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.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.
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.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
;
Female
;
Humans
;
Lung Neoplasms/surgery*
;
Quality of Life
;
Thoracic Surgery, Video-Assisted/adverse effects*
;
Pneumonectomy/adverse effects*
;
Postoperative Complications/surgery*
;
Retrospective Studies
6.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
;
Anti-Bacterial Agents/therapeutic use*
;
China
;
Drug Monitoring/methods*
;
Polymyxin B
;
Practice Guidelines as Topic
7.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.
8.Pharmacological Activation of RXR-α Promotes Hematoma Absorption via a PPAR-γ-dependent Pathway After Intracerebral Hemorrhage.
Chaoran XU ; Huaijun CHEN ; Shengjun ZHOU ; Chenjun SUN ; Xiaolong XIA ; Yucong PENG ; Jianfeng ZHUANG ; Xiongjie FU ; Hanhai ZENG ; Hang ZHOU ; Yang CAO ; Qian YU ; Yin LI ; Libin HU ; Guoyang ZHOU ; Feng YAN ; Gao CHEN ; Jianru LI
Neuroscience Bulletin 2021;37(10):1412-1426
Endogenously eliminating the hematoma is a favorable strategy in addressing intracerebral hemorrhage (ICH). This study sought to determine the role of retinoid X receptor-α (RXR-α) in the context of hematoma absorption after ICH. Our results showed that pharmacologically activating RXR-α with bexarotene significantly accelerated hematoma clearance and alleviated neurological dysfunction after ICH. RXR-α was expressed in microglia/macrophages, neurons, and astrocytes. Mechanistically, bexarotene promoted the nuclear translocation of RXR-α and PPAR-γ, as well as reducing neuroinflammation by modulating microglia/macrophage reprograming from the M1 into the M2 phenotype. Furthermore, all the beneficial effects of RXR-α in ICH were reversed by the PPAR-γ inhibitor GW9662. In conclusion, the pharmacological activation of RXR-α confers robust neuroprotection against ICH by accelerating hematoma clearance and repolarizing microglia/macrophages towards the M2 phenotype through PPAR-γ-related mechanisms. Our data support the notion that RXR-α might be a promising therapeutic target for ICH.
Anilides/pharmacology*
;
Cerebral Hemorrhage/drug therapy*
;
Hematoma/drug therapy*
;
Humans
;
Macrophages
;
Microglia
;
Neuroprotection
;
PPAR gamma
;
Retinoid X Receptor alpha
9. Pharmacological Activation of RXR-α Promotes Hematoma Absorption via a PPAR-γ-dependent Pathway After Intracerebral Hemorrhage
Chaoran XU ; Huaijun CHEN ; Shengjun ZHOU ; Chenjun SUN ; Xiaolong XIA ; Yucong PENG ; Jianfeng ZHUANG ; Xiongjie FU ; Hanhai ZENG ; Hang ZHOU ; Yang CAO ; Qian YU ; Yin LI ; Libin HU ; Guoyang ZHOU ; Feng YAN ; Gao CHEN ; Jianru LI
Neuroscience Bulletin 2021;37(10):1412-1426
Endogenously eliminating the hematoma is a favorable strategy in addressing intracerebral hemorrhage (ICH). This study sought to determine the role of retinoid X receptor-α (RXR-α) in the context of hematoma absorption after ICH. Our results showed that pharmacologically activating RXR-α with bexarotene significantly accelerated hematoma clearance and alleviated neurological dysfunction after ICH. RXR-α was expressed in microglia/macrophages, neurons, and astrocytes. Mechanistically, bexarotene promoted the nuclear translocation of RXR-α and PPAR-γ, as well as reducing neuroinflammation by modulating microglia/macrophage reprograming from the M1 into the M2 phenotype. Furthermore, all the beneficial effects of RXR-α in ICH were reversed by the PPAR-γ inhibitor GW9662. In conclusion, the pharmacological activation of RXR-α confers robust neuroprotection against ICH by accelerating hematoma clearance and repolarizing microglia/macrophages towards the M2 phenotype through PPAR-γ-related mechanisms. Our data support the notion that RXR-α might be a promising therapeutic target for ICH.
10.Influence of Calcineurin Gene Polymorphisms on the Efficacy of Cyclosporine A
Jing YAO ; Yingmin HAI ; Dingding CHEN ; Weihong GE ; Huaijun ZHU
China Pharmacy 2016;27(29):4033-4036,4037
OBJECTIVE:To study the influence of calcineurin gene polymorphism on the efficacy of cyclosporine A (CsA). METHODS:The blood samples of patients treated with CsA were collected. The trough blood concentration of CsA was detected by EMIT. The genotype of PPP3CA and PPP3CB was assayed by RFLP-PCR method. The expression of NFAT-regulated gene IL-2, IFN-γand GM-CSF were measured by RT-qPCR,which were used to define the index of indirect efficacy of CsA. The relationship of gene polymorphism with CsA efficacy was study by relationship analysis and multiple factor regression method,etc. RESULTS:A to-tal of 100 blood samples were collected. There was no significant correlation between the expression of CsA efficacy-related NFAT-reg-ulated gene GM-CSF and trough concentration of CsA(rGM-CSF=-0.04,P=0.238);the expression of IL-2 and IFN-γ were negatively correlated with trough concentration of CsA significantly(rIL-2=-0.384 3,P<0.001;rIFN-γ=-0.335 4,P<0.001). Using the average value of mRNA expression of IL-2 and IFN-γas indirect efficacy index,the polymorphism of PPP3CB rs3763679 site significantly in-fluenced the efficacy of CsA(P<0.05),but PPP3CA rs3804358 had no any effect on it(P>0.05). Stratified analysis showed that among patients with immune disease underwent renal transplantation,efficacy of patients with PPP3CB rs3763679 genovariation(TC+TT) were better than those with wild-type gene (CC)(P<0.05). After the efficacy was normalized by CsA trough concentration, multivariate analysis showed that normalized efficacy of CsA was negatively correlated with gender,PPP3CB rs3763679,lactate dehy-drogenase and creatinine significantly,but positively correlated with PPP3CA rs3804358,leucocyte count,usea nitrogen,glycerin trilaurate,etc. CONCLUSIONS:PPP3CB rs3763679 gene polymorphism influence the efficacy of CsA;among patients with immune disease underwent renal transplantation,efficacy of patients with PPP3CB rs3763679 TT+TC is better than that of CC type. At the same time,gender,PPP3CA rs3804358,leucocyte count,usea nitrogen,glycerin trilaurate and other factors all can influence the nor-malized efficacy of CsA to different extent. Multiple factors should be considered when using CsA.

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