1.Safety and puncture accuracy of visual dilated sheath combined with needle nephroscope percutaneous nephroscopy for renal calculi
Huaijun LIU ; Shaoshan WU ; Fang CHEN ; Wenlian HU ; Qilin SUN ; Cheng ZHANG ; Tao TAO
Journal of Modern Urology 2025;30(4):300-305
Objective: To compare the clinical efficacy of visual dilated sheath combined with needle nephroscope percutaneous nephrolithotomy (PCNL) with traditional PCNL for renal calculi,so as to enhance the intraoperative safety and puncture accuracy. Methods: A retrospective analysis was conducted on 100 patients with renal calculi treated on hospital during Sep.2022 to Sep.2023.Based on the surgical approaches,patients were divided into the needle nephroscope group (PCNL with visual dilator sheath and needle nephroscope,n=52) and traditional group (traditional PCNL,n=48).Clinical characteristics,surgical parameters,and outcomes were compared between the two groups. Results: There were no significant differences between the two groups in baseline data,total operation time and hospital stay (P>0.05).The needle nephroscope group had a longer channel establishment time compared to the traditional group [20.0(17.0-22.0) min vs.16.0 (15.0-21.0) min,P=0.002],but significantly shorter puncture time [2.0 (1.0-2.6) min vs. 2.8(2.0-3.5) min,P<0.001],and fewer adjustments of the puncture needle (9.6% vs. 64.6%,P<0.001).The channel was successfully established on the first attempt in all patients in the needle nephroscope group,while only 41 of patients in the traditional group achieved success on the first attempt,6 cases needed 2 attempts,and 1 case needed 3 attempts.Postoperative complications were absent in the needle nephroscope group,whereas postoperative bleeding requiring interventional treatment occurred in 1 case in the traditional group.There was no significant difference in the first-stage stone-clearance rate between the two groups (88.4%vs. 85.4%,P=0.872). Conclusion: PCNL using a visual dilator sheath combined with a needle nephroscope achieves a comparable first-stage stone-clearance rate to traditional PCNL.However,it offers significant advantages in terms of shorter puncture time,fewer adjustments of the puncture needle,and lower postoperative complication rate.These findings suggest superior safety and precision,making it a valuable technique for clinical application.
2.Clinical Analysis of 311 Cases with Giant Ovarian Mass
Hua LIU ; Jingxian LING ; Xianghong ZHU ; Rong LI ; Xiaoqiu TANG ; Yan ZHANG ; Huaijun ZHOU
Journal of Practical Obstetrics and Gynecology 2024;40(1):73-77
Objective:To analyze the clinicopathological features of giant ovarian masses(mean diameter≥10 cm)and analyze the clinical characteristics of patients in different age groups.Methods:The clinicopathological characteristics of 311 patients diagnosed with giant ovarian masses by surgery at Nanjing Drum Tower Hospital,Affiliated Hospital of Medical School,Nanjing University from January 2014 to December 2022 were retrospectively analyzed.Patients were further stratified by age and mass size to compare the differences of clinical and patho-logical features among different age groups and different mass diameter groups.Results:①The median age of thepatients were 44(24,60)years old.The first symptoms were as follows:ovarian mass discovered during physi-cal examination,abdominal pain,bloating,conscious abdominal distension,and symptoms of compression.②The surgical methods were as follows:unilateral oophorectomy(30.5%,95/311),ovarian cystectomy(28.9%,90/311),tumor staging or cytoreductive surgery(28.0%,87/311),total hysterectomy with bilateral adnexectomy(12.5%,39/311).③The pathological types were benign(49.5%,154/311),malignant(31.8%,99/311)and borderline(18.7%,58/311).④ Patients complained abdominal distension in<20 years old group were signifi-cantly higher than the other two groups(P<0.05).The ovarian resection rate in the>50-year-old group was higher than that of the other two groups(P<0.05),and the rate of unilateral ovarian resection in the<20-year-old group was still as high as 30.1%(15/49).⑤ The size of the mass correlated with the duration of the disease.When the disease course was between 1 to 6 months,the mass diameter line>30 cm was the most common(P<0.05).The incidence of borderline tumors in the>30 cm group was significantly higher than that in the other two groups,and the difference was statistically significant(P<0.05).Conclusions:Ovarian mucinous and mucinous borderline tumors are the most common types of giant adnexal masses.The size of the mass tends to increase with the prolongation of the disease course.The incidence of borderline tumors increases with the in-crease of mass.Health education for young people should be strengthened.When abdominal pain,abdominal bloating,especially lower abdominal distension occurs,they should seek medical treatment in time to avoid adnex-ectomy due to borderline tumors.
3.First-line bevacizumab plus chemotherapy in Chinese patients with stage III/IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer: a phase III randomized controlled trial
Xiaohua WU ; Jihong LIU ; Ruifang AN ; Rutie YIN ; Yu ZHANG ; Huaijun ZHOU ; Aiqin HE ; Li WANG ; Jieqing ZHANG ; Ziling LIU ; Wei DUAN ; Jianqing ZHU ; Ge LOU ; Guilin CHEN ; Ying CHENG ; Fengxia XUE ; Sonja NICK ; Haiyan WANG ; Donghang LI
Journal of Gynecologic Oncology 2024;35(5):e99-
Objective:
First-line bevacizumab plus carboplatin and paclitaxel (CP) is approved for stage III/IV ovarian cancer treatment following initial surgical resection, based on global phase III GOG-0218 and ICON7 trials. This study evaluated the efficacy and safety of bevacizumab + CP as first-line ovarian cancer therapy in Chinese patients.
Methods:
Patients with newly diagnosed, International Federation of Gynecology and Obstetrics (FIGO) stage III/IV epithelial ovarian, fallopian tube, or primary peritoneal cancer post-primary surgery were randomized 1:1 to receive 6 cycles of CP with bevacizumab/ placebo, followed by bevacizumab/placebo maintenance until unacceptable toxicity or disease progression. Primary endpoint was investigator-assessed progression-free survival (PFS). Stratification factors were FIGO stage and debulking status (stage III optimally debulked vs stage III suboptimally debulked vs stage IV) and Eastern Cooperative Oncology Group performance status (0 vs 1 or 2).
Results:
Of randomized patients, 51 received bevacizumab + CP and 49 received placebo + CP. Median PFS was 22.6 months with bevacizumab + CP (95% confidence interval [CI]=18.6, not estimable) and 12.3 months (95% CI=9.5, 15.0) with placebo + CP (stratified hazard ratio=0.30; 95% CI=0.17, 0.53). Treatment-related grade 3/4 adverse events occurred in 46 of 49 (94%) patients receiving bevacizumab + CP, and 34 of 50 (68%) receiving placebo + CP.
Conclusion
Bevacizumab + CP showed clinically meaningful improvement in PFS vs placebo + CP, consistent with GOG-0218 results. Safety data were aligned with the known bevacizumab safety profile. These results support first-line bevacizumab + CP therapy in Chinese patients with ovarian cancer.
4.First-line bevacizumab plus chemotherapy in Chinese patients with stage III/IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer: a phase III randomized controlled trial
Xiaohua WU ; Jihong LIU ; Ruifang AN ; Rutie YIN ; Yu ZHANG ; Huaijun ZHOU ; Aiqin HE ; Li WANG ; Jieqing ZHANG ; Ziling LIU ; Wei DUAN ; Jianqing ZHU ; Ge LOU ; Guilin CHEN ; Ying CHENG ; Fengxia XUE ; Sonja NICK ; Haiyan WANG ; Donghang LI
Journal of Gynecologic Oncology 2024;35(5):e99-
Objective:
First-line bevacizumab plus carboplatin and paclitaxel (CP) is approved for stage III/IV ovarian cancer treatment following initial surgical resection, based on global phase III GOG-0218 and ICON7 trials. This study evaluated the efficacy and safety of bevacizumab + CP as first-line ovarian cancer therapy in Chinese patients.
Methods:
Patients with newly diagnosed, International Federation of Gynecology and Obstetrics (FIGO) stage III/IV epithelial ovarian, fallopian tube, or primary peritoneal cancer post-primary surgery were randomized 1:1 to receive 6 cycles of CP with bevacizumab/ placebo, followed by bevacizumab/placebo maintenance until unacceptable toxicity or disease progression. Primary endpoint was investigator-assessed progression-free survival (PFS). Stratification factors were FIGO stage and debulking status (stage III optimally debulked vs stage III suboptimally debulked vs stage IV) and Eastern Cooperative Oncology Group performance status (0 vs 1 or 2).
Results:
Of randomized patients, 51 received bevacizumab + CP and 49 received placebo + CP. Median PFS was 22.6 months with bevacizumab + CP (95% confidence interval [CI]=18.6, not estimable) and 12.3 months (95% CI=9.5, 15.0) with placebo + CP (stratified hazard ratio=0.30; 95% CI=0.17, 0.53). Treatment-related grade 3/4 adverse events occurred in 46 of 49 (94%) patients receiving bevacizumab + CP, and 34 of 50 (68%) receiving placebo + CP.
Conclusion
Bevacizumab + CP showed clinically meaningful improvement in PFS vs placebo + CP, consistent with GOG-0218 results. Safety data were aligned with the known bevacizumab safety profile. These results support first-line bevacizumab + CP therapy in Chinese patients with ovarian cancer.
5.First-line bevacizumab plus chemotherapy in Chinese patients with stage III/IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer: a phase III randomized controlled trial
Xiaohua WU ; Jihong LIU ; Ruifang AN ; Rutie YIN ; Yu ZHANG ; Huaijun ZHOU ; Aiqin HE ; Li WANG ; Jieqing ZHANG ; Ziling LIU ; Wei DUAN ; Jianqing ZHU ; Ge LOU ; Guilin CHEN ; Ying CHENG ; Fengxia XUE ; Sonja NICK ; Haiyan WANG ; Donghang LI
Journal of Gynecologic Oncology 2024;35(5):e99-
Objective:
First-line bevacizumab plus carboplatin and paclitaxel (CP) is approved for stage III/IV ovarian cancer treatment following initial surgical resection, based on global phase III GOG-0218 and ICON7 trials. This study evaluated the efficacy and safety of bevacizumab + CP as first-line ovarian cancer therapy in Chinese patients.
Methods:
Patients with newly diagnosed, International Federation of Gynecology and Obstetrics (FIGO) stage III/IV epithelial ovarian, fallopian tube, or primary peritoneal cancer post-primary surgery were randomized 1:1 to receive 6 cycles of CP with bevacizumab/ placebo, followed by bevacizumab/placebo maintenance until unacceptable toxicity or disease progression. Primary endpoint was investigator-assessed progression-free survival (PFS). Stratification factors were FIGO stage and debulking status (stage III optimally debulked vs stage III suboptimally debulked vs stage IV) and Eastern Cooperative Oncology Group performance status (0 vs 1 or 2).
Results:
Of randomized patients, 51 received bevacizumab + CP and 49 received placebo + CP. Median PFS was 22.6 months with bevacizumab + CP (95% confidence interval [CI]=18.6, not estimable) and 12.3 months (95% CI=9.5, 15.0) with placebo + CP (stratified hazard ratio=0.30; 95% CI=0.17, 0.53). Treatment-related grade 3/4 adverse events occurred in 46 of 49 (94%) patients receiving bevacizumab + CP, and 34 of 50 (68%) receiving placebo + CP.
Conclusion
Bevacizumab + CP showed clinically meaningful improvement in PFS vs placebo + CP, consistent with GOG-0218 results. Safety data were aligned with the known bevacizumab safety profile. These results support first-line bevacizumab + CP therapy in Chinese patients with ovarian cancer.
6.Comparison of Quality of Life of the Patients Three Months after Uniportal and Multiportal Thoracoscopic Lobectomy.
Qi ZHANG ; Wei DAI ; Xing WEI ; Run XIANG ; Hang GU ; Peihong HU ; Mingxin LIU ; Wei CHEN ; Huaijun GONG ; Yong LIANG ; Shichao ZHANG ; Weixing PENG ; Qiuling SHI ; Qiang LI ; Nanbin YU
Chinese Journal of Lung Cancer 2023;26(11):843-850
BACKGROUND:
The relationship between quality of life at three months after lung cancer surgery and different surgical approaches is remains unclear. This study aimed to compare the quality of life of patients three months after uniportal and multiportal thoracoscopic lobectomy.
METHODS:
Data from patients who underwent lung surgery at the Department of Thoracic Surgery, Sichuan Cancer Hospital between April 2021 and October 2021 were collected. The European Organization for Research and Treatment of Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and Quality of Life Questionnaire-Lung Cancer 29 (EORTC QLQ-LC29) were used to collect quality of life data of the patients. Potential confounding factors in the baseline data were included in a multivariate regression model for adjustment, and the quality of life of the two groups three months postoperatively was compared with traditional clinical outcomes.
RESULTS:
A total of 130 lung cancer patients were included, with 57 males (43.8%) and 73 females (56.2%), and an average age of (57.1±9.5) yr. In the baseline data of the two groups, there was a statistical difference in the number of chest drainage tubes placed (P<0.001). After adjustment with the regression model, at three months postoperatively, there were no significant differences in all symptoms and functional status scores between the two groups (all P>0.05). The multiportal group had longer surgery time (120.0 min vs 85.0 min, P=0.001), postoperative hospital stay (6.0 d vs 4.0 d, P=0.020), and a higher incidence of early ≥ grade 2 complications (39.0% vs 10.1%, P=0.011) compared to the uniportal group.
CONCLUSIONS
Patients undergoing uniportal and multiportal thoracoscopic lobectomy have similar quality of life at three months postoperatively. The uniportal group may have certain advantages in terms of traditional clinical outcome indicators such as operation time, postoperative hospital stay, and early postoperative complications.
Male
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Female
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Humans
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Lung Neoplasms/surgery*
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Quality of Life
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Thoracic Surgery, Video-Assisted/adverse effects*
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Pneumonectomy/adverse effects*
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Postoperative Complications/surgery*
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Retrospective Studies
7.Chinese consensus guidelines for therapeutic drug monitoring of polymyxin B, endorsed by the Infection and Chemotherapy Committee of the Shanghai Medical Association and the Therapeutic Drug Monitoring Committee of the Chinese Pharmacological Society.
Xiaofen LIU ; Chenrong HUANG ; Phillip J BERGEN ; Jian LI ; Jingjing ZHANG ; Yijian CHEN ; Yongchuan CHEN ; Beining GUO ; Fupin HU ; Jinfang HU ; Linlin HU ; Xin LI ; Hongqiang QIU ; Hua SHAO ; Tongwen SUN ; Yu WANG ; Ping XU ; Jing YANG ; Yong YANG ; Zhenwei YU ; Bikui ZHANG ; Huaijun ZHU ; Xiaocong ZUO ; Yi ZHANG ; Liyan MIAO ; Jing ZHANG
Journal of Zhejiang University. Science. B 2023;24(2):130-142
Polymyxin B, which is a last-line antibiotic for extensively drug-resistant Gram-negative bacterial infections, became available in China in Dec. 2017. As dose adjustments are based solely on clinical experience of risk toxicity, treatment failure, and emergence of resistance, there is an urgent clinical need to perform therapeutic drug monitoring (TDM) to optimize the use of polymyxin B. It is thus necessary to standardize operating procedures to ensure the accuracy of TDM and provide evidence for their rational use. We report a consensus on TDM guidelines for polymyxin B, as endorsed by the Infection and Chemotherapy Committee of the Shanghai Medical Association and the Therapeutic Drug Monitoring Committee of the Chinese Pharmacological Society. The consensus panel was composed of clinicians, pharmacists, and microbiologists from different provinces in China and Australia who made recommendations regarding target concentrations, sample collection, reporting, and explanation of TDM results. The guidelines provide the first-ever consensus on conducting TDM of polymyxin B, and are intended to guide optimal clinical use.
Humans
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Anti-Bacterial Agents/therapeutic use*
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China
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Drug Monitoring/methods*
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Polymyxin B
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Practice Guidelines as Topic
8.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.
9.Finite element method simulating bursting process of multi-chamber flexible package infusion bag.
Huaijun YUE ; Guanshi WANG ; Wentao JIANG ; Hongbo TAN ; Wenjun LIU ; Zhongqiang ZHU ; Lin ZHU
Journal of Biomedical Engineering 2021;38(3):556-562
This study aims to overcome the shortcomings such as low efficiency, high cost and difficult to carry out multi-parameter research, which limited the optimization of infusion bag configuration and manufacture technique by experiment method. We put forward a fluid cavity based finite element method, and it could be used to simulate the stress distribution and deformation process of infusion bag under external load. In this paper, numerical models of infusion bag with different sizes was built, and the fluid-solid coupling deformation process was calculated using the fluid cavity method in software ABAQUS subject to the same boundary conditions with the burst test. The peeling strength which was obtained from the peeling adhesion test was used as failure criterion. The calculated resultant force which makes the computed peeling stress reach the peeling strength was compared with experiment data, and the stress distribution was analyzed compared with the rupture process of burst test. The results showed that considering the errors caused by the difference of weak welding and eccentric load, the flow cavity based finite element method can accurately model the stress distribution and deformation process of infusion bag. It could be useful for the optimization of multi chamber infusion bag configuration and manufacture technique, leading to cost reduction and study efficiency improvement.
Finite Element Analysis
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Software
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Stress, Mechanical
10.Numerical study on the effect of the geometry size of multi-chamber infusion bag on its bursting force.
Zidong FAN ; Guanshi WANG ; Huaijun YUE ; Wentao JIANG ; Zhenting DU ; Hongbo TAN ; Wenjun LIU
Journal of Biomedical Engineering 2021;38(4):716-721
This study explored the variation of bursting force of multi-chamber infusion bag with different geometry size, providing guidance for its optimal design. Models of single-chamber infusion bag with different size were established. The finite element based on fluid cavity method was adopted to calculate the fluid-solid coupling deformation process of infusion bag to obtain corresponding critical bursting force. As a result, we proposed an empirical formula predicting the critical bursting force of one chamber infusion bag with specified geometry size. Besides, a theoretical analysis, which determines the force condition of three chamber infusion bag when falling from high altitude, was conducted. The proportion of force loaded on different chamber was gained. The results indicated that critical bursting force is positively related to the length and width of the chamber, and negatively related to the height of the chamber. While the infusion bag falling, the impact force loaded on each chamber is proportional to the total liquid within it. To raise the critical bursting force of in fusion bag, a greater length and width corresponding to reduced height are recommended considering the volume of liquid needed to be filled in.

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