1.Evaluation of secondary cytoreduction surgery in platinum-resistant ovarian cancer patients within three-line recurrent: a multicenter, randomized controlled study
Tingting CHEN ; Junfen XU ; Bairong XIA ; Hui WANG ; Yuanming SHEN
Journal of Gynecologic Oncology 2024;35(1):e22-
Background:
Epithelial ovarian cancer is the leading cause of death among gynecological malignancies. Platinum resistance remains a dilemma and bottleneck in treatment, and salvage chemotherapy has limited effectiveness. Recently, the role of secondary cytoreductive surgery (SCS) in patients with platinum-resistant recurrent ovarian cancer (ROC) has caused attention especially in patients with oligometastases. However, there is neither high-quality evidence-based evidence nor standardized criteria for selecting SCS for patients with platinum-resistant ROC until now.
Methods
This multicenter, randomized, controlled clinical trial is to evaluate the value of SCS and to clarify reliable criteria of utilizing SCS in women with ROC, which is led by Gynecologic Oncology Group, Women’s Hospital, Zhejiang University School of Medicine.Recruitment has started on January 1st, 2023, and is scheduled to end in December 2026.One hundred and forty participants with platinum-resistant ROC who meet the “RSCS criteria” will be randomized assigned at a ratio of 1:1 to either the experimental arm or the standard arm. Patients in the experimental arm will receive SCS followed by non-platinum single agent chemotherapy (paclitaxel, gemcitabine or liposomal adriamycin) for at least 4 cycles while patients in the standard arm will be provided with only non-platinum single agent chemotherapy. The primary outcome is progression-free survival. The secondary outcomes are overall survival, adverse events and health-related cancer-specific quality of life.
2.Evaluation of secondary cytoreduction surgery in platinum-resistant ovarian cancer patients within three-line recurrent: a multicenter, randomized controlled study
Tingting CHEN ; Junfen XU ; Bairong XIA ; Hui WANG ; Yuanming SHEN
Journal of Gynecologic Oncology 2024;35(1):e22-
Background:
Epithelial ovarian cancer is the leading cause of death among gynecological malignancies. Platinum resistance remains a dilemma and bottleneck in treatment, and salvage chemotherapy has limited effectiveness. Recently, the role of secondary cytoreductive surgery (SCS) in patients with platinum-resistant recurrent ovarian cancer (ROC) has caused attention especially in patients with oligometastases. However, there is neither high-quality evidence-based evidence nor standardized criteria for selecting SCS for patients with platinum-resistant ROC until now.
Methods
This multicenter, randomized, controlled clinical trial is to evaluate the value of SCS and to clarify reliable criteria of utilizing SCS in women with ROC, which is led by Gynecologic Oncology Group, Women’s Hospital, Zhejiang University School of Medicine.Recruitment has started on January 1st, 2023, and is scheduled to end in December 2026.One hundred and forty participants with platinum-resistant ROC who meet the “RSCS criteria” will be randomized assigned at a ratio of 1:1 to either the experimental arm or the standard arm. Patients in the experimental arm will receive SCS followed by non-platinum single agent chemotherapy (paclitaxel, gemcitabine or liposomal adriamycin) for at least 4 cycles while patients in the standard arm will be provided with only non-platinum single agent chemotherapy. The primary outcome is progression-free survival. The secondary outcomes are overall survival, adverse events and health-related cancer-specific quality of life.
3.Evaluation of secondary cytoreduction surgery in platinum-resistant ovarian cancer patients within three-line recurrent: a multicenter, randomized controlled study
Tingting CHEN ; Junfen XU ; Bairong XIA ; Hui WANG ; Yuanming SHEN
Journal of Gynecologic Oncology 2024;35(1):e22-
Background:
Epithelial ovarian cancer is the leading cause of death among gynecological malignancies. Platinum resistance remains a dilemma and bottleneck in treatment, and salvage chemotherapy has limited effectiveness. Recently, the role of secondary cytoreductive surgery (SCS) in patients with platinum-resistant recurrent ovarian cancer (ROC) has caused attention especially in patients with oligometastases. However, there is neither high-quality evidence-based evidence nor standardized criteria for selecting SCS for patients with platinum-resistant ROC until now.
Methods
This multicenter, randomized, controlled clinical trial is to evaluate the value of SCS and to clarify reliable criteria of utilizing SCS in women with ROC, which is led by Gynecologic Oncology Group, Women’s Hospital, Zhejiang University School of Medicine.Recruitment has started on January 1st, 2023, and is scheduled to end in December 2026.One hundred and forty participants with platinum-resistant ROC who meet the “RSCS criteria” will be randomized assigned at a ratio of 1:1 to either the experimental arm or the standard arm. Patients in the experimental arm will receive SCS followed by non-platinum single agent chemotherapy (paclitaxel, gemcitabine or liposomal adriamycin) for at least 4 cycles while patients in the standard arm will be provided with only non-platinum single agent chemotherapy. The primary outcome is progression-free survival. The secondary outcomes are overall survival, adverse events and health-related cancer-specific quality of life.
4.Efficacy and Safety of Compound Danshen Dripping Pills Combined with Conventional Western Medicine in the Treatment of Coronary Heart Disease Complicated with Diabetes Mellitus:A Meta-Analysis
Bairong XU ; Jing TIAN ; Dong NIU ; Zuoying XING ; Boyong QIU ; Yongxia WANG
Traditional Chinese Drug Research & Clinical Pharmacology 2024;35(2):280-290
Objective To systematically evaluate the efficacy and safety of Compound Danshen Dripping Pills combined with conventional western medicine in the treatment of coronary heart disease complicated with diabetes mellitus.Methods Wanfang database,CNKI,VIP,SinoMed,Cochrane Library,PubMed,Embase and Web of Science databases were searched to collect randomized controlled trials(RCTs)of Compound Danshen dripping pills combined with conventional western medicine in the treatment of coronary heart disease complicated with diabetes mellitus.The retrieval time is from the establishment of the database to May 2023.Two researchers independently completed literature screening,data collation and risk of bias evaluation.RevMan 5.4 software was used for Meta-analysis.Results Twenty-four RCTs with a total of 2 546 patients were included.Meta-analysis showed that the treatment of Compound Danshen Dripping Pills combined with conventional western medicine was better than that of conventional western medicine in improving the total effective rate of coronary heart disease complicated with diabetes mellitus[OR=4.93,95%CI(3.49,6.98),P<0.000 01],plasma adiponectin[MD= 2.79,95%CI(2.30,3.27),P<0.000 01],reducing fasting blood glucose[SMD=-1.06,95%CI(-1.24,-0.88),P<0.000 01],postprandial two-hour blood glucose[MD=-1.53,95%CI(-1.71,-1.35),P<0.000 01],glycosylated hemoglobin[MD=-1.56,95%CI(-2.01,-1.11),P<0.000 01],homocysteine[MD=-8.47,95%CI(-8.89,-7.97),P<0.000 01],low density lipoprotein[MD=-0.46,95%CI(-0.69,-0.24),P<0.000 01],total cholesterol[MD=-0.45,95%CI(-1.11,-0.20),P=0.005],triglycerides[MD=-0.42,95%CI(-0.50,-0.34),P<0.000 01],interleukin 6[SMD=-1.34,95%CI(-1.61,-1.07),P<0.000 01],cardiovascular adverse events[OR=0.35,95%CI(0.19,0.64),P=0.000 6],incidence of adverse reactions[OR=0.45,95%CI(0.24,0.86),P=0.01].Conclusion Compound Danshen Dripping Pills combined with conventional western medicine in the treatment of coronary heart disease with diabetes mellitus is more effective than conventional western medicine treatment,and with better safety.However,due to the limit of the quality of the included studies and other factors,the above conclusions still need to be verified by more high-quality clinical trials.