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Objective:To confirm the efficacy and safety of cinepazide maleate injection in acute ischemic stroke patients with obvious motor function deficit.Methods:This study is a subgroup analysis of multi-center, randomized, double-blind, placebo-controlled phase Ⅳ clinical trial. A total 812 patients of acute ischemic stroke with obvious limb motor deficit [motor function of limbs score in National Institutes of Health Stroke Scale (NIHSS) ≥4] were enrolled in this subgroup analysis. Patients received either cinepazide maleate injection or placebo. The treatment period was 14 days and follow-up was 90 days. The efficacy endpoints included the proportions of patients with a modified Rankin Scale (mRS) score ≤2, mRS score ≤1 and Barthel Index <95 on day 90. Safety was evaluated by recording all adverse events, monitoring vital signs, laboratory parameters and electrocardiogram.Results:A total of 732 patients were involved in the final efficacy analysis (361 in cinepazide maleate group and 371 in control group). The baseline limb motor function score of NIHSS was 5.23±1.43 in the cinepazide maleate group whereas 5.20±1.36 in the control group. Logistic regression analysis showed that following treatment for 90 days, the proportion of patients with a mRS score ≤2 was significantly higher in the cinepazide maleate group than in the control group [56.0% (202/361) vs 44.2% (164/371), OR=0.60, 95% CI 0.44-0.82, P=0.002]. The proportion of patients with a mRS score ≤1 was higher in the cinepazide maleate group than in the control group [43.3% (139/361) vs 35.2% (118/371), OR=0.69, 95% CI 0.50-0.97, P=0.031]. The proportion of patients with a Barthel Index <95 on day 90 was significantly lower in the cinepazide maleate group than in the control group [45.2% (145/361) vs 55.2% (185/371), OR=0.64, 95% CI 0.46-0.88, P=0.007]. During the treatment and follow-up period, the incidence of the most common adverse events in the cinepazide maleate group was 50.4% (199/395). Constipation and abnormal liver function were more common, but there were no statistically significant differences between the two groups. Conclusion:Cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery and safe in patients with acute ischemic stroke with obvious limb motor deficit.
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Objective:To investigate the blood pressure change in patients with acute ischemic stroke (AIS) and hypertension treated with cinepazide maleate injection.Methods:This was a subgroup analysis of post-marketing clinical confirmation study of cinepazide maleate injection for acute ischemic stroke: a randomized, double-blinded, multicenter, placebo-parallel controlled trial, which conducted in China from August 2016 to February 2019. Eligible patients fulfilled the inclusive criteria of acute anterior circulation ischemic stroke with National Institutes of Health Stroke Scale (NIHSS) scores of 7-25. The primary endpoints were mean blood pressure of AIS patients treated with cinepazide maleate or control, which were assessed during the treatment period (14 days), and the proportion of the patients with normal blood pressure was analyzed after the treatment period. Furthermore, a subgroup analysis was performed to investigate a possible effect of the history of hypertension on outcomes.Results:This analysis included 809 patients with hypertension. There was no significant difference in patients blood pressure and the proportion of patients with normal blood pressure (60.5% vs. 59.0%, P>0.05) between cinepazide maleate group and control group. Conclusion:Administration of cinepazide maleate injection does not affect the management of clinical blood pressure in patients with AIS.
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Objective:To assess the efficacy and safety of cinepazide maleate injection in the treatment of patients with acute ischemic stroke.Methods:A multicenter, randomized, double-blind, placebo-controlled phase Ⅳ clinical trial, led by Peking Union Medical College Hospital, was conducted in 65 Hospitals in China. The efficacy of cinepazide maleate injection in patients with acute anterior circulation cerebral infarction with onset time of ≤48 hours, 7≤National Institute of Health stroke scale (NIHSS) score ≤25 was assessed from August 2016 to February 2019, using the proportion of modified Rankin scale (mRS) score≤1 and Barthel index (BI) score≤95 on day 14 as efficacy endpoint. The patients were divided into treatment group who were treated with cinepazide maleate injection and control group who were treated with placebo.Results:A total 937 patients were involved in the final efficacy analysis (466 in treatment group and 471 in control group). The proportion of subjects with mRS score≤1 on day 14 after treatment were higher in the treatment group than that in the control group (102/466(21.89%) vs76/471(16.14%)). Logistic regression analysis showed that patients treated with cinepazide maleate were significantly more likely to have a favorable outcome (mRS score≤1) than patients treated with placebo on day 14 ( OR=0.677, 95% CI 0.484-0.948 , P=0.023), and patients treated with cinepazide maleate were more likely to reach independence in activities of daily living (Barthel Index ≥95) than those treated with placebo on day 14 (125/466(26.82%) vs 91/471(19.32%); OR=0.632, 95% CI0.459-0.869, P=0.005). The rate of adverse events was similar between the treatment and control groups. Conclusion:The 14-day treatment with cinepazide maleate injection could reduce the degree of disability whereas did not increase the risk of adverse events.
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OBJECTIVE: To screen genetic polymorphisms in the 5'-flank region of 8-hydroxyguanine DNA glycosylase( hOGG1) gene and analyze the characteristics of their genetic distribution in Han population of radon exposure area in Guangdong Province. METHODS: A simple random sampling method was used to select 60 subjects as radon exposure population. The genomic DNA samples were extracted from peripheral blood. The single nucleotide at-1721 nt-+ 164 nt locus of hOGG1 were screened using polymerase chain reaction( PCR) amplification,purification and direct sequencing for polymorphisms. Genetic characteristics of single nucleotide polymorphisms( SNP) in the study population were analyzed and compared with different populations reported in Hap Map data. RESULTS: The 5'-flank region of hOGG1 were amplified and sequenced in these 60 individuals( 120 chromosomes) of healthy Han Chinese in radon exposure area. Eight SNPs were identified by sequence alignment in the study population. Among them,there was 3 known polymorphisms and their minor allele frequencies( MAF) were-1493 G > A( 4. 2%),-834 G > C( 0. 8%) and-18 G > T( 3. 3%),respectively. The MAF of other 5 novel variations were-1455 G > A( 0. 8%),-1293 A > T( 23. 3%),-1187 C > A( 7. 5%),-337 C > A( 36. 7%) and-323 G > A( 0. 8%),respectively. The differences in the MAF distribution of-1493 G > A between the study population and the Hap Map-CEU were statistically significant( P < 0. 05). CONCLUSION: Eight SNPs and their genetic characteristics were screened and identified in the 5'-flank region of hOGG1 of Han Chinese population in radon exposure area. This result provides a basis for construction of polymorphism haplotypes and functional analysis for the target population.
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Objective To investigate the effect of matrix metalloproteinas-9 (MMP-9) and high sensitive C-reactive protein (hs-CRP) in type 2 diabetes mellitus (T2DM) combined with coronary heart disease(CHD). Methods Thirty-one patients with T2DM combined with CHD(T2DM combined with CHD group) ,50 patients with CHD (CHD group) and 30 healthy volunteers (control group) were studied. Serum MMP-9 was measured by ELISA, and serum hs-CRP was measured by scattering immunoturbidimetric assay. Results The level of MMP-9 in T2DM combined with CHD group (409.62 μg/L) was significantly higher than that in CHD group (263.40 μg/L) and control group [(196.15 ±44.89) μg/L] (P < 0.05).The level of hs-CRP in T2DM combined with CHD group (17.20 mg/L) was significantly higher than that in CHD group (4.57 mg/L) and control group [(1.52±0.78) mg/L] (P <0.01). MMP-9 wa significantly related with hs-CRP in T2DM combined with C HD group (r = 0.482,P < 0.01). Conclusion The serum M MP-9 and hs-CRP levels are closely associated with the occurrence and development of diabetes related coronary atherosclerosis.