奥克雷利祖马布的感染和感染相关不良事件:使用FDA不良事件报告系统进行不成比例分析
1Department of Medical Pharmacology, Ordu University Faculty of Medicine, Ordu, Turkiye.
Northern clinics of Istanbul
|January 23, 2026
概括
使用ocrelizumab与各种感染和感染的风险增加有关,包括COVID-19和中枢神经系统感染. 建议对接受ocrelizumab治疗的患者进行仔细监测.
科学领域:
- 药物监督和药物安全研究.
- 免疫学和传染病.
背景情况:
- 奥克雷利祖马布是一种针对性治疗,用于自身免疫性疾病.
- 了解其潜在的不良事件,特别是感染和病,对于患者的安全至关重要.
研究的目的:
- 使用现实世界的数据,识别和描述与ocrelizumab相关的感染和感染不良事件.
- 通过不成比例分析来评估这些不良事件的信号强度.
主要方法:
- 利用FAERS数据库 (Q4 2003Q3 2024) 获取关于ocrelizumab为首要嫌疑人的不良事件报告.
- 通过OpenVigil 2.1使用报告几率比率 (ROR) 和比例报告比率 (PRR) 算法进行不成比例分析.
- 根据ROR和PRR值将信号强度分类为低,中或强.
主要成果:
- 确定了161个与ocrelizumab相关的感染和感染不良事件的积极信号.
- COVID-19是最频繁报告的事件 (n=2287).
- 根据ROR和PRR的顶级不良事件包括肠道病毒性脑炎/脑膜炎,输卵管,鼻疹,神经病变和婴儿病.
结论:
- 治疗ocrelizumab可能会增加各种感染和感染的风险.
- 具体风险包括肠道病毒相关的中枢神经系统感染,传播疾病,COVID-19并发症,生殖道感染和疹感染.
- 对于接受ocrelizumab的患者来说,密切的临床监测对于管理这些潜在风险至关重要.
相关概念视频
01:12Local Anesthetics: Adverse Effects
779
While local anesthetics are generally safe and well-tolerated, they can occasionally cause adverse effects that vary in severity. Local anesthetics can induce toxicity at two distinct levels. They can either produce local effects through direct contact with the neural elements or be absorbed into the bloodstream from the injection site, leading to systemic effects.
Once absorbed into the systemic circulation, local anesthetics can affect the organs that depend on the functioning of sodium...
Once absorbed into the systemic circulation, local anesthetics can affect the organs that depend on the functioning of sodium...
779
01:21Skeletal Muscle Relaxants: Adverse Effects
786
Skeletal muscle relaxants are widely used for muscle paralysis and relieving pain following any muscle injury or stiffness. However, depending on the drug type, they can have adverse effects that range from mild to severe. Usually, nondepolarizing neuromuscular blockers have minimal side effects. For example, drugs like d-tubocurarine, cisatracurium, and rocuronium cause hypotension, whereas drugs like baclofen, when stopped abruptly, can lead to the recurrence of spastic conditions.
Unlike...
Unlike...
786
01:16Insulin: Dosing Regimen and Adverse Effects
711
Insulin-replacement therapy usually includes both long-acting insulin (basal) and short-acting insulin (to cater to postprandial needs). In a diverse group of type 1 diabetes patients, the average daily insulin dose is typically 0.5-0.7 units/kg body weight. However, obese patients and pubertal adolescents may need more due to insulin resistance.
The basal dose constitutes about 40%-50% of the total daily dose, with the rest as premeal insulin. The mealtime insulin dose should mirror...
The basal dose constitutes about 40%-50% of the total daily dose, with the rest as premeal insulin. The mealtime insulin dose should mirror...
711
01:28Integration of Synaptic Events
3.5K
Synaptic integration mainly includes the summation of graded potentials. Graded potentials, regardless of their type, cause subtle alterations in membrane voltage, resulting in either depolarization or hyperpolarization. These incremental changes, when combined or summed, can propel the neuron toward its threshold. Consider, for example, a membrane experiencing a +15 mV shift, causing it to depolarize from -70 mV to -55 mV. In this scenario, graded potentials govern the membrane's ability to...
3.5K
01:21Schwarzschild Radius and Event Horizon
2.7K
No object with a finite mass can travel faster than the speed of light in a vacuum. This fact has an interesting consequence in the domain of extremely high gravitational fields.
The minimum speed required to launch a projectile from the surface of an object to which it is gravitationally bound so that it eventually escapes the object’s gravitational field is called the escape velocity. The escape velocity is independent of the mass of the object. Merging the idea of escape...
The minimum speed required to launch a projectile from the surface of an object to which it is gravitationally bound so that it eventually escapes the object’s gravitational field is called the escape velocity. The escape velocity is independent of the mass of the object. Merging the idea of escape...
2.7K
01:26FDA Approved Drugs: Changes to Approved Drugs
248
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
248