OBJECTIVE: To evaluate the clinical efficacy and safety of Buzhongyiqi pills(BZYQP, 补中益气丸) in improving the appetite of patients with colorectal cancer(CRC) receiving chemotherapy. TRIAL DESIGN: A pilot, randomiz...OBJECTIVE: To evaluate the clinical efficacy and safety of Buzhongyiqi pills(BZYQP, 补中益气丸) in improving the appetite of patients with colorectal cancer(CRC) receiving chemotherapy. TRIAL DESIGN: A pilot, randomized, single-blind crossover clinical trial was conducted on diagnosed stage II-IV CRC patients receiving chemotherapy. METHODS: Patients were randomly assigned to either the BZYQP-placebo or placebo-BZYQP groups. The BZYQP-placebo group received BZYQP for 1-2 d before the first cycle of chemotherapy and continued until the end of the third cycle. A 7-day washout followed, after which they received a placebo until the end of the sixth cycle. The placebo-BZYQP group followed the opposite treatment order. The oral dose of BZYQP and placebo was ten pills three times daily. A total of 12 visit points were scheduled in this study, with each visit point carried out before and after each of the six cycles of chemotherapy. The Simplified Nutrition Appetite Questionnaire(SNAQ), the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire(EORTC QLQ-C30, version 3.0), and the National Cancer Institute Common Terminology Criteria for Adverse Events(CTCAE, V5.0) were used to evaluate patient appetite, quality of life, and drug safety. RESULTS: Totally 62 patients completed the study, and baseline characteristics were balanced between the BZYQP-placebo and placebo-BZYQP groups. The primary outcome, as assessed by SNAQ scores, demonstrates a statistically significant difference between the two groups during the first three cycles of chemotherapy, with the mean SNAQ score of the BZYQP-placebo group consistently higher than that of the placebo-BZYQP group from V1(P < 0.001). After the washout period, the SNAQ score of the BZYQP-placebo group decreased from V7, and the difference in SNAQ scores between the two groups gradually became more significant after the intersection at V9. Secondary outcomes showed that during the first three cycles of chemotherapy, the BZYQP-placebo group had significantly lower scores in physical, role, emotional, cognitive, and social functioning domains, as well as in fatigue, loss of appetite, and diarrhea symptoms, compared to the placebo-BZYQP group(P < 0.001). Scores for physical, role, emotional, cognitive, and social functioning in the BZYQP-placebo group remained lower(P < 0.05) at V11. The chemotherapy-induced adverse events(AEs) in the BZYQP-placebo group were significantly lower than those in the placebo-BZYQP group at V5, mainly in nausea and vomiting(9.1% vs 62.1%, P < 0.001), diarrhea(12.1% vs 44.8%, P = 0.004), and anemia(15.2% vs 41.4%, P = 0.021). No drugrelated events were reported in this study. CONCLUSION: BZYQP is feasible and safe to effectively improve the appetite of patients with CRC receiving chemotherapy and help them with better quality of life.展开更多
目的:基于核磁共振(nuclear magnetic resonance,NMR)的代谢组学方法,对气虚质健康人干预前后的血浆内源性代谢物的变化进行了比较研究,寻找气虚质的可能特征代谢物。方法:招募健康气虚质20人随机分为干预组和对照组,应用补中益气丸进行...目的:基于核磁共振(nuclear magnetic resonance,NMR)的代谢组学方法,对气虚质健康人干预前后的血浆内源性代谢物的变化进行了比较研究,寻找气虚质的可能特征代谢物。方法:招募健康气虚质20人随机分为干预组和对照组,应用补中益气丸进行1个月的干预,并对他们的血浆样品进行代谢组学检测,采用多元统计分析方法寻找补中益气丸干预气虚质血浆内源性差异代谢产物。结果:对补中益气丸干预前后血浆样本应用Simca-P软件分析提取变量重要性预测值(variable importance predictive,VIP),筛选出VIP>1,P<0.05的有差异的化学位移值45个,通过代谢产物数据库发掘对分类贡献较大的特异性代谢物30个。结论:这些差异代谢产物主要与三羧酸循环相关,说明补中益气丸调节了气虚质的能量代谢异常。而补中益气丸干预后疲劳与记忆力下降等症状的改善则可能与其能调节伽马氨基丁酸、磷脂酰胆碱、血氨的浓度有关。展开更多
目的评价补中益气丸联合会阴经皮电刺激对产后盆底功能康复的效果。方法选取阴道动态压力<80 cmH_2O、盆底肌电位值<30 u V、盆底Ⅰ和Ⅱ类肌纤维肌力<3级的初产妇200例,随机分为对照组和观察组,各100例。对照组给予常规盆底治...目的评价补中益气丸联合会阴经皮电刺激对产后盆底功能康复的效果。方法选取阴道动态压力<80 cmH_2O、盆底肌电位值<30 u V、盆底Ⅰ和Ⅱ类肌纤维肌力<3级的初产妇200例,随机分为对照组和观察组,各100例。对照组给予常规盆底治疗,观察组在此基础上予以补中益气丸联合会阴经皮电刺激。评估2组治疗前后的盆底肌功能及症状改善情况。结果治疗后,观察组阴道动态压力、盆底肌电位值显著高于对照组,盆底Ⅰ、Ⅱ类肌纤维肌力优于对照组,阴道壁膨出、尿失禁、子宫脱垂发生率明显低于对照组,差异均有统计学意义(P <0. 05)。结论在常规盆底治疗基础上,应用补中益气丸联合会阴经皮电刺激有利于增强盆底肌肌力,提高盆底康复治疗效果。展开更多
基金Shanghai Municipal Administrator of Traditional Chinese Medicine-funded Project:Ding’s Clinical Medicine Huang Wendong Base Li Dongyuan"Yin Fire"Theory Inheritance and Innovation Team (No. 2021LPTD-009)。
文摘OBJECTIVE: To evaluate the clinical efficacy and safety of Buzhongyiqi pills(BZYQP, 补中益气丸) in improving the appetite of patients with colorectal cancer(CRC) receiving chemotherapy. TRIAL DESIGN: A pilot, randomized, single-blind crossover clinical trial was conducted on diagnosed stage II-IV CRC patients receiving chemotherapy. METHODS: Patients were randomly assigned to either the BZYQP-placebo or placebo-BZYQP groups. The BZYQP-placebo group received BZYQP for 1-2 d before the first cycle of chemotherapy and continued until the end of the third cycle. A 7-day washout followed, after which they received a placebo until the end of the sixth cycle. The placebo-BZYQP group followed the opposite treatment order. The oral dose of BZYQP and placebo was ten pills three times daily. A total of 12 visit points were scheduled in this study, with each visit point carried out before and after each of the six cycles of chemotherapy. The Simplified Nutrition Appetite Questionnaire(SNAQ), the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire(EORTC QLQ-C30, version 3.0), and the National Cancer Institute Common Terminology Criteria for Adverse Events(CTCAE, V5.0) were used to evaluate patient appetite, quality of life, and drug safety. RESULTS: Totally 62 patients completed the study, and baseline characteristics were balanced between the BZYQP-placebo and placebo-BZYQP groups. The primary outcome, as assessed by SNAQ scores, demonstrates a statistically significant difference between the two groups during the first three cycles of chemotherapy, with the mean SNAQ score of the BZYQP-placebo group consistently higher than that of the placebo-BZYQP group from V1(P < 0.001). After the washout period, the SNAQ score of the BZYQP-placebo group decreased from V7, and the difference in SNAQ scores between the two groups gradually became more significant after the intersection at V9. Secondary outcomes showed that during the first three cycles of chemotherapy, the BZYQP-placebo group had significantly lower scores in physical, role, emotional, cognitive, and social functioning domains, as well as in fatigue, loss of appetite, and diarrhea symptoms, compared to the placebo-BZYQP group(P < 0.001). Scores for physical, role, emotional, cognitive, and social functioning in the BZYQP-placebo group remained lower(P < 0.05) at V11. The chemotherapy-induced adverse events(AEs) in the BZYQP-placebo group were significantly lower than those in the placebo-BZYQP group at V5, mainly in nausea and vomiting(9.1% vs 62.1%, P < 0.001), diarrhea(12.1% vs 44.8%, P = 0.004), and anemia(15.2% vs 41.4%, P = 0.021). No drugrelated events were reported in this study. CONCLUSION: BZYQP is feasible and safe to effectively improve the appetite of patients with CRC receiving chemotherapy and help them with better quality of life.
文摘目的:基于核磁共振(nuclear magnetic resonance,NMR)的代谢组学方法,对气虚质健康人干预前后的血浆内源性代谢物的变化进行了比较研究,寻找气虚质的可能特征代谢物。方法:招募健康气虚质20人随机分为干预组和对照组,应用补中益气丸进行1个月的干预,并对他们的血浆样品进行代谢组学检测,采用多元统计分析方法寻找补中益气丸干预气虚质血浆内源性差异代谢产物。结果:对补中益气丸干预前后血浆样本应用Simca-P软件分析提取变量重要性预测值(variable importance predictive,VIP),筛选出VIP>1,P<0.05的有差异的化学位移值45个,通过代谢产物数据库发掘对分类贡献较大的特异性代谢物30个。结论:这些差异代谢产物主要与三羧酸循环相关,说明补中益气丸调节了气虚质的能量代谢异常。而补中益气丸干预后疲劳与记忆力下降等症状的改善则可能与其能调节伽马氨基丁酸、磷脂酰胆碱、血氨的浓度有关。
