Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials

Background

The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies.

枸橼酸咖啡因与氨茶碱对早产儿不同时相血糖值的影响比较

目的观察并比较枸橼酸咖啡因及氨茶碱对早产儿不同时相血糖的影响程度。方法选择新生儿监护室诊断为原发性呼吸暂停的出生胎龄＜34周的早产儿172例，采用随机数字表法分为咖啡因组与氨茶碱组各86例。比较两组早产儿用药前及用药后15、30min、1、1.5、2、4、6、12、12.5、24.5、36.5和48h血糖的变化。结果两组早产儿用药后除6、12和48h血糖值比较差异均无统计学意义（均P＞0.05），其他用药后时相比较差异均有统计学意义（均P＜0.05）。咖啡因组早产儿用药后30min血糖值上升，至1h达峰值，后逐渐回落；用药后30min、1、1.5、2及24.5h血糖值与用药前比较差异均有统计学意义（均P＜0.05）。氨茶碱组早产儿用药后血糖值上升，30min达峰值，后逐渐回落；用药后15、30min、1、1.5、2、4、6、12.5、24.5、36.5h血糖值与用药前比较差异均有统计学意义（均P＜0.05）。结论枸橼酸咖啡因可引起早产儿血糖升高，但升高幅度较氨茶碱小、持续时间也较短。     

A drug safety evaluation of mogamulizumab for the treatment of cutaneous T-Cell lymphoma

Introduction: Cutaneous T-cell lymphomas (CTCL) are rare non-Hodgkin lymphomas of skin-homing T-cells that initially or mainly manifest cutaneously. Treatment of CTCL is challenging given the disease states’ varying presentation and prognosis. Systemic treatment options often lack comparative evidence and have relatively low response rates and short duration of response. The recent Food and Drug Administration (FDA) approval of mogamulizumab in adult patients with relapsed or refractory (R/R) CTCL after at least one prior line of therapy provided a new treatment option to patients with advanced disease.

Areas covered: The authors discuss basic information about CTCL and mogamulizumab’s mechanism of action. Then, the authors discuss the agent’s efficacy. Finally, the authors evaluate the safety of mogamulizumab in comparison to other agents available in CTCL.

Expert opinion: Mogamulizumab has been shown to be an effective and well tolerated therapy for patients with relapsed and refractory MF/SS with excellent activity in the circulating component of the disease.     

Functional beta-cells derived from umbilical cord blood mesenchymal stem cells for curing rats with streptozotocin-induced diabetes mellitus

INTRODUCTIONThis study aimed to investigate the therapeutic response to injected human umbilical cord blood mesenchymal stem cells (UCBMSCs) among albino rats with streptozotocin (STZ)-induced diabetes mellitus.METHODSControl group (GI; n = 25) rats were fed with standard rat diet. Rats with STZ-induced diabetes mellitus without (GII; n = 25) and with (GIII; n = 25) differentiated human UCBMSCs implantation were the test groups. Rats were sacrificed in Week 11 following implantation. Liver biopsies were sectioned and stained in order to highlight both the presence and function of impregnated cells in the liver tissue.RESULTSHaematoxylin and eosin-stained sections in GI and GII rats showed normal liver architecture while GIII rats showed presence of cell clusters inside the liver tissue and around the central veins. Cell clusters with blue cytoplasm were present in sections in GIII rats but absent in GI and GII rats, indicating the presence of injected differentiated human UCBMSCs. The anti-human insulin immunostaining of GIII rats showed clusters of cells within the liver parenchyma and around central veins, indicating that these cells were active and secreting insulin.CONCLUSIONUCBMSCs are proficient in differentiating into insulin-producing cells in vivo under specific conditions and, when transplanted into the liver of albino rats with STZ-induced diabetes mellitus, were able to secrete insulin and partially control the status of diabetes mellitus in rats.     

江苏省儿童专科夜间门诊诊察费定价政策成效分析

2019年5月20日,江苏省医保局推出调整了儿童专科夜间门诊诊察费收费标准举措。文章以江苏省某三甲综合医院为样本,围绕上述政策实施后儿科诊疗工作量、病人满意度、医院收入影响等方面进行了调查,结果表明,上述政策可满足儿科病人就诊差异化需求,合理分流病人,保障急诊优先的诊疗秩序。