Sertraline Hydrochloride

肝移植后终末期肾病患者常合并尿毒症性瘙痒与胆汁淤积性瘙痒，传统治疗手段往往疗效有限。一例关于肝移植后维持性血液透析患者，经多种常规治疗失败后，使用盐酸纳呋拉啡成功控制双重难治性瘙痒的病例报告入选2026年世界肾脏病大会（WCN 2026）（摘要号：WCN26-AB-260）。该病例由解放军联勤保障部队第903医院肾脏科朱可庆医生报道。 大会现场 朱可庆 医生 WCN 2026 WCN 2026 01 病史 患者，女性，60岁。因肝硬化失代偿行肝移植术，术后发生肝肾综合征，肾功能进行性下降，最终进展为终末期肾病，于2025年2月17日起行维持性血液透析治疗。透析频率为每周3次，每次4小时。 病程中反复出现自发性细菌性腹膜炎，病原学培养提示耐万古霉素肠球菌（VRE）粪肠球菌感染，先后使用头孢哌酮舒巴坦、美罗培南、达托霉素、利奈唑胺等抗生素治疗。 2025年4月17日，患者突发全身剧烈瘙痒，伴躯干及四肢荨麻疹。初始考虑药物过敏反应，停用可疑药物并予泼尼松30 mg/d口服。3日后皮疹完全消退，但瘙痒无缓解，呈持续性加重，夜间为甚，严重影响睡眠质量。 02 实验室检查 ALP（碱性磷酸酶）：492 U/L, γ-GTP（γ-谷氨酰转肽酶）：412 U/L, BUN（尿素氮）：18.9 mmol/L, SCr（血清肌酐）：482 μmol/L 03 诊断 尿毒症性瘙痒合并胆汁淤积性瘙痒。 04 传统治疗无效 患者先后接受抗组胺药、强化透析联合血液灌流、加巴喷丁、熊去氧胆酸、舍曲林、局部外用他克莫司、控制血磷和甲状旁腺素等治疗，瘙痒均未获缓解。 05 纳呋拉啡治疗 经全面评估无药物禁忌症后，予纳呋拉啡治疗（2.5 μg，每晚一次）。用药第3天患者自觉瘙痒减轻，第5天症状显著改善，夜间可正常入睡。视觉模拟评分（VAS）量表从7分降低至2分。患者自述睡眠连续性明显改善，日间精力恢复。治疗期间，患者未出现恶心、呕吐、头晕、嗜睡、便秘等常见不良反应，肝肾功能未受影响。 WCN 2026 结论 纳呋拉啡通过其κ-阿片受体激动机制有效应对复杂的双重病理生理表现出对混合性尿毒症性和胆汁淤积性难治性瘙痒较好的疗效。在这一复杂病例中显示的疗效和安全性值得在大规模临床试验中进一步验证，以确立其在管理透析人群中（尤其合并肝功能障碍者）中的应用价值。  作者介绍 朱可庆 医生 中国人民解放军联勤保障部队第九〇三医院 肾内科  主治医师； 从事肾脏病专业10余年，曾于浙大一院、东部战区总院国家肾脏病中心进修学习； 共发表包括 SCI 在内医学论文 4 篇，参与浙江省中医药课题 1 项。 免责声明：本文仅作最新前沿信息交流之目的，仅供医疗卫生行业专业人士阅读参考，文中所有观点不代表梅斯医学立场，亦不代表梅斯医学支持或反对文中观点。如需获得治疗方案指导，请前往正规医院就诊！

– Expands Otsuka portfolio in psychiatric and neurological fields and aims to accelerate development of Transcend's portfolio, including the TSND-201 program for post-traumatic stress disorder (PTSD) – March 27, 2026 -- Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Transcend Therapeutics, Inc. (Transcend) announce that the two companies entered into an agreement today, under which Otsuka, through its wholly owned subsidiary Otsuka America, Inc., will fully acquire Transcend. The acquisition is expected to be completed in the second quarter of 2026, subject to the fulfillment of customary closing conditions and required procedures. Under the terms of the agreement, Otsuka will pay USD 700 million to Transcend shareholders upon closing of the acquisition, and up to USD 525 million in additional contingent consideration based on future sales milestones related to assets in development, for a total potential consideration of USD $1.225 billion. Transcend, founded in 2021, is a clinical stage biotechnology company developing rapid-acting treatments for neuropsychiatric diseases. TSND-201 (methylone), which the company is developing, is a rapid-acting neuroplastogen—an agent that induces rapid and durable neural plasticity in the brain—and is being advanced as a potential treatment for post-traumatic stress disorder (PTSD) and other psychiatric conditions. In the United States, more than 13 million individuals are estimated to be affected by PTSD each year,¹ yet no new treatments have been approved for 25 years, underscoring the significant unmet medical need. Recent research has demonstrated that changes in neuroplasticity in the brain are deeply involved in both the onset and persistence of PTSD symptoms. Neuroplasticity, the brain's ability to reorganize neural circuits, supports memory formation and emotional regulation. In PTSD, alterations in fear-related pathways impair the ability to relearn safety ("overwriting fear"), driving growing interest in interventions that restore or enhance neuroplasticity.² TSND-201 (methylone) acts on monoamine transporters in the brain—including those for serotonin, norepinephrine, and dopamine. By promoting monoamine release, it increases monoamine concentrations within the synaptic cleft, resulting in rapid and sustained enhancement of neuroplasticity.3,4 Importantly, TSND-201 does not act on the serotonin 5-HT2A receptor, which mediates hallucinogenic effects, and is therefore considered a non-hallucinogenic compound.3,5 Transcend is also conducting research and development on novel prodrugs—classified as new chemical entities—to further improve the balance of efficacy, safety, and tolerability of TSND‑201. The company has selected a development candidate and is currently performing non‑clinical studies in preparation for an Investigational New Drug application to the U.S. Food and Drug Administration (FDA). TSND‑201 demonstrated favorable results in the Phase 2 clinical trial IMPACT‑1, which enrolled adults with PTSD, and study findings were published in JAMA Psychiatry in February 2026.5 Due to its rapid onset of activity and robust effects, TSND‑201 was granted Breakthrough Therapy designation by the FDA in July 2025. Transcend met with the FDA in September 2025, to discuss company plans to expedite the development of TSND-201 and confirm the design of the Phase 3 study. Patient recruitment for the Phase 3 trial is underway in the U.S. Makoto Inoue, president and representative director of Otsuka, commented, "We are very pleased to welcome Transcend Therapeutics into the Otsuka group. Although treatment options for PTSD remain limited, TSND‑201 is generating expectations as a potential paradigm‑shifting therapy in the field of psychiatry. By combining Otsuka's long‑standing expertise in the psychiatric and neurological fields with Transcend's innovative approach, we will advance the development of TSND-201 in close collaboration with regulatory authorities to bring this new treatment option to patients." Blake Mandell, CEO and co-founder at Transcend Therapeutics, noted, "We founded Transcend to bring a fundamentally new treatment to patients with PTSD–one that is rapid-acting and accessible. Otsuka's leadership and longstanding commitment in neuroscience reflect the same dedication to patients that has driven our team from day one, and we are proud to continue advancing TSND-201 together in service of that shared mission." Since the 1970s, Otsuka Pharmaceutical has focused on the psychiatric and neurological fields, working to provide new treatment options for disorders such as schizophrenia, bipolar disorder, depression and PTSD, for which therapeutic choices remain limited. In recent years, with the aim of creating next-generation therapies for psychiatric disorders, Otsuka has expanded its global network through partnerships and collaborations, as well as by the acquisition of Mindset Pharma, Inc., a company with innovative, serotonin 5-HT2A agonist discovery technology. Through these efforts, the company is actively working to broaden future treatment options. By acquiring TSND‑201—a novel investigational asset with a mechanism of action distinct from Otsuka's existing medicines and development programs—the company will further accelerate the expansion of its portfolio in the psychiatric and neurological fields. In the U.S. in particular, despite the very large number of individuals living with PTSD, treatment options remain limited to psychotherapy and antidepressants, underscoring the need for new therapeutic approaches supported by scientific evidence of efficacy and safety. By welcoming Transcend into the Otsuka group, the company aims to strengthen its position as a global leader in the psychiatric and neurological fields and to accelerate the development of next‑generation treatments, including those for PTSD, with the goal to expand future treatment options. IMPACT‑1 was a randomized, double‑blind, placebo‑controlled trial that evaluated the efficacy, safety, and tolerability of TSND‑201 in adults with PTSD. A total of 65 patients with severe PTSD, defined as having a CAPS‑5 (Clinician‑Administered PTSD Scale for DSM‑5) total severity score of 35 or higher, were enrolled across 16 sites in the U.S., the U.K., and Ireland (mean age: 43.7 years; 26 males and 39 females). Participants received blinded study drug (orally administered TSND-201 or placebo) once a week for four weeks and were followed for an additional six weeks. The IMPACT‑1 study met its primary endpoint, with the TSND‑201 group demonstrating rapid improvements in CAPS‑5 total severity scores from baseline through Day 64 compared with placebo. Notably, from Day 10 onward, the TSND‑201 group showed statistically significant greater improvement in CAPS‑5 scores relative to the placebo group. TSND‑201 was generally well tolerated. The most frequently reported treatment‑emergent adverse events included headache, decreased appetite, nausea, dizziness, increased blood pressure, dry mouth, and insomnia. These events were typically transient, occurred on the day of dosing, and resolved within one day.5,2 Post‑traumatic stress disorder is a serious mental health condition that develops after experiencing or witnessing a life‑threatening event or a deeply traumatic experience. Common symptoms include flashbacks, nightmares, severe anxiety, and uncontrollable thoughts related to the traumatic event. In the U.S., it is estimated that more than 13 million people live with PTSD each year,¹ and nearly 6 out of every 100 individuals are expected to be diagnosed with PTSD at some point in their lives. Only two medications are FDA-approved for the treatment of PTSD (sertraline and paroxetine), and novel treatments for PTSD are urgently needed. TSND-201 (methylone) is a rapid-acting neuroplastogen developed by Transcend. TSND-201 has well-characterized primary pharmacology, with its primary site of action at the monoamine transporters, and no activity at 5-HT2A receptors (i.e., not hallucinogenic). Transcend is developing TSND-201 as a rapid-acting and durable treatment for PTSD and other central nervous system (CNS) indications. TSND-201 is an investigational medication. Transcend, founded in 2021 and based in New York City, is a clinical-stage, neuroscience-focused company developing rapid-acting treatments for neuropsychiatric diseases. The company's mission is to develop new drugs for the millions of people for whom current psychiatric medicines have not worked. Otsuka Pharmaceutical Co., Ltd. is a total healthcare company that focuses on each individual's potential to enhance their well-being. Our medical-related business provides treatments and diagnostics for both physical and mental health. Our nutraceutical business supports daily health maintenance and improvement. Otsuka's unique products and services are based on scientific evidence, under the guidance of our corporate philosophy: Otsuka-people creating new products for better health worldwide. References 1. U.S. Department of Veteran Affairs. PTSD: National Center for PTSD. 2. Ressler et al., 2022, "Post-traumatic stress disorder: clinical and translational neuroscience from cells to circuits." Nat. Rev. Neurol. doi: 10.1038/s41582-022-00635-8 3. Warner-Schmidt et al., 2024, "Methylone is a rapid-acting neuroplastogen with less off-target activity than MDMA." Front. Neurosci. doi:10.3389/fnins.2024.1353131 4. Warner-Schmidt et al., 2025, "Methylone promotes neurite outgrowth and has long-lasting effects on fear extinction learning." Neuropsychopharmacology. doi:10.1038/s41386-025-02206-z 5. Jones et al., 2026, "Efficacy and safety of the neuroplastogen TSND-201 for the treatment of PTSD: A randomized clinical trial." JAMA Psychiatry. doi:10.1001/jamapsychiatry.2025.4625 The content above comes from the network. if any infringement, please contact us to modify.