗可有效改善晚期结直肠癌患者的临床疗效,效果明显,改善胃肠功能,降低肿瘤标志物指标水平,调节机体免疫功能,可为临床干预此病提供参考。

狂犬病暴露后预防性单克隆抗体药物研究进展

简要介绍狂犬病的流行现状、发病机制、狂犬病病毒G蛋白中和抗原位点及其单克隆抗体的中和机制。重点介绍目前全球已上市或处于研发阶段的多种狂犬病病毒单克隆抗体药物的筛选发现技术、识别位点、作用方式以及体内外病毒中和效果,分析上述单克隆抗体在目前狂犬病暴露后治疗的应用推广中存在的问题,并针对当前狂犬病免疫球蛋白存在的血源供应、中和效价、质量控制及潜在病毒感染等问题,指出狂犬病病毒单克隆抗体研发的重要性,尤其是抗体的中和效价和中和广度,进而提出针对狂犬病病毒遗传谱系Ⅱ/Ⅲ的全人源单克隆抗体开发,以及针对G蛋白多个抗原位点的单克隆抗体鸡尾酒(mAb cocktail)疗法是当前在狂犬病暴露后预防性单克隆抗体药物研发中亟待解决的问题。

关于抗Aβ单克隆抗体的临床应用建议(2024版)

最新研发的抗Aβ单克隆抗体陆续在国内外获批上市,并逐渐应用于我国临床实践。为促进抗Aβ单克隆抗体在我国阿尔茨海默病治疗中更合理、安全的应用,本文结合抗Aβ单克隆抗体现有临床试验证据及阿杜卡单抗在上海交通大学医学院附属瑞金医院海南医院的临床应用经验,总结抗Aβ单克隆抗体的临床应用建议,包括临床用药指征、用药前评估及准备、用药时医嘱及注意事项、用药后临床监测,旨在为临床医师提供翔实的用药指导和建议。

猪细小病毒4型单克隆抗体制备及抗原表位鉴定

为了制备猪细小病毒(PPV)4型Cap蛋白单克隆抗体(mAb)并鉴定其抗原表位,试验采用原核表达的Cap重组蛋白免疫BALB/c小鼠,将其脾细胞与SP2/0细胞进行融合,通过酶联免疫吸附测定(ELISA)、血凝抑制(HI)和免疫过氧化物酶单层细胞试验(IPMA)筛选阳性克隆,最终获得2E7、4D6和5C9这3株特异性杂交瘤细胞株;然后用mAb对Cap蛋白多肽进行ELISA检测,鉴定分析其抗原表位。结果显示:4D6和5C9 mAb识别表位为线性表位,分别为387RRQDN^(391)和578QRKE^(581),而2E7 mAb识别的表位为构象表位;通过对Cap蛋白3D结构定位分析,387RRQDN^(391)和578QRKE^(581)抗原表位位于蛋白表面,且在PPV4亚型中高度保守,而与猪瘟病毒(CSFV)、猪伪狂犬病病毒(PRV)、猪圆环病毒2型(PCV-2)、猪繁殖与呼吸综合征病毒(PRRSV)、猪乙型脑炎病毒(JEV)和猪博卡病毒(PBoV)基因序列同源性低。本研究为PPV4诊断试剂的开发和新型疫苗的研制提供了参考。

牛支原体NM001株单克隆抗体的制备与鉴定

为获得抗牛支原体NM001株单克隆抗体,并评价其特性,以牛支原体分离株NM001作为抗原免疫6周龄BALB/c小鼠,利用杂交瘤技术和间接ELISA方法筛选到2株能稳定分泌抗牛支原体的单克隆抗体细胞,命名为2C5和7G3。其细胞上清的间接ELISA抗体效价分别为6.4×10^(3)和1.2×10^(4)。经亚型测定,单抗2C5和7G3均属于IgG1类,轻链均是λ型。制备腹水并对单抗进行纯化和特性鉴定,两株单抗的间接ELISA抗体效价分别为1.02×10^(5)和4.09×10^(5),且两株单抗与无乳支原体、山羊支原体山羊肺炎亚种、丝状支原体山羊亚种、绵羊肺炎支原体、牛巴氏杆菌均无交叉反应。Western Blot结果显示,2株单抗均能特异性识别牛支原体全菌蛋白中的相应蛋白。试验表明,单抗2C5和7G3能够与牛支原体发生特异性反应,从而为牛支原体血清学检测提供一定的物质基础。

抗H7N9流感病毒的单克隆抗体与胃组织的交叉反应研究

目的筛选鉴定与胃组织交叉反应的抗H7N9流感病毒的单克隆抗体,初步探讨流感病毒感染会引发肠道相关疾病的可能致病机制。方法利用H7N9流感病毒制备了大量的单克隆抗体,对制备的单克隆抗体运用ELISA方法进行亚型和效价测定,免疫组化对制备的单克隆抗体与组织的反应性进行筛选,巢式PCR分子生物学技术克隆单克隆抗体轻重链可变区序列。结果制备的单克隆抗体H7N9-71和H7N9-78均能与H7N9抗原特异性结合,抗体效价达1∶10~5,免疫组化结果表明H7N9-71、H7N9-78与人的胃组织能发生特异性反应,进一步的研究发现这两株单抗与小鼠胃组织能特异性结合。轻重链可变区序列结果证实二者为两株不同的单抗。结论H7N9流感病毒可能与胃组织之间存在异嗜性抗原,提示流感病毒感染可能与胃肠道疾病的发生存在某些关联。

半固体培养法制备非洲猪瘟病毒pA104R蛋白的单克隆抗体

为了快速、高效制备非洲猪瘟病毒(ASFV)单克隆抗体,本研究通过大肠杆菌系统表达并纯化了ASFV重组蛋白pA104R。以ASFV重组蛋白pA104R为抗原,分别比较了CpG ODN联合氢氧化铝佐剂和常规弗氏佐剂两种免疫策略,并重点比较半固体培养法和常规有限稀释法来制备ASFV pA104R单克隆抗体的效率。结果显示,本研究获得了相对分子质量为3.5×104的ASFV重组可溶性蛋白pA104R,通过其与CpG ODN联合氢氧化铝佐剂免疫小鼠,在第21 d即可达到融合要求,本试验方法(重组蛋白pA104R与CpG ODN联合氢氧化铝佐剂免疫)较重组蛋白pA104R与常规弗氏佐剂免疫节省14 d时间。通过半固体培养法筛选单克隆的试验周期比有限稀释法缩短28 d,并减少了亚克隆的工作量。半固体培养法获得5株阳性杂交瘤细胞,挑选效价较高的3株(9A4、9H6、11F5)进行鉴定,重链均为IgG,轻链均为KAPPA。纯化后的3株单克隆抗体针对pA104蛋白和全病毒蛋白质的效价分别达1∶160000~1∶320000和1∶200~1∶400。本研究优选了CpG ODN联合氢氧化铝佐剂结合半固体培养法筛选pA104R的单克隆抗体,为单克隆抗体制备提供了快速高效的新策略。

CD41单克隆抗体建立慢性免疫性血小板减少症小鼠模型失败的初步分析

目的:通过向Balb/c小鼠腹腔注射不同次数和不同剂量CD41单克隆抗体(MWReg30),探究该方法能否构建出一种稳定的慢性免疫性血小板减少症(ITP)模型,并在造模结束后采用党参提取液干预此模型小鼠,以明确其对造模小鼠异常血小板计数的调整作用。方法:首先,使用MWReg30的常用剂量对Balb/c小鼠建立慢性ITP模型,并在抗体注射结束后探究党参提取液对造模小鼠的影响;随后,分别对不同组别的小鼠进行MWReg30的2次注射和2倍剂量注射,明确注射次数和剂量的增加是否有助于建立慢性ITP模型。结果:向小鼠体内注射MWReg30的造模方式不能使Balb/c小鼠血小板数量长期维持低水平,并且通过增加抗体注射次数和剂量的方法也难以实现此目的。但是,MWReg30的2次注射和2倍剂量注射分别使小鼠血小板计数在抗体注射结束7 d内和14 d内反弹升高至较高水平,且低剂量党参提取液干预造模小鼠可使其异常升高的血小板数量呈现下降趋势。结论:对小鼠腹腔注射MWReg30的造模方法无法复制出稳定的慢性ITP模型,此方法能否成为一种理想的慢性ITP模型建立方式仍有待进一步证实。而增加MWReg30的注射剂量能够延长模型小鼠血小板计数低水平的维持时间;且低剂量的党参提取液可能会对造模小鼠异常升高的血小板数量起纠正作用。

抗鸡传染性贫血病毒VP2蛋白单克隆抗体的制备及其应用研究

为制备针对鸡传染性贫血病毒(Chicken infectious anemia virus,CIAV)的单克隆抗体,以CIAV的VP2原核表达蛋白作为抗原免疫小鼠,经杂交瘤技术获得3株能稳定分泌抗VP2蛋白特异性抗体的细胞株,进一步经IFA筛选出特异性和灵敏度俱佳的杂交瘤细胞Mab-VP2-4株,制备的小鼠腹水效价达到1∶2000。结果显示,制备的抗VP2蛋白单克隆抗体可与多株CIAV感染的MDCC-MSB1细胞发生特异性反应,而对EDSV、ALV、ILTV、ARV以及空白MDCC-MSB1细胞、CEF细胞等均无交叉反应,特异性良好,且应用于IFA方法时对CIAV感染的最低检出限为5 TCID 50。以该单克隆抗体对市场上10种不同来源的禽活疫苗进行病毒分离结合单克隆抗体IFA检测,同时与《中国兽药典》规定的鸡检查法进行对比检测,结果一致,均未检出CIAV污染。本研究制备了针对CIAV VP2蛋白的特异性单克隆抗体,为该病特异性诊断方法的建立奠定了基础。

生物制剂疗法在重度哮喘治疗中的研究进展

重度哮喘是需要第4级或第5级哮喘药物治疗才能够维持控制或即使在上述治疗下仍表现为“未控制”的哮喘。目前生物制剂疗法为重度哮喘患者提供了新的治疗方法。本文将对治疗重度哮喘的生物制剂进行综述,阐述现有生物制剂的作用机制、疗效和安全性等,并在此基础上对生物制剂疗法的发展方向进行展望。

抗白细胞介素-5单克隆抗体治疗哮喘效果的Meta分析

目的:系统评价抗白细胞介素-5(IL-5)单克隆抗体治疗哮喘的临床效果。方法:在PubMed、Embase和Cochrane对照试验中央注册中心检索有关抗IL-5单克隆抗体治疗哮喘的随机对照试验文献,检索时间为截至2024年3月,对数据采用CMA 2.0软件进行Meta分析。结果:纳入21篇文献,共8717例患者,试验组4593例,对照组4124例。Meta分析结果显示,在第1秒用力呼气容积(FEV1)、哮喘生活质量问卷评分、不良事件发生情况方面,试验组优于对照组。结论:抗IL-5单克隆抗体治疗哮喘的临床效果较好,可改善患者FEV1、生活质量,且安全性较高。

莫米松糠酸酯高特异性抗体制备及酶联免疫分析方法

莫米松糠酸酯(mometasone furoate,MF)是一种常见的糖皮质激素。为快速、便捷地监控MF的滥用情况,制备了MF单克隆抗体并建立了其竞争酶联免疫检测方法。将氨氧乙酸分别连接至MF和莫米松二糠酸酯(mometasone difuroate,MDF),合成了免疫半抗原和包被半抗原。免疫半抗原以活泼脂法连接钥孔血蓝蛋白获得全抗原,通过免疫小鼠、细胞融合及筛选获得能够稳定分泌抗MF单克隆抗体的细胞株,制备并纯化了抗体。该抗体的主要识别区域为MF的五元环区域,因此不和常见的64种糖皮质激素发生交叉反应。建立了基于异源包被的MF间接竞争酶联免疫检测法,其半抑制浓度(IC_(50))为1.2 ng/mL,对肌肉和肝脏的最低检出限分别为0.52μg/kg和0.59μg/kg。灵敏度相比于同源包被提升了20倍。使用60%甲醇水溶液提取动物组织的添加回收率为70%~82%。该方法能有效应用于动物组织中MF的快速筛查。

基于高通量表面等离子体共振技术筛选与TPBG具有高亲和力的单克隆抗体研究

目的探讨从制备的单克隆抗体中快速筛选出与滋养层糖蛋白(TPBG)具有高亲和力的单克隆抗体的方法。方法采用高通量表面等离子体共振技术(SPR),将不同种属的TPBG通过氨基偶联的方式固定在GLC传感器芯片上,梯度稀释的抗体作为流通相,筛选能高度亲和TPBG的单克隆抗体,并测定相互作用的动力学常数。抗体1结合人和食蟹猴TPBG,亲和力分别为65.0、31.6 nmol/L;抗体6结合人、小鼠、食蟹猴TPBG,亲和力分别为77.6、92.1、87.7 nmol/L。结果该研究成功筛选出2种能与TPBG特异性结合的单克隆抗体。动力学图谱显示,这2种抗体与TPBG蛋白的特异性结合稳定。结论采用SPR可筛选出与TPBG蛋白具有高亲和力的单克隆抗体,为开发出一些新型的抗肿瘤药物提供一种方法。

近5年国家谈判的抗肿瘤药纳入医保的品种及适应症变化分析

目的统计2019年到2023年五版国家医保目录协议期内谈判的抗肿瘤药品种的变化及医保限定的支付病种范围的变更,重点对单克隆抗体和蛋白激酶抑制剂的部分特殊品种的适应症变化进行分析。方法以表格的形式罗列出五版国家医保目录协议期内谈判的各类抗肿瘤药的品种个数、纳入年份及医保限定的支付病种范围。结果五版国家医保目录中协议期内谈判的抗肿瘤药的品种总数呈逐年递增趋势,各类抗肿瘤药的品种数排前3位的均是蛋白激酶抑制剂、单克隆抗体、其他类抗肿瘤药。医保限定的支付病种涵盖各个系统的肿瘤,如呼吸系统、消化系统、血液系统、泌尿系统、乳腺等,其中呼吸系统所占比例最高。部分品种连续5年均进入国家谈判药品目录。结论传统的抗肿瘤药由于不良反应大,患者无法耐受,近年来已逐渐被新型抗肿瘤药所替代。但由于新型抗肿瘤药价格昂贵,患者又需要长时间使用,故需要国家干预,尽可能降低价格,方能满足肿瘤患者的用药需求和可及性,从而减轻经济负担,提高生活质量。