顶空气相色谱法测定泮托拉唑钠中残留的有机溶剂

目的:建立泮托拉唑钠中5种有机溶剂的分离测定方法。方法:采用顶空进样毛细管气相色谱法,FID 检测器,应用 AT-1毛细管柱(30.0m×0.32mm×1μm),载气为氮气,柱温采取程序升温,初始温度40℃,保持4min,再以20℃·min~(-1)的速率升至150℃,保持3min,测定了泮托拉唑钠原料中丙酮、乙醚、二氯甲烷、三氯甲烷、甲苯的残留量。结果:各有机溶剂均能得到有效分离,在所考察的浓度范围内线性关系良好,r 为0.990～0.999,平均回收率为99.3%～105%。结论:本方法灵敏、准确、可靠,可用于泮托拉唑钠中有机溶剂的检测。     

大鼠脑出血灶周HIF-1α、HSP70表达及GM1对其变化的影响

目的研究大鼠脑出血灶周边组织急性期HIF-1α、HSP70的表达机制,探讨GM1对HIF-1α、HSP70表达的影响。方法①Wistar大鼠96只,随机分为：对照组,脑出血组,神经节苷酯钠干预组（局部给药组和腹腔给药组）,各实验组分为脑出血后6、12、24、48h4个时间点。采用大脑立体定位法注入未肝素化动脉血复制大鼠脑出血模型;②采用免疫组化染色法检测脑组织HIF-1α、HSP70的表达。结果①大鼠脑出血周边组织6h可见HSP70和HIF-1α的表达,在6～48h呈逐渐上升趋势;②GM1干预后周边组织HSP70、HIF-1α表达阳性细胞数与脑出血组对应时间点比较显著上升,差异均具有统计学意义（P〈0.05）;③GM1干预组中,与腹腔给药相比,局部用药各时间点周边组织HSP70、HIF-1α表达阳性细胞数显著增高,差异具有统计学意义（P〈0.05）。结论①HIF-1α、HSP70参与脑出血周边组织损伤应答反应;②GM1可增强脑出血急性期HIF-1α、HSP70的表达;③GM1可改善脑出血预后,且局部用药优于腹腔给药。     

缺血性脑卒中患者脑出血风险预测因素

①目的 探讨缺血性卒中患者应用抗血小板药物或抗凝药物等抗栓治疗导致脑出血的主要危险因素.②方法 患者分3组.Ⅰ组为缺血性卒中后再发脑出血的患者,Ⅱ组为同时间住院的脑出血患者,Ⅲ组为缺血性卒中后长期口服抗凝或抗血小板治疗而无脑出血发生的患者.分别对其年龄、性别、高血压、糖尿病、过去脑梗死时间、抗凝及抗血小板药物、服用时间及止血参数等资料进行综合分析.③结果 Ⅰ组和Ⅱ组比较,有卒中史者多于Ⅱ组;Ⅰ组和Ⅲ组比较,其年龄大,卒中史次数多、血压高,服药时间短,血小板数目减少明显,PT,TT,时间延长.④结论 缺血性卒中的患者应用抗血小板药物或抗凝药物等抗栓治疗是导致脑出血的主要危险因素,因此避免抗凝及抗血小板药物应用过量,有助于减少脑出血的发生.     

电针对大鼠脑出血模型海马组织氨基酸含量的影响

目的 :观察不同电针对大鼠脑出血模型海马组织氨基酸含量的影响 ,探讨电针对脑出血大鼠保护作用的可能机制。方法 :选择胶原酶加肝素联合注射法诱导脑出血大鼠模型 ,采用反相高效液相色谱荧光法观察电针不同穴位对大鼠海马氨基酸含量的影响。结果 :造模后模型组海马组织兴奋性氨基酸 (ASP、Glu)和抑制性氨基酸 (GABA)明显升高 ,存在着兴奋性氨基酸 (EAA) /抑制性氨基酸 (IAA)平衡失调。针水组能降低造模所致的Glu和GABA的升高 ,和模型组比有显著性差异 (P <0 .0 5) ,而对ASP的降低作用不明显 ,和模型组比无显著性差异 (P >0 .0 5) ;针风组能降低造模所致的ASP和Glu的升高 ,和模型组比有显著性差异 (P <0 .0 5) ,而对GABA的降低作用不明显 ,和模型组比无显著性差异 (P >0 .0 5)。结论 :针水组、针风组能抑制不同兴奋性氨基酸(Glu、ASP)的释放 ,纠正兴奋性氨基酸 (EAA) /抑制性氨基酸 (IAA)失衡 ,从而达到减轻脑出血后脑组织损害的作用。     

抑肽酶对大鼠实验性脑出血后AQP4mRNA表达及脑水肿的作用

目的研究脑出血后的脑水肿形成与水孔蛋白-4(AQP4) mRNA表达的关系,以及抑肽酶的干预作用。方法采用自体动脉血注入法制作大鼠脑出血模型,RT-PCR法检测AQP4 mRNA表达,并观察给予抑肽酶处置后脑水肿(脑含水量)的变化。结果与对照组相比,脑出血组和抑肽酶组均从脑出血后6h开始出现脑水肿(P<0.05),3d时达到高峰(P<0.05),分别上升到(82.13±0.36)和(79.48±0.46),且抑肽酶组脑水肿程度低于脑出血组(P<0.05);AQP4 mRNA表达同样在3d时达到高峰(P<0.05),分别为(1.34±0.14)和(1.03±0.05)。脑水肿程度与AQP4 mRNA表达的变化呈显著正相关(r=0.815,P<0.01)。结论脑出血后AQP4 mRNA表达明显增加,提示AQP4参与了脑水肿的发生发展过程,而抑肽酶能够抑制脑水肿的形成。     

A randomized placebo controlled trial of ranitidine versus sucralfate in patients with spontaneous intracerebral hemorrhage for prevention of gastric hemorrhage

AIM: Due of paucity of studies on stress ulcer prophylaxis in intracerebral hemorrhage (ICH), we have evaluated the usefulness of ranitidine and sucralfate in preventing gastric hemorrhage (GH) in patients with ICH. SUBJECTS AND METHODS: In a hospital-based randomized placebo-controlled study, patients with CT-proven ICH within 7 days of ictus were randomized into ranitidine 50 mg i.v. eight hourly, sucralfate 1 g six hourly and placebo groups. Patients were conservatively managed. Primary endpoint was occurrence of GH within 15 days of ictus and secondary endpoint 1-month mortality. RESULTS: The mean age of the patients was 57.2 (range 25-90) years and 40 were females. There were 45 patients in ranitidine, 49 in sucralfate and 47 in placebo group. Demographic, clinical and radiological features were not significantly different in 3 groups. GH occurred in 11 (23.4%) patients in placebo, 5 (11.1%) in ranitidine and 7 (14.3%) in sucralfate group, which was not significant. Only one female had GH. There were 13 (27.7%) deaths in placebo, 5 (11.1%) in ranitidine and 12 (24.5%) in sucralfate group. Pneumonia occurred in placebo group in 5 (10.6%), ranitidine in 2 (4.4%) and sucralfate in 5 (10.2%) patients, which was not significantly different. CONCLUSION: Ranitidine and sucralfate do not seem to significantly prevent GH or reduce 1-month mortality.     

Duration and morbidity of newly diagnosed idiopathic thrombocytopenic purpura in children: A prospective Nordic study of an unselected cohort

OBJECTIVE: To determine the duration of the risk period with platelet counts <20 x 10(9)/L and the frequency of bleeding episodes in unselected children with idiopathic thrombocytopenic purpura (ITP). STUDY DESIGN: We established a registry for patients with newly diagnosed ITP in the five Nordic countries, enrolling children aged 0 to 14 years with platelet counts <30 x 10(9)/L. Treatment centers prospectively reported presenting features, management details, and disease-related events during the first six months after diagnosis. RESULTS: At presentation (n=501), more than half of the children had a platelet count <10 x 10(9)/L, but only 15 (3.0%) had a hemorrhage requiring blood transfusion. During follow-up of 409 patients, thrombocytopenia resolved uneventfully in 277. A risk period was present in 376 cases. Among 283 with self-limiting ITP, 26 were at risk >1 month and 25 had 30 events. Among 93 patients with chronic ITP, 73 were at risk >1 month and 44 had 111 events. Events occurred with an average frequency of 0.39 per month at risk. Life-threatening hemorrhages did not occur in the first six months after diagnosis. CONCLUSION: Most children with ITP are at risk for serious bleeding for less than one month. Continuing severe thrombocytopenia is associated with little morbidity, bleeding episodes being infrequent and very rarely serious.     

ICH E9 guideline 'Statistical principles for clinical trials': a case study

The International Conference on Harmonization (ICH) E9 guideline 'Statistical principles for clinical trials' was adopted by the Committee for Proprietary Medicinal Products in March 1998, and consequently is operational in Europe. It has also been adopted in the U.S.A. and Japan. The aim of this paper is to relate the problems encountered during a recent regulatory submission to those discussed in the ICH E9 guideline. Statistical principles discussed in the guideline, but not comprehensively addressed when the clinical development programme was initiated in the mid-1990s, will be reviewed. The impact of each issue on the approvability of the dossier will be discussed, together with recommendations on how to avoid such problems with other ongoing clinical development programmes.     

Cerebrospinal fluid (CSF) and serum S100B: release and wash-out pattern

S100B is an important brain specific protein for monitoring damage and activation of astrocytes. Using a straight forward, non-resource demanding in-house ELISA technique we measured S100B in cerebrospinal fluid (CSF) and serum in patients with traumatic brain injury (TBI) (serum), subarachnoid hemorrhage (SAH) (CSF, serum), intracranial hemorrhage (ICH) (CSF, serum), normal controls (NC) (serum) and a reference population (CSF, N=409). The release and wash-out pattern found in CSF and serum are discussed in relation to the three main determinants for increased brain specific protein levels in body fluids: (i) total mass effect; (ii) pathology; and (iii) time effect.     

Early onset of forced impaired forelimb use causes recovery of forelimb skilled motor function but no effect on gross sensory-motor function after capsular hemorrhage in rats

Intensive use of the impaired forelimb promotes behavioral recovery and induces plastic changes of the central nervous system after stroke. However, the optimal onset of intensive use treatment after stroke is controversial. In this study, we investigated whether early forced impaired limb use (FLU) initiated 24 h after intracerebral hemorrhage (ICH) of the internal capsule affected behavioral recovery and histological damage. Rats were subjected to ICH via low-dose collagenase infusion or sham stroke. One day after surgery, the ipsilateral forelimbs of half of the ICH and sham rats were casted for a week to induce the use of their contralateral forelimbs. Behavioral assessments were performed on days 10-12 and 26-28 after the surgery and followed by histological assessments. Improvements in skilled reaching and coordinated stepping function were found in the FLU-treated group in comparison with the untreated group after ICH. Additionally, FLU-treated ICH animals showed more normal and precise reaching and stepping movements as compared with ICH control animals. In contrast, FLU did not have a significant impact on gross sensory-motor functions such as the motor deficit score, contact placing response and spontaneous usage of the impaired paw. The volume of tissue lost and the number of spared corticospinal neurons in lesioned motor cortex were not affected by early FLU after ICH. These findings demonstrate the efficacy of early focused use of an impaired limb after internal capsule hemorrhage.