1.Hypertension and NAFLD risk: Insights from the NHANES 2017-2018 and Mendelian randomization analyses
Mengqin YUAN ; Jian HE ; Xue HU ; Lichao YAO ; Ping CHEN ; Zheng WANG ; Pingji LIU ; Zhiyu XIONG ; Yingan JIANG ; Lanjuan LI
Chinese Medical Journal 2024;137(4):457-464
Background::Hypertension and non-alcoholic fatty liver disease (NAFLD) share several pathophysiologic risk factors, and the exact relationship between the two remains unclear. Our study aims to provide evidence concerning the relationship between hypertension and NAFLD by analyzing data from the National Health and Nutrition Examination Survey (NHANES) 2017-2018 and Mendelian randomization (MR) analyses.Methods::Weighted multivariable-adjusted logistic regression was applied to assess the relationship between hypertension and NAFLD risk by using data from the NHANES 2017-2018. Subsequently, a two-sample MR study was performed using the genome-wide association study (GWAS) summary statistics to identify the causal association between hypertension, systolic blood pressure (SBP), diastolic blood pressure (DBP), and NAFLD. The primary inverse variance weighted (IVW) and other supplementary MR approaches were conducted to verify the causal association between hypertension and NAFLD. Sensitivity analyses were adopted to confirm the robustness of the results.Results::A total of 3144 participants were enrolled for our observational study in NHANES. Weighted multivariable-adjusted logistic regression analysis suggested that hypertension was positively related to NAFLD risk (odds ratio [OR] = 1.677; 95% confidence interval [CI], 1.159-2.423). SBP ≥130 mmHg and DBP ≥80 mmHg were also significantly positively correlated with NAFLD. Moreover, hypertension was independently connected with liver steatosis ( β = 7.836 [95% CI, 2.334-13.338]). The results of MR analysis also supported a causal association between hypertension (OR = 7.203 [95% CI, 2.297-22.587]) and NAFLD. Similar results were observed for the causal exploration between SBP (OR = 1.024 [95% CI, 1.003-1.046]), DBP (OR = 1.047 [95% CI, 1.005-1.090]), and NAFLD. The sensitive analysis further confirmed the robustness and reliability of these findings (all P >0.05). Conclusion::Hypertension was associated with an increased risk of NAFLD.
2.Clinical study of modified Poge Jiuxin decoction combined with acupuncture in the treatment of septic cardiomyopathy
Zhi'en ZHOU ; Shanxiu YAN ; Ping LU ; Juan YAO ; Mulong BAO ; Juan HOU ; Yimo JIAN ; Yao MA
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care 2024;31(2):151-156
Objective To observe the effects of modified Poge Jiuxin decoction combined with acupuncture in the treatment of septic cardiomyopathy(SIC),and explore its possible mechanism.Methods Totally 72 patients with SIC admitted to Chengdu First People's Hospital from January 2022 to June 2023 were enrolled.The patients were divided into control group and treatment group according to random number table method,with 36 cases in each group.Patients in control group received basic treatment for SIC.On this basis,the treatment group was administrated with modified Poge Jiuxin decoction[includes Prepared Aconite 30 g(earlier decocted),Red Ginseng 30 g(another stew),Cornel Meat 60 g,Dried Ginger 30 g,Raw Keel 30 g(earlier decocted),Raw Oyster 30 g(earlier decocted),Magnet 30 g(earlier decocted),Poria Cocos 90 g,Plantain Seeds 30 g(in bag),Roasted Licorice 60 g,Musk 0.5 g(artificial)],one dose a day,100 mL in 3 meals a day.Acupuncture at bilateral Zusanli,Guangyuan,Neiguan,Sanyinjiao and Qihai points,twice a day.Both groups were treated for 7 days.The changes of C-reactive protein(CRP),procalcitonin(PCT),cardiac tropomin I(cTnI),N-terminal pro-B type natriuretic peptide(NT-proBNP)and lactic acid(Lac)were observed before and after treatment,acute physiology and chronic health evaluationⅡ(APACHEⅡ)and sequential organ failure assessment(SOFA)were calculated,left ventricular ejection fraction(LVEF),left ventricle fractional shortening(LVFS),and mitral orifice early/late diastolic blood flow velocity ratio(E/A ratio)were measured with echocardiography,the heart rate(HR),mean arterial pressure(MAP),mechanical ventilation time,vasoactive drug use time,in the intensive care unit(ICU)stay time,the incidence of multiple organ dysfunction syndrome(MODS)and 28-day mortality were recorded.Results After treatment,the indexes of inflammation(CRP,PCT),myocardial markers(cTnI,NT-proBNP),hemodynamics and perfusion(HR,Lac),illness severity score(APACHEⅡ,SOFA)and the 28-day mortality in the two groups were significantly reduced,while LVEF and MAP were significantly increased compared to before treatment.The improvement of various indexes in the treatment group were better than those in the control group[CRP(mg/L):22.18±9.46 vs.68.45±13.46,PCT(μg/L):1.16±0.59 vs.4.35±1.28,LVEF:0.48±0.06 vs.0.41±0.05,cTnI(μg/L):0.60±0.14 vs.0.98±0.30,NT-proBNP(ng/L):204.35±26.54 vs.240.12±56.12,HR(bmp):88.75±10.05 vs.98.57±10.56,MAP(mmHg,1 mmHg≈0.133 kPa):82.10±5.08 vs.73.46±3.55,Lac(mmol/L):0.75±0.28 vs.1.60±0.36,APACHEⅡscore:10.46±1.80 vs.15.50±2.16,SOFA score:2.60±1.24 vs.6.76±1.60,all P<0.05].After treatment,LVFS and E/A ratio in the two groups increased significantly compared to those before treatment,however,there was no significant difference between the treatment group and the control group after treatment[LVFS:(25.12±3.46)%vs.(22.61±3.88)%,E/A ratio:1.16±0.46 vs.0.96±0.32,both P>0.05].The vasoactive drug use time and ICU stay time were shortened in the treatment group than those in the control group[vasoactive drug use time(days):9.62±3.05 vs.10.48±3.40,ICU stay time(days):12.51±2.04 vs.13.72±1.14,both P<0.05],the incidence of MODS and the 28-day mortality were lower than those of the control group[38.89%(14/36)vs.52.77%(9/36),44.44%(16/36)vs.47.22%(17/36)],but there were no statistical differences(both P>0.05).Conclusion Modified Poge Jiuxin decoction combined with acupuncture can effectively improve the prognosis of patients with SIC,and its mechanism may be related to inhibition of inflammatory reaction and improvement of cardiac function.
3.Clinical characteristics and the risk factors of sepsis-induced myocardial dysfunction
Zhi'en ZHOU ; Shanxiu YAN ; Ping LU ; Juan YAO ; Mulong BAO ; Juan HOU ; Yimo JIAN ; Yao MA
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care 2024;31(4):428-432
Objective To investigate clinical characteristics and the risk factors of sepsis-induced myocardial dysfunction(SIMD),and to provide evidence for the diagnosis,treatment and prevention of SIMD.Methods The clinical data of 284 patients with sepsis(≥18 years old)admitted to the department of critical care medicine of Chengdu Integrated Traditional Chinese Medicine&Western Medicine Hospital/Chengdu First People's Hospital from January 2020 to December 2022 were retrospectively analyzed.This includes gender,age,chronic underlying diseases,the mean arterial pressure(MAP),heart rate(HR),laboratory test results,disease severity score,the proportion of requiring mechanical ventilation,vasoactive drugs treatment and renal replacement therapy,length of intensive care medicine(ICU)stay and the 28-day mortality.Patients were divided into SIMD group and non-SIMD group according to the occurrence of SIMD,allowing for an analysis of the clinical characteristics of two groups of patients.Univariate and multivariate Logistic regression analyses were used to identify the risk factors of SIMD,and receiver operator characteristic curve(ROC curve)were plotted to analyze the predictive value of each risk factor for the occurrence of SIMD.Results A total of 284 septic patients were included,including 136 cases(47.89%)in the SIMD group and 148 cases(52.11%)in the non-SIMD group.Compared with the non-SIMD group,the levels of age,N-terminal pro-brain natriuretic peptide(NT-proBNP),cardiac tropomin I(cTnI),lactic acid(Lac)at admission to ICU,the proportion of vasoactive drugs treatment,acute physiology and chronic health evaluation Ⅱ(APACHEⅡ)and sequential organ failure assessment(SOFA)in the SIMD group were significantly higher than those in the non-SIMD group[age(years):75.92±2.35 vs.55.02±1.68,NT-proBNP(ng/L):3 037.00±544.50 vs.2 493.92±630.21,cTnI(μg/L):0.12±0.07 vs.0.06±0.03,Lac in ICU(mmol/L):4.46±1.21 vs.2.98±1.02,the proportion of vasoactive drugs treatment:40.44%(55/136)vs.21.62%(32/148),APACHEⅡ score:24.25±1.02 vs.20.95±0.85,SOFA score:7.41±4.69 vs.6.21±2.81,all P<0.05],but the 24-hour Lac clearance rate of the SIMD group was significantly lower than that of the non-SIMD group[(13.80±7.01)%vs.(25.41±8.90)%,P<0.05].Multivariate Logistic regression analysis showed that age≥75 years,24-hour Lac clearance rate and NT-proBNP≥3 000 ng/L were the independent factors of SIMD in patients with sepsis[odds ratio(OR)and 95%confidence interval(95%CI)were 5.990(2.143-16.742),0.348(0.155-0.786)and 2.708(1.093-6.711),P values were 0.001,0.011 and 0.031].ROC curve analysis showed that age,24-hour Lac clearance rate,NT-proBNP had predictive value for the development of SIMD[area under the curve(AUC)were 0.637,0.811,0.743,95%CI were 0.573-0.701,0.761-0.860,0.687-0.800,all P<0.05].Conclusions SIMD occurs more frequently in patients with sepsis.Increased age,elevated NT-proBNP,and reduced 24-hour Lac clearance rate are independent risk factors of SIMD,warranting clinical attention.
4.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.
5.Current status of diagnosis and treatment of chronic lymphocytic leukemia in China: A national multicenter survey research.
Wei XU ; Shu Hua YI ; Ru FENG ; Xin WANG ; Jie JIN ; Jian Qing MI ; Kai Yang DING ; Wei YANG ; Ting NIU ; Shao Yuan WANG ; Ke Shu ZHOU ; Hong Ling PENG ; Liang HUANG ; Li Hong LIU ; Jun MA ; Jun LUO ; Li Ping SU ; Ou BAI ; Lin LIU ; Fei LI ; Peng Cheng HE ; Yun ZENG ; Da GAO ; Ming JIANG ; Ji Shi WANG ; Hong Xia YAO ; Lu Gui QIU ; Jian Yong LI
Chinese Journal of Hematology 2023;44(5):380-387
Objective: To understand the current status of diagnosis and treatment of chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL) among hematologists, oncologists, and lymphoma physicians from hospitals of different levels in China. Methods: This multicenter questionnaire survey was conducted from March 2021 to July 2021 and included 1,000 eligible physicians. A combination of face-to-face interviews and online questionnaire surveys was used. A standardized questionnaire regarding the composition of patients treated for CLL/SLL, disease diagnosis and prognosis evaluation, concomitant diseases, organ function evaluation, treatment selection, and Bruton tyrosine kinase (BTK) inhibitor was used. Results: ①The interviewed physicians stated that the proportion of male patients treated for CLL/SLL is higher than that of females, and the age is mainly concentrated in 61-70 years old. ②Most of the interviewed physicians conducted tests, such as bone marrow biopsies and immunohistochemistry, for patient diagnosis, in addition to the blood test. ③Only 13.7% of the interviewed physicians fully grasped the initial treatment indications recommended by the existing guidelines. ④In terms of cognition of high-risk prognostic factors, physicians' knowledge of unmutated immunoglobulin heavy-chain variable and 11q- is far inferior to that of TP53 mutation and complex karyotype, which are two high-risk prognostic factors, and only 17.1% of the interviewed physicians fully mastered CLL International Prognostic Index scoring system. ⑤Among the first-line treatment strategy, BTK inhibitors are used for different types of patients, and physicians have formed a certain understanding that BTK inhibitors should be preferentially used in patients with high-risk factors and elderly patients, but the actual use of BTK inhibitors in different types of patients is not high (31.6%-46.0%). ⑥BTK inhibitors at a reduced dose in actual clinical treatment were used by 69.0% of the physicians, and 66.8% of the physicians had interrupted the BTK inhibitor for >12 days in actual clinical treatment. The use of BTK inhibitors is reduced or interrupted mainly because of adverse reactions, such as atrial fibrillation, severe bone marrow suppression, hemorrhage, and pulmonary infection, as well as patients' payment capacity and effective disease progression control. ⑦Some differences were found in the perceptions and behaviors of hematologists and oncologists regarding the prognostic assessment of CLL/SLL, the choice of treatment options, the clinical use of BTK inhibitors, etc. Conclusion: At present, a gap remains between the diagnosis and treatment of CLL/SLL among Chinese physicians compared with the recommendations in the guidelines regarding the diagnostic criteria, treatment indications, prognosis assessment, accompanying disease assessment, treatment strategy selection, and rational BTK inhibitor use, especially the proportion of dose reduction or BTK inhibitor discontinuation due to high adverse events.
Female
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Humans
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Male
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Aged
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Middle Aged
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Leukemia, Lymphocytic, Chronic, B-Cell/drug therapy*
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Prognosis
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Lymphoma, B-Cell
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Immunohistochemistry
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Immunoglobulin Heavy Chains/therapeutic use*
6.Isolation and identification of dominant strains in the fermentation process of HuaFengDan YaoMu and investigation of their growth under different temperature and pH value
Guo-Qiong CAO ; Min LIU ; Yao LIU ; Jian XU ; You-Li CHEN ; Jing-Lan WU ; Yong-Ping ZHANG
Chinese Traditional Patent Medicine 2023;45(12):4011-4017
AIM To isolate and identify the dominant strains in the fermentation process of the HuaFengDan YaoMu,and to investigate the effects of different temperatures and pH values upon their growth.METHODS During the 0-6 weeks fermentation process of HuaFengDan YaoMu in the selective medium,the cultured bacteria,the molds and the yeasts had the colonies counted,and the dominant strains isolated and purified,particularly the dominant bacteria and fungi determined by 16S rDNA and 26S rDNA sequences.The optimal growth temperature and pH value of Bacillus aryabhattai,Debaryomyces hansenii,Aspergillus oryzae were investigated respectively.RESULTS HuaFengDan YaoMu found its bacterial counts increased from 0 to 4 weeks and stabilized from 4 to 6 weeks;its yeast counts increased during 0-3 weeks,and decreased continuously during 4-6 weeks;and its mold counts remained unchanged at 0 week,but increased steadily from 1 to 4 weeks,and decreased at 5 to 6 weeks of the fermentation.In the fermentation process of HuaFengDan YaoMu,the dominant strains of Bacillus aryabhattai,Debaryomyces hansenii and Aspergillus oryzae,identified and screened out by the phylogenetic tree,adapted best to the growth temperature of 35℃,25-30℃and 35℃,at pH value of 8,6 and 7,respectively.CONCLUSION In the fermentation process of HuaFengDan YaoMu,the dominant microorganisms of Bacillus aryabhattai,Debaryomyces hansenii,Aspergillus oryzae are identifiable and separable.
7.Application and challenges of generative artificial intelligence in enhancing primary healthcare services: using ChatGPT as an example
Huatang ZENG ; Xiatong KE ; Ping XU ; Peng HUANG ; Jian HU ; Yao TANG ; Liqun WU ; Cunrui HUANG ; Wannian LIANG
Chinese Journal of Hospital Administration 2023;39(10):791-794
While generative artificial intelligence(AI), exemplified by ChatGPT, demonstrated impressive capabilities in understanding the semantics and context of natural language, and generating coherent and meaningful responses, its performance in the medical field, which required high-level expertise and complex reasoning, remained uncertain. This article aimed to explore the potential applications and challenges of generative AI technology, with ChatGPT as a representative example, in enhancing the capabilities of primary healthcare services. Generative AI, represented by ChatGPT, had potential applications in enhancing primary healthcare services, including clinical assistance in diagnosis, electronic medical record documentation, remote management of chronic patients, and patient education. However, limitations such as the inability to guarantee accuracy, lack of doctor-patient interaction, language barriers, and concerns related to data security, patient privacy, and ethical considerations constrained its practical implementation. Therefore, the application of ChatGPT in improving the capabilities of primary healthcare services required extensive discussion and analysis throughout society. A comprehensive evaluation of potential risks and the establishment of corresponding policies and regulations were necessary to ensure the prudent and responsible introduction and application of ChatGPT, ultimately achieving the goal of empowering primary healthcare services.
8.Application of the new left ventricular circulation assist device iVAC 2L in high-risk percutaneous coronary intervention
Jian-Fang LUO ; Guan-Chang TAN ; Jun-Qing YANG ; You-Nan YAO ; Yu-Wei LIU ; Jian-Ping LI ; Yong HUO
Chinese Journal of Interventional Cardiology 2023;31(12):929-934
Objective To evaluate the efficacy and safety of the new left ventricular circulation assist device iVAC 2L in high-risk percutaneous coronaryintervention(HR-PCI)in Chinese patients.Methods We reported 6 PCIs in 5 patients supported by iVAC 2L,a new left ventricular circulation assist device,performed in Macao from September 2022 to March 2023.All patients were assessed by heart team and categorize to be high-risk for procedure.Clinical and intra-procedural data were analyzed.iVAC 2L-related complications and 30-day results were also documented.Results Insertion and removement of iVAC 2L successfully performed in all the 5 patients.Three of them underwent complete revascularization in the index procedure;one failed for the first time due to intolerance of the prolonged procedure,but succeeded for the reattempt of complete revascularization a month later,with the support of iVAC 2L.PCI was abandoned due to poor vessel condition.iVAC 2L,the new left ventricular circulation assist device,supported effectively during the 6 procedures.The patients were stable during the procedure.The success rate of hemodynamic support was 100%.No iVAC 2L-related complications and 30-day major adverse cardiac and cerebral events occurred,the 30-day survival was 100%.Conclusions Initial experience suggested that the new left ventricular circulation assist device iVAC 2L could provide effective and safe support in high-risk PCI.
9.Efficacy and safety of various doses of hybutimibe monotherapy or in combination with atorvastatin for primary hypercholesterolemia: a multicenter, randomized, double-blind, double-dummy, parallel-controlled phase Ⅲ clinical trial.
Si Yu CAI ; Xiang GU ; Pei Jing LIU ; Rong Shan LI ; Jian Jun JIANG ; Shui Ping ZHAO ; Wei YAO ; Yi Nong JIANG ; Yue Hui YIN ; Bo YU ; Zu Yi YUAN ; Jian An WANG
Chinese Journal of Cardiology 2023;51(2):180-187
Objective: To evaluate the efficacy and safety of hybutimibe monotherapy or in combination with atorvastatin in the treatment of primary hypercholesterolemia. Methods: This was a multicenter, randomized, double-blind, double-dummy, parallel-controlled phase Ⅲ clinical trial of patients with untreated primary hypercholesterolemia from 41 centers in China between August 2015 and April 2019. Patients were randomly assigned, at a ratio of 1∶1∶1∶1∶1∶1, to the atorvastatin 10 mg group (group A), hybutimibe 20 mg group (group B), hybutimibe 20 mg plus atorvastatin 10 mg group (group C), hybutimibe 10 mg group (group D), hybutimibe 10 mg plus atorvastatin 10 mg group (group E), and placebo group (group F). After a dietary run-in period for at least 4 weeks, all patients were administered orally once a day according to their groups. The treatment period was 12 weeks after the first dose of the study drug, and efficacy and safety were evaluated at weeks 2, 4, 8, and 12. After the treatment period, patients voluntarily entered the long-term safety evaluation period and continued the assigned treatment (those in group F were randomly assigned to group B or D), with 40 weeks' observation. The primary endpoint was the percent change in low density lipoprotein cholesterol (LDL-C) from baseline at week 12. Secondary endpoints included the percent changes in high density lipoprotein cholesterol (HDL-C), triglyceride (TG), apolipoprotein B (Apo B) at week 12 and changes of the four above-mentioned lipid indicators at weeks 18, 24, 38, and 52. Safety was evaluated during the whole treatment period. Results: Totally, 727 patients were included in the treatment period with a mean age of (55.0±9.3) years old, including 253 males. No statistical differences were observed among the groups in demographics, comorbidities, and baseline blood lipid levels. At week 12, the percent changes in LDL-C were significantly different among groups A to F (all P<0.01). Compared to atorvastatin alone, hybutimibe combined with atorvastatin could further improve LDL-C, TG, and Apo B (all P<0.05). Furthermore, there was no significant difference in percent changes in LDL-C at week 12 between group C and group E (P=0.991 7). During the long-term evaluation period, there were intergroup statistical differences in changes of LDL-C, TG and Apo B at 18, 24, 38, and 52 weeks from baseline among the statins group (group A), hybutimibe group (groups B, D, and F), and combination group (groups C and E) (all P<0.01), with the best effect observed in the combination group. The incidence of adverse events was 64.2% in the statins group, 61.7% in the hybutimibe group, and 71.0% in the combination group during the long-term evaluation period. No treatment-related serious adverse events or adverse events leading to death occurred during the 52-week study period. Conclusions: Hybutimibe combined with atorvastatin showed confirmatory efficacy in patients with untreated primary hypercholesterolemia, which could further enhance the efficacy on the basis of atorvastatin monotherapy, with a good overall safety profile.
Male
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Humans
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Middle Aged
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Atorvastatin/therapeutic use*
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Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use*
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Hypercholesterolemia/drug therapy*
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Cholesterol, LDL/therapeutic use*
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Anticholesteremic Agents/therapeutic use*
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Treatment Outcome
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Triglycerides
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Apolipoproteins B/therapeutic use*
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Double-Blind Method
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Pyrroles/therapeutic use*

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