1.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
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Middle Aged
		                        			;
		                        		
		                        			Atorvastatin/therapeutic use*
		                        			;
		                        		
		                        			Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use*
		                        			;
		                        		
		                        			Hypercholesterolemia/drug therapy*
		                        			;
		                        		
		                        			Cholesterol, LDL/therapeutic use*
		                        			;
		                        		
		                        			Anticholesteremic Agents/therapeutic use*
		                        			;
		                        		
		                        			Treatment Outcome
		                        			;
		                        		
		                        			Triglycerides
		                        			;
		                        		
		                        			Apolipoproteins B/therapeutic use*
		                        			;
		                        		
		                        			Double-Blind Method
		                        			;
		                        		
		                        			Pyrroles/therapeutic use*
		                        			
		                        		
		                        	
2.Guidelines for the application of artificial intelligence in the diagnosis of anterior segment diseases(2023)
Yi SHAO ; Ying JIE ; Zu-Guo LIU
International Eye Science 2023;23(9):1421-1430
		                        		
		                        			
		                        			 This paper aims to delve deeply into the practical guidelines for the application of artificial intelligence(AI)in the diagnosis of anterior ocular diseases in ophthalmology. Given the complexities and variability inherent in the images associated with the research of anterior segment diseases, AI has traditionally found its principal application in the sphere of posterior segment diseases within ophthalmology. However, with the evolution and advancement of AI technologies, notably machine learning and deep learning, alongside an exponential surge in anterior segment electronic image data, the implementation of AI in the domain of corneal, conjunctival, lens, and eyelid disease is not only feasible but has become a reality. The Ophthalmic Imaging and Intelligent Medicine Branch of the Chinese Medical Education Association, in tandem with the Ophthalmology Professional Committee of the International Translational Medicine Association, have orchestrated a consortium of experts. These specialists have synthesized the most recent progressions, both nationally and internationally, in the application of AI in the diagnosis of anterior ocular diseases. This includes its use in corneal, conjunctival, lens, and eyelid diseases, and provides an analysis of the current challenges faced as well as the future directions of development. This guideline has been formulated through several iterations of thoughtful discussion and revisions. Its purpose is to empower clinical ophthalmologists with a reliable framework to facilitate the enhanced application of AI in diagnostic decision-making and clinical research for anterior ocular diseases. 
		                        		
		                        		
		                        		
		                        	
3.Global leadership initiative on malnutrition(GLIM)criteria in the diagnosis and treatment of malnutrition in patients with colorectal cancer
Xiao-Hong TAN ; Yi-Chun DING ; Zu-Wei XIA ; Wan-Ming LIANG ; Ying-Ying ZOU ; Deng-Liang LIU
Parenteral & Enteral Nutrition 2023;30(5):280-286,291
		                        		
		                        			
		                        			Objective:This study aims to evaluate the incidence of postoperative malnutrition in colorectal cancer patients who underwent curative colorectal cancer surgery using the Golbal Leadership Initiative on Malnutrition(GLIM)criteria,and to explore the impact of malnutrition defined by the GLIM criteria on short-term clinical outcomes in patients with colorectal cancer.Method:We included a prospective cohort of 171 patients who underwent curative colorectal cancer surgery in Chongqing JiuLongpo People's Hospital from September 2022 to May 2023.Nutritional Risk Screening 2002(NRS 2002)was used for nutritional risk screening and GLIM criteria was used for the diagnosis of malnutrition.To compare the short-term postoperative clinical outcomes between the well-nourished group and the malnourished group under the GLIM criteria.Logistic regression analysis was conducted to analyze the risk factors of postoperative complications.Result:Among the included cases,nutritional screening data showed that 74(43.27%)patients were considered to be at risk of malnutrition(NRS 2002≥3),while based on GLIM criteria,63 patients(36.84%)were diagnosed as malnutrition.Univariate logistic regression analysis showed that GLIM-defined malnutrition was associated with total postoperative complications[odds ratio:2.075(95%CI:1.292~3.333),P=0.002].Multivariat analysis showed that women,BMI<18.5kg/m2,smoking history,low differentiation of tumor,sarcopenia,laparotomy,low prealbumin,were independent risk factors for total postoperative complications.Conclusions:The nutritional diagnosis based on the GLIM criteria can effectively reflect the preoperative nutritional status of patients with colorectal cancer.GLIM-defined preoperative malnutrition can predict the risk of short-term complications in colorectal cancer patients who underwent curative colorectal cancersurgery.
		                        		
		                        		
		                        		
		                        	
4.Patient Blood Management: Single Center Evidence and Practice at Fuwai Hospital.
Yun-Tai YAO ; Xin YUAN ; Li-Xian HE ; Yi-Ping YU ; Yu DU ; Gang LIU ; Li-Juan TIAN ; Zu-Xuan MA ; Yong-Bao ZHANG ; Jie MA
Chinese Medical Sciences Journal 2022;37(3):246-260
		                        		
		                        			
		                        			Blood loss and blood transfusion requirement are important quality control indicators of cardiovascular surgery and cardiovascular anesthesia. Patient blood management (PBM) is an evidence-based, multidisciplinary approach to optimizing the care of patients who may need transfusion, which encompasses anemia management, hemodilution, cell salvage, hemostatic treatment, and other approaches to reducing bleeding and minimizing blood transfusion. PBM in cardiovascular surgery is a "team sport" that involves cardiac and vascular surgeons, anesthesiologists, perfusionist, intensivists, and other health care providers. The current work provides an overview of evidence and practice of PBM at Fuwai Hospital. Implementation of PBM should also take local resource availability and cost-effectiveness of different devices, drugs, technologies, and techniques into consideration.
		                        		
		                        		
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Blood Transfusion/methods*
		                        			;
		                        		
		                        			Anemia/therapy*
		                        			;
		                        		
		                        			Hemorrhage
		                        			;
		                        		
		                        			Hospitals
		                        			;
		                        		
		                        			Blood Loss, Surgical
		                        			
		                        		
		                        	
5.In vitro evaluation of positioning accuracy of trephine bur at different depths by dynamic navigation.
Si Min LIU ; Yi Jiao ZHAO ; Xiao Yan WANG ; Zu Hua WANG
Journal of Peking University(Health Sciences) 2022;54(1):146-152
		                        		
		                        			OBJECTIVE:
		                        			To evaluate the accuracy of trephine bur drilling at different depths guided by dynamic navigation system in 3D printing in vitro model.
		                        		
		                        			METHODS:
		                        			A model at the depth of 5 mm, 10 mm, and 15 mm from the outer surface of which hemispherical cavities was reserved and the 3D printing technology was used to make the standardized model with Veroclear resin. The cone beam CT (CBCT) was taken and the data were imported into the dynamic navigation software (DCARER, China) to establish navigation path programming. Under the guidance of dynamic navigation, a trephine bur with a diameter of 4.5 mm was used to complete the access operation. At each depth, 10 approaches were completed. The postoperative model CBCT was taken. The approach trajectory under navigation was reconstructed and compared with the designed path. The two-dimensional distance deviation, depth deviation, three-dimensional distance deviation, and angle deviation between the actually prepared path and the designed path were calculated.
		                        		
		                        			RESULTS:
		                        			At the depth of 5 mm, the two-dimensional distance deviation between the end position of the prepared path and the designed path was (0.37±0.06) mm, the depth deviation was (0.06±0.05) mm, the three-dimensional distance deviation was (0.38±0.07) mm, and the angle deviation was 2.46°±0.54°; At the depth of 10 mm, the four deviations between the end position of prepared path and the designed path were (0.44±0.05) mm, (0.16±0.06) mm, (0.47±0.05) mm, and 2.45°±1.21°, respectively; At the depth of 15 mm, the four deviations were (0.52±0.14) mm, (0.16±0.07) mm, (0.55±0.15) mm, and 3.25°±1.22°, respectively. With the increase of entry depth, the three-dimensional and depth accuracy of dynamic navigation system decreased (P < 0.01), and the positioning angle deviation had no relation with the entry depth (P>0.01).
		                        		
		                        			CONCLUSION
		                        			Dynamic navigation technology can achieve high positioning accuracy in the depth range of 15 mm, but its deviation increases with the increase of entry depth.
		                        		
		                        		
		                        		
		                        			China
		                        			;
		                        		
		                        			Cone-Beam Computed Tomography
		                        			;
		                        		
		                        			Printing, Three-Dimensional
		                        			;
		                        		
		                        			Surgery, Computer-Assisted
		                        			
		                        		
		                        	
6.Design and Verification of Human Metabolic Measurement System Based on STM32.
Rui JIN ; Hai-Hong HUANG ; Yuan WANG ; Yan-Yan CHEN ; Qing-Qing CAO ; Rui-de LIU ; Zi-Jun HE ; Yi-Ning SUN ; Zu-Zhang MA
Chinese Journal of Medical Instrumentation 2022;46(3):273-277
		                        		
		                        			
		                        			A high-precision human metabolic measurement system is designed. The system uses STM32F103 as the main control chip to acquire oxygen, carbon dioxide and flow signals to calculate four quantitative indicators: oxygen consumption(VO2), carbon dioxide production(VCO2), respiratory entropy(RQ) and resting energy metabolism(REE), and finally uses an upper computer to display the calculation results.In this paper, the signal acquisition circuit design was carried out for the oxygen sensor, carbon dioxide sensor and flow sensor, and the validity of the device was verified with the American machine MGCDiagnositcs using Bland-Altman analysis method, and the results showed that the four parameters of VO2,VCO2, RQ and REE of both devices fell in the agreement interval of more than 95%. The device thus provides accurate metabolic measurements and offers an effective tool for the field of general health and clinical nutrition support in China.
		                        		
		                        		
		                        		
		                        			Calorimetry, Indirect
		                        			;
		                        		
		                        			Carbon Dioxide/metabolism*
		                        			;
		                        		
		                        			Energy Metabolism
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Oxygen
		                        			;
		                        		
		                        			Oxygen Consumption
		                        			
		                        		
		                        	
7.The near-infrared dye IR-61 restores erectile function in a streptozotocin-induced diabetes model via mitochondrial protection.
Xiao-Feng YUE ; Chong-Xing SHEN ; Jian-Wu WANG ; Lin-Yong DAI ; Qiang FANG ; Lei LONG ; Yi ZHI ; Xue-Ru LI ; Ya-Wei WANG ; Gu-Fang SHEN ; Zu-Juan LIU ; Chun-Meng SHI ; Wei-Bing LI
Asian Journal of Andrology 2021;23(3):249-258
		                        		
		                        			
		                        			This study aimed to evaluate the therapeutic effect of IR-61, a novel mitochondrial heptamethine cyanine dye with antioxidant effects, on diabetes mellitus-induced erectile dysfunction (DMED). Eight-week-old male Sprague-Dawley rats were intraperitoneally injected with streptozotocin (STZ) to induce type 1 diabetes. Eight weeks after STZ injection, all rats were divided into three groups: the control group, DM group, and DM + IR-61 group. In the DM + IR-61 group, the rats were administered IR-61 (1.6 mg kg
		                        		
		                        		
		                        		
		                        	
8.Safety and efficacy of ultrafiltration on heart failure patients with reduced ejection fraction and diuretic resistance: results from a single-center randomized controlled trial.
Xiang Li SHEN ; Lan LI ; Jun MA ; Bao Jian ZHANG ; Zhen Rong GE ; Xu Zheng LIU ; Li Bi Ya ZU ; Yi HE ; Shu Bin JIANG
Chinese Journal of Cardiology 2021;49(4):340-344
		                        		
		                        			
		                        			Objective: To investigate the safety and efficacy of ultrafiltration on diuretic sensitivity in heart failure patients with reduced ejection fraction and diuretic resistance. Methods: This was a single-center randomized controlled trial. A total of 148 heart failure patients with reduced ejection fraction admitted to the Hospital of Traditional Chinese Medicine of Xinjiang Uygur Autonomous Region from June 2010 to June 2020 were enrolled in this study, and these patients were randomly divided (ratio 1:1) into the ultrafiltration group (n=74) and the control group (n=74). All patients were treated with diuretics, cardiotonic, vasodilator and other comprehensive drugs according to relevant guidelines. After grouping, the patients in the control group were treated with standard treatment plan, while patients in the ultrafiltration group were treated with ultrafiltration on top of standard therapy. Diuretic drugs were discontinued during ultrafiltration, and intravenously furosemide (40 mg) was given immediately and 24 hours after the end of ultrafiltration. Clinical data including gender, age, complicated diseases, New York Heart Association (NYHA) function classification, etc. were collected. Effectiveness indicators include urine volume (the first 12-hour and 24-hour urine volume and the second 24-hour urine volume after using diuretic), body weight and dyspnea severity score. Safety indicators include systolic blood pressure, serum creatinine, serum Na+ concentration, blood K+ concentration and the number of deaths before and after intervention. Results: Two patients in the control group died due to worsening heart failure after randomization and were excluded in this study, 146 patients were finally analyzed (72 patients in the control group and 74 patients in the ultrafiltration group). There were 93 males, and the age was (68.3±11.2) years. There was no significant difference between patients in the ultrafiltration group and the control group in gender, age, body weight, course of disease, dyspnea severity score, NYHA function classification Ⅲ/Ⅳ, the proportion of patients with severe edema of both lower limbs, the proportion of patients with complicated diseases, and basic medication (all P>0.05). After using diuretics, the urine volume of the first 12-hour and 24-hour and the second 24-hour were significantly higher in the ultrafiltration group than in the control group (all P<0.05). Body weight decreased significantly after ultrafiltration treatment as compared with that before intervention in the ultrafiltration group (P<0.05). Compared with the control group, the dyspnea severity score was significantly improved in the ultrafiltration group (P<0.05). There was no significant difference in systolic blood pressure, serum creatinine, serum Na+ concentration, blood K+ concentration of patients between ultrafiltration group and control group before and after intervention (all P>0.05). During the clinical diagnosis and treatment, 2 male patients in the control group died, and the cause of death was aggravation of basic diseases complicated with acute heart failure and cardiogenic shock. There was no death in the ultrafiltration group, and there were no obvious clinical adverse events during and after ultrafiltration. Conclusion: Ultrafiltration therapy is safe and can improve diuretic sensitivity in heart failure patients with reduced ejection fraction and diuretic resistance.
		                        		
		                        		
		                        		
		                        			Aged
		                        			;
		                        		
		                        			Diuretics/therapeutic use*
		                        			;
		                        		
		                        			Furosemide/therapeutic use*
		                        			;
		                        		
		                        			Heart Failure/drug therapy*
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Male
		                        			;
		                        		
		                        			Middle Aged
		                        			;
		                        		
		                        			Stroke Volume
		                        			;
		                        		
		                        			Ultrafiltration
		                        			
		                        		
		                        	
9. Bioch A inhibits LPS-induced microglial activation through estrogen receptors and its mechanism
Meng-Qing LIU ; Yang-Yang WU ; Jun-Hui HAN ; Yi-Gui YU ; Wen-Ning WU ; Wei-Zu LI ; Yan-Yan YIN ; Han-Qing CHEN
Chinese Pharmacological Bulletin 2021;37(6):809-814
		                        		
		                        			
		                        			 Aim To investigate whether the effect of biochanin A (biochanin, Bioch A) on LPS-induced microglia activation can be inhibited by estrogen receptor. Methods The BV2 cells were divided into: Control group, LPS group (10 mg · L 
		                        		
		                        		
		                        		
		                        	
10.Effect and Mechanism of Qixian Tongluo Prescription on Neural Function Recovery in Patients with Cerebral Infarction
Xiu-hui LIN ; Zhi-min WU ; Yi-ru WANG ; Fang LIU
Chinese Journal of Experimental Traditional Medical Formulae 2021;27(23):118-124
		                        		
		                        			
		                        			Objective:To investigate the effect of Qixian Tongluo prescription on neural function recovery in patients with cerebral infarction and its mechanism. Method:A total of 100 inpatients (January to June,2020)with cerebral infarction in the Neurology Department of Wenzhou Hospital of Traditional Chinese Medicine were assigned to an experimental group (
		                        		
		                        	
            
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