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human immunoglobulin (pH4)

✓ Approved

Shenzhen Weiguang Biological · 多克隆抗体 · 多克隆抗体

什么是 human immunoglobulin (pH4)？

human immunoglobulin (pH4) 是一种多克隆抗体，由Shenzhen Weiguang Biological研发。该药已获批，用于治疗相关适应症，给药途径：Intraarterial Injection、Intravenous (IV)。

药物档案

公司Shenzhen Weiguang Biological
药物类别多克隆抗体, 抗体
给药途径Intraarterial Injection, Intravenous (IV)
状态Approved
来源： ClinicalTrials.gov, Shenzhen Weiguang Biological

治疗适应症

human immunoglobulin (pH4) 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Immune system disordersImmunodeficiency✓ Approved

相关研究文献

PubMedCurrent oncology (Toronto, Ont.)2026-10-26

Serum Free Light Chains in Lymphoma: A Phenotype-First Framework for Biological Interpretation, Analytical Control, and Clinical Use.

Bibas Michele M, Amoroso Barbara B, Matteini Elena E, Antinori Andrea A et al.

Serum free light chains (sFLC) reflect immunoglobulin production and renal clearance, making abnormal results biologically heterogeneous in lymphoma. We reviewed clinical, translational, and analytical evidence using a documented PubMed search. Three operational patterns should be distinguished: monoclonal-pattern elevation, polyclonal-pattern elevation, and ratio-only abnormality. The kappa-plus-lambda concentration is an overlapping measure of total circulating burden rather than a fourth exclusive phenotype. In diffuse large B-cell lymphoma, some cohorts reported International Prognostic Index-adjusted associations and improved model discrimination, whereas other studies did not confirm independent prognostic value. Evidence in classical Hodgkin lymphoma and chronic lymphocytic leukemia also depends on endpoint, adjustment, and treatment setting. Prediagnostic associations in human immunodeficiency virus infection, transplantation, and population cohorts do not establish screening utility. In Waldenström macroglobulinemia, involved-chain kinetics may supplement established assessment in selected patients, although clinical benefit from sFLC-directed management has not been demonstrated. Historical treatment regimens, overlapping cohorts, inconsistent renal adjustment, assay differences, and limited external validation restrict transferability. The proposed framework integrates phenotype, renal function, assay, sampling time, and disease context. It is an interpretive proposal, not a validated prognostic score or treatment algorithm.

PMID 42930147
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PubMedAntibodies (Basel, Switzerland)2026-10-26

Antibody-Related Mechanisms in Ocular Diseases: Autoimmunity, Malignancy, and Therapeutic Targeting.

Xiao Yehan Y, Zou Yaru Y, Yang Mingming M, Gu Wendong W et al.

Antibodies in ocular disease have heterogeneous biological meanings: they may act as direct pathogenic effectors, systemic diagnostic biomarkers, indicators of B-cell clonality, or therapeutic agents. This distinction is particularly important in the eye, where immune privilege and the blood-ocular barrier restrict tissue access, whereas inflammation may permit entry of immunoglobulins, complement, and immune cells or support local humoral responses. This narrative review integrates antibody and B-cell biology across autoimmune and paraneoplastic retinopathies, aquaporin-4-immunoglobulin G-positive neuromyelitis optica spectrum disorder, myelin oligodendrocyte glycoprotein antibody-associated disease, ocular mucous membrane pemphigoid, ocular myasthenia gravis, thyroid eye disease, systemic autoimmune and fibroinflammatory disorders with ocular involvement, and B-cell malignancies including vitreoretinal and ocular adnexal lymphoma. We distinguish the evidence for direct antibody pathogenicity from disease association and emphasize that a positive result is interpretable only in relation to the ocular phenotype, assay platform, titer, specimen compartment, and orthogonal confirmation. Serum testing, ocular-fluid analysis, electrophysiology, multimodal imaging, cytology, histopathology, immunophenotyping, immunoglobulin clonality, and molecular testing have complementary roles. Therapeutic strategies include B-cell or B-lineage depletion, complement inhibition, cytokine- or receptor-directed monoclonal antibodies, insulin-like growth factor-1 receptor blockade, and emerging FcRn- or plasma-cell-directed approaches; however, regulatory status and ocular-specific evidence vary substantially among diseases. A mechanistically stratified framework may reduce overdiagnosis, improve recognition of malignant masquerade syndromes, and support more precise selection of targeted therapy.

PMID 42930036
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PubMedDiseases (Basel, Switzerland)2026-10-26

The Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis Spectrum: A Report of Two Contrasting Cases Managed in a Burn Unit.

Constantinescu Mihai-Codrin MC, Moraru Dan-Cristian DC, Poroch Vladimir V, Avadanei-Luca Stefana S et al.

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are severe, potentially life-threatening mucocutaneous reactions classified based on body surface area (BSA) involvement: SJS affects less than 10% BSA, SJS/TEN overlap affects 10-30% BSA, and TEN affects more than 30% BSA. The mortality rates range from 4.8-9% for SJS to 14.8-48% for TEN. Treatment remains controversial, with corticosteroids and intravenous immunoglobulin (IVIg) being the most debated therapeutic options. While some studies suggest IVIg may block Fas-mediated keratinocyte apoptosis, meta-analyses have shown conflicting results regarding mortality benefit. We describe two patients from opposite ends of the SJS/TEN spectrum, managed in a burn unit with different therapeutic approaches. The first patient, a 47-year-old man with systemic lupus erythematosus, developed TEN with approximately 35% body surface area involvement, complicated by sepsis and rhabdomyolysis; he was treated with systemic corticosteroids and intravenous immunoglobulin (IVIg, 0.4 g/kg/day for 3 days). The second patient, a 66-year-old woman, developed SJS attributed to amoxicillin-clavulanic acid and was treated with systemic corticosteroids alone. Both patients achieved complete re-epithelialization without major sequelae. These two cases illustrate the clinical heterogeneity of the SJS/TEN spectrum and the central role of early recognition, prompt withdrawal of the culprit drug, transfer to a specialized unit, and multidisciplinary supportive care. Given the substantial differences between the two patients in age, sex, comorbidities, culprit drugs, and disease severity, no comparative or causal inference regarding the relative efficacy of the two treatment strategies can be drawn; no efficacy claim is made for either therapeutic approach; this report is descriptive, and the two cases are presented as contrasting rather than comparable.

PMID 42929981
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PubMedOxford medical case reports2026-10-26

One trigger, two systems: post-infectious severe Guillain-Barre syndrome with concurrent central nervous system demyelination": a case report.

Numan Mohammad M, Alhatou Mohammad M, Hussain Zaeem Z, Hussain Maidah M et al.

Combined central and peripheral demyelination is a rare but serious neurological condition that is associated with poor outcomes. We report a 31-year-old male presenting with rapidly progressive Acute inflammatory demyelinating polyradiculoneuropathy (AIDP) variant of Guillain-Barré syndrome following an upper respiratory tract infection. The course was complicated by respiratory failure requiring intubation and significant autonomic dysfunction. Despite treatment with intravenous immunoglobulin, there was minimal clinical improvement. Further imaging of the central nervous system revealed multiple acute demyelinating lesions involving the brain and spinal cord. The patient subsequently received plasmapheresis and high-dose intravenous steroids without significant neurological recovery. A severe hospital-acquired infection delayed rituximab initiation until four months after symptom onset; however, neurological recovery remained minimal. This case highlights the rare coexistence of post-infectious central and peripheral demyelination. Early recognition of central involvement in patients with poor response to standard GBS therapy may help guide escalation of immunotherapy and potentially improve outcomes.

PMID 42928892
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PubMedCureus2026-10-26

Bilateral Earlobe Purpura as an Unusual Initial Manifestation of Systemic Lupus Erythematosus: A Case Report.

Atherton Lucy L

Systemic lupus erythematosus (SLE) is a chronic, multisystem autoimmune disease characterized by autoantibody production, particularly antinuclear antibodies (ANAs). The broad clinical spectrum and absence of pathognomonic features can make diagnosis challenging, particularly when alternative autoimmune, infectious, and hematological conditions must be considered. We report a case of a 31-year-old woman who presented to the emergency department with a two-week history of bilateral earlobe purpura. Initial investigations demonstrated severe thrombocytopenia and normocytic anemia, and subsequent imaging revealed widespread lymphadenopathy. Early multidisciplinary assessment by acute medicine, hematology, and rheumatology, together with exclusion of hematological malignancy and positive autoimmune serology, supported a diagnosis of SLE. Despite initial treatment with intravenous immunoglobulin (IVIg) and corticosteroids, the bicytopenia persisted. Mycophenolate mofetil was commenced; however, worsening cytopenias and concern for secondary hemophagocytic lymphohistiocytosis led to the initiation of rituximab infusions. Her platelet count subsequently improved, and she was discharged with rheumatology and hematology follow-up. This case highlights an unusual cutaneous presentation of newly diagnosed SLE and the diagnostic challenges associated with severe hematological involvement at initial presentation. It also demonstrates the importance of multidisciplinary assessment and timely escalation of immunosuppressive therapy in severe disease.

PMID 42928827
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PubMedBritish journal of haematology2026-10-26

Temporal trends in infectious risk among multiple myeloma patients treated with daratumumab: A meta-analysis.

Visram Alissa A, Mian Hira H, Lee James J, Jones Aaron A et al.

Anti-cluster of differentiation 38 (Anti-CD38) monoclonal antibodies such as daratumumab are widely used in multiple myeloma (MM), yet the timing and magnitude of infectious risk remain incompletely defined. We performed an individual patient-level meta-analysis of six randomized trials (N = 2989) comparing daratumumab- versus non-daratumumab-containing regimens in newly diagnosed and relapsed/refractory MM, assessing infectious events over 2 years. Daratumumab-treated patients had higher rates of any-grade (79% vs. 61%) and grade ≥3 infections (29% vs. 20%) than controls, with risk peaking in the first 3 months (42% vs. 36%, p = 0.001) before plateauing. After adjustment, daratumumab was independently associated with grade ≥1 (odds ratio [OR] 1.31, 95% confidence interval [CI] 1.10-1.57), respiratory (OR 1.38, 95% CI 1.11-1.71) and grade ≥3 (OR 1.47, 95% CI 1.08-2.00) infection by 3 months. Daratumumab-treated patients had a higher rate of infection over 2 years (adjusted incidence rate ratio 1.60, 95% CI 1.47-1.73) and more frequently experienced recurrent infections (33% vs. 22% with multiple any-grade infections; 11% vs. 7% with multiple grade ≥3 infections). Preventive strategies were underused, with <20% of patients with severe respiratory infections receiving immunoglobulin replacement. These findings identify an early window of infectious vulnerability with daratumumab and support temporally targeted prevention and monitoring strategies in contemporary MM care.

PMID 42928979
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