1.Establishment and analysis of an early prognosis model of patients with acute kidney injury in intensive care unit
Yu'an GENG ; Congmei WANG ; Zhijing XU ; Lu QI ; Yangang SHI ; Shiqiong SU ; Kai WANG ; Ruifang LIU
Chinese Critical Care Medicine 2024;36(2):178-182
Objective:To establish a predictive model for the progression of acute kidney injury (AKI) to stage 3 AKI (renal failure) in the intensive care unit (ICU), so as to assist physicians to make early and timely decisions on whether to intervene in advance.Methods:A retrospective analysis was conducted. Thirty-eight patients with AKI admitted to the intensive care medicine of the Third People's Hospital of Henan Province from January 2018 to May 2023 were enrolled. Patient data including acute physiology and chronic health evaluation Ⅱ (APACHEⅡ) upon admission, serum creatinine (SCr), blood urea nitrogen (BUN), daily urine output during hospitalization, and the timing of continuous renal replacement therapy (CRRT) intervention were recorded. Based on clinically collected pathological data, standardized creatinine value ratio mean polynomial fitting models were established as the first criterion for judging the progression to stage 3 AKI after data cleansing, screening, and normalization. Additionally, standardized creatinine value ratio index fitting models were established as the second criterion for predicting progression to stage 3 AKI.Results:A total of 38 AKI patients were included, including 25 males and 13 females. The average age was (58.45±12.94) years old. The APACHEⅡ score was 24.13±4.17 at admission. The intervention node was (4.42±0.95) days. Using a dual regression model approach, statistical modeling was performed with a relatively small sample size of statistical data samples, yielding a scatter index non-linear regression model for standardized creatinine value ratio data relative to day " n", with y = 1.246?2 x1.164?9 and an R2 of 0.860?1, indicating reasonable statistical fitting. Additionally, a quadratic non-linear regression model was obtained for the mean standardized creatinine value ratio relative to day " n", with y = -0.260?6 x2+3.010?7 x-1.612 and an R2 of 0.998?9, indicating an excellent statistical fit. For example, using a baseline SCr value of 66 μmol/L for a healthy individual, the dual regression model predicted that the patient would progress to stage 3 AKI within 3-5 days. This prediction was consistent when applied to other early intervention renal injury patients. Conclusion:The established model effectively predicts the time interval of the progression of AKI to stage 3 AKI (renal failure), which assist intensive care physicians to intervene AKI as early as possible to prevent disease progression.
2.Effect and significance of Wenyang Qudu formula on serum inflammatory factors and immune index in patients with severe infections
Zhijing XU ; Congmei WANG ; Yu'an GEN ; Lu QI ; Yangang SHI ; Huiming ZHANG ; Ying ZHANG ; Yihang ZHONG ; Ruifang LIU
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care 2024;31(1):20-23
Objective To explore effect of Wenyang Qudu formula on serum inflammatory factors and immune index in patients with severe infections.Methods A total of 86 severe infection patients admitted to the Third People's Hospital of Henan Province from January to December 2023 were selected as the research subjects.According to the patient file order,odd numbers were the study group,and even numbers were the control group,with 43 cases in each group.The control group was treated with cefoperazone sulbactam sodium,while the study group was treated with Wenyang Qudu formula in addition to the control group[drug composition:Prepared aconite(first decocted)30 g,Poria cocos 30 g,White peony 15 g,Red peony 15 g,Stir fried atractylodes macrocephala 30 g,Dried ginger 9 g,Roasted licorice 9 g,Cassia twig 15 g,Semen lepidii 15 g,Dragon's bone 15 g,Raw oyster 15 g,Codonopsis pilosula 12 g,Angelica sinensis 12 g,Asarum 3 g,Schisandra chinensis 6 g,and Jujube 12 g].Brew in water,and took one dose daily,once in the morning and once in the evening,for a continuous period of 7 days.The differences in the scores of traditional Chinese medicine symptoms such as fever,dyspnea,frequent urination,urgency,and degree of sputum production,serum levels of interleukin-10(IL-10),C-reactive protein(CRP),eosinophils(EOS),and immune function indicators[immunoglobulin E(IgE),CD3+,CD4+,CD8+,CD4+/CD8+]were compared between two groups after treatment,and observed the occurrence of adverse reactions.Results After treatment,the traditional Chinese medicine symptom scores(fever,dyspnea,frequent urination and urgency,degree of sputum production),as well as IL-10,CRP,EOS levels,IgE,and CD8+ were significantly reduced in both groups compared to before treatment,CD3+,CD4+,and CD4+/CD8+ were significantly increased compared to before treatment.In addition,the study group had significantly lower scores of fever,dyspnea,frequent urination and urgency,degree of sputum production,IL-10,CRP,EOS levels,IgE,and CD8+ compared to the control group(fever score:1.36±0.30 vs.2.57±0.46,dyspnea score:1.22±0.31 vs.2.26±0.75,urinary frequency and urgency score:1.30±0.39 vs.2.33±0.82,degree of sputum production:1.19±0.77 vs.2.51±0.85,IL-10(ng/L):9.03±1.67 vs.10.51±2.40,CRP(mg/L):4.68±1.33 vs.7.82±2.53,EOS(×109/L):0.30±0.04 vs.0.46±0.10,IgE(mg/L):104.62±10.73 vs.135.68±14.64,CD8+:0.228±0.016 vs.0.258±0.020,all P<0.05],the levels of CD3+,CD4+,and CD4+/CD8+ were significantly higher than those in the control group(CD3+:0.636±0.044 vs.0.567±0.055,CD4+:0.537±0.054 vs.0.397±0.045,CD4+/CD8+:1.76±0.51 vs.0.55±0.39,all P<0.05].After treatment,it was discovered that the study group had not experienced any adverse reactions,while the control group had 1 case of nausea and vomiting and 1 case of chest tightness.There was no statistically significant difference in the incidence of adverse reactions between the study group and the control group[0(0/43)vs.0.05%(2/43),P>0.05].Conclusion The Wenyang Qudu formula can reduce the serum factor levels of IL-10,CRP,and EOS in critically infected patients,and improve immune function with good safety.
3.QL1604 plus paclitaxel-cisplatin/ carboplatin in patients with recurrent or metastatic cervical cancer:an open-label, single-arm, phase II trial
Cheng FANG ; Yun ZHOU ; Yanling FENG ; Liping HE ; Jinjin YU ; Yuzhi LI ; Mei FENG ; Mei PAN ; Lina ZHAO ; Dihong TANG ; Xiumin LI ; Buzhen TAN ; Ruifang AN ; Xiaohui ZHENG ; Meimei SI ; Baihui ZHANG ; Lingyan LI ; Xiaoyan KANG ; Qi ZHOU ; Jihong LIU
Journal of Gynecologic Oncology 2024;35(6):e77-
Objective:
QL1604 is a highly selective, humanized monoclonal antibody against programmed death protein 1. We assessed the efficacy and safety of QL1604 plus chemotherapy as first-line treatment in patients with advanced cervical cancer.
Methods:
This was a multicenter, open-label, single-arm, phase II study. Patients with advanced cervical cancer and not previously treated with systemic chemotherapy were enrolled to receive QL1604 plus paclitaxel and cisplatin/carboplatin on day 1 of each 21-day cycle for up to 6 cycles, followed by QL1604 maintenance treatment.
Results:
Forty-six patients were enrolled and the median follow-up duration was 16.5 months. An 84.8% of patients had recurrent disease and 13.0% had stage IVB disease. The objective response rate (ORR) per Response Evaluation Criteria in Advanced Solid Tumors (RECIST) v1.1 was 58.7% (27/46). The immune ORR per immune RECIST was 60.9% (28/46).The median duration of response was 9.6 months (95% confidence interval [CI]=5.5–not estimable). The median progression-free survival was 8.1 months (95% CI=5.7–14.0). Fortyfive (97.8%) patients experienced treatment-related adverse events (TRAEs). The most common grade≥3 TRAEs (>30%) were neutrophil count decrease (50.0%), anemia (32.6%), and white blood cell count decrease (30.4%).
Conclusion
QL1604 plus paclitaxel-cisplatin/carboplatin showed promising antitumor activity and manageable safety profile as first-line treatment in patients with advanced cervical cancer. Programmed cell death protein 1 inhibitor plus chemotherapy may be a potential treatment option for the patient population who have contraindications or can’t tolerate bevacizumab, which needs to be further verified in phase III confirmatory study.
4.QL1604 plus paclitaxel-cisplatin/ carboplatin in patients with recurrent or metastatic cervical cancer:an open-label, single-arm, phase II trial
Cheng FANG ; Yun ZHOU ; Yanling FENG ; Liping HE ; Jinjin YU ; Yuzhi LI ; Mei FENG ; Mei PAN ; Lina ZHAO ; Dihong TANG ; Xiumin LI ; Buzhen TAN ; Ruifang AN ; Xiaohui ZHENG ; Meimei SI ; Baihui ZHANG ; Lingyan LI ; Xiaoyan KANG ; Qi ZHOU ; Jihong LIU
Journal of Gynecologic Oncology 2024;35(6):e77-
Objective:
QL1604 is a highly selective, humanized monoclonal antibody against programmed death protein 1. We assessed the efficacy and safety of QL1604 plus chemotherapy as first-line treatment in patients with advanced cervical cancer.
Methods:
This was a multicenter, open-label, single-arm, phase II study. Patients with advanced cervical cancer and not previously treated with systemic chemotherapy were enrolled to receive QL1604 plus paclitaxel and cisplatin/carboplatin on day 1 of each 21-day cycle for up to 6 cycles, followed by QL1604 maintenance treatment.
Results:
Forty-six patients were enrolled and the median follow-up duration was 16.5 months. An 84.8% of patients had recurrent disease and 13.0% had stage IVB disease. The objective response rate (ORR) per Response Evaluation Criteria in Advanced Solid Tumors (RECIST) v1.1 was 58.7% (27/46). The immune ORR per immune RECIST was 60.9% (28/46).The median duration of response was 9.6 months (95% confidence interval [CI]=5.5–not estimable). The median progression-free survival was 8.1 months (95% CI=5.7–14.0). Fortyfive (97.8%) patients experienced treatment-related adverse events (TRAEs). The most common grade≥3 TRAEs (>30%) were neutrophil count decrease (50.0%), anemia (32.6%), and white blood cell count decrease (30.4%).
Conclusion
QL1604 plus paclitaxel-cisplatin/carboplatin showed promising antitumor activity and manageable safety profile as first-line treatment in patients with advanced cervical cancer. Programmed cell death protein 1 inhibitor plus chemotherapy may be a potential treatment option for the patient population who have contraindications or can’t tolerate bevacizumab, which needs to be further verified in phase III confirmatory study.
5.QL1604 plus paclitaxel-cisplatin/ carboplatin in patients with recurrent or metastatic cervical cancer:an open-label, single-arm, phase II trial
Cheng FANG ; Yun ZHOU ; Yanling FENG ; Liping HE ; Jinjin YU ; Yuzhi LI ; Mei FENG ; Mei PAN ; Lina ZHAO ; Dihong TANG ; Xiumin LI ; Buzhen TAN ; Ruifang AN ; Xiaohui ZHENG ; Meimei SI ; Baihui ZHANG ; Lingyan LI ; Xiaoyan KANG ; Qi ZHOU ; Jihong LIU
Journal of Gynecologic Oncology 2024;35(6):e77-
Objective:
QL1604 is a highly selective, humanized monoclonal antibody against programmed death protein 1. We assessed the efficacy and safety of QL1604 plus chemotherapy as first-line treatment in patients with advanced cervical cancer.
Methods:
This was a multicenter, open-label, single-arm, phase II study. Patients with advanced cervical cancer and not previously treated with systemic chemotherapy were enrolled to receive QL1604 plus paclitaxel and cisplatin/carboplatin on day 1 of each 21-day cycle for up to 6 cycles, followed by QL1604 maintenance treatment.
Results:
Forty-six patients were enrolled and the median follow-up duration was 16.5 months. An 84.8% of patients had recurrent disease and 13.0% had stage IVB disease. The objective response rate (ORR) per Response Evaluation Criteria in Advanced Solid Tumors (RECIST) v1.1 was 58.7% (27/46). The immune ORR per immune RECIST was 60.9% (28/46).The median duration of response was 9.6 months (95% confidence interval [CI]=5.5–not estimable). The median progression-free survival was 8.1 months (95% CI=5.7–14.0). Fortyfive (97.8%) patients experienced treatment-related adverse events (TRAEs). The most common grade≥3 TRAEs (>30%) were neutrophil count decrease (50.0%), anemia (32.6%), and white blood cell count decrease (30.4%).
Conclusion
QL1604 plus paclitaxel-cisplatin/carboplatin showed promising antitumor activity and manageable safety profile as first-line treatment in patients with advanced cervical cancer. Programmed cell death protein 1 inhibitor plus chemotherapy may be a potential treatment option for the patient population who have contraindications or can’t tolerate bevacizumab, which needs to be further verified in phase III confirmatory study.
6.The full process operating procedure for the using of multi -center retrospective electronic medical record data
Xue ZHONG ; Dongfang QIAN ; Zixuan ZHANG ; Siyuan TAN ; Jianfeng LIU ; Xueyan CUI ; Ruifang NIE ; Ting LI ; Qian WANG ; Qi GUO ; Qiushuang LIU ; Yan LIANG ; Lin HUANG ; Lizong LI ; Yufei FENG
China Pharmacy 2022;33(19):2314-2320
With the gradual improvement of medical informatization and the vigorous development of medical and health big data,the exploration and practice of real -world research are becoming more and more mature ,and real -world data have become an important source of evidence for post marketing re -evaluation of drugs . As an important high -quality real -world medical data , electronic medical record data is an indispensable data source for post marketing re -evaluation of drugs . Most of the existing guidelines and norms of real -world research are designed from the perspective of prospective research ,and do not propose specific measures and methods in the implementation of retrospective research ,especially for the operation suggestions on the technical level of using conventionally collected electronic medical record data . In combination with the operational process framework formulated by the existing guidelines and norms ,this paper creatively adds the operating procedures for dataE- validation,data integration ,data verification ,and throughout quality control ,data management and storage of retrospectiveelectronic medical record data ,and describes the data analysis methods and key points involved in carrying out multi -center retrospective real -world research using electronic medical record data ,taking the post marketing safety research of drugs as an example. Finally,the full process operation procedure applicable to the use of multi -center retrospective electronic medical record data is established .
7.Type 2 spondyloepimetaphyseal dysplasia with joint laxity caused by KIF22 gene mutation: a case report and literature review
Zhen LI ; Yachao LU ; Ruifang QI ; Jieying WANG ; Rongmin LI ; Jie CHANG ; Jingna WANG ; Yanmei SANG
Chinese Journal of Orthopaedics 2022;42(21):1460-1464
A male patient aged 1 year and 8 months with type 2 spondyloepimetaphyseal dysplasia with joint laxity (SEMDJL2) was reported. The clinical characteristics included short stature, flat middle face, hypotonia, limb joint relaxation, hyperextension of metacarpophalangeal articulation, etc. In addition, the patient had a history of congenital laryngeal stridor. Thus, SEMDJL2 was determined according to the above symptoms and medical history. Sanger sequencing showed that the child carried a c.443C>T missense mutation in the KIF22 gene, which resulted in an amino acid variation namely p.Pro148Leu. This phenotype was preliminarily determined as a pathogenic mutation. Therefore, it is suggested that next-generation sequencing genetic testing could be helpful for genetic diagnosis in children with congenital laryngeal stridor, systemic joint relaxation, and excessive joint extension.
8.Construction of prediction model for early screening in male patients with gastric cancer based on cell -free DNA methylation and machine learning
Jie Ji ; Jian Qi ; Bo Hong ; Shujie Wang ; Ruifang Sun ; Xueling Cao ; Xiaojun Sun ; Jinfu Nie
Acta Universitatis Medicinalis Anhui 2022;57(12):1991-1996
Objective :
To construct a cell-free DNA ( cfDNA) methylation model for early screening in male pa- tients with gastric cancer by using novel cfDNA methylation detection technology.
Methods :
Methylation informa- tion of the whole genome of gastric cancer patients were detected by cell-free methylated DNA immunoprecipitation and highthroughput sequencing ( cfMeDIP-seq ) technology and locate gastrogenic cfDNA. Then bioinformation methods were used to extract specific methylation labels which could distinguish GC patients and establish diagnosis model by random forest algorithm. Related validation clinical researches were also conducted.
Results :
63 most sig- nificant DMR were selected to construct the cfDNA methylation model based on GC samples and normal control samples,the goal sensitivity was above 85 percent while the goal specificity was above 95% .The sensitivity and specificity of the validation set were 98. 7% and 99. 0% while the area under curve(AUC) was 0. 999.
Conclusion
The cfDNA methylation model constructed in this study has good performance in predicting GC.
9.Effects of hypoxic preconditioning on energy metabolism of mitochondria in mouse hippocampal HT22 cells
Ruifang Qi ; Na Li ; Lijun Wang ; Jun Lv ; Ruili Shi ; Baohui Ma ; Jinghua Shi ; Xiaoqiong Hao ; Guo Shao
Acta Universitatis Medicinalis Anhui 2022;57(10):1585-1588,1594
Objective :
To investigate the effect of hypoxic preconditioning (HPC) on mitochondrial energy metabolism in mouse hippocampal HT22 cells and its possible mechanism.
Methods :
In this paper, mouse hippocampal nerve cells HT22 were divided into control group, hypoxia group, HPC group, and the levels of adenosine triphosphate (ATP) and reactive oxygen species (ROS) in each group were measured for observing the effect of HPC on cell mitochondrial metabolism. Western blot was used to detect the expression of target of rapamycin ( mTOR), phosphorylated mTOR protein and autophagy substrate P62 protein; cellular immunofluorescence was used to detect phosphorylated mTOR, and LysoTrackerTM probe was used to detect lysosomes.
Results :
Compared with the control group, the ATP level was significantly decreased and the ROS level was increased in the hypoxia group. Exposed to HPC, the ATP level was increased and the ROS level was decreased. Compared with the control group, the expression of phosphorylated mTOR was down⁃regulated and the expression of autophagy substrate P62 was down⁃regulated in the HPC group.
Conclusion
HPC may affect the energy metabolism of HT22 cells through the mTOR/autophagy signaling pathway, thereby exerting a protective effect on the HT22 cells.
10.The application of intraoperative transesophageal echocardiography in systolic anterior motion after mitral valvuloplasty
Na ZHAO ; Qinghua QI ; Juan YANG ; Jiangchuan DU ; Suyun HOU ; Honghu WANG ; Ruifang ZHANG
Chinese Journal of Ultrasonography 2021;30(2):105-111
Objective:To predict the risk of systolic anterior motion (SAM) after mitral valvuloplasty(MVP) by intraoperative transesophageal echocardiography (TEE) and its diagnostic value.Methods:From August 2016 to May 2020, 215 patients with mitral valve degeneration underwent MVP, including 182 patients without SAM (non-SAM group), and 33 patients with SAM (SAM group). TEE examination was performed immediately after operation to determine whether SAM phenomenon was relieved. According to the physiological basis of SAM, before cardiopulmonary bypass (CPB) and immediately after CPB, the parameters of SAM group and non-SAM group were measured and compared, including left atrial dimension(LAD), left ventricular end diastolic diameter(LVEDD), left ventricular end systolic diameter(LVESD), left ventricular ejection fraction(LVEF), basal septal diameter(basal-IVDd), left ventricular posterior wall thickness(LVPW), left ventricular outflow tract diameter(LVOTD), left ventricular outflow tract maximum velocity(LVOT-Vmax), left ventricular outflow tract pressure gradient(LVOTG), mitral valve maximum velocity(MV-Vmax), mitral valve mean pressure gradient(MVG-mean), mitral regurgitation area(MR-area), bulging subaortic septum, anterior leaflet length, posterior leaflet length, ratio between the lengths of the anterior and posterior leaflets, coaptation-septum distance(c-sept), nnular diameter of mitral valve, aorto-mitral angle (AMA) to screen the independent risk factors of SAM after MVP.Results:① Compared with the non-SAM group, LVEDd, LVESD, ratio between the length of the anterior and posterior leaflets, c-sep and AMA decreased in SAM group (all P<0.05), while basal-IVDd, LVEF, posterior leaflet length and bulging subaortic septum increased in SAM group (all P<0.05). ②Compared with that before the "edge to edge" technique, LVOT-Vmax decreased from (4.31±2.26)m/s to (2.55±1.39)m/s, LVOTG decreased from (43.58±10.89)mmHg to (23.36±12.76)mmHg, MVG-mean increased from (0.46±0.33)mmHg to (2.27±0.43)mmHg, and MR-area increased from (3.52±0.79)cm 2 to (0.96±0.57)cm 2 (all P<0.05). ③Multivariate logistic regression analysis showed that independent risk factors of SAM were LVEDd<45.430 mm ( OR=0.267, 95% CI=0.084-0.847), basal-IVDd>14.870 mm ( OR=12.049, 95% CI=1.619-89.661), length ratio of anterior and posterior leaflets of mitral valve>1.371 ( OR=0.159, 95% CI=0.045-0.562), angle of bulging angulated subaortic septum>62.330°( OR=18.246, 95% CI=2.824-117.896), c-sept<23.965 mm( OR=0.177, 95% CI=0.05-0.628), and AMA<123.730°( OR=0.197, 95% CI=0.098-0.396). Conclusions:Intraoperative TEE can evaluate the risk factors of SAM before MVP, and find the SAM phenomenon after MVP in time, which is helpful for surgeons to prevent and correct SAM after MVP and avoid secondary operation.


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