Analysis of spontaneous adverse drug reaction (ADR) reports using supplementary information

Assessment of safety of newly marketed drugs is an important public health issue. Once the drug is in the market, clinicians and/or health professionals are responsible for recognizing and reporting suspected side effects known as adverse drug reaction (ADR). Such reports are collected in a so-called spontaneous reporting (SR) system. The primary purpose of spontaneous ADR reporting is to provide early warnings or suspicions, which have not been recognized prior to marketing of a drug because of limitations of clinical trials. We shall discuss the existing work to analyze the SR database and their drawbacks and also suggest methodologies to tackle these drawbacks by defining a source population and considering the problem of under-reporting, with the help of supplementary data. Unbiased estimate of population odds-ratio has been obtained and the corresponding asymptotic results are derived.     

Characteristics and outcomes of in-hospital cardiac arrest in adults hospitalized with acute coronary syndrome in China

AimsThis retrospective study aims to analyze and explore the clinical characteristics, risk factors, and in-hospital outcomes - including return of spontaneous circulation (ROSC) and survival to discharge - of hospitalized patients admitted with acute coronary syndrome (ACS) suffering cardiac arrest.MethodsACS patients admitted to three tertiary hospitals in Fujian, China, were evaluated retrospectively from January 1, 2012 to December 30, 2016. Data were collected, based on the Utstein Style, for all cases of attempted resuscitation for IHCA. We analyzed patient characteristics, pre-event variables, event variables, and the main outcomes, including ROSC and survival to discharge, and identified the influencing factors on the outcomes.ResultsThe total number of ACS admissions across the three hospitals during this study period was 21,337. Among these admissions, 320 ACS patients experienced IHCA (incidence: 1.50%); 134 (41.9%) patients experienced ROSC; and 68 (21.2%) survived to discharge. The findings indicated that four factors were associated with ROSC, including age <70 years-old, shockable rhythm, duration of resuscitation (≤15 min and 16–30 min), and PCI. Five factors were associated with survival to discharge, including age <70 years-old, shockable rhythm, the duration of resuscitation (≤15 min and 16–30 min), Killip ≤ II, and CCI ≤ 2.ConclusionYounger age, shockable rhythm, and shorter duration of resuscitation were all factors demonstrated to be a predictor of ROSC and survival to hospital discharge.     

Comment on “The effect of omalizumab on hematological and inflammatory parameters in patients with chronic spontaneous urticarial”: reply from authors

Abstract

We read Cosansu’s commentary entitled “Effectiveness of the new inflammatory parameters in patients with chronic spontaneous urticarial” to our study with great interest. The author remarked that a limited number of patients had C-reactive protein levels and it was not specified whether there were any other drugs used by the patients and no information was given about the severity of the disease in our study.     

ICU气管插管患者自主呼吸试验通过后拔管失败原因分析

目的:分析ICU气管插管患者通过自主呼吸试验后拔管失败的原因,总结经验以减少I CU气管插管拔管后48h内再插管率。方法:回顾性分析2015年1月至2018年12月,我院ICU收治的气管插管通过自主呼吸试验(SBT)后仍拔管失败的16例患者的临床资料。结果:吞咽功能障碍6例,精神因素3例,运动神经元病3例,声门水肿2例,格林巴利综合征1例,会厌畸形1例。结论:自主呼吸试验指导撤机存在局限性,了解撤机过程中各种失败的原因,并进行针对性预处理,可降低ICU气管插管拔管后48h内再插管率。     

复发性流产患者病因构成分析

背景　复发性流产（RSA）发病率呈逐年上升趋势，严重影响妇女身心健康，目前现代医学对RSA的病因和发病机制尚未完全明确。目的　了解RSA病因的分布情况，以及流产孕周与流产次数和RSA病因之间的关系。方法　选取2018年在新疆医科大学第二附属医院确诊为RSA的患者198例，收集患者的一般资料包括年龄、自然流产次数、流产孕周，并筛查患者的病因：染色体异常、生殖道解剖结构异常、内分泌系统异常、生殖道感染、自身免疫异常等，并对这些资料进行回顾性分析。根据患者的流产孕周，分为早期RSA组（<12周）（155例）和晚期RSA组（≥12周）（43例）；根据流产次数分为2次组（123例）和≥3次组（75例）。分析RSA患者各病因所占比例，以及RSA病因在不同流产孕周组和不同流产次数组间的差异。结果　198例RSA患者，染色体异常9例（4.55%），生殖道解剖结构异常11例（5.56%），内分泌系统异常36例（18.18%），生殖道感染14例（7.07%），自身免疫异常30例（15.15%），不明病因98例（49.49%）。晚期RSA组患者生殖道解剖结构异常发生率大于早期RSA组，不明病因发生率低于早期RSA组（P<0.05）；早期RSA组与晚期RSA组患者染色体异常、内分泌系统异常、生殖道感染、自身免疫异常发生率比较，差异均无统计学意义（P>0.05）。流产次数2次组和流产次数≥3次组患者染色体异常、生殖道解剖结构异常、内分泌系统异常、生殖道感染、自身免疫异常、不明病因发生率比较，差异均无统计学意义（P>0.05）。结论　导致RSA的病因有多种，包括染色体异常、生殖道解剖结构异常、内分泌系统异常、生殖道感染、自身免疫异常及不明病因等多种因素，其中不明病因的RSA占多数；生殖道解剖结构异常对妊娠晚期的影响大于妊娠早期。     

Spontaneous Intracranial and Lumbar Subdural Hematoma Presenting as Vaginal Pain

Background

Spontaneous spinal and intracranial subdural hematomas are rarely reported, especially occurring simultaneously. Anticoagulation use has been associated with spontaneous hemorrhages. Prompt diagnosis is required to prevent permanent neurological sequelae. In this case report, we describe a spontaneous spinal and intracranial subdural hematoma in a woman taking warfarin and initially presenting with severe vaginal pain.

泸州汉族人群MTHFR基因多态性分布及育龄妇女该基因多态性与复发性流产相关性的研究

目的了解泸州市亚甲基四氢叶酸还原酶(MTHFR)基因多态性分布情况以及该单核苷酸多态性与复发性流产的相关性。方法选取2016-2018年在西南医科大学附属医院进行MTHFR基因检测的泸州汉族人群691例为研究对象,利用PCR-微阵列基因芯片法检测其C677T单核苷酸多态性,统计得出3种基因型的频率以及等位基因频率,并与全国其他地区已报道的多态性分布特征进行比较。结果泸州汉族人群CC、CT与TT基因型频率分别为39.2%、46.7%、14.0%,T等位基因频率为37.4%。其中女性T等位基因频率为38.1%,基因分布与纬度相近地区(N25°~31°)差异无统计学意义(P>0.05),与南方的海南、惠州及北方的西安、银川、赤峰、烟台人群差异有统计学意义(P<0.05)。在泸州育龄妇女中,复发性流产与MTHFR C677T基因多态性暂未发现存在直接关联。结论泸州地区汉族人群的MTHFR基因分布具有西南地区的分布特征,T等位基因频率整体呈现出随着纬度升高而升高的趋势。