1.Efficacy and safety of cinepazide maleate injection in acute ischemic stroke patients with obvious motor function deficit
Jun NI ; Huisheng CHEN ; Guofang CHEN ; Yong JI ; Fei YI ; Zhuobo ZHANG ; Yi YANG ; Jin WU ; Xueli CAI ; Bei SHAO ; Jianfeng WANG ; Yafang LIU ; Deqin GENG ; Xinhui QU ; Xiaohong LI ; Yan WEI ; Jianping DING ; Hua LYU ; Yining HUANG ; Yonghua HUANG ; Bo XIAO ; Tao GONG ; Liying CUI
Chinese Journal of Neurology 2022;55(5):474-480
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.
2.Effects of cinepazide maleate injection on blood pressure in patients with acute ischemic stroke and hypertension
Huisheng CHEN ; Yi YANG ; Jun NI ; Guofang CHEN ; Yong JI ; Fei YI ; Zhuobo ZHANG ; Jin WU ; Xueli CAI ; Bei SHAO ; Jianfeng WANG ; Yafang LIU ; Deqin GENG ; Xinhui QU ; Xiaohong LI ; Yan WEI ; Shugen HAN ; Runxiu ZHU ; Jianping DING ; Hua LYU ; Yining HUANG ; Yonghua HUANG ; Bo XIAO ; Tao GONG ; Xiaofei YU ; Liying CUI
Chinese Journal of Internal Medicine 2022;61(8):916-920
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.
3.A comparative study of lumen-apposing metal stent and plastic stent for the treatment of pancreatic walled-off necrosis
Yichen QU ; Haitao HUANG ; Hangbin JIN ; Qifeng LOU ; Xiaofeng ZHANG ; Jianfeng YANG
Chinese Journal of Digestive Endoscopy 2022;39(8):635-640
Objective:To evaluate the efficacy and safety of lumen-apposing metal stent (LAMS) for the treatment of pancreatic walled-off necrosis (WON).Methods:A retrospective cohort study was performed on data of 43 consecutive patients with pancreatic WON who underwent endoscopic ultrasound-guided drainage by LAMS or plastic stents (PS) in Hangzhou First People's Hospital from December 2010 to June 2020. According to the type of stent used, the patients were divided into the LAMS group ( n=16) and the PS group ( n=27). The technical success rate, the clinical success rate, the operation time, the session of endoscopic necrosectomy, the stent insertion time and adverse events were compared between the two groups. Results:All 43 patients were successfully stented, indicating a technical success rate of 100% in both groups. For the LAMS group, the clinical success rate, the operation time, the session of endoscopic necrosectomy, the stent insertion time and overall incidence of adverse events were 75.0% (12/16), 26.0 (19.1, 39.8) min, 0.5 (0, 2.0) times, (41.3±28.4) days, and 43.7% (7/16), respectively, whereas these indices of the PS group were 37.0% (10/27) ( χ2=5.795, P=0.016), 31.0 (26.0, 48.0) min ( Z=1.221, P=0.222), 0 (0, 0) times ( Z=2.245, P=0.025), (176.1±99.1) days ( t=5.187, P<0.001) and 14.8% (4/27) ( χ2=8.893, P=0.064), respectively. Conclusion:LAMS placement is safe and effective for the treatment of pancreatic WON with a higher clinical success rate compared with PS. However, it requires more endoscopic intervention.
4.Cinepazide maleate injection reduced the disability rate for acute ischemic stroke patients: a multicenter, randomized, double-blind, parallel-group, placebo-controlled phase Ⅳ clinical trial
Jun NI ; Huisheng CHEN ; Guofang CHEN ; Yong JI ; Fei YI ; Zhuobo ZHANG ; Yi YANG ; Jin WU ; Xueli CAI ; Bei SHAO ; Jianfeng WANG ; Yafang LIU ; Deqin GENG ; Xinhui QU ; Xiaohong LI ; Yan WEI ; Jianping DING ; Hua LYU ; Yining HUANG ; Yonghua HUANG ; Bo XIAO ; Tao GONG ; Liying CUI
Chinese Journal of Neurology 2020;53(10):790-797
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.
5.Explanation on.
Yingru CHEN ; Jinsheng YANG ; Liang WANG ; Yuan WU ; Jianfeng QU
Chinese Acupuncture & Moxibustion 2017;37(9):991-994
Theof(for short) was officially published as a standard of China Association of Acupuncture and Moxibustion in 2015. From the purpose, methodology, scope, indication, recommended protocol, etc., this was explained to provide convenience for clinical use of acupuncturists. Thiswas developed based oncomprehensive search of literature regarding acupuncture for periarthritis of shoulder, the adoption of best evidence, expert experience, patient value across the world, methods of evidence quality and GRADE, references of clinical experience of famous acupuncturists in the ancient and modern time and expert consensus in the national level, which was hoped to provide solid evidence of acupuncture clinical treatment for periarthritis of shoulder to ensure the safety and effectiveness. In this, the stage-by-stage treatment principle of acupuncture for periarthritis of shoulder was recommended. In the acute stage, the treatment aim was to relieve the pain, and distal acupoints along the meridians were selected with strong stimulation; the local acupoints were combined. In the chronic stage and rehabilitation stage, the treatment aim was to improve the dysfunction of shoulder joint, and acupuncture treatment was based on syndrome differentiation of etiology and meridian; the local acupoints were mainly selected, combined with acupoints based on etiology and acupoints along meridians.
6.Clinical analysis of non-ketotic hyperglycemia chorea
Jianfeng QU ; Yazhi WANG ; Yonglin LIU ; Yangkun CHEN ; Weimin XIAO
Chinese Journal of Nervous and Mental Diseases 2017;43(8):496-499
Objective To investigate the clinical manifestation,neuroimaging characteristics and follow-up results of chorea associated with non-ketotic hyperglycemia (C-H-BG).Methods Clinical data of six patients with C-H-BG were analyzed retrospectively.Results The average age of the six patients (five female and one male) was 65.8±13.9 years,All patients had acute-subacute course.Patients presented with choreic movements involving facial muscles (n=6) and unilateral (n=5) or bilateral limbs (n=1).The average value of plasma glucose at admission was 9.21 ± 5.15 mmol/L.All patients had significantly elevated HbA1c (14.1 ±3.5%).The brain MRI T1 imaging from all patients showed hyperintensity in the basal ganglia,putamen,lenticular nucleus and caudate nucleus.SWI imaging revealed corresponding hypointensity signal in the basal ganglia in three patients.Two patients had severe stenosis of the MCA.Five patients were followed up for an average of 16.2 ±7.2 months.Three patients died.Conclusion The high T1 hypertense lesions in the basal ganglia are the mainly radiological feature of C-H-BG which may be accompanied by SWI hytointense signals in the basal ganglia.
7.Ultrasound assessment of the closure time and Z scores of neonatal ductus venosus
Zhiyong HUANG ; Guoping QU ; Weiquan LUO ; Haotang WU ; Zongping JI ; Jianfeng. LIANG
Chinese Journal of Neonatology 2016;31(2):125-128
Objective To study the closure time of neonatal ductus venosus and the Z score regression equation, and to explore the variation of closure time of neonatal ductus venosus with gestationalage.Methods Color doppler ultrasound was applied to detect the closure time of neonatal ductus venosus in normal newborns, Z score regression equation ( lnY =a +bX +cX2 ) for the closure time of neonatal ductus venosus ( Y ) was developed by regression analysis which used gestational age ( X) as an independent variable. The Z scores of the closure time of neonatal ductus venosus in different gestational age were calculated by the formula [ Z = ( M - Y )/S x , M for observation value, Y for predictivevalue].Results There were 432 cases in our study.The closure time of neonatal ductus venosus was negatively related to gestational age ( r = -0. 938 , P <0. 001 ) . The nonlinear regression equation was lnY= -5. 228+0. 089X-0. 000228X2, R2 =0. 854, Sx =0. 214(P<0. 001). Based on the predicted mean of the closure time and Sx related to different gestational age, Z scores for specific closure time of neonatal ductus venosus could be calculated by the formula [ Z =( M -Y)/Sx ] . The Z scores were normally distributed,and did not change with gestational age.Conclusions Theclosure & nbsp;time of neonatal ductus venosus is negatively related to gestational age. The Z scores obtained by the predicted nonlinear regression equation are normally distributed.
8.Risk factors of cerebral microbleeds in patients with ischemic stroke
Yangkun CHEN ; Yonglin LIU ; Zhuoxin NI ; Weimin XIAO ; Genpei LUO ; Runxiong LI ; Jianfeng QU ; Rong MA ; Xuewen FANG
Chinese Journal of Nervous and Mental Diseases 2016;42(4):234-239
Objective To investigate the clinical, neuroimaging and serum risk factors of cerebral microbleeds (CMBs) in patients with ischemic stroke and find the associations between these risk factors and the location and num?bers of CMBs were also analyzed. Methods One hundred and fifty-three patients with acute ischemic stroke were re?cruited in this study and their data werewas retrospectively analyzed. All of the patients underwent MRI- susceptibility weighted imaging (SWI). The location and numbers of CMBs were recordedexamined. The severity of WMLs was assessed using the Fazekas scale. Logistic regressions were performed to find the predictors of the presence of CMBs. The relation?ships between these risk factors and the location and numbers of CMBs were also analyzed. Results Fifty-nine(38.6%) cases had at least one CMB. The frequency of cortical-subcortical, deep and infratentorial CMBs were 34.0%, 24.8%and 27.5%, respectively. Multivariate logistic regression showed that male sex, hypertension and moderate-to-severe deep white matter hyperintensities (DWMH) were independent risk factors of the presence of CMBs. Adjusted with age and sex, partial correlation showed that hypertension only correlated with the numbers of deep CMBs significantly (r=0.174, P=0.032). Moderate-to-severe DWMH significantly correlated with the numbers of cortical-subcortical and deep CMBs (r=0.285, P<0.001 and r=0.258, P=0.001, respectively). Conclusion Male sex, hypertension and moderate-to-severe DWMH were are independent risk factors of CMBs in patients with ischemic stroke. Hypertension correlates with Deep deep CMBs, while Moderatemoderate-to-severe DWMH correlates with cortical-subcortical and deep CMBs.
9.Mitochondrial DNA mutations and aminoglycoside antibiotics and hearing loss.
Jianwei QU ; Jianfeng WANG ; Sisi XU
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2015;29(22):1936-1940
Mitochondrial DNA mutations are one of the most important causes of sensorineural hearing loss. A1555G and C1494T mutations of mitochondrial 12S rRNA gene are the molecular basis for aminoglycoside hyper- sensitivity and can lead to aminoglycoside-induced hearing loss. Primary mutations in tRNA such as tRNA(Ser(UCN))7472insC are associated with syndromic hearing loss. While other mutations such as tRNA"(Se(UCN) )G7444A were considered synergy with the primary RNA mutations, modulating the phenotypic manifestation. This review de- scribes a detailed summary of hearing loss associated with mtDNA mutations and/or aminoglycoside antibiotics, and provides the possible molecular mechanisms in deafness expression.
Aminoglycosides
;
adverse effects
;
Anti-Bacterial Agents
;
adverse effects
;
DNA, Mitochondrial
;
genetics
;
Hearing Loss, Sensorineural
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chemically induced
;
genetics
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Humans
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Mutation
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RNA, Ribosomal
;
genetics
10.Effects of HMME-SDT on hypertrophic scar of rabbit ear
Wei LI ; Jianfeng FEI ; Xiaofeng LI ; Zhiwei QU ; Jiaqi BI ; Yong CHENG ; Qinggang MENG
Chinese Journal of Medical Aesthetics and Cosmetology 2014;20(1):58-61
Objective To observe the clinical efficacy of HMME-SDT therapy for the treatment of hypertrophic scar (HS) of rabbit ear.Methods 60 white rabbits were randomly divided into five groups.The model group and HMME-SDT treatment group were used to establish the models of hypertrophic scar in ears.Results The effect of HMME-SDT on the fibroblastic density in the hypertrophic scarring models was observed in rabbit ears.The HMME-SDT could lower the fibroblastic density,compared with the model group,with significant difference (P< 0.05).The effect of HMME-SDT on the collagen area density was noted in the hypertrophic scarring models in rabbit ears.The HMME-SDT could lower the collagen area density,compared with the model group,with significant difference from the fourth week of the epithelialization (P<0.01).Conclusions HMME is an effective sonosensitizer.HMME-SDT can significantly inhibit hypertrophic scar of rabbit ear.

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