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Objective:To analyze that if the quality of ethics review is closely related to the protection of human subjects' right and interest. Methods:This article has analyzed all the issues raised by local Ethics Committee in the process of review in recent two years since guideline of ethical review of drug clinical trials was published, summed up the most common problems occurred in protocols and informed consents. Results:Total 94 new drug or medical device clinical trial projects were reviewed by the local ethics committee, among which 29 projects were ap-proved through regular full board meeting, the approval rate in the initial review was 31%. The most common prob-lems in protocols include: the research backgrounds, design, and risk-benefit ratio; Main issues raised on in-formed consent focused on the contents, language and signature terms. Conclusions:The protection of subjects needs more improvement of capability of investigator, sponsor, drug clinical trial institution and the ethics commit-tee.
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One of the important therapeutic measures in the acute stage of cerebral hemorrhage is to treat cerebral edema and lower intracranial pressure. Mannitol, an osmotic dehydrant, is most widely used in clinical practice. Its major effects include the reduction of intracranial pressure and cerebral edema and prevention of cerebral herniation. Besides, mannitol scavenges oxygen free radicals and protects brain cells. So it has extremely important significance in reducing the mortality of intracerebral hemorrhage.
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Intracerebral hemorrhage (ICH) is a common nervous system disease, its mortality and disability are very high. However, the mechanisms of brain injury after ICH have not yet been fully explained. "[he latest studies have suggested that iron overloading plays an important role in the brain injury after ICH. This article reviews the advances in research on the distribution and function of iron in the brain, the mechanisms of brain injury caused by iron overloading after ICH as well as the use of iron chelator.
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@# Objective To observe the therapeutic efficacy and safety of recombinant tissue-type plasminogen activator (rt-PA) combined with edaravone on acute cerebral infarction (ACI).Methods 60 cases of ACI were divided into rt-PA group (30 cases, treated by rt-PA only) and trial group (30 cases, treated with rt-PA combined with edaravone). The nerve function deficits of patients in both groups were evaluated by European Stroke Scale (ESS) and Barthel Index (BI) before and after treatment respectively.Results The ESS scores at 21st day and 90th day after treatment in the trial group were significantly higher than those of the patients in the rt-PA group. The effective rate of patients in the trial group was significantly higher than those in the rt-PA group (P＜0.05).Conclusion The treatment of rt-PA combined with edaravone is effective and safe in patients with ACI.
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Background In recent years,some researches had been conducted on the pathologic changes of the secondary injury of perihematoma in animal experiments,but only a few studies had been done on the dynamic pathologic and ultrastructural changes of the perihematoma in ICH patients. The unique contribution of our study is to investigate the dynamic pathologic and ultrastructural changes of the perihematoma in ICH patients and provide significant insights into how the pathophysiology and ultrastructures changed after ICH.Methods The written informed consents were obtained from the ICH patients or their relatives. 30 patients (the supertentorial hemotoma volume＞30 mi and the cerebellar hemotoma volume ＞10 mi) were divided into 8 groups according to the time passed after ICH:＜6 h (6 patients), 6 ～ 12 h (7 patients), 12 ～24 h (5 patients), 24～48 h (3 patients), 48 ～72 h (3 patients), 3 ～4 days group (3 patients), 5 days group (2 patients) and 8 days group ( 1 patient) and subjected to craniotomy for hemotoma evacuation. During the operation for the hemotoma's evacuation, a small amount of tissues that must be removed, which located at 1 cm near the hematoma, were taken as experimental groups; And the same tissues of 7 patients (＜12 h), which were far from the hemotoma on the operational way, were taken as control group. The pathologic and ultrastructral changes were observed.Results The tissues of the control group were almost normal while the damages of the tissues from the experimental groups were slight in ＜6 h groups, more severe after 6h and got to the maximum between 24 ～48 h , recovered gradually after 72 h, became similar to the 6 ～ 12 h group on 5 th day, got better on 8 th day and resembled the 6 h group.Conclusions The injury of the perihematoma occurred in early stage, reached the peak level between 24 and 48 hours after ICH; which was consistent to the clinical nervous functional deficits in the ICH patients.
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Delayed cerebral vasospasm is a common complication of subarachnoid hemorrhage. Its study has become a topic of general interest in neurology. The article reviews the effects of neuropeptide Y, nitric oxide, endothelin-1,bilirubin oxidation product, Rho kinase, immuno- inflammation, and apoptosis from the pathogenesis of cerebral vasospasm.
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Objective To study the effects of hirudo extract liquor(HEL) on the expressions of HSP70 and TGF?-1 in intracerebral perihematoma tissues of rats.Methods We established the experimental ICH models in Wistar rats by stereotaxical injecting quantitative collagenase(0.7 U collagenaseⅦ) into their left caudate nuclei.The rats continued to be treated with HEL(treatment group) or normal saline(control group) through intravenous injection by vena caudalis and the scores of neurologic impairment in two groups were evaluated every day.The slices of these samples at 3rd,6th and 10th day were stained by immunohistochemistry and the positive cells of HSP70 and TGF?-1 were counted by image analysis system,respectively.Results The scores of neurologic impairment in two groups were remarkably reduced with time going((P
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Objective To investigate the applied value of 99Tcm-HL-91 single photon emission computerized tomography(SPECT) in detecting the hypoxic brain tissue around the focus of cerebral hemorrhage.Methods 26 patients with cerebral hemorrhage were examined by HL-91 SPECT.And the results were compared with their skull CT imagings and other 5 healthy controls.Results 17 case(65.38%) of cerebral hemorrhage group were found hypoxic imaging positive,and the hypoxic zone was closely related to the focus of cerebral hemorrhage in CT imaging.9 cases of cerebral hemmorhage group were found hypoxic imaging negative,6 cases of which were small quantity cerebral hemorrhage,including 2 cases
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Objective To observe dynamically the effect of nimodipine on regional cerebral blood flow (rCBF),brain edema and clinical change of dosage at the different time in the patients with hypertensive cerebral hemorrhage.Methods 108 patients with hypertensive cerebral hemorrhage were divided into the nimodipine treatment group and the controls randomly,and the treatment group was divided into the group of within 12 h with drug and the group of after 12 h with drug again. All patients were given by dynamic observation of SPECT and clinical curative effect;and they were done by dynamic observation of SPECT and CT taking randomly 10 patients out of the groups of control and treatment.Results The improvement of rCBF,clinical curative effect and edema girdle in the treatment group was significantly better than the control group. Patients of within 12 h with drug also showed better outcome than the patients of after 12 h with drug on clinical curative effect.Conclusion Early stage with nimodipine may be positive factor in the improvement of rCBF,clinical curative effect and lightening edema around the hematoma after hypertensive cerebral hemorrhage.