1.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).
2.Efficacy of Da Vinci robot-assisted minimally invasive esophagectomy versus video-assisted minimally invasive esophagectomy: A systematic review and meta-analysis
Gang LI ; Jiani ZHANG ; Xu SHEN ; Guha ALAI ; Zhijie XU ; Tieniu SONG ; Yunke ZHU ; Yidan LIN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2022;29(09):1181-1188
Objective To compare the surgical efficacy of Da Vinci robot-assisted minimally invasive esophagectomy (RAMIE) and video-assisted minimally invasive esophagectomy (VAMIE) on esophageal cancer. Methods Online databases including PubMed, the Cochrane Library, Medline, EMbase and CNKI from inception to 31, December 2019 were searched by two researchers independently to collect the literature comparing the clinical efficacy of RAMIE and VAMIE on esophageal cancer. Newcastle-Ottawa Scale was used to assess quality of the literature. The meta-analysis was performed by RevMan 5.3. Results A total of 14 studies with 1 160 patients were enrolled in the final study, and 12 studies were of high quality. RAMIE did not significantly prolong total operative time (P=0.20). No statistical difference was observed in the thoracic surgical time through the McKeown surgical approach (MD=3.35, 95%CI –3.93 to 10.62, P=0.37) or in surgical blood loss between RAMIE and VAMIE (MD=–9.48, 95%CI –27.91 to 8.95, P=0.31). While the RAMIE could dissect more lymph nodes in total and more lymph nodes along the left recurrent laryngeal recurrent nerve (MD=2.24, 95%CI 1.09 to 3.39, P=0.000 1; MD=0.89, 95%CI 0.13 to 1.65, P=0.02) and had a lower incidence of vocal cord paralysis (RR=0.70, 95%CI 0.53 to 0.92, P=0.009). Conclusion There is no statistical difference observed between RAMIE and VAMIE in surgical time and blood loss. RAMIE can harvest more lymph nodes than VAMIE, especially left laryngeal nerve lymph nodes. RAMIE shows a better performance in reducing the left laryngeal nerve injury and a lower rate of vocal cord paralysis compared with VAMIE.
3.Protective effects of breastfeeding on behavior at four years old in children exposed to maternal gestational diabetes mellitus: a birth cohort study
Wenjing QIANG ; Haiyan LI ; Xiayan YU ; Kexin GONG ; Yidan CAO ; Shuangqin YAN ; Beibei ZHU ; Fangbiao TAO
Chinese Journal of Perinatal Medicine 2022;25(10):751-759
Objective:To explore the protective effects of breastfeeding on behavioral problems at 4 years in children born to mothers with gestational diabetes mellitus (GDM).Methods:Based on the Ma' anshan Birth Cohort (MABC) study, 305 GDM women and their children were recruited in this study from Ma' anshan Maternal and Child Health Care Hospital from May 2013 to September 2014. Total breastfeeding duration was followed up at 42 d, 3, 6, 12, and 18 months postpartum as well as the breastfeeding intensity within 6 months. All the subjects were divided into breastfeeding group ( n=256, including exclusive breastfeeding and mixed feeding) or bottle feeding group ( n=49). Internalizing and externalizing behavioral problems at age 4 were assessed using Achenbach Child Behavior Checklist (CBCL/1.5~5) and their association with breastfeeding were analyzed using robust Poisson regression. Controlling false discovery rate was applied for multiple test correction. Results:Compared with bottle feeding, breastfeeding was a protective factor for depression in children ( RR=0.23, 95% CI: 0.05-0.98, q=0.048) when the duration was 4-5 months; for somatic complaints ( RR=0.36, 95% CI: 0.14-0.95, q=0.047) and anxiety ( RR=0.19, 95% CI: 0.06-0.62, q=0.010) with a breastfeeding duration of 6-11 months; and for depression ( RR=0.46, 95% CI: 0.25-0.83, q=0.039) and anxiety ( RR=0.12, 95% CI: 0.03-0.49, q=0.006) with a breastfeeding duration of 12 months and above. Compared with bottle feeding within 6 months, mixed feeding had a protective effect on somatic complaints ( RR=0.29, 95% CI: 0.13-0.64, q=0.026) and anxiety ( RR=0.18, 95% CI:0.07-0.52, q=0.002). Conclusions:The findings suggested that breastfeeding had a protective effect on behavioral problems at age 4 in children exposed to GDM. Women with GDM should be encouraged to breastfeed.
4.Progresses in clinical treatment of multiple rib fractures and flail chest
Xu SHEN ; Yunke ZHU ; Hanlu ZHANG ; Zeguo ZHUO ; Gang LI ; Tieniu SONG ; Zhijie XU ; Guha ALAI ; Peng YAO ; Xia ZHONG ; Yucheng WANG ; Yidan LIN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2021;28(07):858-862
The incidence of rib fracture in patients with chest trauma is about 70%. Simple rib fractures do not need special treatment. Multiple rib fractures and flail chest are critical cases of blunt trauma, which often cause serious clinical consequences and need to be treated cautiously. Nowadays, there is a controversy about the diagnosis and treatment of multiple rib fractures and flail chest. In the past, most of the patients were treated by non-operative treatment, and only less than 1% of the patients with flail chest underwent surgery. In recent years, studies have confirmed that surgical reduction and internal fixation can shorten the hospital stay, and reduce pain and cost for patients with flail chest, but there is still a lack of relevant clinical consensus and guidelines for diagnosis and treatment, which leads to great differences in clinical diagnosis and treatment plans. This article reviewed the treatment, surgical indications and surgical timing of multiple rib fractures and flail chest.
5.Perioperative outcomes of uniportal versus three-port video-assisted thoracoscopic lobectomy for 2 112 lung cancer patients: A propensity score matching study
Jian ZHOU ; Qiang PU ; Jiandong MEI ; Lin MA ; Feng LIN ; Chengwu LIU ; Chenglin GUO ; Hu LIAO ; Yunke ZHU ; Quan ZHENG ; Zongyuan LI ; Dongsheng WU ; Guowei CHE ; Yun WANG ; Yidan LIN ; Yingli KOU ; Yong YUAN ; Yang HU ; Zhu WU ; Lunxu LIU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2021;28(09):1005-1011
Objective To analyze the perioperative outcomes of uniportal thoracoscopic lobectomy compared with three-port thoracoscopic lobectomy. Methods Data were extracted from the Western China Lung Cancer Database, a prospectively maintained database at the Department of Thoracic Surgery, West China Hospital, Sichuan University. Perioperative outcomes of the patients who underwent uniportal or three-port thoracoscopic lobectomy for lung cancer during January 2014 through April 2021 were analyzed by using propensity score matching. Altogether 5 817 lung cancer patients were enrolled who underwent thoracoscopic lobectomy (uniportal: 530 patients; three-port: 5 287 patients). After matching, 529 patients of uniportal and 1 583 patients of three-port were included. There were 529 patients with 320 males and 209 females at median age of 58 (51, 65) years in the uniportal group and 1 583 patients with 915 males and 668 females at median age of 58 (51, 65) years in the three-port group. Results Uniportal thoracoscopic lobectomy was associated with less intraoperative blood loss (20 mL vs. 30 mL, P<0.001), longer operative time (115 min vs. 105 min, P<0.001) than three-port thoracoscopic lobectomy. No significant difference was found between the two groups regarding the number of lymph node dissected, rate of conversion to thoracotomy, incidence of postoperative complication, postoperative pain score within 3 postoperative days, length of hospital stay, or hospitalization expenses. Conclusion Uniportal video-assisted thoracoscopic lobectomy is safe and effective, and the overall perioperative outcomes are comparable between uniportal and three-port strategies, although the two groups show differences in intraoperative blood loss.
6.Research progress of micro-RNA in intervertebral disc degeneration
Yidan GAO ; Yifeng DA ; Wenlei WANG ; Qiang CHAI ; Zhi HUANG ; Yong ZHU
Chinese Journal of Orthopaedics 2021;41(7):442-449
Low back pain is becoming an important factor affecting people's quality of life, while the age of its onset is getting younger and younger, and the social and economic losses caused by low back pain are huge every year. Intervertebral disc degeneration (IDD) is an important cause of low back pain. Due to multiple factors, biomechanical and structural changes occur in intervertebral disc tissue, including rupture of annulus fibrosus, protrusion of nucleus pulposus, which cause compression of spinal cord and nerve root, and lower back pain. Micro-RNA (miRNA) is a kind of single-stranded non-coding small molecule RNA, with 18-24 nucleotides in length, which exists widely in eukaryotes. As one of the important regulatory molecules of gene expression, it has been proved to play a key role in the initiation and progression of many diseases, and it may also play an important role in intervertebral disc degeneration. At present, the clinical treatment for IDD is mainly surgical treatment to alleviate clinical symptoms. Even if surgical treatment can achieve good results, it will bring great physical trauma and economic burden to patients. The role of miRNA in IDD is one of the hotspots in the current academic research. Studies have shown that miRNA has abnormal expression patterns in degenerative intervertebral disc tissues and participates in a variety of pathological processes of IDD. At present, some miRNAs have been proved to be related to a variety of pathological processes in IDD, including nucleus pulposus cell apoptosis and proliferation, extracellular matrix degradation, autophagy, inflammation and cartilage endplate degeneration. The comparative study of gene chip showed that there were significant differences in the expression of some miRNAs between degenerative and normal nucleus pulposus cells. These differentially expressed miRNAs may be involved in the process of nucleus pulposus cell degeneration by regulating their respective upstream or downstream pathways. Most of the regulatory pathways are crossed and parallel, thus constructing a huge miRNA regulatory network. Understanding the target genes and mechanisms of miRNA in the pathogenic process can provide an important reference for the origin, development and prognosis of IDD. In this article, the important role of miRNA in IDD and the potential significance of clinical treatment are reviewed. With the in-depth study of miRNA and the molecular biological mechanism can provide new ideas for the diagnosis and treatment of IDD, which is likely to become a new strategy for biological treatment of IDD.
7.Biomechanical Response of Macrophages/Microglia Cells to Blast Shock Injury in Mice
Nu ZHANG ; Dasen XU ; Xiyan ZHU ; Yidan ZHOU ; Sijie WANG ; Mingliang JIN ; Liangliang DAI ; Sufang WANG ; Hui ZHAO ; Yulong LI ; Hui YANG
Journal of Medical Biomechanics 2021;36(4):E596-E603
Objective To establish a blast injury experimental model using a shock tube at lateral lying position of C57BL/6 mice, investigate biomechanical responses of macrophages/microglia cells in the heart, lung and brain tissues to mechanical damage by shock wave within 24 hours. Methods Shock tube was employed to generate a shock wave to C57BL/6 mice. Firstly, the weight changes of mice were measured at different time points after the shock. Then the cardiac, pulmonary and whole brain tissue samples were dissected after anesthesia. Pathological sections were stained with HE staining to detect structural damage; the TUNEL staining method was used to mark and count the proportion of dead cells in each tissue. Microglial cells were labeled with fluorescent antibody, while responses and changes of macrophages/microglia after shock loading were analyzed. Results The shock tube exerted 179 kPa overpressure shock wave upon sideway of the mouse, and lethal rate of the mouse was 3.33%. Compared with normal control group, the mice in experimental group had a significant weight loss within 24 hours after loading shock. Pathological sections showed rupture of lung tissues after shock, accompanied by alveolar protein deposition, pulmonary bulla and other diseases. Fluorescence staining showed that lung tissue was recruited and activated in a large amount within 24 hours. The proportion of dead cells cleared rebounded to normal level within 24 hours. The heart was highly tolerant to shock, and macrophages appeared near the large blood vessels. The brain showed unilateral aggregation of microglia due to the impact posture, mainly due to prolonged inflammation and a higher proportion of dead cells at the junction of gray and white matter. Conclusions A blast shock model at lateral lying position of the mouse was established. Within 24 hours, macrophages/microglia were recruited quickly to the injury site after being impacted, which mediated strong immune stress, and might participate in the immune response to trigger a second long-term inflammatory injury. The results of the study provide experimental basis for the evaluation of primary impact injury, such as dose-effect relationship and tissue damage difference.
8.The risk factors for recurrence of peripheral solid small-nodule lung cancer (diameter≤ 2 cm) and the impact of different surgery types on survival: A propensity-score matching study
Jian ZHOU ; Congjia XIAO ; Qiang PU ; Jiandong MEI ; Lin MA ; Feng LIN ; Chengwu LIU ; Chenglin GUO ; Hu LIAO ; Yunke ZHU ; Quan ZHENG ; Lei CHEN ; Guowei CHE ; Yun WANG ; Yidan LIN ; Yingli KOU ; Yong YUAN ; Yang HU ; Zhu WU ; Lunxu LIU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2021;28(11):1283-1291
Objective To identify the risk factors for postoperative recurrence of peripheral solid small-nodule lung cancer (PSSNLC) (T≤2 cm), and to explore the effects of surgery types on prognosis. Methods We extracted data from Western China Lung Cancer Database (WCLCD), a prospectively maintained database at the Department of Thoracic Surgery, West China Hospital, Sichuan University, and Surveillance, Epidemiology, and End Results (SEER) database for peripheral solid small-nodule lung cancer patients (T≤2 cm N0M0, stageⅠ) who underwent surgery between 2005 and 2016. We used univariable and multivariable logistic regression to analyze risk factors for recurrence of PSSNLC. We applied propensity-score matching to compare the long-term results of segmentectomy and lobectomy, as well as the survival of patients from WCLCD and SEER. We finally included 4 800 patients with PSSNLC (T≤2 cm N0M0)(WCLCD: SEER=354∶4 446). We matched 103 segmentectomies and 350 lobectomies in T≤1 cm, and 280 segmentectomies and 1 067 lobectomies in 1 cm
9.Effect evaluation of online lifestyle intervention on women with infertility and central obesity
WU Yidan ; FU Xiaohua ; ZHU Jing ; WU Xiangli
Journal of Preventive Medicine 2021;33(11):1097-1100
Objective:
To evaluate the effect of online lifestyle intervention based on cognitive behavior adjustment on the female patients with infertility and central obesity.
Methods:
From November 2019 to November 2020, the women with infertility and central obesity in the Reproductive Medicine Center of Zhejiang Provincial People's Hospital were recruited and divided into two groups. The intervention group received online lifestyle intervention based on cognitive behavior adjustment for twelve weeks, and the control group received routine health education. Body weight, waist circumference, fasting blood glucose, fasting insulin, insulin resistance index (HOMA-IR), body fat, the pregnancy rate and the abortion rate were compared between the two groups.
Results:
There were 78 cases each in the intervention group and the control group, aged (31.15±4.87) years and (31.17±4.81) years, respectively. There were no significant differences between the two groups in age, body weight, body mass index, waist circumference, waist-hip ratio, fasting blood glucose, fasting insulin, HOMA-IR and body fat percentage before intervention (all P>0.05). After twelve-week intervention, the results of mixed effect model showed that the decrease of waist circumference, fasting insulin and body fat percentage in the intervention group were greater than those in the control group (all P<0.05). After six-month follow-up, there was no significant differences in the pregnancy rate (33.33% vs. 23.08%) and the abortion rate (7.69% vs. 16.67%) between the two groups (both P>0.05).
Conclusion
Online lifestyle intervention based on cognitive behavior adjustment helps to control central obesity and hyperinsulinemia.
10.Chinese consensus on surgical treatment of traumatic rib fractures (2021)
Lingwen KONG ; Guangbin HUANG ; Yunfeng YI ; Dingyuan DU ; Baoguo JIANG ; Jinmou GAO ; Lianyang ZHANG ; Jianxin JIANG ; Xiangjun BAI ; Tianbing WANG ; Xingji ZHAO ; Xingbo DANG ; Zhanfei LI ; Feng XU ; Zhongmin LIU ; Ruwen WANG ; Yingbin XIAO ; Qingchen WU ; Chun WU ; Liming CHENG ; Bin YU ; Shusen CUI ; Jinglan WU ; Gongliang DU ; Jin DENG ; Ping HU ; Jun YANG ; Xiaofeng YANG ; Jun ZENG ; Haidong WANG ; Jigang DAI ; Yong FU ; Lijun HOU ; Guiyou LIANG ; Yidan LIN ; Qunyou TAN ; Yan SHEN ; Peiyang HU ; Ning TAO ; Cheng WANG ; Dali WANG ; Xu WU ; Yongfu ZHONG ; Anyong YU ; Dongbo ZHU ; Renju XIAO ; Biao SHAO
Chinese Journal of Trauma 2021;37(10):865-875
Traumatic rib fractures are the most common injury in thoracic trauma. Previously,the patients with traumatic rib fractures were mostly treated non-surgically,of which 50%,especially those combined with flail chest presented chronic pain or chest wall deformities and over 30% had long-term disabilities,being unable to retain a full-time job. In the past two decades,thanks to the development of internal fixation material technology,the surgical treatment of rib fractures has achieved good outcomes. However,there are still some problems in clinical treatment,including inconsistency in surgical treatment and quality control in medical services. The current consensuses on the management of regional traumatic rib fractures published at home and abroad mainly focus on the guidance of the overall treatment decisions and plans,and relevant clinical guidelines abroad lacks progress in surgical treatment of rib fractures in recent years. Therefore,the Chinese Society of Traumatology affiliated to Chinese Medical Association and Chinese College of Trauma Surgeons affiliated to Chinese Medical Doctor Association,in conjunction with national multidisciplinary experts,formulate the Chinese Consensus for Surgical Treatment of Traumatic Rib Fractures(2021)following the principle of evidence-based medicine,scientific nature and practicality. This expert consensus puts forward some clear,applicable,and graded recommendations from aspects of preoperative imaging evaluation,surgical indications,timing of surgery,surgical methods,rib fracture sites for surgical fixation,internal fixation methods and material selections,treatment of combined injuries in rib fractures,in order to provide references for surgical treatment of traumatic rib fractures.


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