IVIG

摘要： 目的:探究干扰素雾化联合丙种球蛋白(IVIG)对手足口病合并病毒性脑炎患儿免疫球蛋白及T细胞亚群的影响。方法:随机选取2016年5月—2019年1月我院收治的手足口病合并病毒性脑炎患儿120例,使用随机数字表法将其分为单干扰素组、单IVIG组及联合组,每组40例,三组患者基础治疗方案一致,单干扰素组加用α2b干扰素治疗,单IVIG组加用IVIG治疗,联合组加用α2b干扰素联合IVIG治疗。比较三组患儿血清免疫球蛋白、T细胞亚群水平。结果:治疗前三组患儿lgA、lgG、lgE、lgM水平及血清CD3^(+)、CD4^(+)、CD8^(+)水平差异无统计学意义(P>0.05);治疗后,联合组lgA、lgG、lgE、lgM水平及血清CD3^(+)、CD4^(+)水平显著高于单干扰素组及单IVIG组(P<0.05),而CD8^(+)水平显著低于单干扰素组及单IVIG组(P<0.05)。结论:干扰素雾化联合IVIG治疗能有效改善手足口病合并病毒性脑炎患儿免疫球蛋白及T细胞亚群水平,缓解其免疫抑制症状,减轻患儿脑损伤。

摘要： 目的:比较重组人促血小板生成素(rhTPO)与静脉注射丙种球蛋白(IVIG)联合糖皮质激素治疗初治重症原发免疫性血小板减少症(ITP)的有效性及安全性.方法:将66例初治重症ITP患者分为观察组(n=32)和对照组(n=34).观察组采用rhTPO联合糖皮质激素治疗,对照组采用IVIG联合糖皮质激素治疗,比较两组治疗后血小板计数的变化、总反应率、起效及疗效维持时间、不良反应发生率.结果:治疗第15天,观察组中位血小板计数高于对照组(P=0.02),治疗第30天,观察组总有效率高于对照组(P=0.031);观察组起效时间长于对照组(P=0.001),但两组患者出血控制时间、疗效维持时间及不良反应发生率比较,差异无统计学意义(P>0.05).结论:rhTPO联合激素可提高初治重症ITP患者的总有效率.

摘要： 目的 MIL94是我所研发的一种抗西尼罗河病毒单克隆抗体,对西尼罗河病毒具有中和作用,其体内维持时间与抗病毒作用密切相关.该研究考察不同种属新生儿Fc受体(FcRn)对MIL94体内药动特征的影响.方法 比较研究MIL94在表达不同种属FcRn的小鼠(野生型小鼠、表达人源化FcRn小鼠和FcRn基因敲除小鼠)体内药代动力学特征.野生型小鼠和FcRn基因敲除(FcRn-/-)小鼠分别静脉注射MIL94;表达人源化FcRn小鼠(hFcRn小鼠)分为4组,其中两组分别静脉注射MIL94;另外两组先腹腔注射静脉注射用人免疫球蛋白(intravenous immunoglobulin,IVIG),再静脉注射MIL94.应用间接ELISA法测定小鼠血清MIL94浓度,WinNonlin计算药代动力学参数.结果 静脉注射MIL94后,体内的药代动力学基本成线性过程.MIL94在动物体内分布容积与FcRn有关.体内半衰期在不同组别之间有较大差异.结论 FcRn通过影响MIL94的分布和消除改变其在不同种属体内的半衰期,预期在人体内的半衰期比动物体内长.

摘要： 目的:探讨IL-1、IL-6、IL-10与卵巢过度刺激综合征(OHSS)的相关性及静脉注射免疫球蛋白(IVIG)对卵巢过度刺激大鼠的影响.方法:将未成年雌性大鼠(Wistar)按照随机原则分为对照组(n=13)、OHSS组(n=13)和IVIG组(n=13),OHSS组和IVIG组分别给予孕马血清促性腺激素(PMSG)和人绒毛膜促性腺激素(HCG)诱导OHSS,其中IVIG组给予免疫球蛋白治疗,IVIG组注射HCG 48 h后,随后静脉注射伊文思蓝染料(EB),注射30 min后检测卵巢中EB浓度和腹腔灌流液EB浓度以及大鼠血清中VEGF的含量,评价卵巢毛细血管通透性;用ELISA法和RT-PCR法分别测定大鼠血液中IL-1、IL-6和IL-10的含量和卵巢中IL-1、IL-6和IL-10的表达水平.结果:OHSS组双侧卵巢总重量及卵巢EB浓度均显著高于其他各组(P<0.05).OHSS组和IVIG组血清和卵巢IL-1浓度均显著高于对照组(P<0.05).IVIG组卵巢IL-6、IL-10含量明显低于对照组(P<0.05).IVIG组卵巢IL-10浓度明显低于OHSS组(P<0.05).结论:IL-1在OHSS大鼠炎症反应中起重要作用.过度刺激大鼠卵巢,血管通透性增加.OHSS大鼠卵巢可能是炎症的主要部位.IVIG治疗可显著降低OHSS大鼠卵巢重量和卵巢血管通透性,降低卵巢IL-10水平.提示IVIG可能通过抑制IL-10降低OHSS的严重程度.

摘要： 目的:研究静脉注射人免疫球蛋白 (IVIG) 治疗新生儿急性呼吸窘迫综合征 (ARDS) 的临床效果。方法:选择 2019年 5 月至 2020 年 5 月本院收治的 140 例新生儿 ARDS 患儿开展研究,双盲、随机分成参照组(n=70 例)与实验组(n=70 例),参照组实施常规治疗,实验组在常规治疗 IVIG治疗。对比两组疗效。结果:治疗后3d,实验组患儿的血清白细胞介素-6(IL-6)、肿瘤坏死因子 -α(TNF-α) 等水平均低于参照组,而 IL-10 高于参照组,对比 P<0.05;实验组患儿的机械通气时间及住院时间均短于参照组,对比 P<0.05;实验组的病死率低于参照组,对比 P<0.05。结论:对于新生儿急性 ARDS 疾病,静脉注射 IVIG,能有效改善患儿的炎症反应,减少机械通气的时间,促进患儿早日恢复出院,值得推荐。

摘要： Objective To explore the effects of different intravenous immunoglobulin (IVIG) therapy on the prognosis of neonatal ABO hemolysis. Methods 68 children patients with ABO hemolysis were randomly divided into high-dose group (group A, 34 cases) and low-dose group (group B, 34 cases) . Group A was given single high-dose IVIG+ routine treatment, and group B was given two-time low-dose IVIG+ routine treatment. The changes of serum total bilirubin (TBIL) level in the two groups were observed before and after treatment. The red blood cells (RBC) , hematocrit (HCT) , hemoglobin (Hb) , and illumination time and hospital stay were compared between the two groups after 5 d of treatment. Results After 1, 3 and 5 d of treatment, the serum TBIL levels in the two groups were lower than those before treatment, and the level in group A was lower than that in group B (P<0.05) . After 5 d of treatment, the levels of RBC, HCT and Hb in group A were higher than those in group B (P<0.05) . The illumination time and hospital stay in group A were shorter than those in group B (P<0.05) . Conclusion Single high-dose IVIG has good effects in the treatment of ABO hemolysis, and it can effectively improve the anemia symptoms of children patients, shorten the illumination time and hospital stay, and is beneficial to the outcome of disease.%目的 探究不同免疫丙种球蛋白 (IVIG) 治疗方式对新生儿ABO溶血病患儿预后的影响.方法 将68例新生儿ABO溶血病患儿随机分为大剂量组 (A组, 34例) 和小剂量组 (B组, 34例) .A组患儿予以单次大剂量IVIG+常规治疗, B组患儿予以两次小剂量IVIG+常规治疗.观察两组患儿治疗前后血清总胆红素 (TBIL) 水平变化情况, 比较两组患儿治疗5d后红细胞 (RBC) 、红细胞比容 (HCT) 、血红蛋白 (Hb) 水平, 以及光照时间、住院时间.结果 治疗1、3、5d后, 两组患儿血清TBIL水平均较治疗前降低, 且A组低于B组 (P<0.05) .治疗5d后, A组患儿RBC、HCT、Hb水平均高于B组 (P<0.05) .A组患儿光照时间、住院时间均短于B组 (P<0.05) .结论 单次大剂量IVIG治疗ABO溶血病的效果好, 能有效改善患儿贫血症状, 缩短光照时间和住院时间, 于病情转归有利.

摘要： Novel AARS2 gene mutations encoding mitochondrial alanyl-tRNA synthetase are important in the spectrum of different phenotypes expressed in the nervous system. Leukodystrophy and ovarian failure in females are common phenotypes. Peripheral demyelination is not a recognized aspect of the AARS2 phenotype. A patient with preceding Lyme neuroborreliosis developed progressive leukodystrophy and peripheral demyelinating motor polyneuropathy. Serial magnetic resonance imaging showed progressive inflammatory demyelination extending to the corticospinal tracts. Treatment with a standard of care of antibiotics and immune-modulatory therapy employing intravenous immune globulin was employed. The contribution of neuroborreliosis is not well understood in the expression of the AARS2 phenotype.

摘要： Study Objectives: Guillain-Barre syndrome (GBS) is an acute-onset, monophasic immune-mediated disorder of the peripheral nervous system that often follows an infection. The outcome and prognosis of GBS depend on many factors such as the etiology, clinical features, neurophysiology and immunological parameters. The aim of this study was to assess the factors (clinical, investigatory tools, and therapies) that may affect the outcome of patients with GBS. Patients and methods: this was an analytical observational study that was conducted at Ain Shams university hospitals and Kobri Elkoba Military Hospital including twenty patients with the diagnosis of Guillain Barre Syndrome in the duration from 2016 to 2018. This study included twenty patients with the diagnosis of GBS within two weeks from onset of neurologic symptoms, whom their diagnosis based on the established clinical criteria and verified by investigations. Patients were selected from both genders and aged from 18 to 65 years old. Nerve conduction studies and electromyography were performed within two weeks from admission. Various lines of treatment such as plasma exchange (PE), intravenous immunoglobulins (IVIG) or both were used during the period of admission in hospital. Outcome was assessed by the Hughes functional score (F-score), that was applied to the patients on admission, at end of 4 weeks from onset of neuropathy and at the end of 8 weeks. The final outcome at the end of 8 weeks was classified as follow: Group I: good prognosis (0 - 2) on the Hughes functional score (15 patients) and Group II: poor prognosis (3 - 6) on the Hughes functional score (5 patients). Results: the age of the study population ranged from 18 to 65 years with mean of 36.10 ± 16.08 years. Fifteen (75%) patients were males and 5 (25%) patients were females. There was no statistically significant difference found between poor and good prognosis regarding gender. The most common electrophysiological subtype was demyelinating followed by axonal neuropathy. Most patients (75%) had a good outcome at end of study period. It was found that the different line of treatment administered (plasma exchange or IVIG or both) was not associated with poor or good outcome. The patients who needed mechanical ventilation had significantly poor prognosis. Conclusion: the most common electrophysiological subtype was demyelinating followed by axonal neuropathy. Ascending pattern of weakness was more common than descending pattern in this study population and was not related to prognosis. High Hughes score at admission was associated with poor outcome at 8 weeks.

摘要： 川崎病是一种病因不明的急性血管炎,可累及全身中、小血管,尤其是冠状动脉[1]。目前公认町以有效降低冠状动脉损伤(coronary artery injury,CALs)发病率的标准疗法是大剂量静脉丙种球蛋白(intravenous immunoglobuLin,IVIG)结合口服阿司匹林,但仍有超过10%的川崎病患儿对标准疗法无反应,称为IVIG无反应川崎病。有研究指出,川崎病患儿对首次IVIG治疗无反应是CAL的危险因素,而大剂量IVIG联合激素可以降低首次IVIG无反应及CAL的发生率[2]。为了在首次治疗前预测IVIG无反应川崎病,各国学者提出了相应的评分系统,旨在指导临床治疗方案的选择,降低CAL风险,改善川崎病患儿预后。本文就IVIG无反应川崎病预测评分系统的研究进展进行综述。

摘要： 本发明属于生物医药检测技术领域，涉及一种IVIG中IgG Fab片段和Fc片段唾液酸含量的测定方法，经过IVIG经酶切及层析获得双链Fc片段、IVIG去除糖类保护剂处理、唾液酸解离、荧光衍生、高效液相色谱检测、标准曲线的绘制和检测结果代入标准曲线计算步骤，得IVIG唾液酸总含量和Fc片段的唾液酸含量；Fab段唾液酸含量为=（IVIG中的唾液酸总含量×IVIG分子量‑Fc片段的唾液酸含量×Fc片段分子量）/Fab片段分子量，式中IVIG分子量为150,000 Da，Fc片段分子量为55,000 Da，Fab片段分子量为95,000 Da。本发明简单，精确、灵敏度高，重复性和准确性高。

摘要： 本发明的杂交Fc蛋白包括IgG和IgM Fc组分。IgG Fc组分包括铰链区的至少一部分以及CH2和CH3区。IgM组份包括Cμ恒定区的Cμ3和Cμ4区。杂交Fc蛋白可以通过其铰链区中的半胱氨酸之间的链间二硫键形成双链体。杂交Fc蛋白可用于治疗由内源性IgG介导的免疫疾病，例如之前用静脉内免疫球蛋白治疗的疾病。

摘要： 本发明公开了一种以人血浆组份II+III为起始原料，以低温乙醇沉淀结合离子交换柱层析生产制备静注人免疫球蛋白（IVIG）的方法。本发明中层析上样前料液不需要透析脱醇脱盐，也无需调节上样料液电导值，大大简化了工艺流程，使整个工艺具有流程简洁，生产周期短，纯度高的优点。通过本方法生产的IVIG产品所含的IgA和IgM较传统工艺大幅下降，PKA、ACA、抗A抗B血凝素及多聚体比均符合药典规定。

摘要： 本发明提供来自级分II+III的纯化的血浆产物，所述纯化的血浆产物按可用于治疗多种疾病和感染(包括乙型肝炎病毒)的浓度含有蛋白质。还提供生产方法和治疗方法。纯化的血浆产物调节治疗的受试者的器官和外周血中免疫细胞的水平及其蛋白质。受纯化的血浆产物调节的免疫细胞和相关蛋白质的例子包括T细胞、CD4+、CD8+、CD28+和Foxp3+T细胞、B细胞以及粒细胞和巨噬细胞上的CD62L水平。

摘要： 本发明属于生物医药检测技术领域，涉及一种IVIG中IgG Fab片段和Fc片段唾液酸含量的测定方法，经过IVIG经酶切及层析获得双链Fc片段、IVIG去除糖类保护剂处理、唾液酸解离、荧光衍生、高效液相色谱检测、标准曲线的绘制和检测结果代入标准曲线计算步骤，得IVIG唾液酸总含量和Fc片段的唾液酸含量；Fab段唾液酸含量为=（IVIG中的唾液酸总含量×IVIG分子量‑Fc片段的唾液酸含量×Fc片段分子量）/Fab片段分子量，式中IVIG分子量为150,000 Da，Fc片段分子量为55,000 Da，Fab片段分子量为95,000 Da。本发明简单，精确、灵敏度高，重复性和准确性高。