Randomized Controlled Study on Effect of Quxie Capsule on the Median Survival Time and Qualify of Life in Patients with Advanced Colorectal Carcinoma
Yang Yufei, Chen Zhanxin, Xu Yun, Wu Yu. Wu Xianwen, Zhu Yaowu, Li Peihong, Gao Shudi. Randomized Controlled Study on Effect of Quxie Capsule on the Median Survival Time and Qualify of Life in Patients with Advanced Colorectal Carcinoma. Zhong Guo Zhong Xi Yi Jie He Za Zhi. 2008, 28 (2): 111-114.
Forty patients with advanced colorectal carcinoma were observed in a randomized controlled clinical trial (RCT). Out of them the 37 evaluable patients were assigned into the treatment group (18 patients) and the control group (19 patients). They were all treated by the routine treatment for cancer, including chemotherapy and radiotherapy, while those in the treatment group were administered with QXC additionally. After being treated for 3 months, the follow-up study was carried out to evaluate the fatality rate (FR), survival time (ST), median survival time (mST), time to progression (TTP), and quality of life (QOF). FR, mST, ST and TTP in the treatment group were 11.1% (2/18), 17 months, 22.63 +/- 7.34 months, and 17.76 +/- 5.62 months respectively, and those in the control group were 42.1% (8/19), 13 months, 19.76 +/- 8.28 months and 12.68 +/- 9.26 months respectively, showing significant difference between the two groups (P<0.05). The scores of TCM symptom, QOF and KPS in the treatment group were 15.59 +/- 3.78, 54.06 +/- 3.96 and 64.71 +/- 6.24 before treatment, and 10.53 +/- 5.57, 58.65 +/- 4.03, 69.41 +/- 4.29 after treatment, respectively, showing significant improvement (P<0.05). While the three scores in the control group were 16.11 +/- 3.99, 54.06 +/- 4.39 and 64.44 +/- 5.11 before treatment, and 19.61 +/- 7.78, 50.17 +/- 8.26 and 60.00 +/- 9.70 after treatment, respectively, showing a statistically significant worsening tendency in the latter two (P <0.05). QXC can reduce the FR, prolong the ST, mST, mCFPT, and improve the QOF in patients with advanced colorectal carcinoma.
Clinical Randomized Double-blinded Controlled Study on Quxie Capsule in Reducing Post-operational Relapse and Metastasis of Colorectal Cancer
Yang Yu Fei, Xu Yun, Wu Yu, Wang Lanping, Li Zhen, Zhang Lingzhi, Zhu Yaowu, Guo Zhongning, Guo Quan, Yan Xiaoping. Clinical Randomized Double-blinded Controlled Study on Quxie Capsule in Reducing Post-operational Relapse and Metastasis of Colorectal Cancer. Zhong Guo Zhong Xi Yi Jie He Za Zhi. 2007, 27 (10): 879-892.
To investigate the clinical effect of Quxie Capsule (QXC) in subsequent therapy for post-operational colorectal cancer. By the scheme matched to the requirement of randomized controlled trial, 44 patients chosen from 48 patients with colorectal cancer at post-operational period (with 2 dropped out and 2 loss of follow-up) were assigned into two groups (A and B) according to randomized block design and received intervention treatment with QXC and placebo, respectively, which started after terminating the post-operational adjuvant treatment and lasted for 6 months. Out of the 44 patients, 28 were of stage H (15 in Group A and 13 in Group B) and 16 of stage Ill (8 in Group A and 8 in Group B). The relapse-metastasis (R-M) rate, median time of R- M, changes of symptoms, Karnofsky (KPS) score and immune function before and after intervention, as well as the safety of QXC were observed. The follow-up study till April 2007 showed, the 1-year, 2-year and 3-year R-M rate in Group A was 0%, 0% and 50%, and in Group B was 9.5%, 18.2% and 50.0%, respectively, showing insignificant difference between the two groups (P>0.05). Difference in median time of R-M between the two groups (31.5 ± 7.8 months vs 19.0 ± 13.9 months) also showed no statistical significance (P>0.05). However, the symptoms and KPS score in Group A were better obviously (P< 0.05), with improve- ment in B lymphocyte (P< 0.05) superior to that in Group B. No obvious adverse reaction to QXC was found. QXC might be effective in delaying the R-M of colorectal cancer, but the ultimate confirmation only could be obtained through 1 to 2 years observation. Post-operational intervention with QXC in patients with colorectal cancer could apparently improve the quality of life and raise the immune function of patients, it is safeand might have some clinical significance in preventing the R-M of cancer.