1.Prediction of Bioequivalence of Lenvatinib Mesilate Capsules Based on Parallel Artificial Membrane Permeability Analysis
Hua ZHENG ; Guizhou HAO ; Pingping SHANG ; Jipeng HOU ; Qingxiao LIU ; Xingkai GENG ; Guimin ZHANG
Chinese Journal of Modern Applied Pharmacy 2024;41(13):1775-1780
OBJECTIVE
To predict the in vivo bioequivalence of lenvatinib mesilate capsules and reference preparation by using the parallel artificial membrane permeability analysis.
METHODS
Based on the biopharmaceutics classification system classification of lenvatinib mesilate and the parallel artificial membrane permeation model, the in vitro dissolution permeation rate test model of lenvatinib mesilate capsules was established, through real-time monitoring of the dissolution and penetration of lenvartinib mesylate capsules and reference preparations in fasting gastric juice, intestinal fluid and postprandial intestinal fluid, the flux and total penetration of drugs through the membrane were calculated.
RESULTS
In fasting state and fed state, the 90% confidence interval of geometric mean ratio of two key quality parameters (permeation flux and permeation amount) of the preparation A all were in the range of 80.00%−125.00%, the preparation B did not fall into this interval.
CONCLUSION
This research method can predict the bioequivalence of renvartinib mesylate capsule and reference preparation, and has a certain correlation in vivo and in vitro.
2.Progress of IL-21 and Tfh Mediated Immunotherapy in Non-small Cell Lung Cancer
LIU XINGKAI ; ZHANG YIFAN ; ZHANG XIN ; HE GONGHAO ; CAI WENKE
Chinese Journal of Lung Cancer 2024;27(7):550-558
Non-small cell lung cancer(NSCLC)is a prevalent and aggressive global malignancy.Conventional sur-gical treatments,radiotherapy,chemotherapy,and targeted therapies often fall short in halting disease progression due to inher-ent limitations,resulting in suboptimal prognosis.Despite the advent of immunotherapy drugs offering new hope for NSCLC treatment,current efficacy remains insufficient to meet all patient needs.Therefore,actively exploring novel immunotherapeu-tic approaches to further reduce mortality rates in NSCLC patients has become a crucial focus of NSCLC research.This article aims to systematically review the anti-tumor effects ofinterleukin-21 and follicular helper T cells in NSCLC immunotherapy by summarizing and analyzing relevant literatures from both domestic and international sources,as well as exploring the potential for enhancing NSCLC treatment prospects through immune checkpoint regulation via immunotherapeutic means.
3.Real-world Study on the Efficacy,Safety and Economics of Vancomycin Hydrochloride for Injection from Two Manufacturers
Haixia ZHANG ; Xingkai CHEN ; Pei LIANG ; Jinchun LIU ; Yichen LI ; Mengying LIU ; Siliang WANG ; Huaijun ZHU ; Weihong GE
Herald of Medicine 2023;42(12):1850-1855
Objective To evaluate the differences in efficacy,safety and economics of vancomycin hydrochloride for injection between two manufacturers based on real-world data.Methods A total of 6 757 cases of intravenous use of vancomycin hydrochloride for injection from different manufacturers between January 1,2013 and December 31,2019 in the Affiliated Drum Tower Hospital of Nanjing University Medical School were retrospectively analyzed,and 5308 cases were matched by 1∶1 propensity score method,including 2 654 cases in the group A(domestic drug group)and 2 654 cases in group B(the innovator drug group).The differences in efficacy and safety between the two groups were compared.Cost-effectiveness analysis was used to compare the drug economics of the two groups.Results There were no significant differences in clinical cure rate,bacterial clearance rate,and incidence of adverse events between the two groups(P>0.05).In terms of economics,the average cost of vancomycin per capita,average daily cost of vancomycin and average cost of antibiotics per capita were significantly different between the two groups(P<0.05),and the cost of group B was higher than that of group A.Conclusion The efficacy and safety of vancomycin hydrochloride for injection were consistent between the two manufacturers.
4.Prevalence and influencing factors of depressive symptoms among primary and middle school students in Xihu District
Congxiao ZHANG ; Lin ZHENG ; Liming SHEN ; Minyan HUANG ; Hui CHEN ; Xingkai NIU ; Kai SONG
Journal of Preventive Medicine 2023;35(3):196-199
Abstract:
Objective To investigate the prevalence and influencing factors of depressive symptoms among primary and middle school students in Xihu District, Hangzhou City, so as to provide insights into depression control among primary and middle school students.
Methods:
Students were sampled from two primary schools, two junior high schools, two ordinary high schools and one vocational high school in Xihu District using a stratified cluster random sampling method from September to November, 2021. Participants' demographics, diet, exercise, sleep and campus bullying were collected using questionnaire surveys. The depressive symptoms were evaluated using the Chinese version of the Center for Epidemiologic Studies-Depression Scale (CES-D), and factors affecting the depressive symptoms were identified among primary and middle school students using a multivariable logistic regression model.
Results:
A total of 1 518 students were investigated, including 518 primary school students (34.12%), 363 junior high school students (23.91%), 463 ordinary high school students (30.50%) and 174 vocational high school students (11.46%). Of all participants, there were 805 males (53.03%). The prevalence of depressive symptoms was 38.87% among the participants, and was 36.10%, 42.42%, 42.33% and 30.46% among primary school, junior high school, ordinary high school and vocational high school students, respectively. The multivariable logistic regression analysis showed that gender (OR=1.601, 95%CI: 1.289-1.989), type of school (junior high school, OR=1.299, 95%CI: 0.974-1.734; ordinary high school, OR=1.351, 95%CI: 1.025-1.780; vocational high school, OR=0.862, 95%CI: 0.585-1.272), frequency of fresh vegetable intake (less than once daily, OR=0.454, 95%CI: 0.304-0.679; once and more daily, OR=0.359, 95%CI: 0.235-0.548), duration spent on the internet (0.5 to 1 h daily, OR=1.447, 95%CI: 1.044-2.006; 1 h and longer daily, OR=1.456, 95%CI: 1.072-1.978), sufficient sleep (OR=0.525, 95%CI: 0.371-0.744), suffering from campus bullying (OR=1.992, 95%CI: 1.491-2.661) were associated with the development of depressive symptoms.
Conclusions
The prevalence of depressive symptoms is high among primary and middle school students in Xihu District. Gender, type of school, dietary behaviors, sleep duration and campus bullying are factors affecting the development of depressive symptoms.
5.Comparison of effectiveness of lower extremity axial distractor and traction table assisted closed reduction and intramedullary nail fixation in femoral subtrochanteric fracture.
Xingkai ZHANG ; Nan ZHOU ; Mingliang MA ; Gangqiang DU ; Zeyue GENG ; Ruifeng QI ; Zhigang WANG
Chinese Journal of Reparative and Reconstructive Surgery 2023;37(12):1465-1470
OBJECTIVE:
To compare the effectiveness of lower extremity axial distractor (LEAD) and traction table assisted closed reduction and intramedullary nail fixation in treatment of femoral subtrochanteric fracture.
METHODS:
The clinical data of 117 patients with subtrochanteric fracture of femur treated by closed reduction and intramedullary nail fixation between May 2012 and May 2022 who met the selection criteria were retrospectively analyzed. According to the auxiliary reduction tools used during operation, the patients were divided into LEAD group (62 cases with LEAD reduction) and traction table group (55 cases with traction table reduction). There was no significant difference in baseline data, such as gender, age, injured side, cause of injury, fracture Seinsheimer classification, time from injury to operation, and preoperative visual analogue scale (VAS) score, between the two groups ( P>0.05). Total incision length, operation time, intraoperative blood loss, fluoroscopy frequency, closed reduction rate, fracture reduction quality, fracture healing time, weight-bearing activity time, and incidence of complications, as well as hip flexion and extension range of motion (ROM), Harris score, and VAS score at 1 month and 6 months after operation and last follow-up were recorded and compared between the two groups.
RESULTS:
There were 14 cases in the LEAD group from closed reduction to limited open reduction, and 43 cases in the traction table group. The incisions in the LEAD group healed by first intention, and no complication such as nerve and vascular injury occurred during operation. In the traction table group, 3 cases had perineal crush injury, which recovered spontaneously in 1 week. The total incision length, operation time, intraoperative blood loss, fluoroscopy frequency, and closed reduction rate in the LEAD group were significantly better than those in the traction table group ( P<0.05). There was no significant difference in the quality of fracture reduction between the two groups ( P>0.05). Patients in both groups were followed up 12-44 months, with an average of 15.8 months. In the LEAD group, 1 patient had delayed fracture union at 6 months after operation, 1 patient had nonunion at 3 years after operation, and 1 patient had incision sinus pus flow at 10 months after operation. In the traction table group, there was 1 patient with fracture nonunion at 15 months after operation. X-ray films of the other patients in the two groups showed that the internal fixator was fixed firmly without loosening and the fractures healed. There was no significant difference in fracture healing time, weight bearing activity time, incidence of complications, and postoperative hip flexion and extension ROM, Harris score, and VAS score at different time points between the two groups ( P>0.05).
CONCLUSION
For femoral subtrochanteric fracture treated by close reduction and intramedullary nail fixation, compared with traction table, LEAD assisted fracture reduction can significantly shorten the operation time, reduce intraoperative blood loss and fluoroscopy frequency, reduce incision length, effectively improve the success rate of closed reduction, and avoid complications related to traction table reduction. It provides a new method for good reduction of femoral subtrochanteric fracture.
Humans
;
Fracture Fixation, Intramedullary
;
Bone Nails
;
Traction
;
Blood Loss, Surgical/prevention & control*
;
Retrospective Studies
;
Treatment Outcome
;
Femoral Fractures
;
Hip Fractures/surgery*
;
Lower Extremity
;
Surgical Wound
;
Fracture Fixation, Internal
6.Esophagofundostomy combined with pericardial devascularization for the treatment of esophagogastric variceal bleeding
Zhiyong WANG ; Xingkai MENG ; Wanxiang WANG ; Jianjun REN ; Maochun WANG ; Yibo CHEN ; Junjing ZHANG
Chinese Journal of General Surgery 2021;36(5):355-359
Objective:To investigate the clinical effect of esophagofundostomy combined with pericardial devascularization in the treatment of upper gastrointestinal hemorrhage caused by portal hypertension.Methods:The clinical data of 108 patients with portal hypertension admitted to the Affiliated Hospital of Inner Mongolia Medical University from Feb 2009 to Feb 2015 were analyzed. Among them 42 patients underwent esophagofundostomy combined with pericardial devascularization as the study group, and 66 patients underwent pericardial devascularization only as the control group. All patients presented with splenomegaly or hypersplenism; the spleen was routinely removed during the operation.Results:The difference of operation time between the study group and the control group was statistically significant [(157±41) min vs. (143±27) min, t=2.81, P<0.05]. The improvement in the esophagogastric varices in the study group within 6 months was significantly better than that in the control group( Z=2.47, P<0.05). In addition, the rebleeding rates of varicose veins within 1, 3 and 5 years in the study group was 2%, 5% and 10%, while that in the control group was 15%, 21% and 26% (χ 2=5.49, 4.27, 4.31, all P<0.05). Conclusions:Esophagofundostomy combined with pericardia devascularization achieves complete devascularization and low rebleeding rate.
7. Preliminary study of double pancreaticojejunostomy for prevention of pancreatic fistulas after central pancreatectomy
Xingkai MENG ; Huijun WANG ; Quanfa TIAN ; Weihua ZHENG ; Junjing ZHANG
Chinese Journal of Endocrine Surgery 2019;13(6):488-491
Objective:
To evaluate the significance of double pancreatico-jejunostomy in preventing pancreatic fistula after central pancreatectomy (CP) .
Methods:
The clinical data of 10 patients who were admitted to the Affiliated Hospital of Inner Mongolia Medical University from Feb. 2012 to Dec. 2018 were analyzed retrospectively.
Results:
All the 10 patients underwent CP, closure of the proximal pancreatic stump, and end-to-side invaginated pancreaticojejunostomy; At the same time, invaginated pancreaticojejunal anastomosis or duct-to-mucosa pancreaticojejunostomy was performed to the distal pancreatic remnant. The duration of the operation was (240±60) min, and the average intraoperative blood loss was 300 ml. Incidence of pancreatic fistulas was 30% (3/10) . There were no grade B or C pancreatic fistulas, or perioperative deaths. The duration of postoperative hospital stay varied from 9 to 25 days. Endocrine and exocrine functions were well maintained during the follow-ups of 7 months to 5 years, and no tumors recurred.
Conclusions
Although operation time and technical difficulty increase, central pancreatectomy using double pancreaticojejunostomy is safe, feasible, and appears to be associated with a low rate of postoperative pancreatic fistulas.
8. Evaluation of different staging methods on radical resection rate and prognosis of patients with hilar cholangiocarcinoma
Qi XIN ; Xiaoyuan YU ; Xingkai LIU ; Ping ZHANG
Chinese Journal of Hepatobiliary Surgery 2019;25(11):828-833
Objective:
To compare the Bismuth-Corlette typing, modified T-staging and Mayo staging system in predicting the radical resection rates and prognosis of patients with hilar cholangiocarcinoma (HCC).
Methods:
The clinical data of 138 patients with hilar cholangiocarcinoma treated in the First Bethune Hospital of Jilin University were retrospectively analyzed. Three different staging methods were used.
Results:
With increase in the classification level of the Bismuth-Corlette classification, the radical resection rate did not significantly decrease (
9.Clinical significance of early diagnostic value of urinary neutrophil gelatinase-associated lipocalin in acute kidney injury in sepsis patients
Xingkai XU ; Liandong ZHANG ; Meichun TAN ; Hao JIANG ; Wei SHI
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care 2017;24(3):267-269
Objective To estimate the value of urinary neutrophil gelatinase-associated lipocalin (NGAL) level for early diagnosis of acute kidney injury (AKI) in patients with sepsis.Methods One hundred and twenty-six sepsis patients admitted to intensive care unit (ICU) in Baoshan Branch Hospital of Shuguang Hospital Affiliated to Shanghai University ofTraditional Chinese Medicine from June 2014 to December 2015 were enrolled, and they were divided into two groups according to whether complication of AKI was present. The levels of urinary NGAL in the two groups of septic patients were evaluated immediately and at 12, 24 and 48 hours after the definite diagnosis, and the levels were compared between the two groups; the receiver operating characteristic curve (ROC curve) was performed and the value of urinary NGAL level in early diagnosis of sepsis AKI was evaluated.Results There were 60 septic cases complicated with AKI (AKI group), with the prolongation of time after definite diagnosis, the urinary NGAL (g/L) levels were gradually increased at 12, 24 and 48 hours, the levels were significantly higher than those at the corresponding time points in the group without AKI [non AKI group (66 cases), 12 hours: 178.2±32.8 vs. 53.8±10.4, 24 hours: 228.4±24.6 vs. 54.1±9.0, 48 hours: 186.1±43.6 vs. 52.5±9.4, allP < 0.05]. The area under ROC curve (AUC) of urinary NGAL level at 24 hours after definite diagnosis and 95% confidence interval (CI) were 0.863 (0.766-0.929) and 0.686 (0.466-0.696), respectively, when the cutoff value of urinary NGAL was 65.9μg/L, the sensitivity was 81.9% and specificity 76.1%; when the cutoff value of urinary NGAL was 57.9μg/L, the sensitivity was 70.2% and the specificity 57.2%.Conclusion Urinary NGAL level can be used as a reference marker for the early diagnosis of sepsis concomitant AKI.
10.Differential expression of microRNAs in the intervertebral disc of hypoxia-inducible factor-1alpha deficient mice
Xiangchao MENG ; Zhuochao LIU ; Jun WANG ; Qi ZHOU ; Jin QI ; Xingkai ZHANG
Chinese Journal of Tissue Engineering Research 2016;20(7):940-946
BACKGROUND:It is confirmed that the absence of hypoxia-inducible factor-1α (HIF-1α) accelerates the degenerative process in the intervertebral discs, and microRNAs have an important role in degeneration of the intervertebral discs.
OBJECTIVE:To evaluate the changes of microRNAs in the intervertebral discs of HIF-1α-deficient (HIF-1α-/-) mice which may mediate the signaling pathway of HIF-1α in the intervertebral discs.
METHODS: As previously reported, HIF-1α-/- mice were established. HIF-1α-/- mice and HIF-1αflox/flox mice (control mice) aged 4 weeks were used. MRI and histological staining were used to evaluate the degeneration of the intervertebral discs. Total RNAs were extracted from the intervertebral discs tissues by Trizol, and the differential expression profile of microRNAs was harvested by significance analysis of microarrays and Cluster, based on microarray screening. Real-time quantitative reverse transcription-PCR was applied to verify the reliability of microRNA array results.
RESULTS AND CONCLUSION:The number of nucleus pulposus cels in the intervertebral discs of HIF-1α-/- mice was decreased, the cels presented with smal size and the color deepened in the cytoplasm. Finaly, differential expression profile of microRNAs (n=10) was obtained, seven of which were upregulated and three were downregulated. In conclusion, the loss of HIF-1α may cause the imbalance of some important miRNAs, which may result in a large amount of dead nuclear pulposus cels and mediate disc degeneration in HIF-1α-/- mice.


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