医疗器械口咽通气道产品注册的常见问题及改进建议

近年来,医疗器械口咽通气道产品的注册数量日益增加,针对该产品的相关咨询也逐渐增多。但该产品暂无相关的注册技术审查指导原则,以致该产品的注册申报资料经常出现一些共性问题。现根据医疗器械口咽通气道产品相关法规和标准,对日常工作中遇到的常见问题进行归纳,分析该产品注册申报中的技术审评要求及共性问题,并给出对策或建议。     

调理肝脾补肾法治疗老年人高脂血症220例

我们以调理肝脾补肾为法分型论治高脂血症220例,疗效满意,报道如下.     

Reframing climate change as a public health issue: an exploratory study of public reactions

Background  

Climate change is taking a toll on human health, and some leaders in the public health community have urged their colleagues to give voice to its health implications. Previous research has shown that Americans are only dimly aware of the health implications of climate change, yet the literature on issue framing suggests that providing a novel frame - such as human health - may be potentially useful in enhancing public engagement. We conducted an exploratory study in the United States of people's reactions to a public health-framed short essay on climate change.     

Changes of circulating TNF and its effects on Pseudomonas aeruginosa septic shock in rabbits

Itiswellknownthatcertaincytokinesplayapivotalroleinthedevelopmentoftraumaandshock.Tumornecrosisfactor(TNF)isapolypep-tiedcytokinesynthesizedinmonocytesandmacrophagesinresponsetolipopolysaccharide(LPS)stimulation-TherelationshipbetweenTNFandendotoxic-septicshockbecomesafocusoftheresearchofshockmediators[1'2].Alargeamountofexperimentalandclinicaldata[3-9JsuggestthatTNFplaysanimportantroleinthepathogenesisofendotoxic-septicshockbuttheprecisemechanismandtherelationshipofTNFtoshockseverityrem…     

A comparative study of using comet assay and gammaH2AX foci formation in the detection of N-methyl-N'-nitro-N-nitrosoguanidine-induced DNA damage.

Comet assay is a useful technique in the detection of DNA damages, particularly DNA strand breaks; and it has been utilized to show that a potent carcinogen N-methyl-N'-nitro-N-nitrosoguanidine (MNNG), can induce such damages. Recently, gammaH2AX foci formation has been suggested as another sensitive way to detect DNA double strand breaks (DSBs). However, there is no systematic comparison being conducted to evaluate the consistency of these two methods. Using MNNG as a model chemical, the sensitivity of neutral comet assay and gammaH2AX foci formation in detecting MNNG-induced damage was studied. It was found that at concentrations of 0.1 and 1 microg/ml, both methods can detect MNNG-induced damage in human amnion FL cells. However, at 0.1 microg/ml, comet assay revealed more percentage of cells with DNA damage than gammaH2AX fluorescence revealed. On the other hand, while gammaH2AX foci were readily formed at very early times by 10 microg/ml MNNG treatment, neutral comet assay did not detect any significant DNA damage at the same time points. In addition, 10 microg/ml MNNG induced a distinct whole nuclei staining pattern of gammaH2AX, a type of DNA damage which was not detected by neutral comet assay but could be detected by alkaline comet assay. Therefore, gammaH2AX may be used as a sensitive indicator for DNA damage.     

CT-guided stereotactic injection of radionuclide in treatment of brain tumors.

140 patients with brain tumor were treated by CT-guided stereotactic injections of radionuclides, such as Aurum-198 (198 Au), Phosphorus-32 (32 P) and Yttrium-90 (90Y). Of these patients aged from 3 to 67 years (average 37), 64 were male and 76 female. Astrocytoma was found in 75 patients, craniopharyngioma in 46, metastatic carcinoma in 7, meningioma in 5, germinoma in 4 and pituitary adenoma in 3. The tumors were located in the deep part or functionally critical area of the brain. After 267 times of injection of colloidal isotopes, no major adverse effects or complications occurred. Follow-up for 6 to 48 months showed improvement in symptoms in 104 (74.3%) patients and CT scanning showed the diminished tumors.

     

氧氟沙星薄膜包衣片的制备及其相对生物利用度测定

本文采用国产原料试制氧氟沙星薄膜包衣片，并与日本第一制药株式会社生产的片剂进行了体外溶 出度、休内相对生物利用度比较。休内血清药物浓度采用HPLC法测定。自制片剂与进口片剂生物等效。     

86例异位妊娠的超声诊断价值

目的：探讨B超对异位妊娠的诊断价值。方法：对2004年1月～2009年1月的86例异位妊娠患者，采用超声诊断仪进行检查、分析。结果：超声检查的86例异位妊娠患者，诊断符合84例，确诊率为97．6％，误诊2例，误诊率为2．4％。结论：超声检查有着无创性、可重复性等不可比拟的优越性，为异位妊娠患者的诊断及治疗提供了可靠的依据。     

医疗卫生单位的后勤社会化管理与改革

相对于我国企业改革的发展,医疗卫生单位后勤管理与改革不仅起步较晚,而且力度不大,步伐不快。以往的医疗卫生单位后勤往往面面俱到,造成了严重的经济负担和社会资源的浪费。因此,医疗卫生单位后勤改革势在必行。