1.Expert Consensus on Clinical Application of Qinbaohong Zhike Oral Liquid in Treatment of Acute Bronchitis and Acute Attack of Chronic Bronchitis
Jian LIU ; Hongchun ZHANG ; Chengxiang WANG ; Hongsheng CUI ; Xia CUI ; Shunan ZHANG ; Daowen YANG ; Cuiling FENG ; Yubo GUO ; Zengtao SUN ; Huiyong ZHANG ; Guangxi LI ; Qing MIAO ; Sumei WANG ; Liqing SHI ; Hongjun YANG ; Ting LIU ; Fangbo ZHANG ; Sheng CHEN ; Wei CHEN ; Hai WANG ; Lin LIN ; Nini QU ; Lei WU ; Dengshan WU ; Yafeng LIU ; Wenyan ZHANG ; Yueying ZHANG ; Yongfen FAN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(4):182-188
The Expert Consensus on Clinical Application of Qinbaohong Zhike Oral Liquid in Treatment of Acute Bronchitis and Acute Attack of Chronic Bronchitis (GS/CACM 337-2023) was released by the China Association of Chinese Medicine on December 13th, 2023. This expert consensus was developed by experts in methodology, pharmacy, and Chinese medicine in strict accordance with the development requirements of the China Association of Chinese Medicine (CACM) and based on the latest medical evidence and the clinical medication experience of well-known experts in the fields of respiratory medicine (pulmonary diseases) and pediatrics. This expert consensus defines the application of Qinbaohong Zhike oral liquid in the treatment of cough and excessive sputum caused by phlegm-heat obstructing lung, acute bronchitis, and acute attack of chronic bronchitis from the aspects of applicable populations, efficacy evaluation, usage, dosage, drug combination, and safety. It is expected to guide the rational drug use in medical and health institutions, give full play to the unique value of Qinbaohong Zhike oral liquid, and vigorously promote the inheritance and innovation of Chinese patent medicines.
2.Phase Ⅲ, multicenter, randomized comparative study of LY01005 and Zoladex ? for patients with premenopausal breast cancer
Xiying SHAO ; Qingyuan ZHANG ; Zhaofeng NIU ; Man LI ; Jingfen WANG ; Zhanhong CHEN ; Ruizhen LUO ; Guangdong QIAO ; Jianguo WANG ; Liyuan QIAN ; Ronghua YANG ; Zhendong CHEN ; Jian WANG ; Yumin YAO ; Jianghua OU ; Tao SUN ; Qiao CHENG ; Yongsheng WANG ; Jian HUANG ; Hongying ZHAO ; Wuyun SU ; Zhong OUYANG ; Yu DING ; Lilin CHEN ; Sumei YANG ; Mengsheng CUI ; Aimin ZANG ; Enxiang ZHOU ; Peizhi FAN ; Jing ZHANG ; Qiang LIU ; Yuee TENG ; Hui LI ; Jianyun NIE ; Jin YANG ; Xiaojia WANG ; Zefei JIANG
Chinese Journal of Oncology 2025;47(4):340-348
Background:To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex ? in Chinese patients with premenopausal breast cancer. Methods:From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex ? every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results:A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex ?. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex ?. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex ? group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion:LY01005 is as effective as Zoladex ? in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.
3.Effectiveness and safety analysis of camrelizumab combined with chemotherapy and targeted therapy in patients with recurrent,metastatic,and treatment-naive advanced cervical cancer:a retrospective cohort study
Sumei FAN ; Congling XIN ; Laifang ZHU ; Chang LIU ; Rui XU ; Zhengrong ZHOU ; Xi CHENG
China Oncology 2025;35(6):570-577
Background and purpose:The treatment of recurrent,metastatic,and treatment-na?ve advanced cervical cancer remains challenging.Immunotherapy in combination with chemotherapy and targeted therapy has shown preliminary clinical benefits,however,current evidence remains limited.This study aimed to evaluate the impact of camrelizumab combined with chemotherapy and targeted therapy on the prognosis of patients with recurrent,metastatic,and treatment-na?ve advanced cervical cancer.Methods:In this study,we conducted a retrospective analysis of the clinical data from 130 patients with recurrent,metastatic,and treatment-na?ve advanced cervical cancer admitted to Minhang Branch of Fudan University Shanghai Cancer Center from 2019 to 2025.The patients were categorized into the observation group(n=70),which included those who received camrelizumab with or without chemotherapy and targeted therapy,and the control group(n=60),including those who received chemotherapy and targeted therapy.Survival analysis was performed using the log-rank test,and univariate and multivariate Cox regression analyses were conducted to explore prognostic factors.This study was approved by the Ethics Committee of the Minhang Branch of Fudan University Shanghai Cancer Center[Approval number:(2024)Review No.(015)]and all informed consents were exempted.Results:The objective response rate(ORR)in the observation group was 72.9%,and the disease control rate(DCR)was 80.0%,which were significantly higher than those in the control group with an ORR of 20.0%(χ2=36.1,P<0.001)and a DCR of 40.0%(χ2=21.8,P<0.001).The median progression-free survival(PFS)in the observation group was not reached,significantly longer than that in the control group of 7.0 months(P<0.001).Multivariate Cox regression analysis identified camrelizumab treatment as an independent protective factor for PFS(P<0.001).Age,site of recurrence/metastasis,initial treatment approach,and histopathological type were not significantly associated with PFS.In the observation group,adverse events of grade 3 or higher were reported in 29 patients(41.4%),which primarily included vasculitis,hypothyroidism,hypersensitivity reactions,and diarrhea.Conclusion:The use of camrelizumab significantly improved treatment outcomes and prognosis for patients with recurrent,metastatic,and treatment-na?ve advanced cervical cancer,with significantly improved progression-free survival.Although a certain proportion of patients experienced adverse events of grade 3 or higher,the overall safety profile was acceptable.In clinical practice,immunotherapy offers a more effective treatment option for patients.
4.Effectiveness and safety analysis of camrelizumab combined with chemotherapy and targeted therapy in patients with recurrent,metastatic,and treatment-naive advanced cervical cancer:a retrospective cohort study
Sumei FAN ; Congling XIN ; Laifang ZHU ; Chang LIU ; Rui XU ; Zhengrong ZHOU ; Xi CHENG
China Oncology 2025;35(6):570-577
Background and purpose:The treatment of recurrent,metastatic,and treatment-na?ve advanced cervical cancer remains challenging.Immunotherapy in combination with chemotherapy and targeted therapy has shown preliminary clinical benefits,however,current evidence remains limited.This study aimed to evaluate the impact of camrelizumab combined with chemotherapy and targeted therapy on the prognosis of patients with recurrent,metastatic,and treatment-na?ve advanced cervical cancer.Methods:In this study,we conducted a retrospective analysis of the clinical data from 130 patients with recurrent,metastatic,and treatment-na?ve advanced cervical cancer admitted to Minhang Branch of Fudan University Shanghai Cancer Center from 2019 to 2025.The patients were categorized into the observation group(n=70),which included those who received camrelizumab with or without chemotherapy and targeted therapy,and the control group(n=60),including those who received chemotherapy and targeted therapy.Survival analysis was performed using the log-rank test,and univariate and multivariate Cox regression analyses were conducted to explore prognostic factors.This study was approved by the Ethics Committee of the Minhang Branch of Fudan University Shanghai Cancer Center[Approval number:(2024)Review No.(015)]and all informed consents were exempted.Results:The objective response rate(ORR)in the observation group was 72.9%,and the disease control rate(DCR)was 80.0%,which were significantly higher than those in the control group with an ORR of 20.0%(χ2=36.1,P<0.001)and a DCR of 40.0%(χ2=21.8,P<0.001).The median progression-free survival(PFS)in the observation group was not reached,significantly longer than that in the control group of 7.0 months(P<0.001).Multivariate Cox regression analysis identified camrelizumab treatment as an independent protective factor for PFS(P<0.001).Age,site of recurrence/metastasis,initial treatment approach,and histopathological type were not significantly associated with PFS.In the observation group,adverse events of grade 3 or higher were reported in 29 patients(41.4%),which primarily included vasculitis,hypothyroidism,hypersensitivity reactions,and diarrhea.Conclusion:The use of camrelizumab significantly improved treatment outcomes and prognosis for patients with recurrent,metastatic,and treatment-na?ve advanced cervical cancer,with significantly improved progression-free survival.Although a certain proportion of patients experienced adverse events of grade 3 or higher,the overall safety profile was acceptable.In clinical practice,immunotherapy offers a more effective treatment option for patients.
5.Phase Ⅲ, multicenter, randomized comparative study of LY01005 and Zoladex ? for patients with premenopausal breast cancer
Xiying SHAO ; Qingyuan ZHANG ; Zhaofeng NIU ; Man LI ; Jingfen WANG ; Zhanhong CHEN ; Ruizhen LUO ; Guangdong QIAO ; Jianguo WANG ; Liyuan QIAN ; Ronghua YANG ; Zhendong CHEN ; Jian WANG ; Yumin YAO ; Jianghua OU ; Tao SUN ; Qiao CHENG ; Yongsheng WANG ; Jian HUANG ; Hongying ZHAO ; Wuyun SU ; Zhong OUYANG ; Yu DING ; Lilin CHEN ; Sumei YANG ; Mengsheng CUI ; Aimin ZANG ; Enxiang ZHOU ; Peizhi FAN ; Jing ZHANG ; Qiang LIU ; Yuee TENG ; Hui LI ; Jianyun NIE ; Jin YANG ; Xiaojia WANG ; Zefei JIANG
Chinese Journal of Oncology 2025;47(4):340-348
Background:To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex ? in Chinese patients with premenopausal breast cancer. Methods:From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex ? every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results:A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex ?. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex ?. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex ? group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion:LY01005 is as effective as Zoladex ? in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.
6.Long-term efficacy and safety analysis of vedolizumab in the treatment of moderate to severe ulcerative colitis: a single-center retrospective observational study
Haitao SHI ; Sumei SHA ; Qiang LI ; Qing FAN ; Yan WANG ; Xin LIU
Chinese Journal of Inflammatory Bowel Diseases 2024;08(4):274-277
Objective:To evaluate the long-term efficacy and safety of vedolizumab (VDZ) in the treatment of patients with moderate to severe ulcerative colitis (UC) .Methods:Clinical data of patients with moderate to severe active UC receiving VDZ treatment for more than 52 weeks at the Department of Gastroenterology of the Second Affiliated Hospital of Xi′an Jiaotong University from February 2021 to April 2023 were retrospectively collected. The observation indexes were clinical response rate, clinical remission rate, endoscopic mucosal healing rate and adverse events after 52 weeks of treatment.Results:A total of 21 patients with moderate to severe UC with complete data were included in this study, including 17 moderate and 4 severe patients with a mean age of (44.2±14.3) years, 17 males and 4 females, and a disease duration of 60 (36, 103) months. The clinical response rate, clinical remission rate, and endoscopic mucosal healing rate at week 52 were 85.7% (18/21) , 76.2% (16/21) and 71.4% (15/21) respectively. Of the 21 patients, 2 (9.5%) had increased transaminases, 5 (23.8%) had clostridium difficile infection and 1 (4.8%) had intestinal EBV infection, with no other adverse effects. Conclusion:VDZ has favorable long-term efficacy and safety in patients with moderate to severe active UC.
7.Long-term efficacy and safety analysis of vedolizumab in the treatment of moderate to severe ulcerative colitis: a single-center retrospective observational study
Haitao SHI ; Sumei SHA ; Qiang LI ; Qing FAN ; Yan WANG ; Xin LIU
Chinese Journal of Inflammatory Bowel Diseases 2024;08(4):274-277
Objective:To evaluate the long-term efficacy and safety of vedolizumab (VDZ) in the treatment of patients with moderate to severe ulcerative colitis (UC) .Methods:Clinical data of patients with moderate to severe active UC receiving VDZ treatment for more than 52 weeks at the Department of Gastroenterology of the Second Affiliated Hospital of Xi′an Jiaotong University from February 2021 to April 2023 were retrospectively collected. The observation indexes were clinical response rate, clinical remission rate, endoscopic mucosal healing rate and adverse events after 52 weeks of treatment.Results:A total of 21 patients with moderate to severe UC with complete data were included in this study, including 17 moderate and 4 severe patients with a mean age of (44.2±14.3) years, 17 males and 4 females, and a disease duration of 60 (36, 103) months. The clinical response rate, clinical remission rate, and endoscopic mucosal healing rate at week 52 were 85.7% (18/21) , 76.2% (16/21) and 71.4% (15/21) respectively. Of the 21 patients, 2 (9.5%) had increased transaminases, 5 (23.8%) had clostridium difficile infection and 1 (4.8%) had intestinal EBV infection, with no other adverse effects. Conclusion:VDZ has favorable long-term efficacy and safety in patients with moderate to severe active UC.
8.The GRACE risk score predicts no-reflow and MACE in patients with STEMI undergoing PCI
Zhaofei WAN ; Sumei ZHANG ; Yan FAN ; Xiaojun LIU ; Xinhong WANG ; Jiahong XUE ; Qiangsun ZHENG
Journal of Xi'an Jiaotong University(Medical Sciences) 2023;44(2):251-256
【Objective】 Coronary no-reflow during percutaneous conranary intervention (PCI) often results in the failure of ischemic myocardial reperfusion and major adverse cardiovascular events (MACE). The present study sought to evaluate whether the GRACE risk score can predict coronary no-reflow in STEMI patients undergoing PCI. 【Methods】 We consecutively recruited 1 118 patients with STEMI who were admitted to Gansu Provincial People’s Hospital and The First Affiliated Hospital of Xi’an Jiaotong University from January 2009 to December 2011. Main demographic data, cardiovascular risk factors, blood lipid and other biochemical indicators were recorded. Coronary angiography was performed by a radial artery approach using the standard Judkins technique. Coronary no-reflow was evaluated by at least two independent experienced cardiologists. The GRACE risk score was calculated with a computer program. All the cases were followed up by medical records, face-to-face interviews or telephone calls. Finally, we analyzed the predictive value of the GRACE risk score for coronary non-reflow and MACE in STEMI patients undergoing PCI. 【Results】 During a median period of 36 months, 58 of the 1 118 patients (5.2%) were lost to follow-up. Of the remaining 1 060 patients, 118 (11.1%) had no-reflow and 147 (13.9%) had MACE. The GRACE score was higher in patients with no-reflow than those without no-reflow. Multivariate logistic regression established that the GRACE score was an independent predictor for coronary no-reflow (OR=1.034; P=0.002). And multivariate Cox analysis showed the GRACE score was an independent predictor of MACE. The area under the ROC curve for coronary no-reflow and MACE was 0.719 and 0.697, respectively. Kaplan-Meier analysis showed that the probability of rehospitalization for heart failure, reinfarction, all-cause death and cumulative cardiovascular events increased with the increase of the GRACE risk score. 【Conclusion】 The GRACE risk score is a readily available predictive scoring system for coronary no-reflow and MACE in STEMI patients.
9.Four cases of successful live birth after transferred with extremely low-grade cleavage-stage embryos on day 3 of IVF-ET and literature review
Yuanchang ZHU ; Sumei HOU ; Fan YANG ; Jingqian ZHOU ; Sheng WANG ; Feng WANG ; Minqing ZHU ; Weifen DENG
Chinese Journal of Reproduction and Contraception 2023;43(12):1264-1267
Objective:To explore the possible of clinical application value after transferred with day 3 extremely low-grade cleavage-stage embryos during in vitro fertilization and embryo transfer. Methods:The clinical outcomes of four cases with extremely low-grade cleavage-stage embryos on day 3 undergoing IVF-ET were retrospectively analyzed and the related literatures were reviewed.Results:Four cases successfully got pregnant after 12 days of transplantation of extremely low-grade embryos detected by human chorionic gonadotropin testing, and all of them were intrauterine singleton pregnancies. Finally these four patients had successful live births, and three of them were full-term delivery, one of them was delivery prematurely. All the babies were in the good health.Conclusion:There is still a degree of successful pregnancy and live birth rate after transferred with day 3 extremely low-grade cleavage-stage embryos. If the quality of all the embryos was extremely low-grade on day 3, we can provide new attempts and choices for the patients who were often giving up embryos transfer.
10.Four cases of successful live birth after transferred with extremely low-grade cleavage-stage embryos on day 3 of IVF-ET and literature review
Yuanchang ZHU ; Sumei HOU ; Fan YANG ; Jingqian ZHOU ; Sheng WANG ; Feng WANG ; Minqing ZHU ; Weifen DENG
Chinese Journal of Reproduction and Contraception 2023;43(12):1264-1267
Objective:To explore the possible of clinical application value after transferred with day 3 extremely low-grade cleavage-stage embryos during in vitro fertilization and embryo transfer. Methods:The clinical outcomes of four cases with extremely low-grade cleavage-stage embryos on day 3 undergoing IVF-ET were retrospectively analyzed and the related literatures were reviewed.Results:Four cases successfully got pregnant after 12 days of transplantation of extremely low-grade embryos detected by human chorionic gonadotropin testing, and all of them were intrauterine singleton pregnancies. Finally these four patients had successful live births, and three of them were full-term delivery, one of them was delivery prematurely. All the babies were in the good health.Conclusion:There is still a degree of successful pregnancy and live birth rate after transferred with day 3 extremely low-grade cleavage-stage embryos. If the quality of all the embryos was extremely low-grade on day 3, we can provide new attempts and choices for the patients who were often giving up embryos transfer.

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