扶正固本法对青少年哮喘患者基因表达的影响

目的 研究复方中药敏康片治疗青少年哮喘的疗效和作用机理。方法 选择20例青少年哮喘患者进行治疗，另设青少年特应性皮炎患者组（20例）和青少年正常组（19例）为对照。哮喘组和皮炎组口服敏康片，疗程为6个月，观察疗效、血清总IgE及FcεRIβ、IL-4Rα基因表达改变情况。结果 哮喘组显效6例，有效12例，无效2例，总有效率90％；皮炎组显效4例，有效13例，无效3例，总有效率85％；哮喘组IgE治疗前后有显著差异（P〈0．01）。皮炎组IgE治疗前后有差异（P〈0．05）；用Northern blot法检测FctRlt3、IL-4Rα基因，IL-4Rα吸光度值两组治疗前均较正常组高，哮喘组治疗后降低。FcεRIβ吸光度值两组治疗前均较正常组高，治疗后均降低。结论 复方中药可以调整青少年哮喘患者相关基因表达，改善患者过敏状态，缓解临床症状。     

医药行业科技成果产业化的风险控制

医药行业科技成果产业化与其他行业科技成果转化相比具有更高的风险，转化能力也是最低的，因此，对其从事前、事中、事后三方面加强风险控制具有重要的观实意义。     

马来酸罗格列酮胃漂浮型缓释片的研究

目的：根据流体动力学平衡控释原理（HBS）研制了马来酸罗列酮胃漂浮型缓释片。方法；以体外释放度和漂浮情况为筛选指标，采用单因素考察和正交试验设计相结合， 对胃漂浮缓释片的处方、制备工艺及体外释放条件进行优化筛选；采用γ闪烁照相技术对优化处方的内漂浮情况进行胃内动态观察。结果：马来酸罗格列酮胃漂浮缓释片在释放介质中迅速起漂，持漂时间超过12h,12h达最大累积释放；初步确定在胃内滞留时间达3h以上。结论：优化处方的释放过程符合Higuchi方程，释放机制为异常扩散；胃漂浮片在胃滞时间明显长于普通片。     

Open, Double-Blind and Long-Term Study of Vigabatrin in Chronic Epilepsy

We performed an open, double-blind, and long-term study of vigabatrin (gamma-vinyl-GABA, GVG) in patients with treatment-resistant epilepsy who were receiving only one or at most two standard antiepileptic drugs (AEDs). The novel design included a parallel, double-blind, placebo-controlled phase that minimized the number of patients receiving placebo and allowed determination of the optimum dose of GVG for each patient before initiation of the double-blind phase. The study was divided into four phases. The first phase was a 6-week period of baseline observation. In the second phase, GVG was added openly to previous AEDs for 8 weeks. During the first 2 weeks of this phase, the dose of GVG was increased weekly and then, in the absence of adverse effects, was held constant for the next 6 weeks. At the end of this open phase, seizure frequency during the 6 weeks of constant treatment was compared with the baseline seizure frequency for each patient. Patients who experienced reduction greater than 50% in the frequency of any seizure type during the open phase were defined as responders. These responders were then entered into the third and double-blind phase, in which they were randomly allocated wither to continue active GVG treatment or placebo for 8 weeks. Thirty-three patients entered the study; 31 of 33 patients completed the initial open phase. Twenty patients achieved a reduction greater than or equal to 50% in the frequency of one or more seizure types and were eligible for the double-blind phase; 10 were randomized to continue GVG and 10 were randomized to placebo.(ABSTRACT TRUNCATED AT 250 WORDS)     

罗红霉素分散片人体相对生物利用度及其药代动力学研究

目的:通过人血清中罗红霉素的微生物测定法,考察丽珠集团丽珠制药厂研制的罗红霉素分散片丽珠星相对于法国罗素-优克福公司的罗红霉素普通片罗力得的生物等效性,并估算其药代动力学参数.方法:以藤黄八叠球菌为检定菌,通过抑菌圈直径测定血药浓度.临床实验方案采用交叉实验设计,10名受试者随机分两组服用罗红霉素分散片和普通片.结果:本方法日内、日间变异系数均小于15%,线性范围为0.25～10.0 μg/ml(r=0.9992),最低检测浓度为0.25 μg/ml.罗红霉素分散片和普通片的主要药动学参数为:AUC0→36分别为61.41±13.53 μg·h/ml和57.63±11.29 μg·h/ml;AUC0→∞分别为66.62±17.89 μg·h/ml和62.93±14.62 μg·h/ml;cmax分别为7.15±0.18 μg/ml和7.37±0.42 μg/ml;tmax分别为1.10±0.44 h和1.20±0.26 h;T1/2分别为8.21±2.92 h和8.28±2.46 h.方差分析表明两种制剂的药代动力学参数间均无显著性差异.双单侧t检验表明两制剂吸收程度相同.结论:本方法简便准确.分散片的相对生物利用度为(105.9±13.8)%,表明分散片与普通片吸收程度生物等效.     

Chronic GVHD in minor salivary glands and oral mucosa: histopathological and immunohistochemical evaluation of 25 patients

BACKGROUND: Graft-vs.-host disease (GVHD) is the major cause of morbidity and mortality in patients undergoing allogeneic Bone Marrow Transplantation (BMT). The aim of our study was to identify the most relevant histological features for diagnosis of chronic Graft-vs.-Host Disease (cGVHD) in oral mucosa and minor salivary glands of 25 patients, as well as to evaluate the immunophenotype of the inflammatory cells. METHODS: Sixteen patients that were submitted to allogeneic BMT but did not present cGVHD were selected as a control group. The sections were studied on H & E and CD68, CD45, CD4, CD8, CD20 staining. RESULTS: The most frequent histologic findings in oral mucosa at the day of diagnosis of cGVHD were: hydropic degeneration of the basal layer of the epithelium, apoptotic bodies, lymphocytic infiltration, and focal or total cleavage between the epithelial and connective tissue. In the labial salivary glands (LSG), lymphocytic infiltration, acinar loss and fibrosis were the main alterations. Cytotoxic CD8-T cells and macrophages were predominant both in the epithelium and connective tissue, as well as in minor salivary glands. CONCLUSIONS: Histological features were useful in the diagnosis of oral cGVHD. It is suggested that CD8-T cells and macrophages play important role in the pathogenesis of the disease.     

Bioavailability and Pharmacokinetics of a New Sustained-Release Potassium Chloride Tablet

The bioavailability of a new sustained-release potassium chloride (KC1) tablet, designed for once-a-day dosing, was compared to a KC1 elixir using urinary excretion data. The study utilized 25 male volunteers dosed in a crossover design in a dietary/activity-controlled environment. The regimens consisted of a total of 80 mEq of potassium in three equally divided doses of elixir every 6 hr and a single 80-mEq dose using four 20-mEq sustained-release (SR) tablets. The mean time to maximum rate of potassium urinary excretion was 2.2 hr for the first elixir dose and 5.5 hr after the SR tablet (P < 0.01), thereby supporting the prolonged-release properties of this formulation. After correction for baseline urinary potassium excretion, the mean total 24-hr urinary potassium excretion was 42.18 mEq for the elixir and 40.41 mEq for the SR tablet. The results indicate that the absorption pattern from the SR tablet is equal to three doses of KC1 elixir dosed 6 hr apart.     

The quinolone,flumequine, has no effect on theophylline pharmacokinetics

The kinetics of a single i. v. dose of theophylline given either alone or with flumequine was studied in eight healthy volunteers. No statistically significant differences were observed in the pharmacokinetic parameters of theophylline (volume of distribution, elimination half-life, AUC, plasma clearance) following the two treatments.Pretreatment for 5 days with oral flumequine (400 mg, three times daily) had no significant effect on the disposition of a single i. v. dose of theophylline in healthy volunteers.     

左旋氨氯地平治疗轻中度高血压疗效及不良反应的临床研究

目的:为评价左旋氨氯地平降压疗效及不良反应,并与氨氯地平相比较。方法:采用随机分组平行对照方法,将120例轻、中度高血压患者分成左旋氨氯地平组(60例),口服2.5～5mg·d~(-1)和氨氯地平组(60例),口服5～10mg·d~(-1)。观察5周。每周一次上午延迟1～4小时用药并测诊室谷值坐位血压、心率、观察不良反应。结果:5周未左旋氨氯地平与氨氯地平组治疗有效反应率分别为86.7％和83.3％,每组治疗前后比较差异非常显著(P<0.01)。组间比无显著性差异(P>0.05)。左旋氨氯地平组不良反应发生率6.7％,氨氯地平组为16.7％(P>0.05),但试验组不良反应程度更轻微。结论:左旋氨氯地平与氨氯地平治疗高血压同样有效,不良反应可能更小。