Objective： To examine the effect of a Chinese medicinal herbal formula （Feitai Capsule, 肺泰胶囊） on the quality of life （QOL） and progression-free survival （PFS） of patients with unresectable non-small cell lu...Objective： To examine the effect of a Chinese medicinal herbal formula （Feitai Capsule, 肺泰胶囊） on the quality of life （QOL） and progression-free survival （PFS） of patients with unresectable non-small cell lung cancer （NSCLC）. Methods： Sixty-two patients were randomly divided into the treatment group （31 cases） and the control group （31 cases）. For the treatment group, 4 capsules （1.2 g/capsule） of Feitai Capsule were administered 3 times a day after meals for 3 weeks; then no drug was administered for 1 week. This schedule was continued for at least 3 more cycles （12 weeks totally）. If there were no obvious toxic reactions, the treatment was extended. The patients were evaluated at least once every 8 weeks until progressive dJsease （PD）. For the control group, the regular follow-up and evaluation were performed at least once every 8 weeks until PD. Clinical symptoms, objective response, physical constitution and energy, QOL, and PFS were evaluated regularly. Analysis of variance （ANOVA）, a non-parametric test, and analysis of covariance were used to compare clinical features, amelioration of clinical symptoms, physical constitution and energy, and QOL. Kaplan- Meier analysis was used to compare the two-group PFS. Results： Sixty patients finished the final evaluation, with 30 patients in each group. Baseline characters between groups were not significantly different （P〉0.05）. The control group had a 36.7% improvement in clinical symptoms, while the treatment group had a 73.3% improvement. This difference was statistically significant （Z=-2.632, P=0.008）. The control group had a 26.7% improvement in the Karnofsky performance status （KPS）, while the treatment group had a 53.4% improvement. This was also significantly different （Z=-2.182, P=0.029）. A comparative analysis indicated a positive correlation （r=0.917, P〈0.001）. Compared with the control group, QOL in the treatment group was significantly improved, except in the social/family condition and doctor-patient relationship indicators. The PFS of the treatment group and control group were 6.23 months and 4.67 months, respectively （P=0.048）. Conclusion： Feitai Capsule, a Chinese medicinal herbal treatment could improve the QOL and extend the PFS of the unresectable NSCLC patients.展开更多
基金Supported by the Key Subject of People's Liberation Army Eleventh-Five-Year Traditional Chinese Medicine Clinical Research Program(No.2006051002)
文摘Objective： To examine the effect of a Chinese medicinal herbal formula （Feitai Capsule, 肺泰胶囊） on the quality of life （QOL） and progression-free survival （PFS） of patients with unresectable non-small cell lung cancer （NSCLC）. Methods： Sixty-two patients were randomly divided into the treatment group （31 cases） and the control group （31 cases）. For the treatment group, 4 capsules （1.2 g/capsule） of Feitai Capsule were administered 3 times a day after meals for 3 weeks; then no drug was administered for 1 week. This schedule was continued for at least 3 more cycles （12 weeks totally）. If there were no obvious toxic reactions, the treatment was extended. The patients were evaluated at least once every 8 weeks until progressive dJsease （PD）. For the control group, the regular follow-up and evaluation were performed at least once every 8 weeks until PD. Clinical symptoms, objective response, physical constitution and energy, QOL, and PFS were evaluated regularly. Analysis of variance （ANOVA）, a non-parametric test, and analysis of covariance were used to compare clinical features, amelioration of clinical symptoms, physical constitution and energy, and QOL. Kaplan- Meier analysis was used to compare the two-group PFS. Results： Sixty patients finished the final evaluation, with 30 patients in each group. Baseline characters between groups were not significantly different （P〉0.05）. The control group had a 36.7% improvement in clinical symptoms, while the treatment group had a 73.3% improvement. This difference was statistically significant （Z=-2.632, P=0.008）. The control group had a 26.7% improvement in the Karnofsky performance status （KPS）, while the treatment group had a 53.4% improvement. This was also significantly different （Z=-2.182, P=0.029）. A comparative analysis indicated a positive correlation （r=0.917, P〈0.001）. Compared with the control group, QOL in the treatment group was significantly improved, except in the social/family condition and doctor-patient relationship indicators. The PFS of the treatment group and control group were 6.23 months and 4.67 months, respectively （P=0.048）. Conclusion： Feitai Capsule, a Chinese medicinal herbal treatment could improve the QOL and extend the PFS of the unresectable NSCLC patients.
