1.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.
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.Analysis of factors influencing the medical insurance balance of hospitalization expenses for gastric cancer surgery patients under DRG payment
Yangyang FU ; Huaijun ZHU ; Xiaojie BIAN ; Yanqing GAO ; Qinghong ZHANG ; Liang TAO ; Wenxian GUAN
Chinese Journal of Hospital Administration 2023;39(5):326-331
Objective:To analyze the influencing factors of the medical insurance balance of hospitalization expenses for gastric cancer surgery patients under DRG payment, for reference for promoting the reform of DRG payment in public hospitals and controlling hospitalization expenses reasonably.Methods:The gastric cancer patients enrolled in the gastroenterology department of a tertiary comprehensive hospital from January to July 2022 were selected as the research subjects. The indicators such as patient age, medical insurance balance, hospitalization expenses and their composition were extracted from the hospital information management system and the medical insurance settlement system a certain city. Descriptive analysis was conducted for all data, and stepwise multiple linear regression was used to analyze the influencing factors of patients′ medical insurance balance. Monte Carlo simulation method was used to simulate different combination scenarios of various influencing factors to analyze the probability of medical insurance balance.Results:A total of 205 patients were contained, including 117 in the medical insurance balance group and 88 in the loss group. The difference in hospitalization expenses and medical insurance balance between the two groups of patients were statistically significant ( P<0.05). The intervention of medical insurance specialists, correct DRG enrollment, parenteral nutrition preparation costs, anti infective drug costs, examination costs, and consumables costs were the influencing factors of patient medical insurance balance ( P<0.05). Through Monte Carlo simulation verification, patients with different cost parenteral nutrition preparations, or different anti infective drug schemes had the higher probability of medical insurance balance in the scenario where the medical insurance commissioner intervenes and the DRG enrollment was correct. Conclusions:The hospital adopted interventions from medical insurance specialists to ensure the correct DRG enrollment of patients, accurate use of parenteral nutrition and anti infective drugs, and reasonable control the cost of examinations and consumables, which could increase the probability of medical insurance balance for gastric cancer surgery patients. In the future, hospitals should further promote the procurement of drug consumables in bulk, reduce unnecessary examinations, develop standardized perioperative nutritional interventions and anti infection treatment pathways, ensure the accuracy of DRG enrollment, optimize clinical diagnosis and treatment pathways to improve the efficiency of medical insurance fund utilization and provide high-quality medical services for patients.
6.Advances in clinical research on hypoglycemia after bariatric metabolic surgery
Chinese Journal of Endocrine Surgery 2023;17(6):641-644
Obesity has emerged as a significant public health concern with profound implications for human well-being. Bariatric metabolic surgery can significantly reduce the weight of patients with severe obesity and improve the related complications, and has been widely used in clinical practice. With the growth of surgical amount, the occurrence of postoperative hypoglycemia, in addition to surgery-related adverse events, has gradually attracted clinical attention. Post-bariatric hypoglycemia (PBH) occurs 6-12 months after bariatric metabolic surgery. It is characterized by blood glucose levels ≤2.8~3.3 mmol/L within 1-3 hours after a meal, accompanied by symptoms of sympathetic nervous system activation and even neuroglycopenic symptoms. Limited epidemiological investigations suggest that the prevalence of PBH ranges from 0.2% to 44.2%. Notably, severe and recurrent hypoglycemic events have deleterious implications for patients, significantly compromising their quality of life and posing a potential threat to their life safety. Consequently, the management of PBH warrants comprehensive clinical attention.
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.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*
;
China
;
Drug Monitoring/methods*
;
Polymyxin B
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Practice Guidelines as Topic
9.Development and Application of an Individualized Dosing-assisted Decision Platform for Vancomycin Based on Population Pharmacokinetic Model
Jing WANG ; Huaijun ZHU ; Zejun WU ; Yue SHEN ; Bin LI ; Huakai JING ; Shengpeng YANG ; Weihong GE
Chinese Journal of Modern Applied Pharmacy 2023;40(24):3423-3430
Abstract
OBJECTIVE To develop a vancomycin individualized dosing-assisted decision platform suitable for practical clinical application scenarios and provide individualized dosing recommendations for the rational use of vancomycin. METHODS Based on the vancomycin population pharmacokinetic model that had been constructed and verified to be feasible, the vancomycin individualized assisted decision-making platform was developed by using Idea2019, JDK1.8, ETL and other software tools. The platform development had gone through three main stages, included ①requirement analysis; ②design stage; ③software testing and optimization. RESULTS The vancomycin individualized assisted decision-making platform, which was successfully developed and applied, had the advantages of simple page, perfect function and convenient operation, and was divided into four main modules according to functions, namely retrieval module, information module, concentration prediction module and reporting module. The platform could connect to the hospital intranet platform to automatically obtain patient information, medication information and blood concentration test results, and calculate individual pharmacokinetic parameters for subsequent concentration prediction based on the embedded population pharmacokinetic model, combined with individual parameters. The concentration prediction module incorporated the Bayesian feedback method with patient medication information, drug concentration measurement results and relevant covariate parameter values, took the guideline-recommended trough concentration and AUC range as the target value, calculated the individualized drug administration scheme that met the target concentration range, and set up custom simulation functions considering the actual clinical application scenarios, which was of more popularization and application value. CONCLUSION Based on the vancomycin population pharmacokinetic model that has been successfully constructed in the previous stage, with the assistance of Idea2019, JDK1.8, ETL and other software tools, a vancomycin individualized dosing-assisted decision platform has successfully constructed, which can more efficiently and conveniently assist monitoring pharmacists to provide individualized dosing advice for clinical use of vancomycin.
10.Research progress on laboratory examination index of clinical prognosis in individualization of cyclosporine A
Jinwei HU ; Huaijun ZHU ; Qianying LAO ; Danying LI
China Pharmacy 2022;33(18):2285-2289
Cyclosporine A is widely used in organ transplantation and autoimmune diseases . Due to the obvious differences in metabolism between individuals ,the dosage should be adjusted according to the patient ’s blood concentration during clinical use . But the blood concentration does not reflect accurately its clinical prognosis . This article focuses on the four laboratory examination indexes following aspects :the cyclosporine A concentration of peripheral blood mononuclear cells ,calcineurin activity ,T cell function and metabolite concentration of cyclosporine A . The relationship between them and the pharmacokinetics of cyclosporine and clinical prognosis were reviewed . It’s found that the above indicators have a certain predictive effect on the clinical prognosis of patients receiving cyclosporine A ,which can make up for the insufficiency of blood drug concentration monitoring ,and the clinical practicability needs to be further improved .


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