1.Mechanism of Xiangsha Liujunzi Decoction in improving autophagy in interstitial cells of Cajal of rats with functional dyspepsia by regulation of IRE1/ASK1/JNK pathway.
Ming-Kai LYU ; Yong-Qiang DUAN ; Jin JIN ; Wen-Chao SHAO ; Qi WU ; Yong TIAN ; Min BAI ; Ying-Xia CHENG
China Journal of Chinese Materia Medica 2025;50(8):2237-2244
This study explored the mechanism of Xiangsha Liujunzi Decoction(XSLJZD) in the treatment of functional dyspepsia(FD) based on inositol-requiring enzyme 1(IRE1)/apoptosis signal-regulating kinase 1(ASK1)/c-Jun N-terminal kinase(JNK) pathway-mediated autophagy in interstitial cells of Cajal(ICC). Forty-eight SPF-grade male SD suckling rats were randomly divided into a blank group and a modeling group, and the integrated modeling method(iodoacetamide gavage + disturbance of hunger and satiety + swimming exhaustion) was used to replicate the FD rat model. After the model replications were successfully completed, the rats were divided into a model group, high-dose, medium-dose, and low-dose groups of XSLJZD(12, 6, and 3 g·kg~(-1)·d~(-1)), and a positive drug group(mosapride of 1.35 mg·kg~(-1)·d~(-1)), and the intervention lasted for 14 days. The gastric emptying rate and intestinal propulsion rate of rats in each group were measured. The histopathological changes in the gastric sinus tissue of rats in each group were observed by hematoxylin-eosin(HE) staining. The ultrastructure of ICC was observed by transmission electron microscopy. The immunofluorescence double staining technique was used to detect the protein expression of phospho-IRE1(p-IRE1), TNF receptor associated factors 2(TRAF2), phospho-ASK1(p-ASK1), phospho-JNK(p-JNK), p62, and Beclin1 in ICC of gastric sinus tissue of rats in each group. Western blot was used to detect the related protein expression of gastric sinus tissue of rats in each group. Compared with those in the blank group, the rats in the model group showed decreased body weight, gastric emptying rate, and intestinal propulsion rate, and transmission electron microscopy revealed damage to the endoplasmic reticulum structure and increased autophagosomes in ICC. Immunofluorescence staining revealed that the ICC of gastric sinus tissue showed a significant elevation of p-IRE1, TRAF2, p-ASK1, p-JNK, and Beclin1 proteins and a significant reduction of p62 protein. Western blot revealed that the expression levels of relevant proteins in gastric sinus tissue were consistent with those of proteins in ICC. Compared with the model group, the body weight of rats in the high-dose and medium-dose groups of XSLJZD was increased, and the gastric emptying rate and intestinal propulsion rate were increased. Transmission electron microscopy observed amelioration of structural damage to the endoplasmic reticulum of ICC and reduction of autophagosomes, and the p-IRE1, TRAF2, p-ASK1, p-JNK, and Beclin1 proteins in the ICC of gastric sinus tissue were significantly decreased. The p62 protein was significantly increased. Western blot revealed that the expression levels of relevant proteins in gastric sinus tissue were consistent with those of proteins in ICC. XSLJZD can effectively treat FD, and its specific mechanism may be related to the inhibition of the expression of molecules related to the endoplasmic reticulum stress IRE1/ASK1/JNK pathway in ICC and the improvement of autophagy to promote gastric motility in ICC.
Animals
;
Male
;
Drugs, Chinese Herbal/administration & dosage*
;
Autophagy/drug effects*
;
Rats
;
Rats, Sprague-Dawley
;
Interstitial Cells of Cajal/metabolism*
;
Dyspepsia/physiopathology*
;
Protein Serine-Threonine Kinases/genetics*
;
MAP Kinase Kinase Kinase 5/genetics*
;
MAP Kinase Signaling System/drug effects*
;
Humans
;
Endoribonucleases/genetics*
;
Multienzyme Complexes
2.The basal cisternostomy for management of severe traumatic brain injury: A retrospective study.
Tangrui HAN ; Zhiqiang JIA ; Xiaokai ZHANG ; Hao WU ; Qiang LI ; Shiqi CHENG ; Yan ZHANG ; Yonghong WANG
Chinese Journal of Traumatology 2025;28(2):118-123
PURPOSE:
Traumatic brain injury (TBI) is a significant public health issue that impacts individuals all over the world and is one of the main causes of mortality and morbidity. Decompressive craniectomy is the usual course of treatment. Basal cisternostomy has been shown to be highly effective as an alternative procedure to decompressive craniectomy.
METHODS:
We conducted a retrospective cohort of patients who received surgery for severe TBI between January 2019 and March 2023. Inclusion criterias were patients between the ages of 18 and 70 years who met the diagnostic criteria for severe TBI at first presentation and who underwent surgical intervention. The exclusion criteria were patients who have severe multiple injuries at the time of admission; preoperative intracranial pressure > 60 mmHg; cognitive impairment before the onset of the disease; hematologic disorders; or impaired functioning of the heart, liver, kidneys, or other visceral organs. Depending on the surgical approach, the patients were categorized into decompressive craniectomy group as well as basal cisternostomy group. General data and postoperative indicators, including Glasgow coma scale, intracranial pressure, etc., were recorded for both groups of patients. Among them, the Glasgow outcome scale extended assessment at 6 months served as the primary outcome. After that, the data were statistically analyzed using SPSS software.
RESULTS:
The trial enrolled 41 patients (32 men and 9 women) who met the inclusion criteria. Among them, 25 patients received decompressive decompressive craniectomy, and 16 patients received basal cisternostomy. Three days postoperative intracranial pressure levels were 10.07 ± 2.94 mmHg and 17.15 ± 14.65 mmHg (p = 0.013), respectively. The 6 months following discharge Glasgow outcome scale extended of patients was 4.73 ± 2.28 and 3.14 ± 2.15 (p = 0.027), respectively.
CONCLUSION
Our study reveals that basal cisternostomy in patients with surgically treated severe TBI has demonstrated significant efficacy in reducing intracranial pressure as well as patient prognosis follow-up and avoids removal of the bone flap. The efficacy of cisternostomy has to be studied in larger, multi-clinical center randomized trials.
Humans
;
Brain Injuries, Traumatic/surgery*
;
Retrospective Studies
;
Male
;
Female
;
Adult
;
Middle Aged
;
Decompressive Craniectomy/methods*
;
Aged
;
Young Adult
;
Adolescent
;
Glasgow Coma Scale
;
Treatment Outcome
3.Percutaneous coronary intervention vs . medical therapy in patients on dialysis with coronary artery disease in China.
Enmin XIE ; Yaxin WU ; Zixiang YE ; Yong HE ; Hesong ZENG ; Jianfang LUO ; Mulei CHEN ; Wenyue PANG ; Yanmin XU ; Chuanyu GAO ; Xiaogang GUO ; Lin CAI ; Qingwei JI ; Yining YANG ; Di WU ; Yiqiang YUAN ; Jing WAN ; Yuliang MA ; Jun ZHANG ; Zhimin DU ; Qing YANG ; Jinsong CHENG ; Chunhua DING ; Xiang MA ; Chunlin YIN ; Zeyuan FAN ; Qiang TANG ; Yue LI ; Lihua SUN ; Chengzhi LU ; Jufang CHI ; Zhuhua YAO ; Yanxiang GAO ; Changan YU ; Jingyi REN ; Jingang ZHENG
Chinese Medical Journal 2025;138(3):301-310
BACKGROUND:
The available evidence regarding the benefits of percutaneous coronary intervention (PCI) on patients receiving dialysis with coronary artery disease (CAD) is limited and inconsistent. This study aimed to evaluate the association between PCI and clinical outcomes as compared with medical therapy alone in patients undergoing dialysis with CAD in China.
METHODS:
This multicenter, retrospective study was conducted in 30 tertiary medical centers across 12 provinces in China from January 2015 to June 2021 to include patients on dialysis with CAD. The primary outcome was major adverse cardiovascular events (MACE), defined as a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. Secondary outcomes included all-cause death, the individual components of MACE, and Bleeding Academic Research Consortium criteria types 2, 3, or 5 bleeding. Multivariable Cox proportional hazard models were used to assess the association between PCI and outcomes. Inverse probability of treatment weighting (IPTW) and propensity score matching (PSM) were performed to account for potential between-group differences.
RESULTS:
Of the 1146 patients on dialysis with significant CAD, 821 (71.6%) underwent PCI. After a median follow-up of 23.0 months, PCI was associated with a 43.0% significantly lower risk for MACE (33.9% [ n = 278] vs . 43.7% [ n = 142]; adjusted hazards ratio 0.57, 95% confidence interval 0.45-0.71), along with a slightly increased risk for bleeding outcomes that did not reach statistical significance (11.1% vs . 8.3%; adjusted hazards ratio 1.31, 95% confidence interval, 0.82-2.11). Furthermore, PCI was associated with a significant reduction in all-cause and cardiovascular mortalities. Subgroup analysis did not modify the association of PCI with patient outcomes. These primary findings were consistent across IPTW, PSM, and competing risk analyses.
CONCLUSION
This study indicated that PCI in patients on dialysis with CAD was significantly associated with lower MACE and mortality when comparing with those with medical therapy alone, albeit with a slightly increased risk for bleeding events that did not reach statistical significance.
Humans
;
Percutaneous Coronary Intervention/methods*
;
Male
;
Female
;
Coronary Artery Disease/drug therapy*
;
Retrospective Studies
;
Renal Dialysis/methods*
;
Middle Aged
;
Aged
;
China
;
Proportional Hazards Models
;
Treatment Outcome
4.Epidemiology and management patterns of chronic thromboembolic pulmonary hypertension in China.
Wanmu XIE ; Yongpei YU ; Qiang HUANG ; Xiaoyan YAN ; Yuanhua YANG ; Changming XIONG ; Zhihong LIU ; Jun WAN ; Sugang GONG ; Lan WANG ; Cheng HONG ; Chenghong LI ; Jean-François RICHARD ; Yanhua WU ; Jun ZOU ; Chen YAO ; Zhenguo ZHAI
Chinese Medical Journal 2025;138(8):1000-1002
5.Erratum: Author correction to "Up-regulation of glyclipid transfer protein by bicyclol causes spontaneous restriction of hepatitis C virus replication" Acta Pharm Sin B 9 (2019) 769-781.
Menghao HUANG ; Hu LI ; Rong XUE ; Jianrui LI ; Lihua WANG ; Junjun CHENG ; Zhouyi WU ; Wenjing LI ; Jinhua CHEN ; Xiaoqin LV ; Qiang LI ; Pei LAN ; Limin ZHAO ; Yongfeng YANG ; Zonggen PENG ; Jiandong JIANG
Acta Pharmaceutica Sinica B 2025;15(3):1721-1721
[This corrects the article DOI: 10.1016/j.apsb.2019.01.013.].
6.Application of computer-aided design modified 3D printing model in video-assisted thoracoscopic sublobular resection for early lung cancer: A retrospective cohort study
Xinyu ZHANG ; Linqian LI ; Haoran LI ; Qiang GUO ; Hongli YAN ; Jinghua LI ; Shujie CHENG ; Hefei LI ; Ke ZHANG ; Jihong YANG ; Jianguo WU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(09):1266-1273
Objective To compare the effect of three-dimensional visual (3DV) model, three-dimensional printing (3DP) model and computer-aided design (CAD) modified 3DP model in video-assisted thoracoscopic surgery (VATS) sublobular resection. Methods The clinical data of patients who underwent VATS sublobular resection in the Affiliated Hospital of Hebei University from November 2021 to August 2022 were retrospectively analyzed. The patients were divided into 3 groups including a 3DV group, a 3DP group and a CAD-3DP group according to the tools used. The perioperative indexes and subjective evaluation of operators, patients and their families were compared. Results A total of 22 patients were included. There were 5 males and 17 females aged 32-77 (56.95±12.50) years. There were 9 patients in the 3DV group, 6 patients in the 3DP group, and 7 patients in the CAD-3DP group. There was no statistical difference in the operation time, intraoperative blood loss, drainage volume, hospital stay time or postoperative complications among the groups (P>0.05). Based on the subjective evaluations of 4 surgeons, the CAD-3DP group was better than the 3DV group in the preoperative planning efficiency (P=0.025), intuitiveness (P=0.045) and doctor-patient communication difficulty (P=0.034); the CAD-3DP group was also better than the 3DP group in the overall satisfaction (P=0.023), preoperative planning difficulty (P=0.046) and efficiency (P=0.014). Based on the subjective evaluations of patients and their families, the CAD-3DP group was better than the 3DP group in helping understand the vessel around the tumor (P=0.016), surgical procedure (P=0.020), procedure selection (P=0.029), and overall satisfaction (P=0.048); the CAD-3DP group was better than the 3DV group in helping understand the tumor size (P=0.038). Conclusion CAD-modified 3DP model has certain advantages in pre-planning, intraoperative navigation and doctor-patient communication in the VATS sublobectomy.
7.Clinical study of modified suspension reduction method combined with percutaneous vertebroplasty in the treatment of thoracolumbar osteoporotic compression fracture
Yu-Zhou LU ; Yu WANG ; Xiao-Xu YANG ; Cheng-Qiang WU ; Shou-Cui ZHANG ; Jin-Guo WANG ; Ya-Dong WU ; Dong QIN ; Lin DING
China Journal of Orthopaedics and Traumatology 2024;37(1):21-26
Objective To investigate the clinical effect of modified suspension reduction method combined with percuta-neous vertebroplasty in the treatment of osteoporotic thoracolumbar compression fractures.Methods From February 2020 to October 2021,92 patients with thoracolumbar osteoporotic compression fracture were treated by percutaneous vertebroplasty.According to different treatment methods,they were divided into the observation group and the control group.The observation group was treated with modified suspension reduction and then percutaneous vertebroplasty,while the control group was treated with percutaneous vertebroplasty alone.The observation group(47 cases),including 20 males and 27 females,the age ranged from 59 to 76 years old with an average of(69.74±4.50)years old,fractured vertebral bodies:T10(2 cases),T11(7 cases),T12(19 cases),L1(14 cases),L2(5 cases);the control group(45 cases),including 21 males and 24 females,the age ranged from 61 to 78 years old with an average of(71.02±3.58)years old,fractured vertebral bodies:T10(3 cases),T11(8 cases),T12(17 cas-es),L1(12 cases),L2(5 cases);The leakage of bone cement were observed,the visual analogue scale(VAS),Oswestry lumbar dysfunction index(ODI),anterior vertebrae height(AVH),Cobb angle of kyphosis and the amount of bone cement injected before and after operation were recorded and compared between the two groups.Results All patients were followed up,ranged from 6 to1O with an average of(8.45±1.73)months.Two patients ocurred bone cement leakage in observation group and 3 pa-tients in control group.AVH of observation group increased(P<0.05)and Cobb angle of injured vertebrae decreased(P<0.05).Cobb angle of injured vertebrae and AVH of the control group were not significantly changed(P>0.05).Cobb angle of injured vertebrae of the observation group was lower than that of control group(P<0.05)and AVH was higher than that of the control group(P<0.05).In the observation group,VAS before operation and 1 week,3 and 6 months after operation respective-ly were(7.32±1.05)scores,(3.56±1.18)scores,(1.83±0.67)scores,(1.27±0.34)scores,and ODI were(40.12±14.69)scores,(23.76±10.19)scores,(20.15±6.39)scores,(13.45±3.46)scores.In the control group,VAS before operation and 1 week,3 and 6 months after operation respectively were(7.11±5.26)scores,(3.82±0.68)scores,(1.94±0.88)scores,(1.36± 0.52)scores,and ODI were(41.38±10.23)scores,(25.13±14.22)scores,(20.61±5.82)scores,(14.55±5.27)scores.The scores of VAS and ODI after operation were lower than those before operation(P<0.05),but there was no significant difference between the two groups(P<0.05).Conclusion Modified suspension reduction method combined with PVP surgery for osteo-porotic thoracolumbar compression fractures has achieved good clinical results,which can effectively relieve lumbar back pain,restore vertebral height,correct kyphosis,improve lumbar function and patients'quality of life.
8.Subjective measurement of health system performance and influencing factors in the context of high-quality development:An empirical study based on CSS survey from 2015 to 2021
Qiang YAO ; Xuan WU ; Bing-Qing GUO ; Zhao-Hui CHENG ; Juan GAO
Chinese Journal of Health Policy 2024;17(6):17-26
Health system performance and its influencing factors are measured from a subjective perspective in the context of high-quality development.Using data from the Chinese Social Survey from 2015 to 2021,this study constructed a health system performance index from the perspective of the sense of acquisition of the population and analyzed the change trends and influencing factors of China's health system performance through a multilayer regression model.The results showed that the comprehensive index of health system performance in China increased by 12.47%(β=6.143,P<0.01)from 41.732 in 2015 to 46.935 in 2021,of which the process index increased by 4.57%(β=2.391,P<0.01)from 43.961 to 45.968,and the outcome index increased from 48.501 to 58.009,an increase of 19.60%(β=11.504,P<0.01).Meanwhile,the sense of access to health system performance showed obvious heterogeneity,with factors such as gender,age,education,marital status,employment status,economic status,type of health insurance and type of area of residence significantly affecting the sense of access to health system performance of residents.The health system performance in China in the context of high-quality development has significantly improved,and the sense of access of residents has significantly increased.However,the improvement in the process dimension of the health system is relatively limited,and"difficult and expensive to see a doctor"remains serious.It's necessary to strength the health system performance of vulnerable groups,as well as rural areas.
9.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.
10.Tenecteplase versus alteplase in treatment of acute ST-segment elevation myocardial infarction: A randomized non-inferiority trial
Xingshan ZHAO ; Yidan ZHU ; Zheng ZHANG ; Guizhou TAO ; Haiyan XU ; Guanchang CHENG ; Wen GAO ; Liping MA ; Liping QI ; Xiaoyan YAN ; Haibo WANG ; Qingde XIA ; Yuwang YANG ; Wanke LI ; Juwen RONG ; Limei WANG ; Yutian DING ; Qiang GUO ; Wanjun DANG ; Chen YAO ; Qin YANG ; Runlin GAO ; Yangfeng WU ; Shubin QIAO
Chinese Medical Journal 2024;137(3):312-319
Background::A phase II trial on recombinant human tenecteplase tissue-type plasminogen activator (rhTNK-tPA) has previously shown its preliminary efficacy in ST elevation myocardial infarction (STEMI) patients. This study was designed as a pivotal postmarketing trial to compare its efficacy and safety with rrecombinant human tissue-type plasminogen activator alteplase (rt-PA) in Chinese patients with STEMI.Methods::In this multicenter, randomized, open-label, non-inferiority trial, patients with acute STEMI were randomly assigned (1:1) to receive an intravenous bolus of 16 mg rhTNK-tPA or an intravenous bolus of 8 mg rt-PA followed by an infusion of 42 mg in 90 min. The primary endpoint was recanalization defined by thrombolysis in myocardial infarction (TIMI) flow grade 2 or 3. The secondary endpoint was clinically justified recanalization. Other endpoints included 30-day major adverse cardiovascular and cerebrovascular events (MACCEs) and safety endpoints.Results::From July 2016 to September 2019, 767 eligible patients were randomly assigned to receive rhTNK-tPA ( n = 384) or rt-PA ( n = 383). Among them, 369 patients had coronary angiography data on TIMI flow, and 711 patients had data on clinically justified recanalization. Both used a –15% difference as the non-inferiority efficacy margin. In comparison to rt-PA, both the proportion of patients with TIMI grade 2 or 3 flow (78.3% [148/189] vs. 81.7% [147/180]; differences: –3.4%; 95% confidence interval [CI]: –11.5%, 4.8%) and clinically justified recanalization (85.4% [305/357] vs. 85.9% [304/354]; difference: –0.5%; 95% CI: –5.6%, 4.7%) in the rhTNK-tPA group were non-inferior. The occurrence of 30-day MACCEs (10.2% [39/384] vs. 11.0% [42/383]; hazard ratio: 0.96; 95% CI: 0.61, 1.50) did not differ significantly between groups. No safety outcomes significantly differed between groups. Conclusion::rhTNK-tPA was non-inferior to rt-PA in the effect of improving recanalization of the infarct-related artery, a validated surrogate of clinical outcomes, among Chinese patients with acute STEMI.Trial registration::www.ClinicalTrials.gov (No. NCT02835534).

Result Analysis
Print
Save
E-mail