1.Comparison of effectiveness,safety,and economy of generic and original levetiracetam concentrated solution for injection:a real-world study
Yingnan FENG ; Xianzhe DONG ; Jing PENG ; Ke WANG ; Zhizhou WANG ; Jiajie LUAN ; Lan ZHANG ; Xiaolin YUE
Chinese Journal of Pharmacoepidemiology 2024;33(2):152-157
Objective To evaluate the effectiveness,safety and economy of the clinical application of levetiracetam(LEV)concentrated solution for injection generic drug and the original drug in the national centralized volume-based procurement.Methods The information of inpatients using original LEV concentrated solution for injection in the Xuanwu Hospital of Capital Medical University(original drug group)and inpatients using generic LEV concentrated solution for injection in the First Affiliated Hospital of Wannan Medical College(generic drug group)was retrospectively analyzed after the implementation of the procurement policy(from November 2021 to March 2022).To compare the effectiveness,safety and economy of the two in the prevention and treatment of epilepsy.Results In the original drug group and the generic drug group,18 and 17 patients were enrolled in the treatment of epilepsy respectively,the effective rates were 50.00%and 58.82%,the incidence of adverse reactions were both 0%,and the median daily cost was 255.00(255.00,510.00)yuan and 131.78(131.78,131.78)yuan.After propensity score matching,both the original drug group and the generic drug group had 76 patients each received preventive medication,the effective rates were 97.37%and 100%(P>0.05),and the incidence of adverse reactions were both 0%.The median daily fee for the original the generic drug group was 170.00(170.00,170.00)yuan and 131.78(131.78,131.78)yuan,there were significant difference(P<0.01).Conclusion The clinical effect of generic and original LEV concentrated solution for injection in preventing epilepsy is basically the same,the clinical safety are equivalent,the generic has better economy than the original.The effective rate of the treatment of epilepsy is similar,while the sample size needs to be further expanded to verify the results.
2.The value of vesical imaging reporting and data system combined with tumor-wall contact length in diagnosing muscle invasive bladder cancer
Cai QIN ; Qi TIAN ; Hui ZHOU ; Qiaoling CHEN ; Manman LI ; Tianjiao E ; Yueyue LI ; Xiaolin WANG ; Feng FENG
Journal of Practical Radiology 2024;40(1):64-68
Objective To explore the value of vesical imaging reporting and data system(VI-RADS)combined with absolute tumor-wall contact length(ABTCL)and actual tumor-wall contact length(ACTCL)in diagnosing muscle invasive bladder cancer(MIBC).Methods The MRI data of 113 patients with pathologically confirmed bladder cancer(BCa)were analyzed retrospectively.All patients underwent conventional MRI,diffusion weighted imaging(DWI)and dynamic contrast enhanced(DCE)MRI before sur-gery.Two radiologists independently evaluated MRI images based on VI-RADS score,and measured quantitative parameters,inclu-ding ABTCL and ACTCL.The Chi-square test was used to compare the difference of VI-RADS scores between MIBC and non-mus-cle invasive bladder cancer(NMIBC).Quantitative parameters between MIBC and NMIBC were compared by Mann-Whitney U test.The receiver operating characteristic(ROC)curve was used to evaluate the diagnostic value of VI-RADS,quantitative parameters and VI-RADS combined with quantitative parameters in the diagnosis of MIBC.Results VI-RADS,ABTCL and ACTCL had significant differences between MIBC and NMIBC(P<0.05).The area under the curve(AUC)for VI-RADS,ABTCL and ACTCL in diagno-sing MIBC were 0.89,0.76 and 0.77,respectively.There was no significant difference between the AUC for ABTCL and ACTCL(P>0.05).The AUC for VI-RADS combined with ABTCL or ACTCL in diagnosing MIBC was 0.93,higher than that of only VI-RADS(P<0.05).Conclusion The combination of VI-RADS with either ABTCL or ACTCL can effectively improve the diagnostic performance of MIBC.ABTCL obtainedby linear measurement is easier to implement in clinical practice than ACTCL obtained by curved measurement.
3.Unilateral arytenoid chondroplasty combined with minimally invasive mucosal flap plasty for bilateral vocal cord paralysis--clinical analysis of 66 cases
Jie DENG ; Feng ZHANG ; Xingmei WU ; Dan WANG ; Lin CHEN ; Renqiang MA ; Zhangfeng WANG ; Xiaolin ZHU ; Wenbin LEI
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2024;59(10):1037-1041
Objective:To analyze the efficacy of unilateral arytenoid chondroplasty combined with minimally invasive mucosal flap plasty in the management bilateral vocal cord paralysis.Methods:A total of 66 patients with bilateral vocal cord paralysis hospitalized in the First Hospital of Sun Yat-sen University from January 2018 to December 2023 were retrospectively analyzed, among whom there were 8 males and 58 females, with ages ranging from 35 to 86 years old(mean age (57.8±11.6) years). All patients underwent suspension laryngoscopic CO 2 laser unilateral arytenoid chondroplasty and mucosal flap under general anesthesia. Postoperative follow-up period extended from 6 months to 6 years, with a median duration of 28 months. The study compared the degree of dyspnea and voice quality (subjective and objective evaluation) of the patients pre- and post-operatively, and analyzed the clinical differences between patients with and without preoperative or intraoperative tracheotomy, the extubation rate of tracheotomized patients, the recurrence rate, and the complication rate. Continuous variables conforming to normal distribution were tested by t-test and categorical variables by χ2 test,the Wilcoxon rank-sum test was used to analyze the improvement in dyspnea before and after surgery. Results:Compared with the preoperative period, 59 patients showed improvement in postoperative dyspnea ( U=161.5, P<0.01); there was no significant difference in voice disorder index 10, subjective auditory-perceptual assessment, and maximal vocalization time ( P>0.05), all of which remained within the relative normal range. Tracheotomy was performed in 32 out of 66 patients, with predominantly degree Ⅲ- dyspnea (46.9%, 15/32), including 26 patients with preoperative tracheotomy and 6 patients with intraoperative tracheotomy. Among the 34 patients who did not undergo tracheotomy, the majority presented with degree Ⅱ-dyspnea (82.4%, 28/34). All patients achieved successful extubation following surgery, with a mean median time to extubation of 1 month. Conclusions:The combination of unilateral arytenoid chondroplasty and minimally invasive mucosal flap plasty represents a refined and effective therapeutic approach for bilateral vocal cord paralysis. This minimally invasive technique has the potential to reduce the rate of tracheotomy.
4.Prognosis of percutaneous versus laparoscopic microwave ablation for patients with hepatocellular carcinoma of BCLC stages 0 to A
Xiaolin LIU ; Feng XU ; Fanchuang KONG ; Yanhua HUANG ; Chunhui ZHOU ; Jing CHEN
Chinese Journal of Hepatobiliary Surgery 2024;30(9):646-651
Objective:To compare the prognosis of percutaneous versus laparoscopic microwave ablation in patients with hepatocellular carcinoma (HCC) classified as Barcelona Clinic Liver Cancer (BCLC) stage 0 to A, and evaluate the impact of these two ablation modalities on treatment outcome.Methods:Clinical data of 198 patients with HCC of BCLC stages 0 to A undergoing microwave ablation treatment at the Second Hospital of Jiaxing and Shengjing Hospital of China Medical University from January 2011 to December 2018 were retrospectively analyzed, including 149 males and 49 females, aged (57.4±9.6) years. Patients were divided into two groups based on the treatment modality: percutaneous microwave ablation group ( n=133) and laparoscopic microwave ablation group ( n=65). Survival rates were calculated using the Kaplan-Meier method, and the log-rank test was used to compare survival rates. Univariate and multivariate analyses were performed using Cox regression to assess the impacts of percutaneous and laparoscopic microwave ablation on prognosis. Results:The median overall survivals for the percutaneous and laparoscopic microwave ablation groups were 54 months and 77 months, respectively. The 1-, 3-, and 5-year cumulative survival rates postoperatively were 95.6%, 67.3%, 47.4% for the percutaneous group, and 100.0%, 79.9%, 60.4% for the laparoscopic group, respectively, with the latter showing superior cumulative survival rates ( χ2=4.53, P=0.033). The median recurrence-free survival (RFS) was 27 months for the percutaneous group and 52 months for the laparoscopic group. The 1-, 3-, and 5-year RFS postoperatively were 67.4%, 41.1% and 32.8% for the percutaneous group, and 81.5%, 58.1%, and 46.7% for the laparoscopic group, respectively, with the latter showing superior RFS, and the difference was statistically significant ( χ2=7.20, P=0.007). Multivariate analysis indicated that percutaneous microwave ablation was associated with an increased risk of death ( HR=2.475, 95% CI: 1.423-4.305, P=0.001) and recurrence ( HR=1.996, 95% CI: 1.255-3.176, P=0.004). Conclusion:Laparoscopic approach was superior to percutaneous microwave ablation in patients with HCC of BCLC stages 0 to A, and percutaneous microwave ablation could be a risk factor for poor prognosis in these patients.
5.Study of triglyceride glucose index in predicting stroke in elderly hypertensive patients
Feng ZHANG ; Yaping ZENG ; Chenggang WANG ; Jingjing LIU ; Xiaolin ZU ; Hai GAO
Chinese Journal of Geriatrics 2023;42(8):915-920
Objective:To investigate the risk of stroke in elderly hypertensive(HTN)patients with varying baseline triglyceride glucose(TYG)index, and to identify the risk factors associated with stroke in this population.Methods:This study was a prospective cohort study that included 459 elderly patients with hypertension who were admitted to Beijing Anzhen Hospital from January 2018 to January 2020.The patients were divided into four groups based on their quartile of TYG index: Q1 group(TYG index≤8.02, 114 cases), Q2 group(8.02
6.Precise assembly of inside-out cell membrane camouflaged nanoparticles via bioorthogonal reactions for improving drug leads capturing.
Xiaolin ZHANG ; Xueyan ZHEN ; Yixuan YANG ; Quan FENG ; Wanqing YUAN ; Xiaoyu XIE
Acta Pharmaceutica Sinica B 2023;13(2):852-862
Cell membrane camouflaged nanoparticles have been widely used in the field of drug leads discovery attribute to their unique biointerface targeting function. However, random orientation of cell membrane coating does not guarantee effective and appropriate binding of drugs to specific sites, especially when applied to intracellular regions of transmembrane proteins. Bioorthogonal reactions have been rapidly developed as a specific and reliable method for cell membrane functionalization without disturbing living biosystem. Herein, inside-out cell membrane camouflaged magnetic nanoparticles (IOCMMNPs) were accurately constructed via bioorthogonal reactions to screen small molecule inhibitors targeting intracellular tyrosine kinase domain of vascular endothelial growth factor recptor-2. Azide functionalized cell membrane acted as a platform for specific covalently coupling with alkynyl functionalized magnetic Fe3O4 nanoparticles to prepare IOCMMNPs. The inside-out orientation of cell membrane was successfully verified by immunogold staining and sialic acid quantification assay. Ultimately, two compounds, senkyunolide A and ligustilidel, were successfully captured, and their potential antiproliferative activities were further testified by pharmacological experiments. It is anticipated that the proposed inside-out cell membrane coating strategy endows tremendous versatility for engineering cell membrane camouflaged nanoparticles and promotes the development of drug leads discovery platforms.
7.The effect of abdominal visceral fat area on perioperative complications and pancreatic fistula in primary gastric carcinoma patients after laparoscopic assisted radical gastrectomy
Qing TIAN ; Xiaolin HU ; Shijiang LIU ; Huiming LIU ; Kai LIU ; Yong FENG
Chinese Journal of General Surgery 2023;38(5):357-361
Objective:To study the effect of visceral fat area (VFA) on postoperative complications and pancreatic fistula in patients undergoing laparoscopic assisted radical gastrectomy for gastric careinoma.Methods:Clnical data of 214 primary gastric cancer patients undergoing laparoscopic assisted radical gastrectomy between Jan 2017 and Jan 2022 at the Department of General Surgery, Shouguang People's Hospital were retrospectively reviewed.Results:There were 85 patients in high VFA group and 129 patients in the low VFA group. The body mass index (25.1±3.4) kg/m 2 and visceral fat area (143.4±41.1) cm 2 in the high VFA group were higher than those in the low VFA group (21.2±2.9) kg/m 2 and visceral fat area (58.7±31.9) cm 2. The operative time was (228.3±53.1) min vs. (206.3±62.9) min ( t=5.538, P=0.017). The intraoperative blood loss was (264.6±173.6) ml vs. (213.9±156.2) ml ( t=3.373, P=0.035). The postoperative hospital stay was (12.5±4.0) d vs. (10.3±3.7) d ( t=7.781, P=0.013). Twenty-three cases developed postoperative complications in the high VFA group vs. 20 cases in the low VFA group ( χ2=4.261, P=0.039). Patients in the high VFA group had an incidence of clinically relevant pancreatic fistula of 10.6% vs. 3.1% in patients in the low VFA group ( χ2=5.034, P=0.038). Univariate and multivariate analysis of clinically relevant pancreatic fistulas in patients with different VFA groups showed that men ≥134.6 cm 2 and women ≥91.1 cm 2 with VFA and operative time ≥250 min were independent risk factors for the occurence of clinically relevant pancreatic fistulas after laparoscopic assisted radical gastrectomy. Conclusions:VFA increases the difficulty of laparoscopic-assisted radical gastrectomy, resulting in increased postoperative complications. VFA and operation time are independent risk factors for clinically relevant pancreatic fistula after radical gastrectomy for gastric cancer.
8.Determination of Cyperenone and α-Cyperone in Rat Plasma by UPLC-MS/MS and Their Pharmacokinetics
Chuanhua FENG ; Huiling GUO ; Xiaolin TANG ; Xiaojuan ZHAO ; Xinlu FAN ; Dekun LIU ; Gang LI
Chinese Journal of Modern Applied Pharmacy 2023;40(23):3197-3201
OBJECTIVE To establish an UPLC-MS/MS method for the determination of the concentrations of cyperenone and α-cyperone in rat plasma and to study the pharmacokinetics. METHODS Gradient elution was carried out on a Phenomennex C18(150 mm×2.0 mm, 3 μm) column with acetonitrile-water as mobile phase. The column temperature was 30 ℃, injection volume was 1 μL, osthenite was used as the internal standard, electrospray ion source and positive ion mode were used. The m/z values of cyperenone, α-cyperone and osthenite were 219.1/135.1, 219.1/111.0 and 245.0/123.0, respectively. The plasma concentrations of cyperenone and α-cyperone were measured, and the main pharmacokinetic parameters were calculated using DAS 2.0 software. RESULTS The linear relationship of cyperenone was good in the range of 10-500 ng·mL-1(r=0.991 0), and the linear relationship of α-cyperone was good in the range of 2.5-300 ng·mL-1(r=0.994 1), RSDs of intra-day precision were less than 9.45%. RSDs of daytime precision were less than 9.09%. The recoveries were greater than 86.79%. After intragastric administration of essential oil extract(20 mg·kg-1) from Cyperus rotundus L. in SD rats. The pharmacokinetic parameters of Cmax, AUC0-∞ and MRT(0-∞) of cyperenone and α-cyperone were (8 862.59±1 106.81)ng·L-1, (7 060.94±774.25)ng·L-1·h, (3.21±0.72)h and (934.69±106.81)ng·L-1, (792.26±74.52)ng·L-1·h, (4.94± 0.82)h, respectively. CONCLUSION The established method can be used for the rapid and accurate determination of the concentration of cyperenone and α-cyperone in plasma, and can be used for the pharmacokinetic study of cyperenone and α-cyperone in rats in vivo.
9.The association of renalase single-nucleotide polymorphisms rs2576178 and rs10887800 with hypertension in patients with obstructive sleep apnea
Jundong YANG ; Wenjun XUE ; Zhicheng WEI ; Caiqiong HOU ; Xinyi LI ; Huajun XU ; Xiaolin WU ; Yunhai FENG ; Shankai YIN
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2023;58(10):966-973
Objective:To evaluate the associations between the renalase single-nucleotide polymorphisms rs2576178 and rs10887800 and the risk of hypertension in OSA patients. Methods:A total of 3, 570 male OSA subjects diagnosed via standard polysomnography were included in this retrospective study. We recorded anthropometric, genomic, and polysomnographic parameters and blood pressure levels. All subjects were divided into four groups based on quartiles of the apnea-hypopnea index (AHI). The relationships between rs2576178 and rs10887800 and the risk of hypertension were evaluated using the binary logistic regression, and haplotype analysis.Results:In the bottom AHI quartile, rs10887800 was significantly associated with the risk of hypertension according to the dominant model [odds ratio( OR)=0.691, 95% confidence interval ( CI)=0.483-0.990, P=0.044] even after adjustment for age, sex, and the body mass index. The G-A haplotype was associated with a co-effect of the two SNPs, namely, the risk of hypertension decreased ( OR=0.879, 95% CI=0.784-0.986, P=0.028). Conclusions:We find no association between single rs2576178 or rs10887800 variants with the risk of hypertension in our OSA population. But, the synergistic effect of the two polymorphisms is associated with the risk of hypertension in OSA patients.
10.Accuracy analysis of amylase, C-reactive protein and procalcitonin in abdominal cavity of postoperative gastric cancer in predicting the occurrence of clinically related pancreatic fistula
Qing TIAN ; Yong FENG ; Shijiang LIU ; Huiming LIU ; Kai LIU ; Xiaolin HU
International Journal of Surgery 2022;49(5):333-337,C2
Objective:To evaluate the relationship between abdominal amylase, C-reactive protein (CRP), procalcitonin (PCT) and clinically relevant pancreatic fistula in the early stage after radical gastrectomy for gastric cancer, and to explore whether they can be used as early predictors of pancreatic fistula and their accuracy, in order to help identify pancreatic fistula in the early stage after gastrectomy.Methods:The clinical data of 372 patients diagnosed as gastric cancer and underwent gastrectomy in Shouguang People′s Hospital from January 2017 to December 2021 were retrospectively analyzed, including 190 males and 182 femals, aged from 28 to 32 years old, with the average years of 63.5±10.6. The receiver operating characteristic (ROC) curves of abdominal amylase on the first day and serum CRP and procalcitonin on the third day after surgery for gastric cancer were analyzed. The ROC curve was used to determine the optimal cutoff value and the sensitivity, specificity, positive and negative predictions, and accuracy of the optimal cutoff value were calculated. Single factor and multivariate analysis were used to analyze the risk factors of pancreatic fistula after gastric cancer surgery. SPSS 25.0 software was used for statistical analysis.Results:The incidence of clinically relevant pancreatic fistula after surgery for gastric cancer was 5.37%(20/372), including 18 cases of grade B pancreatic fistula and 2 cases of grade C pancreatic fistula. The critical values of amylase on the first postoperative day of clinically relevant pancreatic fistula after surgery for gastric cancer are predicted to be 2036 U/L, serum CRP 18 mg/dL, and procalcitonin 0.85 μg/L. In univariate analysis, body mass index, abdominal amylase concentration on the 1st postoperative day, serum CRP and procalcitonin on the 3rd postoperative day were the influencing factors for the occurance of pancreatic fistula after gastric cancer surgery. Multivariate Logistic regression analysis showed that body mass index>25 kg/m 2, abdominal amylase >2036 U/L on the first postoperative day and serum CRP>18 mg/dL on the third postoperative day were the independent predictors for pancreatic fistula. The sensitivity and specificity of the combination of intraperitoneal amylase on the first day and serum CRP on the third day after surgery for gastric cancer in predicting the occurrence of clinically relevant pancreatic fistula were 87.6% and 90.4%, respectively. Conclusions:The combination of amylase in abdominal cavity on the 1st day and CRP on the 3rd day after radical gastrectomy has high sensitivity and specificity in predicting clinically related pancreatic fistula. PCT on the 3rd day after gastric cancer surgery has limited accuracy in predicting clinically related pancreatic fistula, so it is not recommended as an early prediction index of pancreatic fistula after gastric cancer surgery.


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