ABSTRACT
Objective To evaluate the current situation and problems of the application of modified Rankin scale (mRS) in the outcome assessment in Chinese stroke trials. Methods Randomised and quasi-randomised controlled tri?als on stroke therapy published before September 2013 in 3 Chinese databases were included. All clinical trials applied mRS as the method of outcome assessment. Subarachnoid hemorrhage and transient cerebral ischemia were excluded. Types of stroke, statistical methods used for data analysis, duration of follow up, blinding of outcome assessment, types of intervention and the significance of the results were evaluated. Results Two hundred and ninety-eight trials were includ?ed in this analysis. 71.14%was for ischemic stroke, 21.48%for hemorrhagic stroke, 7.38%for both ischemic and hemor?rhagic stroke and 91.28%was for acute stroke(onset time<14d). Regarding to statistical methods used for data analysis, 50.00%of the trials used t-test or variance analysis which treated the mRS score as continuous data, while 22.15%used rank sum test or Chi-square test which regarded the mRS score as ranked data or multiply variable data. Dichotomous data was applied in statistical analysis accounts for 25.50%of trials. 12.42%trials applied mRS with other scales as the methods of outcome assessment. Duration of follow up ranged from 10d to 2 years (median 90 d, interquartile range 30-90 d). Only 5.03%assessed outcome blindly. 60.07%of the trials were drug therapy, 7.72%was rehabilitation thera?py, 10.40%were surgical treatment, 14.43%were combined therapy, 2.35%were management mode, 0.67%were nurs?ing, and 4.36%other therapy. Results in 86.91%of the trials were favorable to the tested interventions. Conclusions In aspects of, there is large difference between domestic and foreign clinical stroke trials in methodology of mRS including duration of follow up, blinding of outcome assessment and statistical methods used for data analysis.
ABSTRACT
Objective To investigate the effect of peroxisome proliferator-activated receptor γ (PPARγ) agonist pioglitazone on white matter lesions and spatial memory function in chronic hypertensive rats.Methods Thirty-six male Sprague-Dawley rats were randomly divided into a sham operation group (n =6),a hypertensive group,(n =15),and a pinglitazone group (n =15).A model of stroke-prone renovascular hypertensive rat (RHRSP) was induced by the two-kidney two clip method in the hypertensive group and pioglitazone group.At 8 weeks after procedure,the rats were administered intragastrically.10 mg/(kg · d) pioglitazone was given in the pioglitazone group and an equal volume of saline was given in the hypertensive group.Blood pressure was monitored via caudal artery every 2 weeks before procedure,before administration,and after administration,respectively.After 12 weeks of continuous administration,Loyez staining was used to observe the degree of leukoaraiosis,and Morris water maze test was used to detect spatial memory function.Results After modeling,the blood pressure of RHRSP increased gradually.It was significantly higher than the sham operation group (all P =0.001).There was no significant difference in blood pressure between the hypertensive group and the pioglitazone group (P =0.897).The Morris water maze test showed that escape latencies of the sham operation group and the pioglitazone group were significantly shorter than the hypertensive group (all P ＜0.05).The numbers of crossing hidden platform in the 3 groups of rats were 5.200 ± 1.798,4.560 ± 1.592,and 2.333 ± 1.978 times,respectively.There were significantly differences (F =8.143,P =0.001).Both the sham operation group and the pioglitazone group were significantly more than the hypertensive group (all P ＜0.05).Loyez staining showed that the grades of white matter lesions in corpus callosum of the sham operation group,the hypertensive group,and the pioglitazone group were 0.333 ± 0.516,2.600 ± 0.507,and 0.500 ± 0.522,respectively.There were significantly differences among the 3 groups (F =25.652,P =0.000).The grade of the sham operation group and the pioglitazone group was significantly lower than the hypertensive group (all P＜ 0.05).Conclusions PPARγ agonist pioglitazone may protect the spatial memory function by relieving white matter lesions of the chronic hypertensive rats.