1.Evaluation of the performance of the artificial intelligence - enabled snail identification system for recognition of Oncomelania hupensis robertsoni and Tricula
Jihua ZHOU ; Shaowen BAI ; Liang SHI ; Jianfeng ZHANG ; Chunhong DU ; Jing SONG ; Zongya ZHANG ; Jiaqi YAN ; Andong WU ; Yi DONG ; Kun YANG
Chinese Journal of Schistosomiasis Control 2025;37(1):55-60
Objective To evaluate the performance of the artificial intelligence (AI)-enabled snail identification system for recognition of Oncomelania hupensis robertsoni and Tricula in schistosomiasis-endemic areas of Yunnan Province. Methods Fifty O. hupensis robertsoni and 50 Tricula samples were collected from Yongbei Township, Yongsheng County, Lijiang City, a schistosomiasis-endemic area in Yunnan Province in May 2024. A total of 100 snail sample images were captured with smartphones, including front-view images of 25 O. hupensis robertsoni and 25 Tricula samples (upward shell opening) and back-view images of 25 O. hupensis robertsoni and 25 Tricula samples (downward shell opening). Snail samples were identified as O. hupensis robertsoni or Tricula by schistosomiasis control experts with a deputy senior professional title and above according to image quality and morphological characteristics. A standard dataset for snail image classification was created, and served as a gold standard for recognition of snail samples. A total of 100 snail sample images were recognized with the AI-enabled intelligent snail identification system based on a WeChat mini program in smartphones. Schistosomiasis control professionals were randomly sampled from stations of schistosomisis prevention and control and centers for disease control and prevention in 18 schistosomiasis-endemic counties (districts, cities) of Yunnan Province, for artificial identification of 100 snail sample images. All professionals are assigned to two groups according the median years of snail survey experiences, and the effect of years of snail survey experiences on O. hupensis robertsoni sample image recognition was evaluated. A receiver operating characteristic (ROC) curve was plotted, and the sensitivity, specificity, accuracy, Youden’s index and the area under the curve (AUC) of the AI-enabled intelligent snail identification system and artificial identification were calculated for recognition of snail sample images. The snail sample image recognition results of AI-enabled intelligent snail identification system and artificial identification were compared with the gold standard, and the internal consistency of artificial identification results was evaluated with the Cronbach’s coefficient alpha. Results A total of 54 schistosomiasis control professionals were sampled for artificial identification of snail sample image recognition, with a response rate of 100% (54/54), and the accuracy, sensitivity, specificity, Youden’s index, and AUC of artificial identification were 90%, 86%, 94%, 0.80 and 0.90 for recognition of snail sample images, respectively. The overall Cronbach’s coefficient alpha of artificial identification was 0.768 for recognition of snail sample images, and the Cronbach’s coefficient alpha was 0.916 for recognition of O. hupensis robertsoni snail sample images and 0.925 for recognition of Tricula snail sample images. The overall accuracy of artificial identification was 90% for recognition of snail sample images, and there was no significant difference in the accuracy of artificial identification for recognition of O. hupensis robertsoni (86%) and Tricula snail sample images (94%) (χ2 = 1.778, P > 0.05). There was no significant difference in the accuracy of artificial identification for recognition of snail sample images with upward (88%) and downward shell openings (92%) (χ2 = 0.444, P > 0.05), and there was a significant difference in the accuracy of artificial identification for recognition of snail sample images between schistosomiasis control professionals with snail survey experiences of 6 years and less (75%) and more than 6 years (90%) (χ2 = 7.792, P < 0.05). The accuracy, sensitivity, specificity and AUC of the AI-enabled intelligent snail identification system were 88%, 100%, 76% and 0.88 for recognition of O. hupensis robertsoni snail sample images, and there was no significant difference in the accuracy of recognition of O. hupensis robertsoni snail sample images between the AI-enabled intelligent snail identification system and artificial identification (χ2 = 0.204, P > 0.05). In addition, there was no significant difference in the accuracy of artificial identification for recognition of snail sample images with upward (90%) and downward shell openings (86%) (χ2 = 0.379, P > 0.05), and there was a significant difference in the accuracy of artificial identification for recognition of snail sample images between schistosomiasis control professionals with snail survey experiences of 6 years and less and more than 6 years (χ2 = 5.604, Padjusted < 0.025). Conclusions The accuracy of recognition of snail sample images is comparable between the AI-enabled intelligent snail identification system and artificial identification by schistosomiasis control professionals, and the AI-enabled intelligent snail identification system is feasible for recognition of O. hupensis robertsoni and Tricula in Yunnan Province.
2.3D print-guided fenestration/branch stent treatment of abdominal aortic disease: a national multicenter retrospective study
Yuexue HAN ; Yi JIN ; Dongsheng FU ; Jianhang HU ; Jianfeng DUAN ; Lili SUN ; Mian WANG ; Hao YU ; Yiming SU ; Zhengdong HUA ; Zhidan CHEN ; Shikui GUO ; Zhaohui HUA ; Xiaoqiang LI ; Zhao LIU
Chinese Journal of General Surgery 2024;39(7):527-533
Objective:To study the application of 3D printing technology in multi-center fenestrated/branched endovascular repair (F/B-EVAR) for endovascular repair of abdominal aortic diseases.Methods:From Feb 2018 to Mar 2023, The clinical and followup data of 316 cases of abdominal aortic lesions undergoing repair with F/B-EVAR at 69 medical centers nationwide using 3D printing technology to guide physician-modified stent graft were retrospectively analyzed.Results:The mean follow-up time of the patients was 23 months (2-60 months), and 24 cases were lost to follow up, the follow-up rate was 92.4% (292/316), the mean postoperative hospitalization time was (8.2±4.9) days. A total of 944 main abdominal branch arteries were reconstructed. Intraoperative reconstruction of 11 branches failed, with a success rate of 98.8% (933/944). Within 30 days after surgery, 8 patients died (2.5%), and 6 patients died during follow-up, a total of 14 patients died (4.4%). There were 11 cases (3.5%) of spinal cord ischemia and no patient suffered from permanent paraplegia. There were 19 patients (6.0%) with postoperative renal function injury. Internal leakage was found in 26 patients, and the rate of internal leakage was 8.2%.Conclusion:3D printing technology can accurately locate the location of branch arteries, simplifing the surgical process, shortening the learning curve , and improving clinical efficacy.
3.Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients (version 2024)
Yao LU ; Yang LI ; Leiying ZHANG ; Hao TANG ; Huidan JING ; Yaoli WANG ; Xiangzhi JIA ; Li BA ; Maohong BIAN ; Dan CAI ; Hui CAI ; Xiaohong CAI ; Zhanshan ZHA ; Bingyu CHEN ; Daqing CHEN ; Feng CHEN ; Guoan CHEN ; Haiming CHEN ; Jing CHEN ; Min CHEN ; Qing CHEN ; Shu CHEN ; Xi CHEN ; Jinfeng CHENG ; Xiaoling CHU ; Hongwang CUI ; Xin CUI ; Zhen DA ; Ying DAI ; Surong DENG ; Weiqun DONG ; Weimin FAN ; Ke FENG ; Danhui FU ; Yongshui FU ; Qi FU ; Xuemei FU ; Jia GAN ; Xinyu GAN ; Wei GAO ; Huaizheng GONG ; Rong GUI ; Geng GUO ; Ning HAN ; Yiwen HAO ; Wubing HE ; Qiang HONG ; Ruiqin HOU ; Wei HOU ; Jie HU ; Peiyang HU ; Xi HU ; Xiaoyu HU ; Guangbin HUANG ; Jie HUANG ; Xiangyan HUANG ; Yuanshuai HUANG ; Shouyong HUN ; Xuebing JIANG ; Ping JIN ; Dong LAI ; Aiping LE ; Hongmei LI ; Bijuan LI ; Cuiying LI ; Daihong LI ; Haihong LI ; He LI ; Hui LI ; Jianping LI ; Ning LI ; Xiying LI ; Xiangmin LI ; Xiaofei LI ; Xiaojuan LI ; Zhiqiang LI ; Zhongjun LI ; Zunyan LI ; Huaqin LIANG ; Xiaohua LIANG ; Dongfa LIAO ; Qun LIAO ; Yan LIAO ; Jiajin LIN ; Chunxia LIU ; Fenghua LIU ; Peixian LIU ; Tiemei LIU ; Xiaoxin LIU ; Zhiwei LIU ; Zhongdi LIU ; Hua LU ; Jianfeng LUAN ; Jianjun LUO ; Qun LUO ; Dingfeng LYU ; Qi LYU ; Xianping LYU ; Aijun MA ; Liqiang MA ; Shuxuan MA ; Xainjun MA ; Xiaogang MA ; Xiaoli MA ; Guoqing MAO ; Shijie MU ; Shaolin NIE ; Shujuan OUYANG ; Xilin OUYANG ; Chunqiu PAN ; Jian PAN ; Xiaohua PAN ; Lei PENG ; Tao PENG ; Baohua QIAN ; Shu QIAO ; Li QIN ; Ying REN ; Zhaoqi REN ; Ruiming RONG ; Changshan SU ; Mingwei SUN ; Wenwu SUN ; Zhenwei SUN ; Haiping TANG ; Xiaofeng TANG ; Changjiu TANG ; Cuihua TAO ; Zhibin TIAN ; Juan WANG ; Baoyan WANG ; Chunyan WANG ; Gefei WANG ; Haiyan WANG ; Hongjie WANG ; Peng WANG ; Pengli WANG ; Qiushi WANG ; Xiaoning WANG ; Xinhua WANG ; Xuefeng WANG ; Yong WANG ; Yongjun WANG ; Yuanjie WANG ; Zhihua WANG ; Shaojun WEI ; Yaming WEI ; Jianbo WEN ; Jun WEN ; Jiang WU ; Jufeng WU ; Aijun XIA ; Fei XIA ; Rong XIA ; Jue XIE ; Yanchao XING ; Yan XIONG ; Feng XU ; Yongzhu XU ; Yongan XU ; Yonghe YAN ; Beizhan YAN ; Jiang YANG ; Jiangcun YANG ; Jun YANG ; Xinwen YANG ; Yongyi YANG ; Chunyan YAO ; Mingliang YE ; Changlin YIN ; Ming YIN ; Wen YIN ; Lianling YU ; Shuhong YU ; Zebo YU ; Yigang YU ; Anyong YU ; Hong YUAN ; Yi YUAN ; Chan ZHANG ; Jinjun ZHANG ; Jun ZHANG ; Kai ZHANG ; Leibing ZHANG ; Quan ZHANG ; Rongjiang ZHANG ; Sanming ZHANG ; Shengji ZHANG ; Shuo ZHANG ; Wei ZHANG ; Weidong ZHANG ; Xi ZHANG ; Xingwen ZHANG ; Guixi ZHANG ; Xiaojun ZHANG ; Guoqing ZHAO ; Jianpeng ZHAO ; Shuming ZHAO ; Beibei ZHENG ; Shangen ZHENG ; Huayou ZHOU ; Jicheng ZHOU ; Lihong ZHOU ; Mou ZHOU ; Xiaoyu ZHOU ; Xuelian ZHOU ; Yuan ZHOU ; Zheng ZHOU ; Zuhuang ZHOU ; Haiyan ZHU ; Peiyuan ZHU ; Changju ZHU ; Lili ZHU ; Zhengguo WANG ; Jianxin JIANG ; Deqing WANG ; Jiongcai LAN ; Quanli WANG ; Yang YU ; Lianyang ZHANG ; Aiqing WEN
Chinese Journal of Trauma 2024;40(10):865-881
Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.
4.Research Path and Paradigm of Digitization and Intelligentization of Ancient TCM Books Based on the Deep Integration of Knowledge Element Theory and Clinical Needs
Feng YANG ; Yi ZHANG ; Xiaohua TAO ; Jianfeng LI ; Tao LUO ; Jingling CHANG ; Jian CHEN ; Liyun CHEN ; Ming DAI ; Fenglan WANG ; Xiang LU
Journal of Traditional Chinese Medicine 2024;65(12):1201-1207
With the rapid development of information technology, research on ancient TCM books has shifted from the traditional collation and digitization into intelligent knowledge service, thereby achieving the deep integration of ancient TCM books collation and clinical needs. Based on the clinical problem and knowledge element theory, we implemented in-depth indexing and knowledge mining for 600 kinds of ancient TCM books, built a knowledge sharing service platform for ancient TCM books by integrating database, cloud platform, knowledge graph and other technologies, and carried out the thematic literature research and developed databases for four major diseases including stroke, heart failure, liver cirrhosis, and diabetes. The digital intelligence products have been applied in hundreds of hospitals for evaluation and feedback. Finally, through "digital processing plus intelligent application", the two-way interaction between ancient TCM books and current clinical practice is realized, and the path and paradigm of ancient TCM books knowledge serving the modern prevention and control of major diseases is formed, providing reference for the innovative utilization of ancient TCM books.
5.Construction of a visual intelligent identification model for Oncomelania hupensis robertsoni in Yunnan Province based on the EfficientNet-B4 model
Shaowen BAI ; Jihua ZHOU ; Yi DONG ; Jianfeng ZHANG ; Liang SHI ; Kun YANG
Chinese Journal of Schistosomiasis Control 2024;36(6):555-561
Objective To construct a visual intelligent recognition model for Oncomelania hupensis robertsoni in Yunnan Province based on the EfficientNet-B4 model, and to evaluate the impact of data augmentation methods and model hyperparameters on the recognition of O. hupensis robertsoni. Methods A total of 400 O. hupensis robertsoni and 400 Tricula snails were collected from Yongsheng County, Yunnan Province in June 2024, and snail images were captured following identification and classification of 300 O. hupensis robertsoni and 300 Tricula snails. A total of 925 O. hupensis robertsoni images and 1 062 Tricula snail images were collected as a dataset and divided into a training set and a validation set at a ratio of 8:2, while 352 images captured from the remaining 100 O. hupensis robertsoni and 354 images from the remaining 100 Tricula snails served as an external test set. All acquired images were subjected to preprocessing, including cropping and resizing. Three data augmentation approaches were employed, including baseline, Mixup and Gaussian blurring, and model hyperparameters included two optimization algorithms of adaptive moment estimation (Adam) and stochastic gradient descent (SGD), two loss functions of focal loss and cross entropy loss, and two learning rate decay strategies of cosine annealing and multi-step. The intelligent recognition models of O. hupensis robertsoni and Tricula snails were constructed based on the EfficientNet-B4 model, and 7 training strategy groups were generated by combinations of different data augmentation approaches and hyperparameters. The performance of intelligent recognition models was tested with external test sets, and evaluated with accuracy, precision, recall, F1 score, loss, Youden’s index, and the area under the receiver operating characteristic curve (AUC) under different training strategies. Results The variation of loss values was comparable among intelligent recognition models with different data augmentation approaches. The Group 4 model constructed with Mixup and Gaussian blurring data augmentation approaches showed the optimal performance, with an accuracy of 90.38%, precision of 90.07%, F1 score of 89.44%, Youden’s index of 0.81 and AUC of 0.961 in the external test set. The accuracy of models using the SGD optimizer reduced by 29.16% as compared to those using the Adam optimizer (χ2 = 81.325, P < 0.001), and the accuracy of models using the cross entropy loss function reduced by 0.80% as compared to the Group 4 model (χ2 = 3.147, P > 0.05), while the accuracy of models using the multi-step learning rate decay strategy increased by 0.65% as compared to the Group 4 model (χ2 = 0.208, P > 0.05). In addition, the model with the baseline + Mixup + Gaussianblurring data augmentation approach and hyperparameters of Adam optimizer, focal loss function and multi-step learning rate decay strategy showed the highest performance, with an accuracy of 91.03%, precision of 91.97%, recall of 88.11%, F1 score of 90.00%, Youden’s index of 0.82 and AUC values of 0.969 in external test set, respectively. Conclusions The intelligent recognition model of O. hupensis robertsoni based on EfficientNet-B4 model is accurate for identification of O. hupensis robertsoni and Tricula snails in Yunnan Province.
6.Study on the Application of Named Entity Recognition in Electronic Medical Records for Lymphedema Disease
Haocheng TANG ; Wanchun SU ; Xiuyuan JI ; Jianfeng XIN ; Song XIA ; Yuguang SUN ; Yi XU ; Wenbin SHEN
Journal of Medical Informatics 2024;45(2):52-58
Purpose/Significance The paper discusses the application of artificial intelligence technology to the key entity recognition ofunstructured text data in the electronic medical records of lymphedema patients.Method/Process It expounds the solution of model fine-tuning training under the background of sample scarcity,a total of 594 patients admitted to the department of lymphatic surgery of Beijing Shijitan Hospital,Capital Medical University are selected as the research objects.The prediction layer of the GlobalPointer model is fine-tuned according to 15 key entity categories labeled by clinicians,nested and non-nested key entities are identified with its glob-al pointer.The accuracy of the experimental results and the feasibility of clinical application are analyzed.Result/Conclusion After fine-tuning,the average accuracy rate,recall rate and Macro_F1 ofthe model are 0.795,0.641 and 0.697,respectively,which lay a foundation for accurate mining of lymphedema EMR data.
7.Mechanism of TLR4/RhoA signaling pathway in endothelial cell permeability changes induced by continuous hemofiltration therapy in sepsis
Huilin Yu ; Jianfeng Wang ; Yi Liu ; Yuyao Liu ; Wei Jiang ; Chengying Meng ; Huan Wang ; Delin Hu
Acta Universitatis Medicinalis Anhui 2023;58(7):1159-1164
Objective :
To investigate the molecular mechanism of Toll⁃like receptor 4 ( TLR4)/Ras homologue A (RhoA) signaling pathway involved in regulating the effect of septic serum on vascular endothelial cell permeability
before and after continuous hemofiltration.
Methods :
The serum of 5 patients with sepsis before and after continuous hemofiltration treatment was collected , and the levels of inflammatory cytokines in serum before and after hemofiltration were detected. Human umbilical vein endothelial cells (HUVEC) were treated with serum before and after continuous hemofiltration for 24 hours. The expression of VE⁃cadherin , F ⁃actin , TLR4 and RhoA in vascular endothelial cells were detected by Western blot. A TLR4 low expression cell line was constructed to detect the effect of TLR4 low expression on the expression of VE⁃cadherin , F ⁃actin and RhoA and the permeability of endothelial cells.
Results :
After continuous blood treatment , the serum levels of TLR4 , RhoA , interleukin⁃1 (IL⁃1) , interleukin⁃6 (IL⁃6) and tumor necrosis factor⁃α (TNF⁃α ) significantly decreased. The expression levels of VE⁃cadherin , F ⁃actin , TLR4 and RhoA in the serum intervention group after continuous hemofiltration treatment significantly decreased , and the cell permeability significantly decreased. Low expression of TLR4 significantly promoted the expression of VE⁃cadherin and F ⁃actin , and inhibited the expression of RhoA protein.
Conclusion
TLR4/RhoA signaling pathway is involved in the regulation of changes in vascular endothelial cell permeability induced by septic serum after continuous hemofiltration treatment.
8.A meta-analysis of the effect of neuromuscular blocking agents on oxygenation in patients with acute respiratory distress syndrome
Zhiwei GAO ; Cong LI ; Hui CHEN ; Jianfeng XIE ; Ling LIU ; Yi YANG
Chinese Journal of Internal Medicine 2022;61(1):86-94
Objective:To evaluate the effects of neuromuscular blocking agents (NMBA) on oxygenation and respiratory conditions in patients with acute respiratory distress syndrome(ARDS).Methods:English databases such as MEDLINE, Embase and Web of Science were searched online, as well as Chinese databases such as China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database and Wanfang Database. Randomized controlled trials (RCTs) of NMBA therapy for ARDS with publication date up to May 2020 were retrieved. Literature was screened according to inclusion and exclusion criteria, and the main analysis indicators were oxygenation index.Results:A total of 5 RCTs were included, and 1 462 ARDS patients were enrolled. Compared with the control group, the ratio of partial arterial oxygen pressure to fraction of inspired (PaO 2)/(FiO 2) significantly improved in the intervention group after 72 hours MD=14.39, (95 %CI 6.40-22.38, P=0.000 4) and 96 hours of NMBA, but there was no difference between PaO 2/FiO 2 at 24 and 48 hours ( P>0.05).Positive end expiratory pressure (PEEP) significantly decreased at 72 hours ( MD=-0.45, 95 %CI -0.87--0.03, P=0.04) and 96 hours ( MD=-0.82, 95 %CI -1.39--0.26, P=0.004) treatment with NMBA, while there was no significant difference in PEEP between 24 and 48 hours after treatment ( P>0.05). At 96 h, plateau pressure (Pplat) in the intervention group was significantly lower ( MD=-1.69, 95 %CI -2.64--0.75, P=0.000 4), and there was no significant difference in Pplat between 24, 48 and 72 h after treatment ( P>0.05). Conclusion:The early use of NMBA within 48 hours has a delayed improvement effect on oxygenation and ventilator conditions in ARDS patients.
9.Camrelizumab salvage therapy for extrahepatic recurrent hepatocellular carcinoma with PD-L1 negativity in transplanted liver tissue
Yinan DENG ; Guoying WANG ; Jianfeng WANG ; Linda FAN ; Yingcai ZHANG ; Tong ZHANG ; Xuhong YI ; Jian ZHANG ; Hua LI ; Yang YANG
Chinese Journal of Organ Transplantation 2022;43(5):276-280
Objective:To explore the safety and efficacy of camrelizumab salvage therapy for extrahepatic recurrent hepatocellular carcinoma with PD-L1 negativity in transplanted liver tissue.Methods:From May 2020 to December 2020, retrospective analysis was performed for 3 cases of camrelizumab salvage therapy for extrahepatic recurrent hepatocellular carcinoma recipients with PD-L1 negative in transplanted liver tissue.Three recipients with extrahepatic recurrence progressed after first/second-line targeted drug therapy.Camrelizumab was given as salvage therapy after normal tissue of ransplanted liver was confirmed as negative for PD-L1 by immunohistochemistry.The safety and efficacy of treatment were observed by monitoring the changes in the levels of alanine aminotransferase, aspartate aminotransferase and bilirubin, the occurrence of complications and the outcome of treatment before and after dosing.Results:During a follow-up period of 1.5 to 15.5 months, no recipients showed acute rejection symptoms such as sharp elevations of transaminase and bilirubin.Headache ( n=1), vomiting ( n=1) and fatigue & hypertension ( n=1) became relieved after treatment.As of February 28, 2022, there were one survivor and two deaths.The fatal causes were tumor progression ( n=1) and thoracic aortic rupture due to esophageal perforation ( n=1). The survival time of recipients was (11-15.5) months and the progression-free survival time (4-6) months. Conclusions:For extrahepatic recurrent hepatocellular carcinoma with PD-L1-negative liver transplantation in normal liver tissue, camrelizumab salvage therapy can control tumor progression to a certain extent and prolong the survival time of recipients.
10.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.


Result Analysis
Print
Save
E-mail