1.Effects of strengthened nutritional interventions on pregnancy outcomes in Chinese women with gestational diabetes mellitus
Lu LIU ; Zhongxin HONG ; Jia WANG ; Bingjie DING ; Yanxia BI
Chinese Journal of Health Management 2015;9(6):413-417
Objective To explore the impacts of intensive nutritional intervention on maternal and infant outcomes in women with gestational diabetes mellitus(GDM). Methods From January 2014 to ecember 2014, a total of 518 women with GDM were stratified by age, height, body mass index (BMI), and were divided into treatment group (n=258) and control group (n=260) according to the random number generated by the computer software. Women in control group underwent conservative treatment while those in treatment group were given intensive nutritional intervention including keeping records of eating habits, measurement of blood glucose and regular follow-up. The incidence of pregnancy-related complications and newborn outcomes in both groups were compared. Results Women of the two groups were similar in basic clinical data. The range of gestational weight gain (GWG) [(12.2 ± 4.7) vs. (13.9 ± 5.0)kg] and birth weight of infants [(3 406.4±495.4) vs. (3 494.9±484.7)g] in the intervention group was significantly lower than those in the control group (P<0.01). The rate of reaching recommended target of GWG was significantly higher in the intervention group (60.9%) than in the control group (51.9%, χ2=4.2, P<0.05). There was a significant reduction in glucose-related parameters in both groups (P<0.01). In the intervention group, fasting blood glucose and postprandial blood glucose were reduced from (5.21 ± 0.71) mmol/L, (6.68 ± 0.90) mmol/L to (4.71 ± 0.73) mmol/L,(6.21 ± 0.71) mmol/L (P<0.01), respectively in comparison with the control group, the intervention group had lower incidence of cesarean section (44.6% vs. 53.8%), postpartum hemorrhage (2.3%vs. 6.2%), polyhydramnios (7.8%vs. 13.5%), neonatal hypoglycemia (3.1%vs. 6.5%) and macrosomia (8.1%vs. 13.8%, P<0.05). Conclusions Strengthening nutritional intervention in women with GDM could increase the rate of reaching recommended target of GWG, improve the glucose-related parameters and reduce the incidence rate of pregnancy complications.
2.Survival of Cancer Patients in Northeast China: Analysis of Sampled Cancers from Population-Based Cancer Registries.
Yanxia LI ; Liya YU ; Jun NA ; Shuang LI ; Li LIU ; Huijuan MU ; Xuanjuan BI ; Xiaoxia AN ; Xun LI ; Wen DONG ; Guowei PAN
Cancer Research and Treatment 2017;49(4):1106-1113
PURPOSE: The cancer survival was characterized by following up sampled subgroups of cancer cases from three population-based cancer registries in Northeast China. MATERIALS AND METHODS: Survival analysis was used to analyze 6,871 patients, who had one of the 21 most common cancers based on sampling from the population-based cancer registries of three cities in Liaoning Province. All patients were diagnosed between 2000 and 2002 and were followed up to the end of 2007 by active and passive methods. The 5-year age standardized relative survival rates (ASRS) were estimated for all cancers combined and each of the 21 individual cancers. RESULTS: The survival status was traced for 80.8% of 8,506 sampled cancer cases. The 5-year ASRS for all 21 cancers combined was 41.5% (95% confidence interval, 40.3 to 42.7), the highest ASRS was observed for thyroid cancer (85.2%), breast cancer (78.9%), uterine corpus cancer (75.9%), and urinary bladder cancer (70.2%); the lowest 5-year ASRS was noted in pancreatic cancer (8.8%), liver cancer (11.0%), esophageal cancer (18.8), and lung cancer (19.6%). The cancer survival rates in Liaoning cities were similar to those of urban areas in mainland China, but significantly lower than those in Hong Kong, Korea, and Japan. CONCLUSION: The strikingly poor cancer survival rates in three cities of Liaoning Province and in other places in China highlight the need for urgent investment in cancer prevention, early detection, and standardized and centralized treatment.
Breast Neoplasms
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China*
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Esophageal Neoplasms
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Hong Kong
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Humans
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Investments
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Japan
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Korea
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Liver Neoplasms
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Lung Neoplasms
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Pancreatic Neoplasms
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Registries*
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Survival Rate
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Thyroid Neoplasms
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Urinary Bladder Neoplasms
3.Pyrotinib Combined with Vinorelbine in Patients with Previously Treated HER2-Positive Metastatic Breast Cancer: A Multicenter, Single-Arm, Prospective Study
Kuikui JIANG ; Ruoxi HONG ; Wen XIA ; Qianyi LU ; Liang LI ; Jianhao HUANG ; Yanxia SHI ; Zhongyu YUAN ; Qiufan ZHENG ; Xin AN ; Cong XUE ; Jiajia HUANG ; Xiwen BI ; Meiting CHEN ; Jingmin ZHANG ; Fei XU ; Shusen WANG
Cancer Research and Treatment 2024;56(2):513-521
Purpose:
This study aims to evaluate the efficacy and safety of a new combination treatment of vinorelbine and pyrotinib in human epidermal growth factor receptor 2 (HER2)–positive metastatic breast cancer (MBC) and provide higher level evidence for clinical practice.
Materials and Methods:
This was a prospective, single-arm, phase 2 trial conducted at three institutions in China. Patients with HER2-positive MBC, who had previously been treated with trastuzumab plus a taxane or trastuzumab plus pertuzumab combined with a chemotherapeutic agent, were enrolled between March 2020 and December 2021. All patients received pyrotinib 400 mg orally once daily plus vinorelbine 25 mg/m2 intravenously or 60-80 mg/m2 orally on day 1 and day 8 of 21-day cycle. The primary endpoint was progression-free survival (PFS), and the secondary endpoints included the objective response rate (ORR), disease control rate (DCR), overall survival, and safety.
Results:
A total of 39 patients were enrolled. All patients had been pretreated with trastuzumab and 23.1% (n=9) of them had accepted trastuzumab plus pertuzumab. The median follow-up time was 16.3 months (95% confidence interval [CI], 5.3 to 27.2), and the median PFS was 6.4 months (95% CI, 4.0 to 8.8). The ORR was 43.6% (95% CI, 27.8% to 60.4%) and the DCR was 84.6% (95% CI, 69.5% to 94.1%). The median PFS of patients with versus without prior pertuzumab treatment was 4.6 and 8.3 months (p=0.017). The most common grade 3/4 adverse events were diarrhea (28.2%), neutrophil count decreased (15.4%), white blood cell count decreased (7.7%), vomiting (5.1%), and anemia (2.6%).
Conclusion
Pyrotinib plus vinorelbine showed promising efficacy and tolerable toxicity as second-line treatment in patients with HER2-positive MBC.
4.Cost-effectiveness of primary prophylaxis with PEG-rhG-CSF in early-stage breast cancer patients receiving chemotherapy in China
Wen XIA ; Shusen WANG ; Hao HU ; Feili ZHAO ; Fei XU ; Ruoxi HONG ; Kuikui JIANG ; Zhongyu YUAN ; Yanxia SHI ; Kun ZHAO ; Jiajia HUANG ; Cong XUE ; Xiwen BI ; Qianyi LU ; Xin AN ; Jingmin ZHANG
Chinese Journal of Oncology 2020;42(10):861-867
Objective:To evaluate the cost effectiveness of primary prophylaxis (PP) with pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF), PP with recombinant human granulocyte colony stimulating factor (rhG-CSF) and no prophylaxis in women with early-stage breast cancer in China.Methods:Two phase Markov models were constructed for a hypothetical cohort of patients aged 45 with stage Ⅱ breast cancer. The first phase modelled costs and outcomes of 4 cycles docetaxel combined with cyclophosphamide [TC×4, febrile neutropenia (FN) risk>20%] chemotherapy, which assumptions based on literature reviews, including FN rates [base-case (deterministic sensitivity analysis range), 0.29 (0.24-0.35)] and related events [FN case-fatality, 3.4 (2.7-4.1)]. Second phase modelled the long term survival which was link with the relative dose intensity (RDI) [mortality hazard ratio ( HR) of RDI < 85% vs ≥85%, 1.45 (1.00-2.32)]. Clinical effectiveness, therapeutic costs, and economic utilities were estimated from peer-reviewed publications and expert opinions in case of unavailability of published evidences. Results:Compared to rhG-CSF PP and no prophylaxis, the cost of PEG-rhG-CSF PP increased to 5 208.19 RMB and 5 222.73 RMB, respectively. The quality-adjusted life-years (QALYs) enhanced to 0.066 and 0.297, respectively. Accordingly, the incremental cost effectiveness ratios (ICERs) are 79 146.3 RMB and 17 558.77 RMB per QALY, which were both below the willingness to pay (WTP) threshold of three times GDP per capita (18, 000 RMB) recommended by the WHO. Sensitivity analysis suggested that the more clinically effective the primary prophylaxis with PEG-rhG-CSF is, the more cost-effective primary prophylaxis with PEG-rhG-CSF will be. And the lower the mortality HR of RDI<85% vs ≥85% is, the more cost-effective primary prophylaxis with PEG-rhG-CSF will be. Conclusion:Although the cost of PP PEG-rhG-CSF is higher, considering the additional benefits, the administrating of PP PEG-rhG-CSF is likely to be a cost-effective alternative to PP rhG-CSF and no prophylaxis in patients with early stage breast cancer whose FN risks are more than 20% in China.
5.Cost-effectiveness of primary prophylaxis with PEG-rhG-CSF in early-stage breast cancer patients receiving chemotherapy in China
Wen XIA ; Shusen WANG ; Hao HU ; Feili ZHAO ; Fei XU ; Ruoxi HONG ; Kuikui JIANG ; Zhongyu YUAN ; Yanxia SHI ; Kun ZHAO ; Jiajia HUANG ; Cong XUE ; Xiwen BI ; Qianyi LU ; Xin AN ; Jingmin ZHANG
Chinese Journal of Oncology 2020;42(10):861-867
Objective:To evaluate the cost effectiveness of primary prophylaxis (PP) with pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF), PP with recombinant human granulocyte colony stimulating factor (rhG-CSF) and no prophylaxis in women with early-stage breast cancer in China.Methods:Two phase Markov models were constructed for a hypothetical cohort of patients aged 45 with stage Ⅱ breast cancer. The first phase modelled costs and outcomes of 4 cycles docetaxel combined with cyclophosphamide [TC×4, febrile neutropenia (FN) risk>20%] chemotherapy, which assumptions based on literature reviews, including FN rates [base-case (deterministic sensitivity analysis range), 0.29 (0.24-0.35)] and related events [FN case-fatality, 3.4 (2.7-4.1)]. Second phase modelled the long term survival which was link with the relative dose intensity (RDI) [mortality hazard ratio ( HR) of RDI < 85% vs ≥85%, 1.45 (1.00-2.32)]. Clinical effectiveness, therapeutic costs, and economic utilities were estimated from peer-reviewed publications and expert opinions in case of unavailability of published evidences. Results:Compared to rhG-CSF PP and no prophylaxis, the cost of PEG-rhG-CSF PP increased to 5 208.19 RMB and 5 222.73 RMB, respectively. The quality-adjusted life-years (QALYs) enhanced to 0.066 and 0.297, respectively. Accordingly, the incremental cost effectiveness ratios (ICERs) are 79 146.3 RMB and 17 558.77 RMB per QALY, which were both below the willingness to pay (WTP) threshold of three times GDP per capita (18, 000 RMB) recommended by the WHO. Sensitivity analysis suggested that the more clinically effective the primary prophylaxis with PEG-rhG-CSF is, the more cost-effective primary prophylaxis with PEG-rhG-CSF will be. And the lower the mortality HR of RDI<85% vs ≥85% is, the more cost-effective primary prophylaxis with PEG-rhG-CSF will be. Conclusion:Although the cost of PP PEG-rhG-CSF is higher, considering the additional benefits, the administrating of PP PEG-rhG-CSF is likely to be a cost-effective alternative to PP rhG-CSF and no prophylaxis in patients with early stage breast cancer whose FN risks are more than 20% in China.