随机对照试验(randomized control test,RCT)在判断干预措施效应的真实程度上,较其它类型的研究设计能提供更强的论证强度,是目前国际上公认的、评价干预措施是否有效的金标准。基于随机对照试验方法的科学性,它不仅适用于西医药...随机对照试验(randomized control test,RCT)在判断干预措施效应的真实程度上,较其它类型的研究设计能提供更强的论证强度,是目前国际上公认的、评价干预措施是否有效的金标准。基于随机对照试验方法的科学性,它不仅适用于西医药干预措施的疗效评价,同样也适用于中医药干预措施的临床疗效评价,因而受到越来越多的中医临床科研工作者的重视。但我们也应认识到,非随机对照试验(non—randomized control trial,non—RCT)对于各级证据均主要源于临床实践的中医药学,以及有着大量非盲法、非随机化临床试验的中医药和中西医结合临床研究,也有着重要的、特殊的意义。展开更多
Objective: To assess the role of chemotherapy combined with the compound Chinese herbal medicine,Fuzhenggubenfang (FZGBF), for treating advanced non-small-cell lung cancer. Methods: A total of 84 eligible patients...Objective: To assess the role of chemotherapy combined with the compound Chinese herbal medicine,Fuzhenggubenfang (FZGBF), for treating advanced non-small-cell lung cancer. Methods: A total of 84 eligible patientswere enrolled from October 2013 to July 2016. Patients were randomized to receive either chemotherapy alone as thecontrol group or chemotherapy combined with FZGBF as the experimental group. The primary endpoint of the study wasquality of life (QOL) and progression-free survival (PFS). Secondary endpoints were tumor response rate, toxicity,dropout rate, and univariate and multivariate analyses of clinicopathologic factors for QOL and PFS. Results: There wasa significant improvement in QOL, including better overall health (P 〈 0.001), physical function (P 〈 0.001), rolefunction (P 〈 0.001), emotional function (P 〈 0.001), cognitive function (P 〈 0.001), and social function (P = 0.031).Less fatigue, nausea or vomiting, insomnia, appetite loss, constipation, and alopecia were noted (All P 〈 0.001) whenFZGBF was combined with chemotherapy in comparison to chemotherapy alone. The experimental group had a betterPFS compared with the control group (P = 0.032). There was no significant difference in tumor response rate. FZGBFsignificantly reduced chemotherapy-induced anemia (P 〈 0.001), neutropenia (P = 0.023), nausea and vomiting (P 〈0.001). The use of Chinese herbal compounds had only mild side effects. In this study, factors influencing QOL were theuse of the Chinese herbal compounds (P 〈 0.001), performance status score (P = 0.027), clinical staging of cancer (P =0.009), and sex (P = 0.044). Use of traditional Chinese medicine (P = 0.043) and the number of previous chemotherapysessions (P = 0.003) were the factors influencing PFS in this study. Conclusion: FZGBF could improve QOL,compliance to treatment, relieved chemotherapy-related toxicities of patients, and consequently improved PFS, which isa promising drug combination in complementary medicine for the treatment of advanced NSCLC.展开更多
文摘随机对照试验(randomized control test,RCT)在判断干预措施效应的真实程度上,较其它类型的研究设计能提供更强的论证强度,是目前国际上公认的、评价干预措施是否有效的金标准。基于随机对照试验方法的科学性,它不仅适用于西医药干预措施的疗效评价,同样也适用于中医药干预措施的临床疗效评价,因而受到越来越多的中医临床科研工作者的重视。但我们也应认识到,非随机对照试验(non—randomized control trial,non—RCT)对于各级证据均主要源于临床实践的中医药学,以及有着大量非盲法、非随机化临床试验的中医药和中西医结合临床研究,也有着重要的、特殊的意义。
文摘Objective: To assess the role of chemotherapy combined with the compound Chinese herbal medicine,Fuzhenggubenfang (FZGBF), for treating advanced non-small-cell lung cancer. Methods: A total of 84 eligible patientswere enrolled from October 2013 to July 2016. Patients were randomized to receive either chemotherapy alone as thecontrol group or chemotherapy combined with FZGBF as the experimental group. The primary endpoint of the study wasquality of life (QOL) and progression-free survival (PFS). Secondary endpoints were tumor response rate, toxicity,dropout rate, and univariate and multivariate analyses of clinicopathologic factors for QOL and PFS. Results: There wasa significant improvement in QOL, including better overall health (P 〈 0.001), physical function (P 〈 0.001), rolefunction (P 〈 0.001), emotional function (P 〈 0.001), cognitive function (P 〈 0.001), and social function (P = 0.031).Less fatigue, nausea or vomiting, insomnia, appetite loss, constipation, and alopecia were noted (All P 〈 0.001) whenFZGBF was combined with chemotherapy in comparison to chemotherapy alone. The experimental group had a betterPFS compared with the control group (P = 0.032). There was no significant difference in tumor response rate. FZGBFsignificantly reduced chemotherapy-induced anemia (P 〈 0.001), neutropenia (P = 0.023), nausea and vomiting (P 〈0.001). The use of Chinese herbal compounds had only mild side effects. In this study, factors influencing QOL were theuse of the Chinese herbal compounds (P 〈 0.001), performance status score (P = 0.027), clinical staging of cancer (P =0.009), and sex (P = 0.044). Use of traditional Chinese medicine (P = 0.043) and the number of previous chemotherapysessions (P = 0.003) were the factors influencing PFS in this study. Conclusion: FZGBF could improve QOL,compliance to treatment, relieved chemotherapy-related toxicities of patients, and consequently improved PFS, which isa promising drug combination in complementary medicine for the treatment of advanced NSCLC.