1.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.
2.Influence of curative-intent resection with textbook outcomes on long-term prognosis of gall-bladder carcinoma: a national multicenter study
Zhipeng LIU ; Zimu LI ; Yule LUO ; Xiaolin ZHAO ; Jie BAI ; Yan JIANG ; Yunfeng LI ; Chao YU ; Fan HUANG ; Zhaoping WU ; Jinxue ZHOU ; Dalong YIN ; Rui DING ; Wei GUO ; Yi ZHU ; Wei CHEN ; Kecan LIN ; Ping YUE ; Yao CHENG ; Haisu DAI ; Dong ZHANG ; Zhiyu CHEN
Chinese Journal of Digestive Surgery 2024;23(7):926-933
Objective:To investigate the influence of curative-intent resection with textbook outcomes of liver surgery (TOLS) on long-term prognosis of gallbladder carcinoma (GBC).Methods:The retrospective cohort study was conducted. The clinicopathological data of 824 patients with GBC in the national multicenter database of Biliary Surgery Group of Elite Group of Chinese Journal of Digestive Surgery, who were admitted to 15 medical centers from January 2014 to January 2021, were collected. There were 285 males and 539 females, aged (62±11)years. According to the evalua-tion criteria of TOLS, patients were divided into those who achieved TOLS and those who did not achieve TOLS. Measurement data with normal distribution were represented as Mean± SD, and com-parison between groups was conducted using the independent sample t test. Measurement data with skewed distribution were represented as M( Q1, Q3), and comparison between groups was conducted using the Mann-Whitney U test. Count data were described as absolute numbers, and comparison between groups was conducted using the chi-square test. Comparison of ordinal data were conduc-ted using the Mann-Whitney U test. The Kaplan-Meier method was used to calculate survival rate and draw survival curve, and the Log-rank test was used for survival analysis. The COX stepwise regression model with backward Wald method was used for univariate and multivariate analyses. Results:(1) Achievement of TOLS. Of the 824 patients undergoing curative-intent resection for GBC, there were 510 cases achieving TOLS and 314 cases not achieving TOLS. (2) Follow-up. Of the 824 patients undergoing curative-intent resection for GBC, after excluding 112 deaths within 90 days after discharge, 712 cases were included for the survival analysis. The median follow-up time, median overall survival time and 5-year overall survival rate of the 510 patients achieving TOLS were 22.1(11.4,30.1)months, 47.6(30.6,64.6)months and 47.5%. The median follow-up time, median overall survival time and 5-year overall survival rate of the 202 patients not achieving TOLS were 14.0(6.8,25.5)months, 24.3(20.0,28.6)months and 21.0%. There was a significant difference in overall survival between patients achieving TOLS and patients not achieving TOLS ( χ2=58.491, P<0.05). (3) Analysis of factors influencing prognosis of patients. Results of multivariate analysis showed that TOLS, carcinoembryonic antigen (CEA), CA19-9, poorly differentiation of tumor, T2 stage of eighth edition of American Joint Committee on Cancer (AJCC) staging, T3 and T4 stage of eighth edition of AJCC staging, N1 stage of the eighth edition of AJCC staging, N2 stage of the eighth edition of AJCC staging, adjuvant therapy were independent factors influencing overall survival time of patients undergoing curative-intent resection for GBC ( hazard ratio=0.452, 1.479, 1.373, 1.612, 1.455, 1.481, 1.835, 1.978, 0.538, 95% c onfidence interval as 0.352-0.581, 1.141-1.964, 1.052-1.791, 1.259-2.063, 1.102-1.920, 1.022-2.147, 1.380-2.441, 1.342-2.915, 0.382-0.758, P<0.05). Conclusion:Patients under-going curative-intent resection for GBC with TOLS can achieve better long-term prognosis.
3.Expert consensus on the evaluation and rehabilitation management of shoulder syndrome after neek dissection for oral and maxillofacial malignancies
Jiacun LI ; Moyi SUN ; Jiaojie REN ; Wei GUO ; Longjiang LI ; Zhangui TANG ; Guoxin REN ; Zhijun SUN ; Jian MENG ; Wei SHANG ; Shaoyan LIU ; Jie ZHANG ; Jicheng LI ; Yue HE ; Chunjie LI ; Kai YANG ; Zhongcheng GONG ; Qing XI ; Bing HAN ; Huaming MAI ; Yanping CHEN ; Jie ZHANG ; Yadong WU ; Chao LI ; Changming AN ; Chuanzheng SUN ; Hua YUAN ; Fan YANG ; Haiguang YUAN ; Dandong WU ; Shuai FAN ; Fei LI ; Chao XU ; Wei WEI
Journal of Practical Stomatology 2024;40(5):597-607
Neck dissection(ND)is one of the main treatment methods for oral and maxillofacial malignancies.Although ND type is in con-stant improvement,but intraoperative peal-pull-push injury of the accessory nerve,muscle,muscle membrane,fascia and ligament induced shoulder syndrome(SS)is still a common postoperative complication,combined with the influence of radiochemotherapy,not only can cause pain,stiffness,numbness,limited dysfunction of shoulder neck and arm,but also may have serious impact on patient's life quality and phys-ical and mental health.At present,there is still a lack of a systematic evaluation and rehabilitation management program for postoperative SS of oral and maxillofacial malignant tumors.Based on the previous clinical practice and the current available evidence,refer to the relevant lit-erature at home and abroad,the experts in the field of maxillofacial tumor surgery and rehabilitation were invited to discuss,modify and reach a consenusus on the etiology,assessment diagnosis,differential diagnosis,rehabilitation strategy and prevention of SS,in order to provide clinical reference.
4.The measurement of critical quality attributes of Tongren niuhuang qingxin pills based on MIF-HEMT biosensor technology
Chao-fu MA ; Zi-jian WANG ; Li-juan MA ; Xiao-yan HU ; Yu-nan WEI ; Xiao-meng ZHANG ; Xin-yu GUO ; Xing-yue HUAN ; Jing ZHAO ; Jin-fan XU ; Nan LI ; Zhi-bin WANG ; Jing DU ; Zhi-sheng WU
Acta Pharmaceutica Sinica 2023;58(10):2853-2861
There is still a serious challenge of the measurement of critical quality attributes (CQAs) related to clinical efficacy for Chinese materia medica manufacturing. To overcome this challenge, an integrated strategy of biosensor and ultra-performance liquid chromatography/tandem mass spectrometry (UPLC-MS/MS) was proposed using Tongren niuhuang qingxin pills as a trial. Firstly, an original biosensor was created using a semiconductor chip material high electron mobility transistor (HEMT) as the transducer and the macrophage migration inhibitory factor (MIF) as the identification element. By this MIF-HEMT biosensor, the efficacy on stoke of different components from Tongren niuhuang qingxin pills was measured. It was clear that all three components of Tongren niuhuang qingxin pills had strong therapeutic effects on stroke, especially the section A, the
5.Influencing factors of textbook outcomes in liver surgery after radical resection of gallbladder carcinoma: a national multicenter study
Zhipeng LIU ; Xuelei LI ; Haisu DAI ; Weiyue CHEN ; Yuhan XIA ; Wei WANG ; Xianghao YE ; Zhihua LONG ; Yi ZHU ; Fan HUANG ; Chao YU ; Zhaoping WU ; Jinxue ZHOU ; Dong ZHANG ; Rui DING ; Wei CHEN ; Kecan LIN ; Yao CHENG ; Ping YUE ; Yunfeng LI ; Tian YANG ; Jie BAI ; Yan JIANG ; Wei GUO ; Dalong YIN ; Zhiyu CHEN
Chinese Journal of Digestive Surgery 2023;22(7):866-872
Objective:To investigate the influencing factors of textbook outcomes in liver surgery (TOLS) after radical resection of gallbladder carcinoma.Methods:The retrospective case-control study was conducted. The clinicopathological data of 530 patients who underwent radical resection of gallbladder carcinoma in 15 medical centers, including the First Affiliated Hospital of Army Medical University et al, from January 2014 to January 2020 were collected. There were 209 males and 321 females, aged (61±10)years. Patients underwent radical resection of gallbladder carcinoma, including cholecystectomy, hepatectomy, invasive bile duct resection, and lymph node dissection. Observation indicators: (1) situations of TOLS; (2) influencing factors of TOLS. Measure-ment data with normal distribution were represented as Mean± SD, and comparison between groups was conducted using the independent sample t test. Measurement data with skewed distribution were represented as M( Q1, Q3), and comparison between groups was conducted using the Mann-Whitney U test. Count data were described as absolute numbers or percentages, and comparison between groups was conducted using the chi-square test. Comparison of ordinal data between groups was conducted using the Mann-Whitney U test. The univariate analysis was conducted using the corresponding statistical methods based on data type, and variables with P<0.10 were included in multivariate analysis. Multivariate analysis was conducted using the Logistic stepwise regression model. Results:(1) Situations of TOLS. All 530 patients underwent radical resection of gallbladder carcinoma, and there were 498 cases achieving R 0 resection, 508 cases without ≥grade 2 intra-operative adverse events, 456 cases without postoperative grade B and grade C biliary leakage, 513 cases without postoperative grade B and grade C liver failure, 395 cases without severe com-plications within postoperative 90 days, 501 cases did not being re-admission caused by severe com-plications within postoperative 90 days. Of the 530 patients, 54.53%(289/530) of patients achieved postoperative TOLS, while 45.47%(241/530) of patients did not achieve postoperative TOLS. (2) Influencing factors of TOLS. Results of multivariate analysis showed that American Society of Anesthesiologists classification >grade Ⅱ, preoperative jaundice, T staging as T3?T4 stage, N staging as N2 stage, liver resection as right hemi-hepatectomy, and neoadjuvant therapy were independent factors influencing TOLS in patients undergoing radical resection of gallbladder carcinoma ( odds ratio=2.65, 1.87, 5.67, 5.65, 2.55, 3.34, 95% confidence interval as 1.22?5.72, 1.18?2.95, 2.51?12.82, 2.83?11.27, 1.41?4.63, 1.88?5.92, P<0.05). Conclusion:American Society of Anesthesiologists classification >grade Ⅱ, preoperative jaundice, T staging as T3?T4 stage, N staging as N2 stage, liver resection as right hemi-hepatectomy, and neoadjuvant therapy are independent factors influencing TOLS in patients undergoing radical resection of gallbladder carcinoma.
6.Associations between NLRP3 Levels and Coronary Artery Disease Risk: Mendelian Randomized Study
Jun-yue YANG ; Si-yu FAN ; Ying-chao TAN ; Hong ZHI ; Li-na WANG
Journal of Sun Yat-sen University(Medical Sciences) 2022;43(1):133-139
ObjectiveUsing the Mendelian randomization (MR) study design to infer the causal relationship between NLRP3 levels and the risk of CAD. MethodsTotally 321 CAD cases confirmed by coronary angiography(CAG) and 293 normal controls were included in this MR study. Serum NLRP3 levels of all the subjects were determined by ELISA. The polymorphism of NLRP3 gene rs10754558 (C/G) was detected by RFLP-PCR and it was considered as the instrumental variable (Ⅳ) to evaluate the causal relationship between NLRP3 levels and CAD risks. Logistic regression analysis and Linear regression analysis were used to test the association between genotype-phenotype, genotype-disease outcome, and then MR method was used to infer the causal relationship between NLRP3 and CAD risks. ResultsThe association between the NLRP3 gene rs10754558(C/G) variant and the risk of CAD and the level of NLRP3 were statistically significant. The regression coefficients βZY = 0.45 and βZX = 2.34 respectively. The regression coefficient βXY = βZY/βZX = 0.45/2.34 = 0.19, and then it was transformed into OR value (OR=e0.19=1.209), which meant subjects with the 1 ng/mL increased of NLRP3 level had the 20.9% increased risk of CAD. And also, the traditional case-control study of the NLRP3 levels and CAD risks showed that the subjects with the 1 ng/mL increased of NLRP3 levels were associated with 3.1% increased CAD risk (βXY=0.03, OR=e0.03=1.031, 95%CI=1.003-1.058), which was a little bit lower than that of MR result. ConclusionsThe inflammasome NLRP3 levels were associated with the increased risk of CAD in a mendelian randomization study and it might be a robust evidence than that of the traditional association study.
7.Guideline for postoperative rehabilitation treatment following vertebral augmentation for osteoporotic vertebral compression fracture (version 2022)
Zhengwei XU ; Dingjun HAO ; Liming CHENG ; Baorong HE ; Bohua CHEN ; Chen CHEN ; Fei CHE ; Jian CHEN ; Qixin CHEN ; Liangjie DU ; Shunwu FAN ; Zhong FANG ; Shiqing FENG ; Yanzheng GAO ; Haishan GUAN ; Zhong GUAN ; Hua JIANG ; Weimin JIANG ; Dianming JIANG ; Jun JIANG ; Yue JIANG ; Lijun HE ; Yuan HE ; Bo LI ; Tao LI ; Jianjun LI ; Xigong LI ; Yijian LIANG ; Bin LIN ; Bin LIU ; Bo LIU ; Yong LIU ; Zhibin LIU ; Xuhua LU ; Chao MA ; Lie QIAN ; Renfu QUAN ; Hongxun SANG ; Haibo SHEN ; Jun SHU ; Honghui SUN ; Tiansheng SUN ; Jun TAN ; Mingxing TANG ; Sheng TAO ; Honglin TENG ; Yun TIAN ; Jiwei TIAN ; Qiang WANG ; Xinwei WANG ; Jianhuang WU ; Peigen XIE ; Weihong XU ; Bin YAN ; Yong YANG ; Guoyong YIN ; Xiaobing YU ; Yuhong ZENG ; Guoqing ZHANG ; Xiaobo ZHANG ; Jie ZHAO ; Yue ZHU
Chinese Journal of Trauma 2022;38(11):961-972
Osteoporotic vertebral compression fracture (OVCF) can lead to lower back pain and may be even accompanied by scoliosis, neurological dysfunction and other complications, which will affect the daily activities and life quality of patients. Vertebral augmentation is an effective treatment method for OVCF, but it cannot correct unbalance of bone metabolism or improve the osteoporotic status, causing complications like lower back pain, limited spinal activities and vertebral refracture. The post-operative systematic and standardized rehabilitation treatments can improve curative effect and therapeutic efficacy of anti-osteoporosis, reduce risk of vertebral refracture, increase patient compliance and improve quality of life. Since there still lack relevant clinical treatment guidelines for postoperative rehabilitation treatments following vertebral augmentation for OVCF, the current treatments are varied with uneven therapeutic effect. In order to standardize the postoperative rehabilitation treatment, the Spine Trauma Group of the Orthopedic Branch of Chinese Medical Doctor Association organized relevant experts to refer to relevant literature and develop the "Guideline for postoperative rehabilitation treatment following vertebral augmentation for osteoporotic vertebral compression fracture (2022 version)" based on the clinical guidelines published by the American Academy of Orthopedic Surgeons (AAOS) as well as on the principles of scientificity, practicality and advancement. The guideline provided evidence-based recommendations on 10 important issues related to postoperative rehabilitation treatments of OVCF.
8.Improving native human sperm freezing protection by using a modified vitrification method.
Dai ZHOU ; Xing-Ming WANG ; Rui-Xue LI ; Yi-Ze WANG ; Yuan-Chi CHAO ; Zhi-Zhong LIU ; Zeng-Hui HUANG ; Hong-Chuan NIE ; Wen-Bing ZHU ; Yue-Qiu TAN ; Li-Qing FAN
Asian Journal of Andrology 2021;23(1):91-96
Slow freezing is the most commonly used technique for the cryopreservation of spermatozoa in clinical practice. However, it has been shown to have a negative impact on sperm function and structure. Vitrification as a successful alternative method has been proved to have better protective effects on human embryos, but vitrification of spermatozoa is still subject to low recovery rates. In this study, a modified vitrification method for native spermatozoa was developed. A total of 28 semen samples were included; each sample was divided into three equal parts and assigned to fresh, slow freezing, and vitrification groups. Sperm vitality, motility, morphology, DNA integrity, and acrosome reaction were assessed for each of the groups. The results showed that vitrification achieves better results for several sperm protection parameters than slow freezing; vitrification achieves a higher recovery rate (P < 0.05), motility (P <0.05), morphology (P <0.05), and curve line velocity (P <0.05) than slow freezing. Furthermore, DNA fragmentation was decreased (P <0.05) and better acrosome protection (P <0.05) was exhibited in the spermatozoa after vitrification. Principal component analysis of all sperm parameters revealed that the vitrification cluster was closer to the fresh cluster, indicating that spermatozoa are better preserved through vitrification. In conclusion, while both slow freezing and vitrification have negative effects on sperm function and structure, the vitrification protocol described here had a relatively better recovery rate (65.8%) and showed improved preservation of several sperm quality parameters compared with slow freezing.
9.Clinical Recommendations for Perioperative Immunotherapy-induced Adverse Events in Patients with Non-small Cell Lung Cancer.
Jun NI ; Miao HUANG ; Li ZHANG ; Nan WU ; Chunxue BAI ; Liang'an CHEN ; Jun LIANG ; Qian LIU ; Jie WANG ; Yilong WU ; Fengchun ZHANG ; Shuyang ZHANG ; Chun CHEN ; Jun CHEN ; Wentao FANG ; Shugeng GAO ; Jian HU ; Tao JIANG ; Shanqing LI ; Hecheng LI ; Yongde LIAO ; Yang LIU ; Deruo LIU ; Hongxu LIU ; Jianyang LIU ; Lunxu LIU ; Mengzhao WANG ; Changli WANG ; Fan YANG ; Yue YANG ; Lanjun ZHANG ; Xiuyi ZHI ; Wenzhao ZHONG ; Yuzhou GUAN ; Xiaoxiao GUO ; Chunxia HE ; Shaolei LI ; Yue LI ; Naixin LIANG ; Fangliang LU ; Chao LV ; Wei LV ; Xiaoyan SI ; Fengwei TAN ; Hanping WANG ; Jiangshan WANG ; Shi YAN ; Huaxia YANG ; Huijuan ZHU ; Junling ZHUANG ; Minglei ZHUO
Chinese Journal of Lung Cancer 2021;24(3):141-160
BACKGROUND:
Perioperative treatment has become an increasingly important aspect of the management of patients with non-small cell lung cancer (NSCLC). Small-scale clinical studies performed in recent years have shown improvements in the major pathological remission rate after neoadjuvant therapy, suggesting that it will soon become an important part of NSCLC treatment. Nevertheless, neoadjuvant immunotherapy may be accompanied by serious adverse reactions that lead to delay or cancelation of surgery, additional illness, and even death, and have therefore attracted much attention. The purpose of the clinical recommendations is to form a diagnosis and treatment plan suitable for the current domestic medical situation for the immune-related adverse event (irAE).
METHODS:
This recommendation is composed of experts in thoracic surgery, oncologists, thoracic medicine and irAE related departments (gastroenterology, respirology, cardiology, infectious medicine, hematology, endocrinology, rheumatology, neurology, dermatology, emergency section) to jointly complete the formulation. Experts make full reference to the irAE guidelines, large-scale clinical research data published by thoracic surgery, and the clinical experience of domestic doctors and publicly published cases, and repeated discussions in multiple disciplines to form this recommendation for perioperative irAE.
RESULTS:
This clinical recommendation covers the whole process of prevention, evaluation, examination, treatment and monitoring related to irAE, so as to guide the clinical work comprehensively and effectively.
CONCLUSIONS
Perioperative irAE management is an important part of immune perioperative treatment of lung cancer. With the continuous development of immune perioperative treatment, more research is needed in the future to optimize the diagnosis and treatment of perioperative irAE.
10.Effects on Elbow Stability of the Terrible Triad Using Medial Collateral Ligament Repair and Ulnar Coronoid Process Fixation
Xinbin FAN ; Chao SONG ; Zhihong DING ; Liang WU ; Wenchao ZHOU ; Gang FENG ; Yue LIU ; Dece KONG ; Tieyi YANG ; Yan ZHANG
Journal of Medical Biomechanics 2020;35(5):E540-E545
Objective To investigate the effect of medial collateral ligament (MCL) repair and coronoid process fracture fixation on stability of the Terrible Triad of the elbow. Methods CT and MRI scan images of elbow joints from one healthy 28-year-old male volunteer were used to establish three elbow models. Model A: normal model. Model B: repair of coronoid process fractures, without MCL repair. Model C: repair of MCL, without repair of ulnar coronoid processes. Longitudinal loads were applied on the three models to analyze the displacement and stress distributions of the elbow joint under different working conditions and compare the stability of the elbow joint. Results The displacement and stress distributions of the three models were similar. The maximum displacement and maximum stress of the articular surface were located at the ulna pulley notch, while the minimum displacement was located at the coronoid process and its medial side. The minimum stress was located at the lower lateral side of the coronoid process. There were no statistical differences in the maximum displacement and stress among the three models (P>0.05). Conclusions When the lateral column is stable, the effect of repairing the MCL and fixing the fracture block of ulnar coronoid process is similar.

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