治疗性单克隆抗体类制品质量控制标准的思考

治疗性单克隆抗体制品在肿瘤、自身免疫、器官移植和感染性疾病的治疗中均取得了显著疗效,其品种和市场份额逐年显著提高。随着新的治疗性单克隆抗体制品的研发和上市,不同产品的质量控制研究,特别是新技术在质量控制中的应用被提到新的高度。由于治疗性单克隆抗体制品结构和生产的复杂性,使得质量控制的复杂程度也相应提高。本文结合治疗性单克隆抗体质量控制的工作经验和国际上的最新进展,对治疗性单克隆抗体质量控制项目设定、标准和方法进展进行论述。     

Secondary Prevention of Drug Dependence through the Transcendental Meditation Program in Metropolitan Philadelphias

Using mailed questionnaires, the Transcendental Meditation program was investigated as an approach to the secondary prevention of substance dependence. Significant differences were found between a random sample of meditators and matched control subjects in usage levels and percentage of users for almost all legal and illegal drugs. Meditators had used more prescribed psychoactive medications before learning meditation, but usage levels returned to normal soon after starting. Former     

艾灸配合心理护理在产科术后预防尿潴留的应用．

目的探讨艾灸配合心理护理在产科术后尿潴留的应用效果。方法回顾性分析2011年2月-2013年2月我院产科32例术后尿潴留的临床资料,产妇应用艾灸配合心理护理,分析尿潴留的病因及护理效果。结果32例产妇全部痊愈出院。结论产科术后尿潴留多由于心理因素、手术创伤、麻醉等多种因素导致,艾灸配合心理护理对术后尿潴留产妇有效,值得临床推广应用。     

硝苯地平缓释片与苯磺酸氨氯地平片治疗原发性高血压的效果分析

目的对比分析硝苯地平缓释片与苯磺酸氨氯地平片治疗原发性高血压的临床疗效。方法将120例原发性高血压患者随机分为观察组和对照组。观察组给予苯磺酸氨氯地平片,对照组给予硝苯地平缓释片,定期测量记录患者的血压。结果观察组患者总有效率为91．67％,对照组患者总有效率为86．67％,观察组在血压改善和疗效上均优于对照组,在不良反应上观察组少于对照组。结论苯磺酸氨氯地平片临床疗效好,不良反应小,药效持续时间长,更适合老年高血压患者;而硝苯地平缓释片费用相对较低,同样是一种安全有效又价廉的降压药,可以作为低收入患者的首选药物。     

循证护理模式在改善儿科患儿态度及依从性中的效果观察

【摘要】目的探讨循证护理模式在改善儿科患儿态度及依从性中的效果。方法选取2011年11月～2012年6月于本院进行治疗的86例儿科患儿为研究对象,将其随机分为对照组（常规护理组）和观察组（循证护理组）,每组各43例,将两组患儿护理前后的静脉穿刺及服药依从性情况、家长对护理的满意程度进行比较。结果护理后观察组的静脉穿刺及服药依从性较佳率均高于对照组。而家长对护理的总满意率也高于对照组,差异均有统计学意义（P〈0．05）。结论循证护理模式在改善儿科患者治疗态度中的效果较佳,家长对本护理模式的认可性也较高。     

中医药治疗慢性肾功能衰竭研究概况

慢性功能肾衰竭(chronic renal failure,CRF)病机为脾肾虚损,导致湿浊、瘀血等浊毒潴留于体内,弥漫于三焦。本虚标实为其致病特点。从病因病机、治则、方药、综合治疗等方面,介绍中医药治疗慢性肾功能衰竭研究概况。中医药能有效延缓病情进展,延长患者寿命,防治早中期肾功能不全有独特优势。指出应重视古代文献研究,全面掌握有关本病论述,验证于临床,辅助现代科技,中西医结合,扩展中医药治疗CRF临床研究思路,提高疗效及生存质量,使中医药治疗该病发挥更大优势。     

Assessment of Folate Receptor-α and Epidermal Growth Factor Receptor Expression in Pemetrexed-Treated Non–Small-Cell Lung Cancer Patients

IntroductionFolate receptor-α regulates cellular uptake of folates and antifolates (eg, pemetrexed) and is frequently expressed in pulmonary adenocarcinoma. EGFR is an established therapeutic target in NSCLC. Therapies targeting FRA or EGFR are available. The association between FRA and EGFR expression in advanced NSCLC has not been explored. Combining therapeutic FRA antibodies with an EGFR inhibitor might be beneficial, if both of the targets are significantly coexpressed.Patients and MethodsSpecimens from 160 advanced NSCLC patients receiving pemetrexed-based chemotherapy were assessed for membranous FRA and EGFR protein expression using immunohistochemistry and the Hybrid (H)-score. EGFR (exons 18-21) and Kirsten RNA-associated rat sarcoma 2 virus (exon 2) mutations were determined. Results were correlated to patients' clinicopathological data, progression-free survival (PFS), and overall survival (OS).ResultsForty-seven patients (29%) had tumors with strong FRA and EGFR expression, but no statistically significant correlation was seen between protein levels of FRA and EGFR. High membranous FRA expression (H-score ≥ 20) was associated with prolonged PFS (5.5 vs. 3.4 months; hazard ratio [HR], 0.6060; P = .0254) and improved OS (12.1 vs. 6.4 months; HR, 0.5726; P = .0076).ConclusionSurvival times are improved in NSCLC patients whose tumors show strong membranous FRA expression. No statistical correlation between membranous FRA and EGFR expression was demonstrated in advanced NSCLC, but 47 patients (29%) had higher expression of both of the receptors and could be suitable for combined targeted therapies.     

颅内动脉瘤栓塞术后并发症的相关因素分析

【目的】探讨颅内动脉瘤栓塞术后患者出现栓塞并发症的相关因素。【方法】选择宣武医院2010年6月至2013年3月间进行颅内动脉瘤栓塞术的252例患者,对颅内动脉瘤不同直径以及颅内不同部位的动脉瘤栓塞后出现栓塞相关并发症的情况进行分析。【结果】本组252例患者中,颅内动脉瘤直径未超过5mm患者出现栓塞并发症的几率显著低于颅内动脉瘤直径在5～10mm及10～25mm的颅内动脉瘤直径的患者,且各组比较差异均有显著性（P〈0．05）;后交通动脉瘤和颈内动脉瘤出现栓塞并发症的几率显著低于大脑中动脉瘤、前交通动脉瘤）及大脑后动脉瘤的发生率,且差异有显著性（P〈0．05）。【结论】颅内动脉瘤的直径越小,出现栓塞并发症的几率越低;后交通动脉瘤和颈内动脉瘤的栓塞并发症的发生率相对较低。     

An observational study of patient selection criteria for post-cardiac arrest therapeutic hypothermia

Background

To date, there is no comprehensive assessment of how therapeutic hypothermia and post-arrest care are being implemented clinically. At this stage in the translation of post-arrest science to clinical practice, this analysis is overdue. This study examines the first step of post-arrest care – the selection of patients for TH and post-arrest care.

Methods

We conducted a systematic review to search for all publicly available TH and post-arrest protocols. Observational data was reported and no statistical inferences were made.

Results

Notable variation was observed in the following selection criteria: total ischemic time and hemodynamic requirements. Additionally, only some of the criteria were evidence based.

Conclusion

This study demonstrates the wide range and variety of patient selection criteria that are being used for implementation of post-cardiac arrest care. The consequences of this selection criteria variability are currently unmeasured and likely underestimated. Variability is likely to breed inefficiency. Some patients who could benefit do not get treated. Other patients get cooled, yet will never regain consciousness. This variability may be important when considering inter-hospital variation in post-arrest care and outcomes.     

Therapeutic hypothermia and vasopressor dependency after cardiac arrest

Objective

Clinical trials of therapeutic hypothermia (TH) after cardiac arrest excluded patients with persistent hemodynamic instability after return of spontaneous circulation (ROSC), and thus equipoise may exist regarding use of TH in these patients. Our objective was to determine if TH is associated with worsening hemodynamic instability among patients who are vasopressor-dependent after ROSC.

Methods

We performed a prospective observational study in vasopressor-dependent post-cardiac arrest patients. Inclusion criteria were age >17, non-trauma cardiac arrest, comatose after ROSC, and persistent vasopressor dependence. The decision to initiate TH (33–34 °C) was made by the treating physician. We measured cumulative vasopressor index (CVI) and mean arterial pressure (MAP) every 15 min during the first 6 h after ROSC. The outcome measures were change in CVI (primary outcome) and MAP (secondary outcome) over time. We graphed median CVI and MAP over time for the treated and not treated cohorts, and used propensity adjusted repeated measures mixed models to test for an association between TH induction and change in CVI or MAP over time.

Results

Seventy-five post-cardiac arrest patients were included (35 treated; 40 not treated). We observed no major differences in CVI or MAP over time between the treated and not treated cohorts. In the mixed models we found no statistically significant association between TH induction and changes in CVI or MAP.

Conclusion

In patients with vasopressor-dependency after cardiac arrest, the induction of hypothermia was not associated with a decrease in mean arterial pressure or increase in vasopressor requirement.