从GAMP的理念谈制药行业自动化工程建设与验证的有关问题

根据国际药物工程协会(ISPE)所提GAMP的理念,谈有关制药行业自动化工程建设与验证方面的问题,其中包括GAMP的基本思想与概念、制药行业自动化工程建设与验证关系问题以及我国制药行业自动化工程建设与验证所存在的问题。     

Family Caregivers' Subjective Caregiving Burden,Quality of Life,and Depressive Symptoms Are Associated With Terminally Ill Cancer Patients' Distinct Patterns of Conjoint Symptom Distress and Functional Impairment in Their Last Six Months of Life

Context

Family caregivers constitute a critical component of the end-of-life care system with considerable cost to themselves. However, the joint association of terminally ill cancer patients' symptom distress and functional impairment with caregivers' subjective caregiving burden, quality of life (QOL), and depressive symptoms remains unknown.

Rabs and axonal regeneration

Membrane trafficking processes are presumably vital for axonal regeneration after injury, but mechanistic understanding in this regard has been sparse. A recent loss-of-function screen had been carried out for factors important for axonal regeneration by cultured cortical neurons and the results suggested that the activity of a number of Rab GTPases might act to restrict axonal regeneration. A loss of Rab27b, in particular, is shown to enhance axonal regeneration in vitro, as well as in C. elegans and mouse central nervous system injury models in vivo. Possible mechanisms underlying this new finding, which has important academic and translational implication, are discussed.     

Soluble triggering receptor expressed on myeloid cells-1 in acute respiratory infections.

Levels of the soluble form of the triggering receptor expressed on myeloid cells (sTREM)-1 are elevated in severe sepsis. However, it is not known whether sTREM-1 measurements can distinguish milder bacterial infections from noninfectious inflammation. The present authors studied whether serum sTREM-1 levels differ in community-acquired pneumonia, exacerbations of chronic obstructive pulmonary disease (COPD), asthma and controls, and whether sTREM-1 may be used as a surrogate marker for the need for antibiotics. Serum sTREM-1 levels in 150 patients with pneumonia, COPD and asthma exacerbations and 62 healthy controls were measured. Serum sTREM-1 levels were significantly elevated in pneumonia (median 295.2 ng x mL(-1)), COPD (280.3 ng x mL(-1)) and asthma exacerbations (184.0 ng x mL(-1)) compared with controls (83.1 ng x mL(-1)). Levels were higher in pneumonia and Anthonisen type 1 COPD exacerbations than in type 2 and 3 COPD and asthma exacerbations. The area under the receiver operating characteristics curve for sTREM-1 as a surrogate marker for the need for antibiotics was 0.77. Serum levels of the soluble form of the triggering receptor expressed on myeloid cells-1 were elevated predominantly in pneumonia and Anthonisen type 1 COPD exacerbations versus type 2 and 3 chronic obstructive pulmonary disease exacerbations, asthma and controls. Serum levels of the soluble form of the triggering receptor expressed on myeloid cells-1 has moderate but insufficient accuracy as a surrogate marker for the need for antibiotics in lower respiratory tract infections.     

促血小板生成素对预测脑瘫高危儿的意义

目的探讨缺氧缺血性脑病(hypoxia-ischem ia encephalopathy,H IE)胎儿和H IE新生儿血清中促血小板生成素(Thrombopoietin,TPO)水平与脑损伤的关系,为脑瘫(cerebral palsy,CP)高危儿人群进行早期干预提供监测手段。方法收集23例H IE胎儿和34例H IE新生儿血清以及25例正常胎儿和30例正常新生儿血清,34例H IE新生儿包括11例轻度H IE,8例中度H IE和15例重度H IE。采用双抗体夹心ABC-ELISA法检测H IE胎儿组和轻、中、重H IE新生儿组血清中TPO的水平,并与正常胎儿组和正常新生儿组比较。结果H IE胎儿组和H IE新生儿组TPO分别高于正常胎儿组和正常新生儿组(分别P<0.01,P<0.01),重度H IE组TPO低于轻度H IE组(P<0.05)。结论血清TPO水平与H IE所致脑损伤严重程度有关。脐血TPO检测可为脑瘫高危儿人群进行早期干预提供监测手段。     

Pulmonary Lophomonas blattarum infection in patients with kidney allograft transplantation

The aim of the study was to analyse the clinical manifestation and management of pulmonary Lophomonas blattarum infection in four allograft transplantation recipients retrospectively. Four patients with pulmonary L. blattarum infection were diagnosed by using Fiberoptic bronchoscopy (FOB) and bronchoalveolar lavage (BAL) examination. Their clinical manifestation and management are summarized. Four cases of pulmonary L. blattarum were found during the period from the second month to the third month after transplantation. Concurring infection by other pathogens was found in three of them. Common initial symptoms included fever (>38 degrees C) without cough and breathlessness. Lower lobe shadowing could be found on chest X-ray. Body temperature decreased to the normal range in three patients and to 37.5 degrees C in the other one, after intravenous injection of metronidazole and tapering immunosuppressant. Radiological examination confirmed improved health condition of the patients afterwards. Two patients received repeated FOB and only dead L. blattarum was found. Pulmonary L. blattarum infection in allograft transplant recipients carry relatively obscure initial symptoms. Possible L. blattarum infection needs to be screened in post-transplantation pulmonary infection patients with similar symptoms, especially in those who respond poorly to anti-infection treatment. Microscopic examination of BAL fluid can help to identify pulmonary L. blattarum infection and metronidazole is an ideal treatment choice.     

社区卫生服务:行走在点线面之间

2006开年,一个似曾相识的专有名词重返人们的视野——社区卫生服务,作为一种由政府强力推动的解困手法,被迅速纳入到有效缓解“看病难看病贵”的社会预期之中。由上而下的理论先导,只能经由行之有效的实践打磨才能得以还原。如果将整个社区卫生服务网络比作一个完整的神经系统,那么只有这个新     

大树倒了?

2004年8月26日,哈医大二院建院50周年庆典,位于哈市近郊的这所庞大的医院一扫往日的紧张忙碌,被欢快的乐、缤纷的鲜花、五色的气球和飞扬的条幅紧紧包裹。在庆典活动的中心——该院科技会馆,前去采访的本刊记者穿过络绎不绝的祝贺来宾和整齐划一的迎宾方阵,流连在会场外整齐摆放的各类奖杯、奖牌和科研成果宣传展板之间。这些被物化了的荣誉,几乎挤满了偌大的会堂一层走廊的每一寸角落,静静地宣示着这家医院半个世纪的所有自尊和自豪。在随后进行的庆祝仪式上,在医院各科室职工代表声情并茂的发言之后,哈医大二院院长张岂凡走上讲台。面对眼前如云的嘉宾和着装整齐统一的医护人员方阵,看得出这位著名的技术型院长难掩激情。他在题为“弘扬二院精神,再创世纪辉煌“的演讲词中这样形容：“50年的砥砺前行,50年的春华秋实,令天的哈医大二院已经成为我国医院之林中的一棵生机盎然的大树,根深叶茂,硕果累累。”命运总是在不动声色间逆转,谁能料到,一年后爆出的“天价医药费”事件,使曾经激情飞扬的哈医大二院再一次名动天下,所不同的是,再度亮相的哈医大二院,这一次坐在了被告席上。这棵生长了50年的医疗常青树,难道就此在瞬间轰然倒地?