GAMMA GLOBULIN

GAMMA GLOBLIN
  • 文章类型: Case Reports
    毒性表皮坏死松解症(TEN)是皮肤科紧急情况中的一种药疹,在临床实践中很少见,但死亡率很高。主要原因是药物和病毒感染。不幸的是,在治疗这种疾病方面没有专家共识,并且缺乏标准疗法。到目前为止,糖皮质激素联合丙种球蛋白是临床常用的,但它们的功效极具争议。这项研究报道了一名患有TEN的7岁女孩对传统疗法没有反应,如甲泼尼龙联合丙种球蛋白,但最终治愈了额外的低剂量依那西普。结果表明,依那西普治疗儿科TEN是安全的,可靠,值得推荐。
    Toxic epidermal necrolysis (TEN) is a type of drug eruption in dermatology emergencies that is rare in clinical practice but has a high mortality rate. The main causes are drug and viral infections. Unfortunately, no expert consensus on treating this disease exists, and a standard therapy is absent. Up to now, glucocorticoids combined with gamma globulin are commonly used in clinical practice, but their efficacy is highly controversial. This study reports on a 7-year-old girl with TEN who did not respond to traditional therapy, such as methylprednisolone combined with gamma globulin, but was finally cured with an additional low-dose etanercept. The results showed that etanercept therapy in paediatric TEN is safe, reliable and worth recommending.
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  • 文章类型: Journal Article
    背景:静脉免疫球蛋白G(IVIG)用于治疗血型不相容性新生儿溶血病(BTHDN)。虽然IVIG治疗BTHDN的疗效受到挑战,正如最新的系统审查所表明的那样,IVIG可以显著减少交换输血。我们进行了邮寄问卷调查,以确定IVIG在日本的BTHDN的实际使用情况。
    方法:调查,2014年进行,包括2009年1月1日至2013年12月31日出生的婴儿.问卷已发送给日本新生儿学家协会围产期中心的新生儿重症监护病房(NICU)负责人。
    结果:共有195个中心(64.6%)回答了问卷。在学习期间,170个中心(87.2%)报告了BTHDN的发病率。在这些中心中,新生儿中有1726例诊断为BTHDN。在这些案件中,127个中心的419名婴儿接受了IVIG治疗,约占所有中心的74.7%。在排除数据缺失和未获得数据使用同意的情况后,本研究共纳入916例婴儿.其中,光疗后用IVIG治疗219例(23.9%),其中187例(20.4%)婴儿不需要进一步输血.IVIG的剂量范围为40至1200mg/kg/剂,但大多数在500到1000毫克/千克/剂之间,中位数为800mg/kg/剂。接受IVIG治疗的婴儿中约有20%表现为迟发性贫血,需要治疗。不良事件报告少于1%的婴儿。
    结论:对于BTHDN的治疗,IVIG给药在日本的NICU中广泛使用,没有严重的不良事件。
    BACKGROUND: Intravenous immunoglobulin G (IVIG) is used to treat blood-type incompatibility hemolytic disease of newborns (BTHDN). Although IVIG\'s efficacy for treating BTHDN has been challenged, as an updated systematic review suggests, IVIG could significantly reduce exchange transfusions. We conducted a mail-in questionnaire survey to ascertain actual use of IVIG for BTHDN in Japan.
    METHODS: The survey, conducted in 2014, included infants born between January 1, 2009, and December 31, 2013. Questionnaires were sent to the heads of neonatal intensive care units (NICUs) at perinatal centers of the Japan Neonatologist Association.
    RESULTS: A total of 195 centers (64.6%) responded to the questionnaire. During the study period, 170 centers (87.2%) reported incidences of BTHDN. Among these centers, there were 1726 diagnosed cases of BTHDN in neonates. Of these cases, 419 infants were treated with IVIG in 127 centers, representing approximately 74.7% of all centers. After the exclusion of cases with missing data and those where consent for data usage was not obtained, a total 916 infants were included in this study. Of these, 219 (23.9%) were treated with IVIG after phototherapy, and 187 (20.4%) of these infants did not require further blood exchange transfusion. The IVIG dosages ranged from 40 to 1200 mg/kg/dose, but the majority were between 500 and 1000 mg/kg/dose, with a median of 800 mg/kg/dose. About 20% of the infants treated with IVIG showed late-onset anemia and required treatment. Adverse events were reported in less than 1% of infants.
    CONCLUSIONS: For the treatment of BTHDN, IVIG administration was widely used in NICUs in Japan without severe adverse events.
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    文章类型: Journal Article
    背景:传染性单核细胞增多症(IM)的特征是咽炎,颈淋巴结病,疲劳和发烧。IM最常见于原发性EB病毒(EBV)感染,儿童发病率较高。
    目的:探讨丙种球蛋白联合阿昔洛韦治疗IM患儿的价值及其对免疫功能的影响。
    方法:本前瞻性随机对照研究于2019年3月至2022年3月在安徽省儿童医院招募了111名14岁以下IM患儿。其中,11个孩子退出了,100名符合条件的儿童以1:1的比例随机分为对照组和研究组.对照组接受阿昔洛韦,和研究组接受额外的丙种球蛋白。基线数据,临床疗效,免疫功能,收集并比较不良反应。
    结果:研究组退热时间较短,淋巴结减少时间,咽炎改善时间,住院时间与对照组比较(P<0.05)。研究组的白细胞总数较低,丙氨酸氨基转移酶,肌酸激酶同工酶-MB高于对照组(P<0.05)。治疗后,CD3+和CD8+水平较低,和CD4+的水平,CD4+/CD8+,IgA,研究组IgG水平高于对照组(均P<0.05)。两组不良反应发生率具有可比性(14.00%vs.24.00%)。研究组EBV特异性抗体和核抗原阳性率均低于对照组(P<0.05)。
    结论:与单用阿昔洛韦相比,丙种球蛋白和阿昔洛韦的联合治疗是IM患者的一种有希望的替代治疗方法。这种联合治疗方案缩短了儿童临床表现的持续时间,促进实验室指标的恢复,提高临床疗效,增强免疫功能。此外,它的安全性是可以接受的,保证其进一步推广。
    BACKGROUND: Infectious mononucleosis (IM) is characterized by pharyngitis, cervical lymphadenopathy, fatigue and fever. IM is most commonly seen in primary Epstein-Barr virus (EBV) infection, with higher occurrence in children.
    OBJECTIVE: To explore the value of gamma globulin combined with acyclovir for IM children and their impact on immune function.
    METHODS: This prospective randomized controlled study recruited 111 children under 14 years old with IM from Anhui Provincial Children\'s Hospital during March 2019 and March 2022. Among them, 11 children dropped out, and 100 eligible children were randomized 1:1 into a control group and a study group. The control group received acyclovir, and the study group received additional gamma globulin. The baseline data, clinical efficacy, immune function, and adverse reactions were collected and compared.
    RESULTS: The study group had a shorter antipyretic time, lymph node reduction time, pharyngitis improvement time, and hospital stay compared to the control group (P < 0.05). The study group yielded lower levels of total white blood cell count, alanine aminotransferase, and creatine kinase-MB than the control group (P < 0.05). After treatment, the levels of CD3+ and CD8+ were lower, and the levels of CD4+, CD4+/CD8+, IgA, and IgG were higher in the study group than those in the control group (all P < 0.05). The incidence of adverse reactions between the two groups was comparable (14.00% vs. 24.00%). The positive rates of EBV-specific antibody and nuclear antigen in the study group were lower than those in the control group (P < 0.05).
    CONCLUSIONS: The combined treatment of gamma globulin and acyclovir is a promising alternative for patients with IM compared to acyclovir alone. This combined regimen shortens the duration of clinical manifestations in children, promotes the recovery of laboratory indices, improves clinical efficacy, and enhances immune function. Furthermore, its safety profile is acceptable, warranting its further promotion.
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  • 文章类型: Journal Article
    本研究旨在表征中间体,和生产人肌内超免疫丙种球蛋白抗SARS-CoV-2(hIHGG抗SARS-CoV-2)过程中获得的终产物(FP),并测定其稳定性。材料和方法:使用Cohn方法从270个恢复期血浆捐赠中分离hIHGG抗SARS-CoV-2。在分馏之前,将血浆灭活(TheraflexMB血浆)。使用抗S1,抗RBDS1和抗N抗体的酶免疫测定(EIA)定义样品。和SARS-CoV-2(VN)和假病毒(PVN,用SARS-CoV-2S蛋白装饰)。结果表示为在四参数非线性回归模型中估计的滴度(EIA)或中和滴度的50%(IC50)。结果:灭活前后血浆中抗S1抗体浓度相似。分馏后,抗S1,抗RBD,FP中的抗N(总测试)滴度从1:4浓缩到1:63(1800BAU/mL)约15倍,分别从1:111到1:802和从1:13到1:88的7倍。在生产过程中,IgA(抗S1)抗体滴度降低至检测不到的水平,IgM(抗RBD)滴度从1:115降至1:24。中和抗体(nAb)滴度在VN(从1:40到1:160)和PVN(IC50从63到313)中增加。FP中特异性IgG的浓度在14个月内没有显著改变。结论:hIHGG抗SARS-CoV-2是稳定的,与来源血浆池相比,浓度高达约15倍的nAb。
    This study aims to characterize the intermediates, and the final product (FP) obtained during the production of human intramuscular hyperimmune gamma globulin anti-SARS-CoV-2 (hIHGG anti-SARS-CoV-2) and to determine its stability. Material and methods: hIHGG anti-SARS-CoV-2 was fractionated from 270 convalescent plasma donations with the Cohn method. Prior to fractionation, the plasma was inactivated (Theraflex MB Plasma). Samples were defined using enzyme immunoassays (EIA) for anti-S1, anti-RBD S1, and anti-N antibodies, and neutralization assays with SARS-CoV-2 (VN) and pseudoviruses (PVN, decorated with SARS-CoV-2 S protein). Results were expressed as a titer (EIA) or 50% of the neutralization titer (IC50) estimated in a four-parameter nonlinear regression model. Results: Concentration of anti-S1 antibodies in plasma was similar before and after inactivation. Following fractionation, the anti-S1, anti-RBD, and anti-N (total tests) titers in FP were concentrated approximately 15-fold from 1:4 to 1:63 (1800 BAU/mL), 7-fold from 1:111 to 1:802 and from 1:13 to 1:88, respectively. During production, the IgA (anti-S1) antibody titer was reduced to an undetectable level and the IgM (anti-RBD) titer from 1:115 to 1:24. The neutralizing antibodies (nAb) titer increased in both VN (from 1:40 to 1:160) and PVN (IC50 from 63 to 313). The concentration of specific IgG in the FP did not change significantly for 14 months. Conclusions: The hIHGG anti-SARS-CoV-2 was stable, with concentration up to approximately 15-fold nAb compared to the source plasma pool.
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  • 文章类型: Journal Article
    研究热毒宁联合丙种球蛋白对症状改善和血清白细胞介素-6(IL-6)水平的影响,25-羟基维生素D[25-(OH)D]和乳酸脱氢酶(LDH)在儿童重症支原体肺炎(MP)。
    选择2018年5月至2020年4月苏州大学附属常州市肿瘤医院收治的123例重症MP患儿为研究对象,随机分为三组:对照组A,对照组和观察组,每组41例。对照组A给予热毒宁,对照组B用丙种球蛋白治疗,观察组给予热毒宁注射液联合丙种球蛋白治疗。临床疗效,症状改善,不良反应发生率,血清IL-6、25-(OH)D、LDH,比较3组治疗前后Toll样受体4/髓样分化因子88(TLR4/MyD88)信号通路及T淋巴细胞亚群的差异。
    观察组治疗总有效率高于对照组A、对照组B(p<0.05);肺部啰音,观察组咳嗽恢复正常时间短于对照组A、对照组B(p<0.05)。治疗后,观察组血清IL-6、LDH水平较低,与对照组A和对照组B相比,25-(OH)D的水平更高(p<0.05)。此外,观察组血清TLR4和MyD88表达水平较低(p<0.05),较高的CD4+血清水平,CD4+/CD8+,与对照组-A和对照组-B相比,CD8+降低(p<0.05)。三组不良反应发生率比较差异无统计学意义(p>0.05)。
    热毒宁联合丙种球蛋白治疗重症MP值得临床推广应用。有了这样的治疗方案,重症MP患儿的免疫功能可明显增强,炎症反应可以被抑制,可以促进症状的改善,进一步改善治疗效果。
    UNASSIGNED: To investigate the effects of Reduning combined with gamma globulin on symptom improvement and serum levels of interleukin-6 (IL-6), 25-hydroxyvitamin D[25-(OH)D] and lactate dehydrogenase (LDH) in children with severe mycoplasma pneumonia (MP).
    UNASSIGNED: A total of 123 children with severe MP admitted to the Changzhou Cancer Hospital affiliated to Soochow University from May 2018 to April 2020 were selected as subjects and randomly divided into three groups: control Group-A, control Group-B and the observation group, with 41 cases in each group. Control Group-A was given with Reduning, control Group-B was treated with gamma globulin, while the observation group was treated with Reduning injection combined with gamma globulin. The clinical efficacy, symptom improvement, incidence of adverse reactions, serum levels of IL-6, 25-(OH)D, LDH, Toll-like receptor 4/myeloid differentiation factor 88 (TLR4/MyD88) signaling pathway and T lymphocyte subsets before and after treatment were statistically compared between the three groups.
    UNASSIGNED: The total effective rate of treatment in the observation group was higher than that in control Group-A and control Group-B (p<0.05); The time for body temperature, lung rales, and cough to return to normal in the observation group was shorter than that in control Group-A and control Group-B (p<0.05). After treatment, the observation group had lower serum levels of IL-6, LDH, and higher levels of 25-(OH)D compared with control Group-A and control Group-B (p<0.05). Moreover, the observation group had lower serum expressions of TLR4 and MyD88 (p<0.05), higher serum levels of CD4+, CD4+/CD8+, and lower CD8+ compared with control Group-A and control Group-B (p<0.05). No significant difference can be seen in the comparison of the incidence of adverse reactions between the three groups (p>0.05).
    UNASSIGNED: Reduning combined with gamma globulin in the treatment of severe MP is worthy of clinical promotion and application. With such a treatment regimen, the immune function of children with severe MP can be significantly enhanced, the inflammatory response can be suppressed, and symptom improvement can be promoted, further improving the treatment outcome.
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  • DOI:
    文章类型: Journal Article
    目的:本研究旨在研究丙种球蛋白(IVIG)和磷酸肌酸(CP)对病毒性心肌炎(VMC)的影响。
    方法:我们选取我院2017年2月至2018年9月收治的121例年轻VMC患者,将其分为两组:IVIG+CP+常规治疗),对照组(59例,常规治疗)。患者的基线数据,包括性别,年龄,病程,病因学,心功能分类,和严重性,被收集。射血分数(EF),分数缩短(FS),记录治疗前后二尖瓣舒张早期与晚期充盈速度峰值比值(E/A比值)。这些变化包括乳酸脱氢酶,肌酸激酶(CK),天冬氨酸转氨酶,肌酸激酶同工酶(CK-MB),和心肌肌钙蛋白I(CTnI)。此外,免疫因子如CD3+的变化,CD4+,治疗前后测定CD8+。
    结果:研究组有效率明显高于对照组(P<0.05)。治疗后,射血分数,分数缩短,与对照组相比,研究组舒张早期至晚期的二尖瓣峰值充盈速度比值改善更为显著(P<0.05)。研究组的心电图结果也明显优于对照组(P<0.05)。乳酸脱氢酶(LDH)的水平,肌酸激酶(CK),天冬氨酸转氨酶(AST),肌酸激酶同工酶(CK-MB),研究组心肌肌钙蛋白I(CTnI)均优于对照组(P<0.05)。症状恢复,心功能恢复,研究组心电图和心肌酶复常均明显快于对照组(P<0.05)。研究组患者的免疫因子水平较治疗前也有明显改善(P<0.05)。同时,两组不良反应比较差异无统计学意义(P>0.05)。
    结论:IVIG联合CP具有较好的临床疗效,可有效增强VMC患者的免疫系统。
    OBJECTIVE: This study aimed to investigate the effect of gamma globulin (IVIG) and creatine phosphate (CP) on viral myocarditis (VMC).
    METHODS: We enrolled 121 young patients with VMC who were admitted in our hospital from February 2017 to September 2018, and divided them into two groups as follows: study group (62 patients, IVIG + CP + routine treatment), and control group (59 patients, conventional treatment). Patient\'s baseline data, including gender, age, disease course, etiology, cardiac function classification, and severity, were collected. Ejection fraction (EF), fractional shortening (FS), and mitral ratio of peak early to late diastolic filling velocity (E/A ratio) before and after treatment were recorded. These changes include the lactate dehydrogenase, creatine kinase (CK), aspartate aminotransferase, creatine kinase isoenzyme (CK-MB), and cardiac troponin I (CTnI). Furthermore, the changes in immune factors such as CD3+, CD4+, and CD8+ before and after the treatment were determined.
    RESULTS: The study group had a significantly higher response rate than the control group (P < 0.05). After treatment, the ejection fraction, fractional shortening, and mitral ratio of peak early-to-late diastolic filling velocity were more significantly improved in the study group than in the control group (P < 0.05). The electrocardiogram (ECG) results of the study group were also significantly better than those of the control group (P < 0.05). The levels of lactate dehydrogenase (LDH), creatine kinase (CK), aspartate aminotransferase (AST), creatine kinase isoenzyme (CK-MB), and cardiac troponin I (CTnI) in the study group were all significantly better than those in the control group (P < 0.05). Symptom recuperation, cardiac function recovery, and ECG and myocardial enzyme normalization were significantly faster in the study group than those in the control group (P < 0.05). The immune factor levels in the study group also significantly improved compared with those before the treatment (P < 0.05). Meanwhile, the adverse reactions in both groups showed no differences (P < 0.05).
    CONCLUSIONS: IVIG combined with CP exhibited better clinical effects and effectively boosted the immune system of patients with VMC.
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  • 文章类型: Journal Article
    Long-term storage of proteins at ambient temperature is required for applications in pharmaceutics and biotechnology. Lyophilization is a versatile approach for stabilizing proteins at ambient temperature, although its freezing and drying processes negatively affect the protein structure. In this study, we show a glass-like protein condensate (GLPC) as a new method for protein stabilization at ambient temperature. Various protein types, including immunoglobulin G, gamma globulin, albumin, and chymotrypsin, formed a glassy state during ultracentrifugation and natural drying, while proteins that tend to crystalize, such as hen egg-white lysozyme, did not. The GLPCs were characterized by a transparent solid state, similar to a dry glass ball. Importantly, the GLPCs were dissolved easily in saline solution at a physiological concentration, thereby retaining their native structures and functions. The GLPCs preserved their native structures even after 1 year of incubation at ambient temperature. These results provide a framework for the development of protein preservation methods at ambient temperature other than lyophilization.
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  • 文章类型: Journal Article
    The present study aimed to investigate the expression of microRNAs (miRNAs/miRs) and inflammatory factors in patients with immunoglobulin-sensitive and IVIG-insensitive incomplete Kawasaki disease (KD). One hundred and eighty-five patients with incomplete KD were included as the study group (KD group), and 182 patients with respiratory infection as the control group. Neutrophil to lymphocyte ratio (NLR), C-reactive protein (CRP) levels, alanine aminotransferase (ALT), aspartate aminotransferase (AST), white blood cell count (WBC), hemoglobin level (Hb), platelet count (PLT) and T cell subsets (CD3+, CD3+ CD4+) were compared. Patients in the KD group received aspirin (30 mg/kg orally daily) and gamma globulin (IVIG, 1 g/kg intravenously daily). According to the sensitivity to IVIG, patients were divided into IVIG-sensitive group and IVIG-insensitive KD group. The relative expression levels of miRNA-21, miRNA-145, miRNA-155 and miRNA-199b-5p in the serum were detected by RT-qPCR. Serum TNF-α, IL-6 and IL-1β levels were assessed using ELISA. Before treatment, the neutrophil to lymphocyte ratio (NLR), levels C-reactive protein, and leukocytes in the KD group were significantly higher compared with the control group (P<0.05). After medical intervention, the relative expression of miRNA-21, miRNA-145 and miRNA-155 in the serum of patients in IVIG-sensitive and IVIG-insensitive KD groups were increased when compared with these levels in the control group (P<0.05). Meanwhile, the relative expression of miRNA-199b-5p was decreased (P<0.05). Compared with the IVIG-sensitive KD group, the relative expression levels of miRNA-145 and miRNA-155 were increased in the serum of patients in the IVIG-insensitive KD group (P<0.05). Compared with the control group, the levels of TNF-α, IL-6 and IL-1β were increased in the serum of patients in the IVIG-sensitive and IVIG-insensitive KD groups (P<0.05). Compared with the IVIG-sensitive KD group, the serum levels of TNF-α and IL-6 were increased in patients of the IVIG-insensitive KD group (P<0.05). Except for NLR and CRP, there were differences in the expression of peripheral blood miRNA-145, miRNA-155 and serum TNF-α and IL-6 in patients with immunoglobulin-sensitive and -insensitive incomplete KD.
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  • 文章类型: Clinical Study
    BACKGROUND: Henoch-Schonlein purpura nephritis (HSPN) is a serious complication of Henoch-Schonlein purpura (HSP), which is usually treated with immunosuppressant and glucocorticoid. This study was designed to explore the effect of dexamethasone and gamma globulin combined with prednisone in the treatment of pediatric HSPN.
    METHODS: According to the treatment plan, 60 children treated with dexamethasone and gamma globulin were included in the control group, and the rest 55 children treated with dexamethasone and gamma globulin combined with prednisone were selected as the research group. The clinical manifestations, therapeutic effect, immune function, serum inflammatory factors, blood coagulation function, urine routine, renal function, and adverse reactions were compared between the two groups.
    RESULTS: The clinical manifestations of children in the research group were significantly better than those in the control group after treatment (P < .05). The total effective rate in the research group (94.55%) was markedly higher than that in the control group (76.67%) (P < .05). CD3+, CD4+, CD8+, IL-10, PT, and APTT increased while CD4+/CD8+, IgA, IL-8, TNF-α, FIB, urine protein, urine red blood cell, Scr, and BUN decreased in both groups after treatment, and the changes of all the above indexes in the research group were significant than those in the control group (P < .05). The incidence of adverse reactions in the research group was remarkably superior to that in the control group (P < .05).
    CONCLUSIONS: Dexamethasone and gamma globulin combined with prednisone can improve the immune function of children with HSPN and promote the recovery of renal function.
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  • DOI:
    文章类型: Journal Article
    UNASSIGNED: To explore the effect of different doses of Gamma Globulin (GG) on the condition of children with Hemolytic Disease of Newborn (HDN) and the influence of immune factors in serum.
    UNASSIGNED: Overall, 180 infants with hemolytic disease of newborn in the People\'s Hospital of Zhangqiu Area, Jinan, China from April 2016 to August 2018 were divided into group A (88 cases) and group B (92 cases). Group A was given intravenous low-dose GG on the basis of phototherapy, and group B was given intravenous high-dose GG on the basis of phototherapy. The level of serum total bilirubin of the infants, the levels of CD3+, CD4+, CD8+, IgA, IgG and IgM of the infants, the time of jaundice disappearance and the length of hospital stay, hemoglobin and reticulocyte levels were recorded before treatment and after treatment. The number and condition of adverse reactions were recorded.
    UNASSIGNED: After treatment, the levels of TBiL, hemoglobin and reticulocyte, the time of jaundice disappearance and hospital stay in group B were significantly lower than those in group A. The level of immune cells in group B was significantly higher than that in group A after 7 days of treatment, and the levels of IgA / IgG / IgM in group B were significantly higher than those in group A after 28 days of treatment.
    UNASSIGNED: Intravenous high-dose GG has a better effect on the condition of neonatal hemolytic disease patients, and more effectively improve the immune function of children.
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