进口化学药品说明书的基本要素

药品说明书是药品获批准上市后的重要证明文件之一，是对被批准的适应症、用法、用量等有关用药重要信息的详细说明，是指导医患用药的关键依据。在《中华人民共和国药品管理法》、《药品注册管理办法》（试行）以及国家食品药品监督管理局局23号令等法律、法规和条例中，对药品说明书及相关内容明确了其要求和责任等，这对认识说明书的作用和地位，并且对其进行制订和核准都起着重要的指导作用。     

煤工尘肺患者下呼吸道产金属内酰胺酶铜绿假单胞菌感染状况

目的了解煤工尘肺患者下呼吸道产金属内酰胺酶的铜绿假单胞菌(PA)的感染状况及其耐药特性。方法分离下呼吸道感染的煤工尘肺患者痰液标本中的PA，根据药敏试验，筛选可疑产金属内酰胺酶PA，最后依据2-巯基丙酸双纸片法鉴定产金属内酰胺酶PA。结果40株PA中共筛选出10株可疑PA，最终确定产金属内酰胺酶PA6株。这些菌株均有很强的耐药性，对亚胺培南、头孢菌素、含酶抑制剂类抗菌药物全部耐药；对阿米卡星、环丙沙星、左氧氟沙星、庆大霉素等药物部分耐药。产金属内酰胺酶PA的耐药性远强于不产金属内酰胺酶的PA。结论产金属内酰胺酶PA的耐药性很强，应加强煤工尘肺患者产金属内酰胺酶PA的检测，以利于指导治疗和控制感染。     

第一产程异常胎心监护图形与新生儿结局的关系

目的　探讨第一产程异常胎心监护图形与新生儿结局的关系。方法　回顾分析 2 0 0 2年 8月至 2 0 0 3年 6月在我院足月单胎头位分娩产妇 ,第一产程中胎心率 (FHR)异常图形 2 1 7例 (观察组 )和FHR正常图形的2 6 9例 (对照组 )的临床资料。结果　第一产程异常FHR图形的发生率为 4 4 7% ,常见类型为轻度变异减速(6 4 5 % )、基线变异减弱 (2 1 6 % )和轻度心动过速 (1 2 0 % )。晚期减速、基线变异减弱和重度变异减速是导致新生儿窒息的危险因素。观察组羊水过少 (5 1 % )、脐带缠绕 (2 2 6 % )、羊水粪染 (1 0 6 % )、新生儿窒息 (6 5 % )、新生儿转入NICU(1 0 1 % )的发生率和剖宫产率 (31 8% )明显高于对照组 (P <0 0 5 )。结论　第一产程异常FHR图形的发生率较高 ,其中晚期减速、基线变异减弱、重度变异减速与新生儿窒息的发生相关 ,其他图形可在严密监护下继续试产     

剖宫产术后自控镇痛对母婴的影响

目的　观察剖宫产术后产妇自控镇痛对母婴的影响。方法　 2 0 0 2年 1月至 2 0 0 3年 1月首都医科大学附属复兴医院将剖宫产产妇 2 16例分为观察组和对照组 ,两组均为连续硬膜外麻醉 ,手术结束时 ,观察组将自控镇痛泵接在硬膜外管上。术后分别取产妇肘静脉血、初乳、尿及新生儿尿 ,测定吗啡含量 ;观察镇痛效果及副反应。结果　与对照组比较观察组镇痛效果明显 (P <0 0 5 )。观察组血吗啡质量浓度 5 0～ 12 6 0 μg/L ,初乳吗啡质量浓度 5 0～ 33 6 μg/L ,91 8%的产妇尿吗啡呈阳性 ,12 7%的新生儿尿吗啡呈阳性。随访 1年两组婴儿的体格及发育商比较 ,P >0 0 5。结论　剖宫产术后硬膜外腔应用吗啡镇痛 ,对产妇及新生儿是安全可行的     

上海市人群自报健康分布的综合测量(三)

基于经HOPIT模型校正后的上海市嘉定、宝山、金山和崇明4区(县)的人群自报健康资料，应用伤残集中指数进行人群自报健康分布的综合测量研究。结果表明，在样本地区存在收入相关健康不平等，并提示改善低收入人群的经济状况，特别是收入状况对改善健康的重要性。     

The long-term impact of 2-3 years of hormone replacement therapy on cardiovascular mortality and atherosclerosis in healthy women.

OBJECTIVE: The effect of hormone replacement therapy (HRT) on cardiovascular risk is intensely debated. The aim of this study was to investigate the long-term effects of HRT given for a few years on all-cause and cardiovascular mortality and the severity of atherosclerosis. METHODS: This analysis was based on a cohort of 1,458 postmenopausal women (55.8 +/- 6.1 years old) who previously participated in a number of randomized, placebo-controlled, clinical trials assessing the efficacy of 2-3 years of therapy with various estrogen plus progestin combinations for preventing bone loss. Women were followed on average for 9.8 years and came for a follow-up visit. Outcome variables were all-cause and cardiovascular mortality and the severity of atherosclerosis, as estimated by semi-quantitative scoring of vascular calcification in the lumbar aorta on lateral radiographs. RESULTS: A total of 174 women died during the observation period. All-cause mortality was decreased by 30% in the HRT+ group compared with the HRT- group (hazard ratio (HR) 0.70; 95% confidence interval (CI) 0.50-0.97) after adjusting for age, body mass index and smoking. Under the same conditions, similar results characterized mortality from cardiovascular disease (n = 61 deaths; 35.1% of all deaths) and coronary heart disease (n = 39 deaths; 22.4% of all deaths), which were decreased by 46% (HR 0.54, 95% CI 0.29-0.98, p = 0.045) and 53% (HR 0.47, 95% CI 0.21-1.03, p = 0.062), respectively. Furthermore, the mean severity score of aortic calcification at follow-up was significantly lower in hormone-treated compared to non-treated women (p < 0.0001). CONCLUSION: Women who receive 2-3 years of HRT after menopause do not have increased all-cause mortality, and results of the present study suggest relative cardiovascular benefits compared to those who had not used hormones.     

更昔洛韦治疗特发性血小板减少性紫癜应用指征

目的探讨更昔洛韦(GCV)治疗人巨细胞病毒(HCMV)感染相关的特发性血小板减少性紫癜的(ITP)应用指征。方法选择血清HCMV DNA PCR和(或)HCMV IgM检测呈阳性ITP患儿46例,采用逆转聚合酶扩增反应(RT-PCR)检测巨核系祖细胞中HCMV晚期抗原mRNA,并行GCV治疗,判定其疗效及应用指征。结果46例血清HCMV-DNA PCR阳性和(或)血清HCMV-IgM阳性的ITP骨髓巨核祖细胞HCMV晚期抗原基因mRNA阳性19例,GCV治疗有效16例,mRNA阴性27例,GCV治疗有效4例。阳性组疗效高于阴性组,有显著性差异(P<0.01)。结论HCMV感染的ITP患儿,若对常规治疗无效,应检测其巨核祖细胞内HCMV晚期抗原基因mRNA,阳性者是应用更昔洛韦的有效指征。     

Vascular endothelial growth factor expressing mesenchymal stem cells improves cardiac function in chronic myocardial infarction in pigs

Transplantation of mesenchymal stem cells （MSCs） for myocardial reconstruction has shown promise in both animal models and human phase 1 clinical studies. Vascular endothelial growth factor （VEGF） is a strong therapeutic agent for treating ischaemia by inducing angiogenesis. The feasibility of ex vivo MSCs mediated gene transfer is documented. Matsumoto and colleagues have recently reported genetically engineered MSCs carrying VEGF165 delivery for revascularization in a model of acute myocardial infarction （MI）. The promising data from our laboratory in both angiogenesis and MSCs transplantation in cunicular heart model of acute MI have prompted us to attempt the combined and simultaneous application of the two strategies.     

Immune responses against SARS-coronavirus nucleocapsid protein induced by DNA vaccine

The nucleocapsid （N） protein of SARS-coronavirus （SARS-CoV） is the key protein for the formation of the helical nucleocapsid during virion assembly. This protein is believed to be more conserved than other proteins of the virus, such as spike and membrane glycoprotein. In this study, the N protein of SARS-CoV was expressed in Escherichia coli DHSalpha and identified with pooled sera from patients in the convalescence phase of SARS. A plasmid pCI-N, encoding the full-length N gene of SARS-CoV, was constructed. Expression of the N protein was observed in COS1 cells following transfection with pCI-N. The immune responses induced by intramuscular immunization with pCI-N were evaluated in a murine model. Serum anti-N immunoglobutins and splenocytes proliferative responses against N protein were observed in immunized BALB/c mice. The major immunoglobulin G subclass recognizing N protein was immunoglobulin G2a, and stimulated splenocytes secreted high levels of gamma interferon and IL-2 in response to N protein. More importantly, the immunized mice produced strong delayed-type hypersensitivity （DTH） and CD^8＋ CTL responses to N protein.