OBJECTIVE:To further evaluate the complementary effect of Yiqi Huoxue Jiedu decoction(YHJD)on patients with advanced epithelial ovarian cancer(EOC).METHODS:All 330 enrolled participants diagnosed with stageⅢc EOC wer...OBJECTIVE:To further evaluate the complementary effect of Yiqi Huoxue Jiedu decoction(YHJD)on patients with advanced epithelial ovarian cancer(EOC).METHODS:All 330 enrolled participants diagnosed with stageⅢc EOC were randomly divided into two groups that received YHJD or a placebo.The primary end point was health-related quality of life(HRQL)measured by the functional assessment of cancer therapy-ovary cancer(FACT-O)questionnaire.The secondary end point was progression-free survival(PFS).RESULTS:A total of 299 participants completed the trial with 153 and 146 in YHJD and control groups,respectively.After 6 months of treatment,YHJD increased physical wellbeing(PWB),functional wellbeing(FWB),additional concerns(AC),and the trial outcome index(TOI)(P<0.05)by various degrees compared with the baseline.YHJD also had notable advantages over the placebo at 3 and 6 months in terms of PWB,FWB,AC(P<0.05),and TOI(P<0.01).In addition,YHJD had a significant advantage in terms of PFS compared with the placebo(21 vs18 months,P<0.05).No adverse events were reported.CONCLUSION:YHJD is an effective and safe choice as a complementary therapy to improve HRQL and prolong PFS of stageⅢc EOC patients.展开更多
基金Supported by National Natural Science Foundation of China(NSFC)-funded Project:the Mechanisms of Tailored Immunotherapy of Yiqi Huoxue Jiedu Decoction Modulating T Regulatory Cells at the Level of the Tumor Microenvironment and Inherited Single Nucleotide Polymorphisms in Advanced Ovarian Cancer(No.81473566).
文摘OBJECTIVE:To further evaluate the complementary effect of Yiqi Huoxue Jiedu decoction(YHJD)on patients with advanced epithelial ovarian cancer(EOC).METHODS:All 330 enrolled participants diagnosed with stageⅢc EOC were randomly divided into two groups that received YHJD or a placebo.The primary end point was health-related quality of life(HRQL)measured by the functional assessment of cancer therapy-ovary cancer(FACT-O)questionnaire.The secondary end point was progression-free survival(PFS).RESULTS:A total of 299 participants completed the trial with 153 and 146 in YHJD and control groups,respectively.After 6 months of treatment,YHJD increased physical wellbeing(PWB),functional wellbeing(FWB),additional concerns(AC),and the trial outcome index(TOI)(P<0.05)by various degrees compared with the baseline.YHJD also had notable advantages over the placebo at 3 and 6 months in terms of PWB,FWB,AC(P<0.05),and TOI(P<0.01).In addition,YHJD had a significant advantage in terms of PFS compared with the placebo(21 vs18 months,P<0.05).No adverse events were reported.CONCLUSION:YHJD is an effective and safe choice as a complementary therapy to improve HRQL and prolong PFS of stageⅢc EOC patients.
