Myelography with a dimeric (iodixanol) and a monomeric (iohexol) contrast medium: a clinical multicentre comparative study

The purpose of this study was to evaluate and compare the radiographic efficacy and safety of iodixanol (Visipaque; 270 and 320 mg I/ml) and iohexol (Omnipaque; 300 mg I/ml) in myelography. The study was randomized, double-blind and comparative including 398 patients from five European university clinics. The radiographic visualisation was evaluated as poor, good or excellent. Adverse events were recorded by interviewing the patients after the myelography, and each patient was given a questionnaire to be returned after 1 week. In cervical myelography with cervical puncture more films with excellent quality was obtained after iodixanol 320 mgI/ml compared with iohexol 300 mgI/ml (p = 0.009). Also in lumbar myelography iodixanol 320 mgI/ml compared favourably with iohexol 300 mgI/ml (p = 0.006). The most frequent adverse event was headache, which occurred in 5–35 % of patients during the first 24 h and in 19–61 % within the first 7 days, depending on the centre. There was no difference in frequency and severity of the adverse effects between the contrast media. Received 13 March 1997; Revision received 29 December 1997; Accepted 5 January 1997     

Safety and efficacy of combined upper blepharoplasties and open Coronal Browlift: A consecutive series of 600 patients

Surgical rejuvenation of the upper face involves the correction of excess and lax forehead, eyelid, and periorbital skin. Improving the appearance by correcting the effects of aging involves a combination of blepharoplasty and open coronal foreheadplasty. Many surgeons and several reports question the safety of both procedures being performed concomitantly. The difficulty arises in precisely balancing the skin excision from the frontal forehead and upper eyelid areas. Over-resection of skin may result in incomplete closure of the eyelid and dry-eye syndrome, while an inadequate resection may produce a poor aesthetic result. There is no large series that documents the safety and effectiveness of these two procedures being performed concomitantly. Furthermore, with the recent and rapid development of complex multiplanar endoscopic facial rejuvenation techniques, the basic open forehead-plasty has become increasingly overlooked as a legitimate, efficacious technique for rejuvenation of the upper face. The technique utilized in this series is presented in detail. The consistently excellent results obtained satisfy the aesthetic goals of patients as well as the goals of surgeons, and suggest a renewed interest in the technique based upon its simplicity and easily reproducible results.     

基于FAERS的地舒单抗安全警戒信号挖掘与评价

基于FAERS数据库挖掘安全警戒信号,分析评估地舒单抗潜在不良反应信号,为其临床使用提供一定参考依据。方法 通过Openvigil 2.1访问 FAERS 数据库,将地舒单抗作为主要药物,检索自该药首次上市时间（2010年5月—2021年9月）的数据,获得与地舒单抗相关的不良事件报告记录。使用报告比值比法（ROR）和贝叶斯置信度递进神经网络法（BCPNN）筛选地舒单抗安全警戒信号,挖掘潜在的不良反应,并通过工具BioPortal对不良事件信号挖掘结果进行系统分类,通过判断信号间置信区间的变化,发现与药物不良事件关联性较大的信号。结果 从FAERS数据库中收集到270503份不良反应事件（ADE）报告,根据ROR法和BCPNN法共得到343个不良事件信号,通过信号间同义合并、剔除与药物无关的信号后,得到316个不良事件信号。地舒单抗的不良事件系统分类主要为肌肉骨骼和结缔组织疾病、医学检查、胃肠道疾病。FAERS数据库的信号挖掘结果发现,高风险且说明书中未收录的安全警戒信号包括颞下颌关节综合征、下颌脓肿、雌激素缺乏症、血液甲状旁腺激素增加,计算高风险信号的置信区间显示颞下关节综合征较有可能发展成为新的不良反应;另外,也发现种植体周围炎为具有临床意义的可疑警戒信号,但有待进一步观察研究。结论 基于FAERS数据库的信号挖掘结果提示临床应规范使用地舒单抗,治疗期间需警惕患者是否出现颞下颌关节综合征、下颌脓肿、雌激素缺乏症、血液甲状旁腺激素增加等不良反应事件,以便尽早发现尽早处理,从而有效降低临床用药风险     

Safety and efficacy of oral nemonoxacin versus levofloxacin in treatment of community-acquired pneumonia: A phase 3, multicenter,randomized, double-blind,double-dummy,active-controlled,non-inferiority trial

Background/Purpose

Nemonoxacin is a novel nonfluorinated quinolone with excellent in vitro activity against most pathogens in community-acquired pneumonia (CAP), especially Gram-positive isolates. The purpose of this study was to assess the efficacy and safety of nemonoxacin compared with levofloxacin in patients with CAP.

Performance of platinum stimulating electrodes,mapped on the limitvoltage plane

The paper introduces the electrode limit-voltage plane (ELVP)—a useful tool for describing in electrical terms what a polarisable electrode is doing under a particular set of conditions. The ELVP is then used to consider the charge-injection capability of a platinum stimulating electrode.     

Electronic aspects of spinal-cord stimulation in multiple sclerosis

Patients receiving chronic spinal-cord stimulation in the management of multiple sclerosis have been stimulated at a frequency of 33 Hz, with pulses whose duration has been varied between 0·05 ms and 2·0 ms. Measurements on the stimulating pulses show that the energy requirement was at a minimum when the pulse duration was 0·2 ms. The current and energy requirements of different patients using 0·2 ms pulses vary over a large range but measurement of the current requirement of a particular patient can be a useful observation in predicting his response to treatment: low current requirements are often associated with a good response and high currents with a poor response to treatment. The use of 0·2 ms pulses of the amplitude we have used meets the safety requirements established by other workers and our results indicate that this pulse duration is optimal in terms of safety requirements, as well as energy requirements.     

经颅磁刺激安全性的实验研究

目的 :探讨重复经颅磁刺激的安全性。方法 :选用 3 6只健康Wistar大鼠 ,随机分为对照组 ,低频刺激组和高频刺激组 ,对低频组和高频组分别给予不同频率和强度的经颅磁刺激 ,然后对各组大鼠的行为、组织病理形态学、血清髓鞘碱性蛋白 (MBP)及神经元特异性烯醇化酶 (NSE)含量进行观察。结果 :低频刺激组 (5Hz)和高频刺激组 (2 0Hz)在刺激过程中均未出现异常活动 ,无肢体强直、阵挛等 ,脑组织形态学包括大体观察、普通光镜及电镜改变不明显 ,其血清MBP和NSE含量与正常对照组比较 ,差异无显著性意义 (P >0 0 5 )。结论 :在一定强度和频率内经颅磁刺激是一种比较安全的方法     

Immunogenicity and Safety of Two Different Haemophilus influenzae Type b Conjugate Vaccines in Korean Infants

The incidence of invasive diseases, including meningitis caused by Haemophilus influenzae type b (Hib) was markedly decreased after routine immunization of Hib vaccine through diverse schedules in many countries. The purpose of this study was to evaluate the immunogenicity and safety of Hib conjugate vaccines in Korean children before the implementation of a national immunization program against Hib in Korea. A multicenter controlled trial was performed on two different Hib vaccines in Korean children. A total of 319 infants were enrolled: 199 infants were immunized with the Hib polysaccharide conjugated to the tetanus toxoid (PRP-T) and 120 infants with the Hib polysaccharide conjugated to the outer-membrane protein of Neisseria meningitides (PRP-OMP). Immunogenicity was evaluated by enzyme-linked immunosorbent assay (ELISA) and serum bactericidal assay. Both vaccines showed good immunologic responses after primary immunization. After 2 doses of PRP-T or PRP-OMP, 78.9% and 91.7% of infants achieved an antibody level of ≥1.0 µg/mL, respectively. Both vaccines were safe and well-tolerated. No serious adverse events were observed. Thus, Hib conjugate vaccines appear to be safe and show good immunogenicity in Korean infants. These results will be important reference data for the implementation of Hib vaccine in the national immunization program of Korea.     

道路交通安全执法对医院质控的启示

道路交通安全执法对机动车的管理井然有序,而行人违规过马路现象却比比皆是。医院质控也常常出现类似的现象。文章比较了道路交通安全执法对机动车管理与行人管理的异同,认为道路交通安全执法与医院质控虽然属于不同的领域,但拥有相同或相似的功能和流程,可以作为跨行业功能性标杆来学习。道路交通安全执法对医院质控的启示为:（1）医院质控必须遵循结构质量—过程质量—结果质量（SPO）三维质量评价模型,且有机协同;（2）有效的质量控制必须符合热炉法则;（3）质控工作的重心应放在监控和改进上,即“有时去应急,常常去改进,总是去监控”;（4）遵循规章制度的自律文化的养成是良好质控的保证。     

1例用药错误事件的分析与改进

采用根本原因分析及行动法对1例儿科用药错误事件进行分析,确定根本原因,从人员、环境、制度等方面提出针对性改进措施。采取措施后,类似不良事件未再发生。建议医疗机构加强关键环节的有效沟通,鼓励患者参与医疗安全管理,营造病区安静环境,严格执行查对制度,正确识别患者身份,优化护理人力资源配置,以保证患者用药安全。