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.Safety of high-carbohydrate fluid diet 2 h versus overnight fasting before non-emergency endoscopic retrograde cholangiopancreatography: A single-blind, multicenter, randomized controlled trial
Wenbo MENG ; W. Joseph LEUNG ; Zhenyu WANG ; Qiyong LI ; Leida ZHANG ; Kai ZHANG ; Xuefeng WANG ; Meng WANG ; Qi WANG ; Yingmei SHAO ; Jijun ZHANG ; Ping YUE ; Lei ZHANG ; Kexiang ZHU ; Xiaoliang ZHU ; Hui ZHANG ; Senlin HOU ; Kailin CAI ; Hao SUN ; Ping XUE ; Wei LIU ; Haiping WANG ; Li ZHANG ; Songming DING ; Zhiqing YANG ; Ming ZHANG ; Hao WENG ; Qingyuan WU ; Bendong CHEN ; Tiemin JIANG ; Yingkai WANG ; Lichao ZHANG ; Ke WU ; Xue YANG ; Zilong WEN ; Chun LIU ; Long MIAO ; Zhengfeng WANG ; Jiajia LI ; Xiaowen YAN ; Fangzhao WANG ; Lingen ZHANG ; Mingzhen BAI ; Ningning MI ; Xianzhuo ZHANG ; Wence ZHOU ; Jinqiu YUAN ; Azumi SUZUKI ; Kiyohito TANAKA ; Jiankang LIU ; Ula NUR ; Elisabete WEIDERPASS ; Xun LI
Chinese Medical Journal 2024;137(12):1437-1446
Background::Although overnight fasting is recommended prior to endoscopic retrograde cholangiopancreatography (ERCP), the benefits and safety of high-carbohydrate fluid diet (CFD) intake 2 h before ERCP remain unclear. This study aimed to analyze whether high-CFD intake 2 h before ERCP can be safe and accelerate patients’ recovery.Methods::This prospective, multicenter, randomized controlled trial involved 15 tertiary ERCP centers. A total of 1330 patients were randomized into CFD group ( n = 665) and fasting group ( n = 665). The CFD group received 400 mL of maltodextrin orally 2 h before ERCP, while the control group abstained from food/water overnight (>6 h) before ERCP. All ERCP procedures were performed using deep sedation with intravenous propofol. The investigators were blinded but not the patients. The primary outcomes included postoperative fatigue and abdominal pain score, and the secondary outcomes included complications and changes in metabolic indicators. The outcomes were analyzed according to a modified intention-to-treat principle. Results::The post-ERCP fatigue scores were significantly lower at 4 h (4.1 ± 2.6 vs. 4.8 ± 2.8, t = 4.23, P <0.001) and 20 h (2.4 ± 2.1 vs. 3.4 ± 2.4, t= 7.94, P <0.001) in the CFD group, with least-squares mean differences of 0.48 (95% confidence interval [CI]: 0.26–0.71, P <0.001) and 0.76 (95% CI: 0.57–0.95, P <0.001), respectively. The 4-h pain scores (2.1 ± 1.7 vs. 2.2 ± 1.7, t = 2.60, P = 0.009, with a least-squares mean difference of 0.21 [95% CI: 0.05–0.37]) and positive urine ketone levels (7.7% [39/509] vs. 15.4% [82/533], χ2 = 15.13, P <0.001) were lower in the CFD group. The CFD group had significantly less cholangitis (2.1% [13/634] vs. 4.0% [26/658], χ2 = 3.99, P = 0.046) but not pancreatitis (5.5% [35/634] vs. 6.5% [43/658], χ2 = 0.59, P = 0.444). Subgroup analysis revealed that CFD reduced the incidence of complications in patients with native papilla (odds ratio [OR]: 0.61, 95% CI: 0.39–0.95, P = 0.028) in the multivariable models. Conclusion::Ingesting 400 mL of CFD 2 h before ERCP is safe, with a reduction in post-ERCP fatigue, abdominal pain, and cholangitis during recovery.Trail Registration::ClinicalTrials.gov, No. NCT03075280.
3.Single mini-incision combined with honeycomb titanium plate in treatment of acute acromioclavicular joint disloca-tion
Yu-Chen WANG ; Wei-Zhong YU ; Yun-Feng LI ; Wen-Ke ZHU ; Chuan JIA ; Jun-Qi WU ; Hua GAO ; Lin JI
China Journal of Orthopaedics and Traumatology 2024;37(6):576-582
Objective To explore clinical effect of single small incision with honeycomb titanium plate in treating acute acromioclavicular dislocation.Methods The clinical data of 40 patients with acute acromioclavicular dislocation admitted from December 2019 to December 2021 were retrospectively analyzed and divided into two groups according to different surgical methods.Among them,20 patients were fixed with single small incision with honeycomb titanium plate(titanium plate group),including 11 males and 9 females,aged from 23 to 65 years old with an average of(47.40±12.58)years old;12 patients on the left side,8 patients on the right side;11 patients with type Ⅲ,3 patients with type Ⅳ,and 6 patients with type Ⅴ according to Rockwood classification.Twenty patients were fixed with clavicular hook plate(clavicular hook group),including 8 males and 12 females,aged from 24 to 65 years old with an average of(48.40±12.08)years old;12 patients on the left side,8 patients on the right side;10 patients with type Ⅲ,2 patients with type Ⅳ,and 8 patients with type V according to Rockwood classifica-tion.Operative time,incision length,intraoperative blood loss,hospital stay,visual analogue scale(VAS)and Constant-Murley score of shoulder joint function were compared between two groups.Anteroposterior radiographs of the affected shoulder joint were recorded before,immediately and 6 months after surgery,and the coracoclavicular distance was measured and compared.Results Both groups of patients were successfully completed operation without serious complications.All patients were fol-lowed up for 6 to 15 months with an average of(11.9±4.8)months.There were no incisional infection,internal plant fracture or failure,bone tunnel fracture and other complications occurred.The incision length of titanium plate group(35.90±3.14)mm was significantly shorter than that of clavicular hook group(49.30±3.79)mm(P<0.05).There were no significant difference in operative time,intraoperative blood loss and hospital stay between two groups(P>0.05).At 1 and 3 months after operation,VAS of titanium plate group was lower than that of clavicular hook group(P<0.05).Connstant-Murley scores in titanium plate group at 1,3 and 6 months after operation were(86.80±1.36),(91.60±2.32)and(94.90±2.22),respectively;and in clavicular hook group were(78.45±5.47),(85.55±2.01)and(90.25±1.92),which were higher than that of clavicular hook group(P<0.05).There was no significant difference in coracoclavicular distance between two groups immediately and 6 months after op-eration(P>0.05).Conclusion For the treatment of acute acromioclavicular joint dislocation,single small incision combined with honeycomb titanium plate have advantages of shorter incision,fast recovery of shoulder joint function without the second operation,and has good satisfaction of patient.
4.One-stage posterior debridement and spinal internal fixation for the treatment of lumbar Brucellar spondylitis
Xian-Shuai KOU ; Wei SHE ; Gui-Fu MA ; Xing-Yu PU ; Yun-Biao WU ; Yang QI ; Wen-Yuan LUO
China Journal of Orthopaedics and Traumatology 2024;37(8):764-771
Objective To explore the clinical efficacy and safety of one-stage posterior lesion removal and internal spinal fixation in patients with lumbar Brucellosis spondylitis.Methods The clinical data of 24 patients admitted from October 2017 to October 2022 were retrospectively analyzed,2 patients were lost to follow-up at 10 months after surgery,at the final 22 cases were included in the study,including 13 males and 9 females with an average age of(52.00±6.89)years old,were treated with one-stage posterior lesion removal and internal spinal fixation.The operation time,intraoperative bleeding,follow-up time,ery-throcyte sedimentation rate(ESR)and C-reactive protein(CRP)before and after operation were recorded.The pain visual ana-logue scale(VAS),Oswestry disability index(ODI),the Japanese Orthopaedic Association(JOA)score for neurofunction,American Spinal Injury Association(ASIA)spinal cord injury grade and modified MacNab criteria were ussed to evaluate the efficacy.Results All patients were followed up from 12 to 30 months with an average of(17.41±4.45)months.The operation time was 70 to 155 min with an average of(1 16.59±24.32)min;the intraoperative bleeding volume was 120 to 520 ml with an average of(275.00±97.53)ml.CRP and ESR levels decreased more significantly at 1 week and at the final follow-up than pre-operative levels(P<0.05).VAS,JOA score and ODI at 1 week and at the latest follow-up were more significantly improved than preoperative results(P<0.05).There was no significant difference between ASIA preoperative and 1 week after operation(P>0.05),and a significant difference between preoperative and last follow-up(P<0.05).In the final follow-up,21 patients had ex-cellent efficacy,1 patient had fair,and there was no recurrence during the follow-up.Conclusion One-stage transpedicular le-sion removal and internal spinal fixation,with few incisions and short operation time,helps the recovery of neurological func-tion,and the prognosis meets the clinical requirements,which can effectively control Brucella spondylitis.
5.Failures and successes learned from 160 years of echinococcosis control and countermeasures in China
Chuan-Chuan WU ; Zhuang-Zhi ZHANG ; Jun LI ; Wen-Jing QI ; Jian-Ping CAO ; Can-Jun ZHENG ; Wen-Bao ZHANG
Chinese Journal of Zoonoses 2024;40(5):464-470
The transmission cycle of echinococcosis was established in 1853.More than 160 years have elapsed since Iceland initiated control measures to break the transmission cycle of echinococcosis in 1863.Control plans have been implemented in more than a dozen countries/territories,and lessons have been learned from failures as well as successes.In this review,we fo-cus on the failure experiences,which have also promoted successes in the control of cystic echinococcosis(caused by the para-site Echinococcus granulosus)in regions including Iceland,New Zealand,Uruguay,Wales(England),Turkana(Kenya),and Sardinia(Italy).The causes of the failures were analyzed,and the effects of health education,dog deworming,and con-trol measures for infected animal slaughter on echinococcosis control are comprehensively summarized.However,no suc-cessful experience has been reported in the control of alveolar echinococcosis(caused by the parasite Echinococcus multilocu-laris).On the basis of the biological characteristics of E.mul-tilocularis parasitization in dogs for a duration of 30 days and larvae parasitization in rodents,the fundamental measure for controlling alveolar echinococcosis is administration of monthly deworming treatments to dogs in high prevalence areas.
6.Expert consensus on the disease burden and strategies of dengue prevention and control in China
Chinese Society of Tropical Disease and Parasitology ; Society for Vector Biology and Control of the Chinese Preventive Medicine Association ; Basic Research Committee China Association for Vaccines ; Anjing ; Qi-Yong LIU ; Wen-Wu YIN
Chinese Journal of Zoonoses 2024;40(6):489-497
Dengue fever(DF)is a natural zoonotic disease caused by dengue virus infection which is mainly transmitted by the bite of Aedes mosquito and is endemic in tropical and subtropical regions.At present,DF is spreading rapidly worldwide.Although local transmission caused by imported cases is still the main feature of dengue epidemic in China,its incidence is rap-idly increasing,and the scope of impact is gradually expanding,seriously endangering the health of people.However,no spe-cific antiviral drugs or ideal vaccines are currently available.The experts and scholars from the Chinese Society of Tropical Dis-ease and Parasitology,the Society for Vector Biology and Control of the Chinese Preventive Medicine Association and the Basic Research Committee,China Association for Vaccines formed this consensus on the basis of combing the latest advances in the disease burden of globe and China,traditional vector control and new prevention and control methods,aiming to provide a sci-entific basis for relevant departments to better formulate dengue prevention and control policies.
7.Human resource efficiency and spatial distribution characterization of district-level center for disease control and prevention in city N of Jiangsu Province
Yang LI ; Yu-Meng WEI ; Yu-Qi YANG ; Wen-Jie XU ; Ming-Yao GU ; Zi-Fa HUANG ; Zhi-Hao ZHANG ; Fang WU
Chinese Journal of Health Policy 2024;17(10):52-58
Objective:To analyze the efficiency of human resource allocation and its spatial distribution characteristics of district-level Center for Disease Control and Prevention(CDC)in city N of Jiangsu Province in 2020,in order to provide a strong decision-making reference for optimizing and strengthening the CDC talent team.Methods:The efficiency of human resources of district-level CDC of City N in2020 was measured using the Super-Efficiency SBM model,and the spatial association pattern was analyzed using the natural break point classification method and Moran's index,with the visualization presented through LISA maps.Results:The overall level of human resource efficiency in district-level CDC of City N is relatively high.However,spatially,there are significant differences among the regions,showing a trend of high efficiency in the central areas and low efficiency at the ends.Moran's index and LISA maps indicate a negative spatial correlation in efficiency,with a low-high(L-H)cluster centered on Area L and a high-low(H-L)cluster centered on Area J.The high-high(H-H)cluster pattern has not yet formed,exhibiting a characteristic of interspersed high and low efficiency.Conclusions:There are regional differences in the human resource efficiency of the Disease Control Center in City N,and the spatial cluster pattern needs to be optimized.It is recommended to focus on efficiency improvement in Areas P and L,formulate appropriate policies,and promote coordinated regional development.
8.Application of egg yolk oil combined with Qingrejiedu decoction for external washing to promote wound healing after perianal abscess surgery
Shixiong WU ; Lihui WEN ; Manjun LIU ; Lei ZHANG ; Bo LIU ; Xutao QI
Journal of China Medical University 2024;53(5):446-450,457
Objective To explore the promoting effect of egg yolk oil combined with heat-clearing and detoxi-fying traditional Chinese medicine external washing on postoperative wound healing in patients with perianal abscesses based on growth factors in the wound granu-lation tissue.Methods Eighty patients with perianal abscesses admitted to our hospital from January 2023 to May 2023 were randomly divided into a control group and an observation group,with 40 patients in each group.Three days after surgery,the control group received routine treatment,such as external washing with heat-clearing and detoxifying Chinese herbal medicine and dressing changes with vase-line gauze.The observation group received additional treatment with egg yolk oil,and both groups were treated continuously for 7 days.The clinical efficacy,improvement in clinical symptoms,and wound recovery at different time points;serum inflammatory cytokines;and expression levels of wound granulation tissue-related factors were compared between the two groups.Results The total effective rate was higher in the observation group than the control group(95%vs.75%,P<0.05).The time of pruritus disappearance,decaying flesh,emer-gence of new epithelium,and healing were shorter in the observation group than in the control group(P<0.05).The pain degree,wound secretion,granulation morphology and surrounding tissue edema score of the observation group were significantly decreased at 7 and 10 days after surgery compared with the control group(P<0.05).Serum levels of interleukin(IL)-1β,IL-8,and tumor necrosis factor-α were lower in the observation group than the control group at 7 and 10 days after surgery(P<0.05).The levels of basic fibroblast growth factor,vascular endothelial cell growth factor,and transforming growth factor-βin wound granulation tissue were higher in the observation group than the control group at 7 and 10 days after surgery(P<0.05).Conclusion The external application of egg yolk oil combined with heat-clearing and detoxifying Chinese herbs can significantly improve the clinical symptoms of patients with perianal abscesses and promote wound healing,with significant therapeutic effects.This may be related to the inhibition of inflammatory cytokine expression and the promotion of wound granulation tissue growth factor expression.
9.Exercise intervention in children with hematopoietic stem cell transplantation:a scoping review
Yinzhi YAN ; Fang WEN ; Min WANG ; Xuemei ZHOU ; Qi YANG ; Huifang WU ; Yiming ZHANG
Chinese Journal of Nursing 2024;59(11):1331-1339
Objective To systematically retrieve relevant research on the application of exercise intervention dur-ing hematopoietic stem cell transplantation for hospitalized children at home and abroad,to generalize and summa-rize the content of exercise intervention,the effect of intervention,and safety monitoring,with the purpose of provid-ing reference bases for the clinical application of exercise intervention in the future.Methods In accordance with the scoping review framework,we systematically retrieved databases including Web of Science,PubMed,Scopus,Cochrane Library,Embase,CINAHL,CNKI,VIP Database,Wanfang Data and China Biomedical Literature Database,with a retrieval timeframe from database establishment to May 19,2023.Based on the criteria for inclusion and ex-clusion of literature,we screened,summarized,extracted,and analyzed the literature.Results A total of 17 pieces of literature were included,including 5 randomized controlled trials,9 quasi-experimental studies,and 3 mixed-method studies.There were 4 categories of exercise including aerobic,anti-gravity,resistance,and stretching;most of the ex-ercises were of low to moderate intensity;the exercise interventions had a positive impact on muscle strength,quali-ty of life,cardiorespiratory function,body composition,and hematological indices;the safety monitoring consisted of red blood cell,hemoglobin,and platelet counts,temperature,joint and muscle pains,as well as falls,and syringe shedding.Conclusion The application of exercise intervention is safe and feasible,with a positive effect on chil-dren with hematopoietic stem cell transplantation in muscle strength,quality of life.Medical staff should combine with the clinical situation to formulate a reasonable and unified exercise program and to carry out scientific and standardized exercise management.
10.Application of single-sperm sequencing in resolving the carrier status of preimplantation genetic testing for chromosomal structural rearrangements in Robertsonian translocations
Bao-Qiong LIAO ; Li-Dan LAI ; Ru-Tian LIU ; Qi ZHANG ; Wen-Chang LIAN ; Wu-Ming XIE
National Journal of Andrology 2024;30(6):499-506
Objective:To investigate the application value of single-sperm sequencing in resolving the carrier status of preim-plantation genetic testing(PGT)for chromosomal structural rearrangements in Robertsonian translocations.Methods:Haplotypes were constructed by single-sperm isolation combined with single-sperm sequencing for a patient with 45,XY,der(13;14)(q10;q10).Twenty single-sperm samples were isolated by mechanical braking and subjected to whole-genome amplification(WGA),and then the Asian Screening Array(ASA)gene chip was used to detect the 183 708 single nucleotide polymorphisms(SNP)of the WGA products.The single sperm associated with the translocation that could be used as haplotype inference was detected by copy number variation(CNV)sequencing,and the chromosomal haplotypes with normal and Robertsonian translocations were inferred.Three biopsy samples of embryonic trophoblast cells were used as the objects.After whole-genome amplification,high-throughput sequencing was employed to determine the status of the translocation chromosome carried by the embryos.The available blastocysts were selected for transfer,and the amniotic fluid samples were taken at 18 weeks of gestation to confirm whether the fetus carried the pathogenic muta-tion.Results:A total of 6 037 SNP sites were screened by single-sperm sequencing,and 30 sites selected to distinguish normal and translocation haplotypes.Preimplantation haplotype analysis showed that all the three embryos were euploids without Robertsonian translocation chromosome.Genetic testing of amniotic fluid in the second trimester confirmed that the karyotype of the fetus was 46,XN,carrying no Robertsonian translocation chromosome.Conclusion:For male carriers of Robertsonian translocation,single sperm sequencing can be used to screen SNP sites to construct haplotypes for distinguishing normal and Robertsonian translocation em-bryos,and to provide a basis for embryo selection by preimplantation chromosomal structural genetic testing.

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