1.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.
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.A non-human primate derived anti-P-selectin glycoprotein ligand-1 antibody curtails acute pancreatitis by alleviating the inflammatory responses.
Yuhan LI ; Xiangqing DING ; Xianxian WU ; Longfei DING ; Yuhui YANG ; Xiaoliang JIANG ; Xing LIU ; Xu ZHANG ; Jianrong SU ; Jianqing XU ; Zhiwei YANG
Acta Pharmaceutica Sinica B 2023;13(11):4461-4476
Acute pancreatitis (AP) is a devastating disease characterized by an inflammatory disorder of the pancreas. P-selectin glycoprotein ligand-1 (PSGL-1) plays a crucial role in the initial steps of the adhesive at process to inflammatory sites, blockade of PSGL-1 might confer potent anti-inflammatory effects. In this study, we generated two non-human primate derived monoclonal antibodies capable of efficiently targeting human PSGL-1, RH001-6 and RH001-22, which were screened from immunized rhesus macaques. We found that RH001-6, can effectively block the binding of P-selectin to PSGL-1, and abolish the adhesion of leukocytes to endothelial cells in vitro. In vivo, we verified that RH001-6 relieved inflammatory responses and pancreatic injury in both caerulein and l-arginine induced AP models. We also evaluated the safety profile after RH001-6 treatment in mice, and verified that RH001-6 did not cause any significant pathological damages in vivo. Taken together, we developed a novel non-human primate derived PSGL-1 blocking antibody with high-specificity, named RH001-6, which can interrupt the binding of PSGL-1 and P-selectin and attenuate inflammatory responses during AP. Therefore, RH001-6 is highly potential to be further developed into therapeutics against acute inflammatory diseases, such as AP.
5.Teaching reform and practice of bioengineering comprehensive experiment based on virtual simulation technology.
Bin DONG ; Tao WU ; Zhigang YAO ; Jun WANG ; Jianqing LI ; Wenjuan ZHAO ; Longxiang LIU ; Chunlong SUN ; Zhiwei SU ; Bin LIU
Chinese Journal of Biotechnology 2022;38(4):1671-1684
Bioengineering majors require students to acquire excellent abilities of thinking and analyzing complex problems and have high requirements for students' comprehensive practical skills. Because of the professional characteristics, it is necessary to develop students' abilities to solve complex problems via the teaching of a series of experiments. Therefore, it is particularly important to reform the traditional experiment teaching for students majoring in bioengineering to improve the teaching quality, which have great significance for the cultivation of comprehensive talents. In this study, with the advantages of geographical location and resources to cultivate application-oriented innovative talents, the course group of Comprehensive Experiment of Bioengineering has designed the course based on virtual simulation technology in Binzhou University. Taking the experiment of extraction and bioactivity analysis of Suaeda salsa (growing in the Yellow River Delta) polysaccharide in fermentation as a case, we studied the course design idea, experimental process, teaching method and result analysis, and have improved the teaching performance. This case analysis provides new ideas and content reference for the teaching reform of similar courses.
Bioengineering/education*
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Biomedical Engineering/education*
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Humans
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Students
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Technology
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Universities
6.Analysis of the prognostic factors for hospital-acquired pneumonia in elderly patients
Quan SHE ; Min LI ; Wen LIU ; Bo CHEN ; Jianqing WU
Chinese Journal of Geriatrics 2022;41(8):908-912
Objective:To explore the prognostic factors predicting the recovery of elderly patients with hospital-acquired pneumonia(HAP).Methods:Data of HAP inpatients aged over 60 years in the First Affiliated Hospital of Nanjing Medical University between October 2015 and October 2020 were collected.Body mass index(BMI), neutrophil/lymphocyte rate(NLR), Charlson Comorbidity Index(CCI), Combined Comorbidity Score(CCS)and other data were retrospectively analyzed.The predictive value of the related factors was evaluated by using the Student's t test, the Logistic regression model and the receiver operating characteristic curve(ROC). Results:A total of 200 cases were enrolled in this study, and grouped into survival group(n=158)and death group(n=42). There were significant differences between the death group and the survival group in length of age, BMI hospital stay, state of consciousness, swallowing function, indwelling gastric tube, the use of proton pump inhibitors, leukocyte count, lymphocyte count, neutrophil count, hemoglobin, NLR, albumin, alanine aminotransferase, aspartate aminotransferase, D-dimer, C-reaction protein, procalcitonin(all P<0.05). Scores of CCI and CCS were higher in the death group than in the survival group[(6.79±2.86) vs.(3.42±1.98), (6.21±3.08) vs.(1.66±1.94), t=-7.193, -9.116, both P<0.001]. Multivariate Logistic analysis showed that age>86 years( OR=1.155, 95% CI: 1.014-1.316), BMI<21.77 kg/m 2( OR=0.651, 95% CI: 0.480-0.883), neutrophil count>10.10×10 9/L( OR=1.208, 95% CI: 1.025-1.422), C-reaction protein>59.32 mg/L( OR=1.055, 95% CI: 1.018-1.093), CCS>6.21 scores( OR=2.859, 95% CI: 1.559-5.244)were risk factors for death inpatients aged 60 years and older with HAP.Area under the ROC curve showed that CCS could better predict the mortality of elderly patients than CCI, and the areas under the ROC curve were 0.831(95% CI: 0.753-0.909)and 0.898(95% CI: 0.850-0.946)respectively(both P< 0.001). Conclusions:The elderly patients with HAP are inclined to multiplecomplications and high mortality rates.Combined application of multiple assessment systems and clinical indicators can improve the ability to predict the outcome of HAP.
7.Addendum: A phase II trial of cytoreductive surgery combined with niraparib maintenance in platinum-sensitive, secondary recurrent ovarian cancer: SGOG SOC-3 study
Tingyan SHI ; Libing XIANG ; Jianqing ZHU ; Jihong LIU ; Ping ZHANG ; Huaying WANG ; Yanling FENG ; Tao ZHU ; Yingli ZHANG ; Aijun YU ; Wei JIANG ; Xipeng WANG ; Yaping ZHU ; Sufang WU ; Yincheng TENG ; Jiejie ZHANG ; Rong JIANG ; Wei ZHANG ; Huixun JIA ; Rongyu ZANG
Journal of Gynecologic Oncology 2022;33(4):e63-
8.New idea to promote the clinical applications of stem cells or their extracellular vesicles in central nervous system disorders: Combining with intranasal delivery.
Yaosheng LI ; Honghui WU ; Xinchi JIANG ; Yunfei DONG ; Juanjuan ZHENG ; Jianqing GAO
Acta Pharmaceutica Sinica B 2022;12(8):3215-3232
The clinical translation of stem cells and their extracellular vesicles (EVs)-based therapy for central nervous system (CNS) diseases is booming. Nevertheless, the insufficient CNS delivery and retention together with the invasiveness of current administration routes prevent stem cells or EVs from fully exerting their clinical therapeutic potential. Intranasal (IN) delivery is a possible strategy to solve problems as IN route could circumvent the brain‒blood barrier non-invasively and fit repeated dosage regimens. Herein, we gave an overview of studies and clinical trials involved with IN route and discussed the possibility of employing IN delivery to solve problems in stem cells or EVs-based therapy. We reviewed relevant researches that combining stem cells or EVs-based therapy with IN administration and analyzed benefits brought by IN route. Finally, we proposed possible suggestions to facilitate the development of IN delivery of stem cells or EVs.
9.Procedure and teaching verses of supraclavicular subclavian catheterization
Pingqing GUO ; Yilong WU ; Siming LIN ; Lei CHEN ; Congjuan LIN ; Xide CHEN ; Jianqing ZHENG ; Guangwei ZHENG ; Shaodan FENG ; Zhenlyu LIN ; Zhihong LIN
Chinese Critical Care Medicine 2021;33(6):755-756
In order to improve the success rate of supraclavicular deep venous catheterization and reduce mechanical complications, we present an auxillary maneuver in regard to supraclavicular subclavian catheterization basing on the relatively fixed anatomy of subclavian vein and its adjacent surroundings, furthermore, we revised the standardized procedure of supraclavicular subclavian catheterization. The maneuver is summarized in the shape of verses (verses: thumb navigation is well designed according to anatomy. Needle penetrated into vein should be parallel to coronal plane. Fine needle in position should be immobilized. Is it difficult for parallel puncture? Pressure determination is required when needle is in place. It is critical to distinguish which vessel has been inserted. Guidewire is advanced smoothly. Check blood return after expansion of skin and catheterization.). For teaching convenience, verses are considered to be more concise and memorable, as well as applicable to clinical practice, in order to provide some help for clinical teaching.
10.Application of simulation teaching method in promoting competency of undergraduate medical students of pediatrics
Liyuan HU ; Wenwei QIU ; Jianqing SHEN ; Wenhao ZHOU ; Jingyan WU
Chinese Journal of Medical Education Research 2021;20(8):922-925
In 2013, Shanghai Medical College of Fudan University restarted the enrollment of the undergraduate students in directional pediatrics. To cultivate medical talents in pediatrics, a serious of educational innovations and practices have been carried out guided by competency training, including training a team of teachers with simulated teaching skills and establishing a teaching platform for simulation teaching. Medical students can practice medicine and gain experience through the risk-free simulated scenarios, that is helpful to enhance their confidence in clinical skills and communications and decrease medical errors in their future careers.

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