1.Alanine transferase test results and exploration of threshold adjustment strategies for blood donors in Shenzhen, China
Xin ZHENG ; Yuanye XUE ; Haobiao WANG ; Litiao WU ; Ran LI ; Yingnan DANG ; Tingting CHEN ; Xiaoxuan XU ; Xuezhen ZENG ; Jinfeng ZENG
Chinese Journal of Blood Transfusion 2025;38(4):488-494
[Objective] To conduct a retrospective statistical comparison of alanine aminotransferase (ALT) test values in blood donors prior to blood collection, aiming to analyze the objective characteristics of the population with elevated ALT levels (ALT>50 U/L) and provide reference data for adjusting the screening eligibility threshold for ALT. [Methods] The preliminary ALT screening data of 30 341 blood donor samples collected prior to blood donation from three smart blood donation sites at the Shenzhen Blood Center between 2022 and 2023 were extracted and compared with data from a health examination department of a tertiary hospital in Shenzhen (representing the general population, n=24 906). Both datasets were categorized and statistically described. A retrospective analysis was conducted to examine the associations between ALT test results and factors such as donors' gender, age, ethnicity, donation site, donation season, and frequency of blood donation. [Results] The ALT levels in both blood donors and the general population were non-normally distributed. The 95th percentile of ALT values was calculated as 61.4 U/L (male: 67.8 U/L, female: 39.3 U/L) for blood donors and 58.1 U/L (male: 63.7 U/L, female: 51.2 U/L) for the general population. The non-compliance rates (ALT>50 U/L) were 7.65% (2 321/30 341) in blood donors and 7.08% (1 763/24 906) in the general population. There were significant differences (P<0.05) in the ALT failure rate among blood donors based on gender, age, and donation site, but no significant differences (P>0.05) during the blood donation season. There was no statistically significant difference (P>0.05) in the positive rates of four serological markers (HBsAg, anti HCV, HIV Ag/Ab, anti TP) for blood screening pathogens between ALT unqualified and qualified individuals (2.05% vs 1.5%). If the ALT qualification threshold was raised from 50 U/L to 90 U/L, the non qualification rates of male and female blood donors would decrease from 9.82% (2 074/21 125) to 2.23% (471/21 125) and from 2.70% (249/9 216) to 0.75% (69/9 216), respectively. Among the 154 blood donors who donated blood more than 3 times, 88.31% of the 248 ALT test results were in the range of 50-90 U/L. Among them, 9 cases had ALT>130 U/L, and ALT was converted to qualified in subsequent blood donations. [Conclusion] There are differences in the ALT failure rate among blood donors of different genders and ages, and different blood donation sites and operators can also affect the ALT detection values of blood donors. The vast majority of blood donors with ALT failure are caused by transient and non pathological factors. With the widespread use of blood virus nucleic acid testing, appropriately increasing the ALT qualification threshold for blood donors can expand the qualified population and alleviate the shortage of blood sources, and the risk of blood safety will not increase.
2.Analysis of abnormal ALT in blood donors in five Zang autonomous prefectures of Qinghai Province, China: characteristics and screening strategies
Yingnan DANG ; ; Rong TANG ; Liqin HUANG ; Hailin WU ; Tingting CHEN ; Shengju LI ; Yanli SUN ; Xin ZHENG ; Yanxia LI ; Xianlin YE ; Jinfeng ZENG
Chinese Journal of Blood Transfusion 2025;38(4):502-507
[Objective] To investigate the factors associated with alanine aminotransferase (ALT) abnormalities in multi-ethnic blood donors across five Zang autonomous prefectures in the plateau regions of Qinghai Province, and to provide evidence for ensuring blood safety and formulating screening strategies. [Methods] A retrospective analysis was performed on the ALT abnormal test results of blood donors in the Zang autonomous prefectures of Qinghai from 2022 to 2024. The correlations between ALT levels and factors including gender, age, altitude, and infectious markers were investigated. [Results] The overall ALT unqualified rate among blood donors in this region was 9.01%. Significant differences in ALT levels were observed across genders and age groups (P<0.05). Variations in ALT abnormality rates were also noted among different plateau regions (P<0.05). Overall, ALT values exhibited an increasing trend with rising altitude. The average ALT unqualified rates were 11.19% in Zang donors, 7.96% in Han donors, and 4.79% in donors from other ethnic groups (P<0.05). No statistically significant association was observed between ALT abnormality and the presence of HBV/HCV infectious markers (P>0.05). [Conclusion] In the plateau areas of Qinghai, multi-ethnic blood donors have a relatively high ALT levels and ALT unqualified rates, showing distinct regional characteristics. ALT elevation in voluntary blood donors is related to non-pathological factors such as gender, age, and dietary habits, but not to infectious indicators.
3.A ten-year retrospective analysis of HCV infection among blood donors in Qinghai province
Yingnan DANG ; Shengju LI ; Yanxia LI ; Hailin WU ; Shiyu WANG ; Chenglin MA ; Xianlin YE
Chinese Journal of Blood Transfusion 2025;38(11):1562-1566
Objective: To retrospectively analyze the prevalence of hepatitis C virus (HCV) infection among voluntary blood donors in Qinghai Province over a ten-year period and to provide evidence for refining blood safety screening strategies. Methods: Blood samples from 362 066 blood donors in Qinghai collected between January 2015 and April 2024 were simultaneously screened using enzyme-linked immunosorbent assay (ELISA) and nucleic acid testing (NAT). Follow-up was conducted for donors with reactive HCV RNA screening results, and alanine transaminase (ALT) was detected by rate method. Results: The HCV positive rate among blood donors in Qinghai was 0.22%. Gender, marital status, number of blood donations, and educational level were associated with HCV infection. Significant differences in HCV positive rates were observed among donors across regions and ethnic groups. The HCV positive rate among donors in Golog Tibetan Autonomous Prefecture (with an average altitude of 4 330 m) was significantly higher than that in Xining (0.52% vs 0.21%, P<0.001). Positivity rates were also significantly higher in Salar (0.84%), Hui (0.81%), Zang (0.60%), and Tu (0.45%) ethnic groups compared to the Han ethnic group (0.17%) (P<0.001). The abnormal rate of ALT in HCV-positive donors was higher than in non-HCV donors (6.13% vs 1.55%) (P<0.001). Conclusion: The relatively high HCV positivity rate among blood donors in Qinghai highlights the need for further investigation into viral sources, risk factors, and transmission routes. Optimized screening strategies are essential to ensure blood safety.
4.Value of using ultrasound features to improve the Ovarian-Adnexal Image Reporting and Data System Category 4 in the benign-malignant differential diagnosis of ovarian-adnexal masses
Lei WU ; Yingnan WU ; Jing ZHAO ; Liping GONG ; Shuang ZHANG ; Jiawei TIAN ; Zhirong HE ; Litao SUN
Chinese Journal of Ultrasonography 2025;34(3):232-238
Objective:To explore the value of ultrasound features modified version 2022 of the Ovarian-Adnexal Imaging Reporting and Data System(O-RADS)Category 4 in the differential diagnosis of benign and malignant ovarian-adnexal tumors.Methods:Retrospective analysis was conducted in 501 cases with ovarian masses classified into 4 categories according to the 2022 version of O-RADS who were collected from 4 clinical centers[the Second Afliated Hospital of Harbin Medical University(188 cases),Zhejiang Provincial People's Hospital(146 cases),Sichuan Provincial Maternity and Child Health Care Hospital(90 cases),and Fuling Hospital of Chongqing University(77 cases)]from January 2018 to July 2024 with concomitant surgical resection.The 424 cases from 3 of the clinical centers(the Second Hospital of Harbin Medical University,Zhejiang Provincial People's Hospital,and Sichuan Maternal and Child Health Hospital)were randomly divided into a training group(339 cases)and an internal validation group(85 cases)according to an 8∶2 randomization,while the cases from the other clinical center(Fuling Hospital of Chongqing University)were selected as the external validation group(77 cases),and the pathological diagnosis was used as the “gold standard”.Univariate and multifactorial logistic regression analyses were performed on the ultrasound characteristics of the training group to screen the independent predictors associated with ovarian carcinogenesis,and to formulate the stratification rules for the 4 types of masses in O-RADS. The ROC curve of this stratification method was plotted and the area under the curve(AUC)was calculated,and it was validated in the internal validation group and the external validation group;and the diagnostic accuracy was compared with that of the 2022 version of O-RADS.Results:Univariate logistic analysis showed that cysts with solid components,≥ 4 papillary projections,smooth inner wall of the cyst,color flow score ≥ 3 points,and acoustic shadowing were independent predictors of ovarian cancer(all P < 0.05);while multifactorial logistic analysis showed that cysts with a solid component and a color flow score ≥3 points were independent risk factors of ovarian cancer(all P < 0.05),and smooth cyst walls and acoustic shadows were independent protective factors(all P < 0.05).The diagnostic accuracies of the modified training group,internal validation group,and external validation group were 73.7%,68.2%,70.1%,respectively,which were significantly higher than the diagnostic accuracies of the 2022 version of the O-RADS(38.9%,37.6%,33.8%)(all P < 0.05).The diagnostic sensitivity,specificity and AUC of the training group were 0.871,0.652,0.762,respectively,while the internal validation group were 0.844,0.585,0.714,and 0.846,0.627,0.737 in the external validation group. Conclusions:Improvement of the 2022 version of O-RADS category 4 using ultrasound features may improve the identification of benign and malignant ovarian-adnexal tumors.
5.Effect of threshold inspiratory muscle training on pulmonary rehabilitation in postoperative lung cancer patients:a meta-analysis
Yingnan ZHAO ; Xintong ZHENG ; Junling LIU ; Zidan WANG ; Hongyue WU ; Bing LI ; Yan LI
Chinese Journal of Rehabilitation Theory and Practice 2025;31(10):1164-1171
Objective To systematically evaluate the effect of threshold inspiratory muscle training on pulmonary rehabilitation in postoperative lung cancer patients,with a focus on exploring the difference in efficacy under different interven-tion modes.Methods Randomized controlled trials on the effect of threshold inspiratory muscle training on pulmonary rehabilitation in postoperative lung cancer patients were retrieved from PubMed,Cochrane Library,Embase,Web of Science,CNKI,Wanfang data,VIP and China Biomedical Literature Database.Meanwhile,gray literature from ProQuest and clinicaltrials.gov was searched as supplements.The retrieval period was from the establishment of each data-base to May 9,2025.Cochrane 5.1.0 was used to evaluate the quality of literature,and a meta-analysis was per-formed using RevMan 5.4.Results Twelve studies involving 701 patients were included,all of which were of moderate to high quality.Threshold inspiratory muscle training could reduce the pulmonary complications of postoperative lung cancer patients(OR=0.45,95%CI 0.29 to 0.68,P<0.001),shorten the hospital stay(MD=-1.85,95%CI-3.29 to-0.42,P=0.010),improve the inspiratory muscle strength(MD=5.84,95%CI 0.96 to 10.71,P=0.020),enhance their ex-ercise endurance(SMD=0.40,95%CI 0.10 to 0.71,P=0.010),and did not increase the risk of pulmonary air leakage(OR=0.88,95%CI 0.47 to 1.63,P=0.680).Subgroup analysis revealed that shortening of hospital stay(MD=-2.98,95%CI-5.87 to-0.09,P=0.040)and the improvement in exercise endurance(SMD=0.57,95%CI 0.14 to 1.00,P=0.009)were significant only when threshold inspiratory muscle training was combined with aerobic exercise.However,standalone threshold inspiratory muscle training showed no statistical signifi-cance in these two outcomes.Conclusion Threshold inspiratory muscle training can effectively reduce postoperative pulmonary complications and im-prove inspiratory muscle strength in postoperative lung cancer patients with good safety.Threshold inspiratory muscle training could shorten hospital stay and improve exercise endurance only when combining with aerobic exercise.
6.Effect of threshold inspiratory muscle training on pulmonary rehabilitation in postoperative lung cancer patients:a meta-analysis
Yingnan ZHAO ; Xintong ZHENG ; Junling LIU ; Zidan WANG ; Hongyue WU ; Bing LI ; Yan LI
Chinese Journal of Rehabilitation Theory and Practice 2025;31(10):1164-1171
Objective To systematically evaluate the effect of threshold inspiratory muscle training on pulmonary rehabilitation in postoperative lung cancer patients,with a focus on exploring the difference in efficacy under different interven-tion modes.Methods Randomized controlled trials on the effect of threshold inspiratory muscle training on pulmonary rehabilitation in postoperative lung cancer patients were retrieved from PubMed,Cochrane Library,Embase,Web of Science,CNKI,Wanfang data,VIP and China Biomedical Literature Database.Meanwhile,gray literature from ProQuest and clinicaltrials.gov was searched as supplements.The retrieval period was from the establishment of each data-base to May 9,2025.Cochrane 5.1.0 was used to evaluate the quality of literature,and a meta-analysis was per-formed using RevMan 5.4.Results Twelve studies involving 701 patients were included,all of which were of moderate to high quality.Threshold inspiratory muscle training could reduce the pulmonary complications of postoperative lung cancer patients(OR=0.45,95%CI 0.29 to 0.68,P<0.001),shorten the hospital stay(MD=-1.85,95%CI-3.29 to-0.42,P=0.010),improve the inspiratory muscle strength(MD=5.84,95%CI 0.96 to 10.71,P=0.020),enhance their ex-ercise endurance(SMD=0.40,95%CI 0.10 to 0.71,P=0.010),and did not increase the risk of pulmonary air leakage(OR=0.88,95%CI 0.47 to 1.63,P=0.680).Subgroup analysis revealed that shortening of hospital stay(MD=-2.98,95%CI-5.87 to-0.09,P=0.040)and the improvement in exercise endurance(SMD=0.57,95%CI 0.14 to 1.00,P=0.009)were significant only when threshold inspiratory muscle training was combined with aerobic exercise.However,standalone threshold inspiratory muscle training showed no statistical signifi-cance in these two outcomes.Conclusion Threshold inspiratory muscle training can effectively reduce postoperative pulmonary complications and im-prove inspiratory muscle strength in postoperative lung cancer patients with good safety.Threshold inspiratory muscle training could shorten hospital stay and improve exercise endurance only when combining with aerobic exercise.
7.Value of using ultrasound features to improve the Ovarian-Adnexal Image Reporting and Data System Category 4 in the benign-malignant differential diagnosis of ovarian-adnexal masses
Lei WU ; Yingnan WU ; Jing ZHAO ; Liping GONG ; Shuang ZHANG ; Jiawei TIAN ; Zhirong HE ; Litao SUN
Chinese Journal of Ultrasonography 2025;34(3):232-238
Objective:To explore the value of ultrasound features modified version 2022 of the Ovarian-Adnexal Imaging Reporting and Data System(O-RADS)Category 4 in the differential diagnosis of benign and malignant ovarian-adnexal tumors.Methods:Retrospective analysis was conducted in 501 cases with ovarian masses classified into 4 categories according to the 2022 version of O-RADS who were collected from 4 clinical centers[the Second Afliated Hospital of Harbin Medical University(188 cases),Zhejiang Provincial People's Hospital(146 cases),Sichuan Provincial Maternity and Child Health Care Hospital(90 cases),and Fuling Hospital of Chongqing University(77 cases)]from January 2018 to July 2024 with concomitant surgical resection.The 424 cases from 3 of the clinical centers(the Second Hospital of Harbin Medical University,Zhejiang Provincial People's Hospital,and Sichuan Maternal and Child Health Hospital)were randomly divided into a training group(339 cases)and an internal validation group(85 cases)according to an 8∶2 randomization,while the cases from the other clinical center(Fuling Hospital of Chongqing University)were selected as the external validation group(77 cases),and the pathological diagnosis was used as the “gold standard”.Univariate and multifactorial logistic regression analyses were performed on the ultrasound characteristics of the training group to screen the independent predictors associated with ovarian carcinogenesis,and to formulate the stratification rules for the 4 types of masses in O-RADS. The ROC curve of this stratification method was plotted and the area under the curve(AUC)was calculated,and it was validated in the internal validation group and the external validation group;and the diagnostic accuracy was compared with that of the 2022 version of O-RADS.Results:Univariate logistic analysis showed that cysts with solid components,≥ 4 papillary projections,smooth inner wall of the cyst,color flow score ≥ 3 points,and acoustic shadowing were independent predictors of ovarian cancer(all P < 0.05);while multifactorial logistic analysis showed that cysts with a solid component and a color flow score ≥3 points were independent risk factors of ovarian cancer(all P < 0.05),and smooth cyst walls and acoustic shadows were independent protective factors(all P < 0.05).The diagnostic accuracies of the modified training group,internal validation group,and external validation group were 73.7%,68.2%,70.1%,respectively,which were significantly higher than the diagnostic accuracies of the 2022 version of the O-RADS(38.9%,37.6%,33.8%)(all P < 0.05).The diagnostic sensitivity,specificity and AUC of the training group were 0.871,0.652,0.762,respectively,while the internal validation group were 0.844,0.585,0.714,and 0.846,0.627,0.737 in the external validation group. Conclusions:Improvement of the 2022 version of O-RADS category 4 using ultrasound features may improve the identification of benign and malignant ovarian-adnexal tumors.
8.Preparation of human SET8 monoclonal antibody and its effect on hepatocellular carcinoma cell proliferation,apoptosis,and cell cycle
Yingnan WANG ; Jianhua WU ; Chensi WU ; Fengbin ZHANG ; Ruixing ZHANG ; Zhanjun GUO
Chinese Journal of Comparative Medicine 2024;34(12):70-76
Objective To prepare human SET8 monoclonal antibody and explore its effects on the proliferation,apoptosis,and cell cycle of hepatoma cells,and to evaluate its anti-tumor effect in mouse models of hepatocellular carcinoma.Methods We immunized mice with human SET8 polypeptide fragment and screened and fused B cells and myeloma cells to establish a hybridoma cell line that stably secreted SET8 monoclonal antibody.Production was expanded by intraperitoneal injection into mice and the collection and purification of ascites.We investigated the effects of SET8 monoclonal antibody on the proliferation,apoptosis,cell cycle,and apoptosis-related protein expression of hepatocellular carcinoma cells by CCK-8,flow cytometry,and Western blot,respectively.Finally,we constructed a mouse model of human hepatocellular carcinoma by cell transplantation to evaluate the inhibitory effect of SET8 monoclonal antibody on tumor growth in vivo.Results Human SET8 monoclonal antibody significantly inhibited the viability of Huh-7 and Mahlavu hepatoma cells at concentrations of 50 and 100 μg/mL,in a concentration-dependent manner(P<0.05).Flow cytometry analysis showed that SET8 monoclonal antibody,paclitaxel,and their combination significantly increased the apoptosis rate of Mahlavu cells compared with the blank control group,with the combination group having the greatest effect(P<0.05).SET8 monoclonal antibody also induced Mahlavu cell cycle arrest in S and G2 phases and reduced G1 phase cells.Western blot analysis showed that the monoclonal antibody increased the expression of the apoptosis-related proteins Bax and Caspase-3(P<0.05).SET8 monoclonal antibody,alone or in combination with paclitaxel,also effectively inhibited the proliferation of hepatocellular carcinoma cells in nude mice,with the combination therapy having the most significant effect(P<0.05).Conclusions The prepared human SET8 monoclonal antibody effectively inhibited the proliferation and promoted the apoptosis of hepatocellular carcinoma cells,and showed good anti-tumor effects in mice.
9.First-in-human Results of the Novel Transcatheter Mitral Valve Repair System for Severe Mitral Regurgitation
Zhi-Nan LU ; Yutong KE ; Yingnan BIAN ; Jing HE ; Wenhui WU ; Xinmin LIU ; Yang LI ; Ran LIU ; Taiyang LUO ; Xunan GUO ; Guangyuan SONG
Cardiology Discovery 2024;04(2):148-159
Objective::To evaluate the feasibility, safety, and effectiveness of a novel edge-to-edge mitral valve repair system (the NovoClasp system) in patients with severe mitral regurgitation.Methods::In this prospective, single-arm, first-in-human study conducted at Beijing Anzhen Hospital, data were collected from patients undergoing transcatheter edge-to-edge repair using the NovoClasp system. The study candidates were patients exhibiting a mitral regurgitation severity of 3+ or more and were at high-risk or contraindicated for surgical intervention. Technical success and device success according to the Mitral Valve Academic Research Consortium definitions were used as primary outcomes. Other safety and efficacy outcomes were prospectively assessed at device implantation, discharge, and 30 d, 6 months, and 12 months post-procedure.Results::Between October 1, 2021, and January 31, 2022, 11 patients were treated for moderate-to-severe (grade 3+) or severe (grade 4+) mitral regurgitation using the NovoClasp system. All patients had a baseline New York Heart Association functional class of III-IV, with 7/11 exhibiting complex mitral valve disease. All patients achieved the primary endpoints of technical and device success, with a post-operative 30-d mitral regurgitation grade reduction to 2+ or lower, which was maintained at 12 months. One patient had minor bleeding and hematoma at the access site before discharge, and 2 patients were readmitted due to fast atrial fibrillation within 12 months post-discharge. No additional cases of death, adverse cerebral or cardiovascular events, or device-related complications was observed during the follow-up.Conclusion::This study suggested the potential feasibility and safety of the NovoClasp system, showing a promising technical and device success rate, along with a decrease in mitral regurgitation severity. A further pivotal study is needed to assess the procedural and long-term outcomes.
10.First-in-human Results of the Novel Transcatheter Mitral Valve Repair System for Severe Mitral Regurgitation
Zhi-Nan LU ; Yutong KE ; Yingnan BIAN ; Jing HE ; Wenhui WU ; Xinmin LIU ; Yang LI ; Ran LIU ; Taiyang LUO ; Xunan GUO ; Guangyuan SONG
Cardiology Discovery 2024;04(2):148-159
Objective::To evaluate the feasibility, safety, and effectiveness of a novel edge-to-edge mitral valve repair system (the NovoClasp system) in patients with severe mitral regurgitation.Methods::In this prospective, single-arm, first-in-human study conducted at Beijing Anzhen Hospital, data were collected from patients undergoing transcatheter edge-to-edge repair using the NovoClasp system. The study candidates were patients exhibiting a mitral regurgitation severity of 3+ or more and were at high-risk or contraindicated for surgical intervention. Technical success and device success according to the Mitral Valve Academic Research Consortium definitions were used as primary outcomes. Other safety and efficacy outcomes were prospectively assessed at device implantation, discharge, and 30 d, 6 months, and 12 months post-procedure.Results::Between October 1, 2021, and January 31, 2022, 11 patients were treated for moderate-to-severe (grade 3+) or severe (grade 4+) mitral regurgitation using the NovoClasp system. All patients had a baseline New York Heart Association functional class of III-IV, with 7/11 exhibiting complex mitral valve disease. All patients achieved the primary endpoints of technical and device success, with a post-operative 30-d mitral regurgitation grade reduction to 2+ or lower, which was maintained at 12 months. One patient had minor bleeding and hematoma at the access site before discharge, and 2 patients were readmitted due to fast atrial fibrillation within 12 months post-discharge. No additional cases of death, adverse cerebral or cardiovascular events, or device-related complications was observed during the follow-up.Conclusion::This study suggested the potential feasibility and safety of the NovoClasp system, showing a promising technical and device success rate, along with a decrease in mitral regurgitation severity. A further pivotal study is needed to assess the procedural and long-term outcomes.

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