1.Machine learning-based prediction of orthokeratology therapeutic outcomes in pediatric patients
Jinju CONG ; Zhimin ZHOU ; Hui SUN
International Eye Science 2026;26(8):1496-1500
AIM: To explore the application value of machine learning models in predicting the myopia control efficacy of orthokeratology(OK)in pediatric population, and analyze the key factors affecting axial length(AL)elongation.METHODS: This retrospective study included myopic subjects aged 8-17 y who were fitted with OK lenses and completed a 6 mo follow-up between January 1, 2021 and December 1, 2023. Baseline demographic and ocular biometric parameters were collected, including age, eye laterality, cycloplegic refraction, corneal curvature(K1 and K2)and AL. AL change(ΔAL)at 6 mo after lens wearing was defined as the primary outcome. Four machine learning models—decision tree, random forest, extreme gradient boosting(XGBoost), and neural network—were developed to predict treatment efficacy, and their predictive performance was compared. Multiple linear regression analysis was performed to identify relevant factors associated with ΔAL.RESULTS: A total of 102 myopic patients(159 eyes)aged 8-17 y were included in this study, including 57 bilateral eyes and 45 unilateral cases. Among them, 56 were boys(54.9%)and 46 were girls(45.1%). The mean age was 11.98±1.93 y. At baseline, the mean spherical error was -2.28±1.37 D, the mean cylindrical power was -0.65±0.36 D, and AL was 24.60±0.82 mm, the mean flat keratometry(K1)was 42.55±1.39 D, and the mean steep keratometry(K2)was 43.58±1.44 D.After 6 mo of lens wear, the AL increased to 24.68±0.59 mm, The mean spherical power was -2.45±1.46 D, the cylindrical power was -0.68±0.38 D, the K1 value was 42.52±1.33 D, and the K2 value was 43.61±1.51 D. The mean ΔAL was 0.08±0.17 mm.The performance comparison of four machine learning models in predicting the efficacy of OK on AL control showed that the decision tree model achieved the best predictive performance(MAE=0.11, MSE=0.02, R2=0.44). Feature importance analysis indicated that age, baseline AL and K1 were the top three predictors. Multiple linear regression showed that age was negatively associated with ΔAL(β=-0.03, P<0.001), while other variables were not significantly associated(all P>0.05).CONCLUSION: Machine learning models can effectively predict the efficacy of OK in controlling axial elongation in children. The decision tree model shows the best performance. Age is a key factor affecting the therapeutic effect of OK, while baseline AL and corneal curvature also contribute to prediction.This study provides new data support for individualized myopia prevention and control strategies in the pediatric population.
2.Identification and cluster analysis of non-O1/O139 Vibrio cholerae by MALDI-TOF MS
Maosuo XU ; Hui ZHANG ; Cong ZHOU ; Chunmei SHEN ; Yong LIN
Chinese Journal of Clinical Laboratory Science 2025;43(3):161-166
Objective To identify and cluster non-O1/O139 Vibrio cholerae(NOVC)using matrix-assisted laser desorption/ionization time-of-flight mass spectrometry(MALDI-TOF MS),and evaluate the feasibility of MALDI-TOF MS as a method for the identification and clustering of NOVC.Methods The NOVC was identified by the MALDI-TOF MS equipped with V5 database,V12 database,highly pathogenic bacteria database,and V5 database combined with self-built spectrum projection and analyzed by the principal com-ponent analysis(PCA)and main spectrum projection(MSP)clustering.Results The NOVC was incorrectly identified as Vibrio al-bensis by the MALDI-TOF MS equipped with V5 database or V12 database,while the MALDI-TOF MS equipped with highly pathogenic bacteria database or V5 database combined with self-built spectrum projection could correctly identify NOVC.The PCA clustering of MALDI-TOF MS could distinguish NOVC from other bacterial strains and refine the differentiation of NOVC species to show the dis-tance relationship between NOVC species.Some spectrum projections of NOVC were extremely similar to the reference strains used to establish the database,and MSP clustering could not distinguish the differences between NOVC species.Conclusion The identifica-tion ability of MALDI-TOF MS for NOVC is limited by its database.The MALDI-TOF MS equipped with highly pathogenic bacteria da-tabase or V5 database combined with the self-built spectrum projection can accurately identify NOVC.The PCA clustering of MALDI-TOF MS has certain reference significance for the intra-and inter-species identification and homology analysis of NOVC.
3.Identification and cluster analysis of non-O1/O139 Vibrio cholerae by MALDI-TOF MS
Maosuo XU ; Hui ZHANG ; Cong ZHOU ; Chunmei SHEN ; Yong LIN
Chinese Journal of Clinical Laboratory Science 2025;43(3):161-166
Objective To identify and cluster non-O1/O139 Vibrio cholerae(NOVC)using matrix-assisted laser desorption/ionization time-of-flight mass spectrometry(MALDI-TOF MS),and evaluate the feasibility of MALDI-TOF MS as a method for the identification and clustering of NOVC.Methods The NOVC was identified by the MALDI-TOF MS equipped with V5 database,V12 database,highly pathogenic bacteria database,and V5 database combined with self-built spectrum projection and analyzed by the principal com-ponent analysis(PCA)and main spectrum projection(MSP)clustering.Results The NOVC was incorrectly identified as Vibrio al-bensis by the MALDI-TOF MS equipped with V5 database or V12 database,while the MALDI-TOF MS equipped with highly pathogenic bacteria database or V5 database combined with self-built spectrum projection could correctly identify NOVC.The PCA clustering of MALDI-TOF MS could distinguish NOVC from other bacterial strains and refine the differentiation of NOVC species to show the dis-tance relationship between NOVC species.Some spectrum projections of NOVC were extremely similar to the reference strains used to establish the database,and MSP clustering could not distinguish the differences between NOVC species.Conclusion The identifica-tion ability of MALDI-TOF MS for NOVC is limited by its database.The MALDI-TOF MS equipped with highly pathogenic bacteria da-tabase or V5 database combined with the self-built spectrum projection can accurately identify NOVC.The PCA clustering of MALDI-TOF MS has certain reference significance for the intra-and inter-species identification and homology analysis of NOVC.
4.Identification of Mycobacterium abscessus subsp.abscessus and subsp.massiliense based on MALDI-TOF MS and analysis for their characteristics
Xueya QIN ; Yong LIN ; Cong ZHOU ; Hui ZHANG ; Maosuo XU
Chinese Journal of Clinical Laboratory Science 2025;43(2):81-87
Objective To perform the identification at the subspecies-level of Mycobacterium abscessus(M.abscessus)and analyze its characteristics based on matrix-assisted laser desorption ionization time-of-flight mass spectrometry(MALDI-TOF MS).Methods Bi-otyper software was used to construct the predicted peak spectrum of M.abscessus subsp.abscessus and M.abscessus subsp.massiliense.The predicted peak spectrum was constructed with expected maximum peak value number of 70 and peak frequency of 100%in the ex-perimental group and control group,respectively.A blind test was performed on 31 strains of M.abscessus that were not used to con-struct predictive peak spectra to evaluate the identification efficiency of predictive peak spectra.FlexAnalysis software was used to sum-marize and analyze the list of mass spectral peak value of M.abscessus,and screen the specific peaks in mass spectra of different sub-species of M.abscessus.The principal component analysis(PCA)algorithm was used to perform the cluster analysis for the data from mass spectrometry of M.abscessus,and explore the feasibility of PCA clustering in distinguishing the subspecies of M.abscessus.Results In the experimental group,96.8%(30/31)of the strains were correctly identified,and one strain of M.abscessus subsp.massiliense with rough colony form was mistakenly identified as M.abscessus subsp.abscessus.In control group,77.4%(24/31)of the strains were correctly identified,but 7 strains of M.abscessus subsp.massiliense were incorrectly identified or unable to be identified.The identification efficiency in the experimental group was significantly better than that in the control group with statistical difference(X2=5.167,P=0.026).M.abscessus subsp.abscessus exhibited three specific peaks(m/z 4 001.67,4 386.81 and 4 963.17),and M.abscessus subsp.massiliense also exhibited three specific peaks(m/z 4 950.48,4 381.78 and 5 214.90).In the PCA 3D scatter plot,the data points of M.abscessus subsp.abscessus and M.abscessus subsp.massiliense were relatively dispersed without obvious clus-tering.The PC A dendrograph could be divided into six branches in which only four branches were composed of a single subspecies.The minimum level value of distance between M.abscessus subsp.abscessus and M.abscessus subsp.massiliense was about 0.1.Conclusion The predicted peak spectrum based on MALDI-TOF MS with the expected maximum peak number of 70 could accurately identify M.abscessus at the subspecies level.The specific peak of mass spectrometry method in this study should be feasible to distinguish the subspecies of M.abscessus subsp.abscessus and the subspecies of M.abscessus subsp.Massiliense,but PCA cluster analysis cannot be used as a means to distinguish M.abscessus subsp.abscessus from M.abscessus subsp.massiliense.
5.Identification of Mycobacterium abscessus subsp.abscessus and subsp.massiliense based on MALDI-TOF MS and analysis for their characteristics
Xueya QIN ; Yong LIN ; Cong ZHOU ; Hui ZHANG ; Maosuo XU
Chinese Journal of Clinical Laboratory Science 2025;43(2):81-87
Objective To perform the identification at the subspecies-level of Mycobacterium abscessus(M.abscessus)and analyze its characteristics based on matrix-assisted laser desorption ionization time-of-flight mass spectrometry(MALDI-TOF MS).Methods Bi-otyper software was used to construct the predicted peak spectrum of M.abscessus subsp.abscessus and M.abscessus subsp.massiliense.The predicted peak spectrum was constructed with expected maximum peak value number of 70 and peak frequency of 100%in the ex-perimental group and control group,respectively.A blind test was performed on 31 strains of M.abscessus that were not used to con-struct predictive peak spectra to evaluate the identification efficiency of predictive peak spectra.FlexAnalysis software was used to sum-marize and analyze the list of mass spectral peak value of M.abscessus,and screen the specific peaks in mass spectra of different sub-species of M.abscessus.The principal component analysis(PCA)algorithm was used to perform the cluster analysis for the data from mass spectrometry of M.abscessus,and explore the feasibility of PCA clustering in distinguishing the subspecies of M.abscessus.Results In the experimental group,96.8%(30/31)of the strains were correctly identified,and one strain of M.abscessus subsp.massiliense with rough colony form was mistakenly identified as M.abscessus subsp.abscessus.In control group,77.4%(24/31)of the strains were correctly identified,but 7 strains of M.abscessus subsp.massiliense were incorrectly identified or unable to be identified.The identification efficiency in the experimental group was significantly better than that in the control group with statistical difference(X2=5.167,P=0.026).M.abscessus subsp.abscessus exhibited three specific peaks(m/z 4 001.67,4 386.81 and 4 963.17),and M.abscessus subsp.massiliense also exhibited three specific peaks(m/z 4 950.48,4 381.78 and 5 214.90).In the PCA 3D scatter plot,the data points of M.abscessus subsp.abscessus and M.abscessus subsp.massiliense were relatively dispersed without obvious clus-tering.The PC A dendrograph could be divided into six branches in which only four branches were composed of a single subspecies.The minimum level value of distance between M.abscessus subsp.abscessus and M.abscessus subsp.massiliense was about 0.1.Conclusion The predicted peak spectrum based on MALDI-TOF MS with the expected maximum peak number of 70 could accurately identify M.abscessus at the subspecies level.The specific peak of mass spectrometry method in this study should be feasible to distinguish the subspecies of M.abscessus subsp.abscessus and the subspecies of M.abscessus subsp.Massiliense,but PCA cluster analysis cannot be used as a means to distinguish M.abscessus subsp.abscessus from M.abscessus subsp.massiliense.
6.Effects of human umbilical cord-derived mesenchymal stem cell therapy for cavernous nerve injury-induced erectile dysfunction in the rat model.
Wei WANG ; Ying LIU ; Zi-Hao ZHOU ; Kun PANG ; Jing-Kai WANG ; Peng-Fei HUAN ; Jing-Ru LU ; Tao ZHU ; Zuo-Bin ZHU ; Cong-Hui HAN
Asian Journal of Andrology 2025;27(4):508-515
Stem cell treatment may enhance erectile dysfunction (ED) in individuals with cavernous nerve injury (CNI). Nevertheless, no investigations have directly ascertained the implications of varying amounts of human umbilical cord-derived mesenchymal stem cells (HUC-MSCs) on ED. We compare the efficacy of three various doses of HUC-MSCs as a therapeutic strategy for ED. Sprague-Dawley rats (total = 175) were randomly allocated into five groups. A total of 35 rats underwent sham surgery and 140 rats endured bilateral CNI and were treated with vehicles or doses of HUC-MSCs (1 × 10 6 cells, 5 × 10 6 cells, and 1 × 10 7 cells in 0.1 ml, respectively). Penile tissues were harvested for histological analysis on 1 day, 3 days, 7 days, 14 days, 28 days, 60 days, and 90 days postsurgery. It was found that varying dosages of HUC-MSCs enhanced the erectile function of rats with bilateral CNI and ED. Moreover, there was no significant disparity in the effectiveness of various dosages of HUC-MSCs. However, the expression of endothelial markers (rat endothelial cell antigen-1 [RECA-1] and endothelial nitric oxide synthase [eNOS]), smooth muscle markers (alpha smooth muscle actin [α-SMA] and desmin), and neural markers (neurofilament [RECA-1] and neurogenic nitric oxide synthase [nNOS]) increased significantly with prolonged treatment time. Masson's staining demonstrated an increased in the smooth muscle cell (SMC)/collagen ratio. Significant changes were detected in the microstructures of various types of cells. In vivo imaging system (IVIS) analysis showed that at the 1 st day, the HUC-MSCs implanted moved to the site of damage. Additionally, the oxidative stress levels were dramatically reduced in the penises of rats administered with HUC-MSCs.
Male
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Animals
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Erectile Dysfunction/metabolism*
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Rats, Sprague-Dawley
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Mesenchymal Stem Cell Transplantation/methods*
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Rats
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Penis/pathology*
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Humans
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Disease Models, Animal
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Umbilical Cord/cytology*
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Peripheral Nerve Injuries/complications*
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Mesenchymal Stem Cells
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Nitric Oxide Synthase Type III/metabolism*
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Actins/metabolism*
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Nitric Oxide Synthase Type I/metabolism*
7.Effects of laparoscopic transabdominal preperitoneal repair and Lichtenstein surgery on post-operative early pain and mobility in patients with inguinal hernia
Cong TONG ; Xi CHEN ; Zheqi ZHOU ; Hui WANG ; Xiaolong ZHANG ; Xu ZHAO ; Likun YAN
Chinese Journal of Digestive Surgery 2024;23(12):1530-1537
Objective:To investigate the effects of laparoscopic transabdominal preperitoneal repair (TAPP) and Lichtenstein surgery on postoperative early pain and mobility in patients with inguinal hernia.Methods:The retrospective cohort study was conducted. The clinical data of 184 pati-ents with unilateral inguinal hernia who were admitted to Shaanxi Provincial People's Hospital from June 2021 to December 2022 were collected. There were 152 males and 32 females, aged (64±8)years. Of the 184 patients, 92 cases undergoing TAPP were divided into the TAPP group, and 92 cases under-going Lichtenstein surgery were divided into the Lichtenstein group. Observation indicators: (1) surgical situations; (2) postoperative pain; (3) postoperative mobility. Comparison of measurement data with normal distribution between groups was conducted using the independent sample t test. Paired sample t test was used for comparison within group before and after surgery. Comparison of measurement data with skewed distribution between groups was conducted using the Mann-Whitney U test. Comparison of count data between groups was conducted using the chi-square test. Results:(1) Surgical situations. Total duration of hospital stay, duration of postoperative hospital stay, expense of hospitalization were 1.70(1.00,2.00)days, 1.00(1.00,1.00)days, 14 808(14 385,15 292)yuan in the TAPP group, versus 2.12(2.00,3.00)days, 1.42(1.00,2.00)days, 10 590(9802,11 362)yuan in the Lichtenstein group, showing significant differences in the above indicators between the two groups ( Z=-3.23, -4.07, -11.72, P<0.05). (2) Postoperative pain. Score of verbal rating scale (VRS) were 1.36±0.75 and 3.22±0.66 before surgery and at 20-22 hours after surgery in the TAPP group, versus 1.34±0.80 and 3.42±0.80 in the Lichtenstein group, showing significant differences within the two groups ( t=-29.15, -31.46, P<0.05). (3) Postoperative mobility. The time from getting up to standing bedside of patients before surgery and at 20-22 hours after surgery were (5.47±1.08)seconds and (7.94±2.23)seconds in the TAPP group, versus (5.87±1.13)seconds and (11.59±1.88)seconds in the Lichtenstein group, showing a significant difference at 20-22 hours after surgery between the two groups and significant differences within the two groups ( t=-11.99, -15.64, -27.26, P<0.05). The time for hip flexion 90° of patients before surgery and at 20-22 hours after surgery were (0.74±0.32)seconds and (1.23±0.54)seconds in the TAPP group, versus (0.81±0.19)seconds and (1.97±0.69)seconds in the Lichtenstein group, showing a significant difference at 20-22 hours after surgery between the two groups and significant differences within the two groups ( t=-8.11, -16.53, -17.81, P<0.05). The time for walking 10 meters of patients before surgery and at 20-22 hours after surgery were (10.30±1.53)seconds and (12.80±1.67)seconds in the TAPP group, versus (10.38±1.35)seconds and (18.35±1.69)seconds in the Lichtenstein group, showing a significant difference at 20-22 hours after surgery between the two groups and significant differences within the two groups ( t=-22.44, -33.66, -32.46, P<0.05). The time for walking 20 meters of patients before surgery and at 20-22 hours after surgery were (17.87±2.89)seconds and (24.16±2.54)seconds in the TAPP group, versus (18.02±2.82)seconds and (32.64±2.56)seconds in the Lichtenstein group, showing a significant difference at 20-22 hours after surgery between the two groups and significant differences within the two groups ( t=-22.55, -38.75, -34.59, P<0.05). Conclusion:Compared to Lichtenstein surgery, patients with TAPP experience faster recovery of mobility, earlier discharge, and higher expense of hospitalization.
8.Effects of laparoscopic transabdominal preperitoneal repair and Lichtenstein surgery on post-operative early pain and mobility in patients with inguinal hernia
Cong TONG ; Xi CHEN ; Zheqi ZHOU ; Hui WANG ; Xiaolong ZHANG ; Xu ZHAO ; Likun YAN
Chinese Journal of Digestive Surgery 2024;23(12):1530-1537
Objective:To investigate the effects of laparoscopic transabdominal preperitoneal repair (TAPP) and Lichtenstein surgery on postoperative early pain and mobility in patients with inguinal hernia.Methods:The retrospective cohort study was conducted. The clinical data of 184 pati-ents with unilateral inguinal hernia who were admitted to Shaanxi Provincial People's Hospital from June 2021 to December 2022 were collected. There were 152 males and 32 females, aged (64±8)years. Of the 184 patients, 92 cases undergoing TAPP were divided into the TAPP group, and 92 cases under-going Lichtenstein surgery were divided into the Lichtenstein group. Observation indicators: (1) surgical situations; (2) postoperative pain; (3) postoperative mobility. Comparison of measurement data with normal distribution between groups was conducted using the independent sample t test. Paired sample t test was used for comparison within group before and after surgery. Comparison of measurement data with skewed distribution between groups was conducted using the Mann-Whitney U test. Comparison of count data between groups was conducted using the chi-square test. Results:(1) Surgical situations. Total duration of hospital stay, duration of postoperative hospital stay, expense of hospitalization were 1.70(1.00,2.00)days, 1.00(1.00,1.00)days, 14 808(14 385,15 292)yuan in the TAPP group, versus 2.12(2.00,3.00)days, 1.42(1.00,2.00)days, 10 590(9802,11 362)yuan in the Lichtenstein group, showing significant differences in the above indicators between the two groups ( Z=-3.23, -4.07, -11.72, P<0.05). (2) Postoperative pain. Score of verbal rating scale (VRS) were 1.36±0.75 and 3.22±0.66 before surgery and at 20-22 hours after surgery in the TAPP group, versus 1.34±0.80 and 3.42±0.80 in the Lichtenstein group, showing significant differences within the two groups ( t=-29.15, -31.46, P<0.05). (3) Postoperative mobility. The time from getting up to standing bedside of patients before surgery and at 20-22 hours after surgery were (5.47±1.08)seconds and (7.94±2.23)seconds in the TAPP group, versus (5.87±1.13)seconds and (11.59±1.88)seconds in the Lichtenstein group, showing a significant difference at 20-22 hours after surgery between the two groups and significant differences within the two groups ( t=-11.99, -15.64, -27.26, P<0.05). The time for hip flexion 90° of patients before surgery and at 20-22 hours after surgery were (0.74±0.32)seconds and (1.23±0.54)seconds in the TAPP group, versus (0.81±0.19)seconds and (1.97±0.69)seconds in the Lichtenstein group, showing a significant difference at 20-22 hours after surgery between the two groups and significant differences within the two groups ( t=-8.11, -16.53, -17.81, P<0.05). The time for walking 10 meters of patients before surgery and at 20-22 hours after surgery were (10.30±1.53)seconds and (12.80±1.67)seconds in the TAPP group, versus (10.38±1.35)seconds and (18.35±1.69)seconds in the Lichtenstein group, showing a significant difference at 20-22 hours after surgery between the two groups and significant differences within the two groups ( t=-22.44, -33.66, -32.46, P<0.05). The time for walking 20 meters of patients before surgery and at 20-22 hours after surgery were (17.87±2.89)seconds and (24.16±2.54)seconds in the TAPP group, versus (18.02±2.82)seconds and (32.64±2.56)seconds in the Lichtenstein group, showing a significant difference at 20-22 hours after surgery between the two groups and significant differences within the two groups ( t=-22.55, -38.75, -34.59, P<0.05). Conclusion:Compared to Lichtenstein surgery, patients with TAPP experience faster recovery of mobility, earlier discharge, and higher expense of hospitalization.
9.Investigation and control of a pseudo-outbreak of suspected Mycobacterium abscessus infection due to contamination of fiberbronchoscope in department of pulmonary and critical care medicine
Hui-Fang ZHOU ; Yan-Ling LIANG ; Jin-Zhou WEI ; Cong HE ; Hui-Qing LU ; Qing-Song ZHANG ; Zhong-Sheng WEI
Chinese Journal of Infection Control 2024;23(9):1167-1172
Objective To investigate a suspected outbreak event of Mycobacterium abscessus(Mab)infection in department of pulmonary and critical care medicine in a hospital,provide basis for the precise prevention and control of healthcare-associated infection(HAI).Methods On-site epidemiological investigation and environmental hygienic detection were carried out in patients with Mab infection following fiberbronchoscopic bronchoalveolar lavage in the department of pulmonary and critical care medicine in this hospital,and targeted intervention measures were pro-posed.Results From September 7 to October 20,2022,a total of 344 cases of bronchoalveolar lavage were per-formed for patients in fiberbronchoscopy room of department of pulmonary and critical care medicine.Mab was de-tected from bronchoalveolar lavage fluid(BALF)of 10 patients.Through on-site and follow-up investigation,the initial case was defined as community-associated infection,and the other 9 cases were due to the contamination of specimens.A total of 33 environmental hygienic specimens were collected,and no Mab was detected.The event was effectively controlled after standardizing the process of bronchoscope decontamination,strengthening the infection management of ward and bronchoscopy room,and strictly implementing the certificate system of bronchoscopy de-contamination personnel.Conclusion This pseudo-outbreak is due to the contamination of fiberbronchoscope by Mab.Timely identifying risk factors as well as taking targeted prevention and control measures can effectively con-trol the spread and prevalence of Mab infection.
10.Efficacy and safety of recombinant human anti-SARS-CoV-2 monoclonal antibody injection(F61 injection)in the treatment of patients with COVID-19 combined with renal damage:a randomized controlled exploratory clinical study
Ding-Hua CHEN ; Chao-Fan LI ; Yue NIU ; Li ZHANG ; Yong WANG ; Zhe FENG ; Han-Yu ZHU ; Jian-Hui ZHOU ; Zhe-Yi DONG ; Shu-Wei DUAN ; Hong WANG ; Meng-Jie HUANG ; Yuan-Da WANG ; Shuo-Yuan CONG ; Sai PAN ; Jing ZHOU ; Xue-Feng SUN ; Guang-Yan CAI ; Ping LI ; Xiang-Mei CHEN
Chinese Journal of Infection Control 2024;23(3):257-264
Objective To explore the efficacy and safety of recombinant human anti-severe acute respiratory syn-drome coronavirus 2(anti-SARS-CoV-2)monoclonal antibody injection(F61 injection)in the treatment of patients with coronavirus disease 2019(COVID-19)combined with renal damage.Methods Patients with COVID-19 and renal damage who visited the PLA General Hospital from January to February 2023 were selected.Subjects were randomly divided into two groups.Control group was treated with conventional anti-COVID-19 therapy,while trial group was treated with conventional anti-COVID-19 therapy combined with F61 injection.A 15-day follow-up was conducted after drug administration.Clinical symptoms,laboratory tests,electrocardiogram,and chest CT of pa-tients were performed to analyze the efficacy and safety of F61 injection.Results Twelve subjects(7 in trial group and 5 in control group)were included in study.Neither group had any clinical progression or death cases.The ave-rage time for negative conversion of nucleic acid of SARS-CoV-2 in control group and trial group were 3.2 days and 1.57 days(P=0.046),respectively.The scores of COVID-19 related target symptom in the trial group on the 3rd and 5th day after medication were both lower than those of the control group(both P<0.05).According to the clinical staging and World Health Organization 10-point graded disease progression scale,both groups of subjects improved but didn't show statistical differences(P>0.05).For safety,trial group didn't present any infusion-re-lated adverse event.Subjects in both groups demonstrated varying degrees of elevated blood glucose,elevated urine glucose,elevated urobilinogen,positive urine casts,and cardiac arrhythmia,but the differences were not statistica-lly significant(all P>0.05).Conclusion F61 injection has initially demonstrated safety and clinical benefit in trea-ting patients with COVID-19 combined with renal damage.As the domestically produced drug,it has good clinical accessibility and may provide more options for clinical practice.

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