祛邪胶囊对晚期结直肠癌患者生存期和生活质量的随机对照研究

目的 评价祛邪胶囊对晚期结直肠癌患者中位生存期和生活质量的影响。方法 采用随机对照临床研究方法，纳入晚期结直肠癌患者40例，可评价37例，治疗组18例，对照组19例，两组均采用化疗（FOLFOX、FOLFRI方案）等西医治疗，治疗组在此基础上加用祛邪胶囊，治疗3个月后，进行长期随访，观察患者的病死率、生存期、中位生存期、疾病进展期（time to progression，TTP）及生活质量。结果 治疗组和对照组的病死率分别为111%（2/18）和421%（8/19）；生存期分别为（22.63±7.34）个月和（19.76±8.28）个月，中位生存期分别为17个月和13个月； TTP分别为（17.76±5.62）个月和（12.68±9.26）个月，经统计分析均有统计学意义（P＜0.05）。中医症状积分、生活质量及KPS评分治疗组治疗前分别为15.59±3.78、54.06±3.96、64.71±6.24，治疗后分别为10.53±5.57、58.65±4.03、69.41±4.29，治疗前后比较差异均有统计学意义（P＜0.05）；对照组治疗前分别为16.11±3.99、54.06±4.39及64.44±5.11；治疗后分别为19.61±7.78、50.17±8.26、60.00±9.70，治疗前后生活质量及KPS评分比较差异有统计学意义（P＜0.05），但趋势是向差的方向。结论 晚期结直肠癌患者加用祛邪胶囊，能减少病死率，延长生存期、中位生存期和TTP，提高生活质量。

Randomized Controlled Study on Effect of Quxie Capsule on the Median Survival Time and Qualify of Life in Patients with Advanced Colorectal Carcinoma

OBJECTIVE: To evaluate the effect of Quxie Capsule (QXC) on the median survival time and quality of life in patients with advanced colorectal carcinoma. METHODS: 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). RESULTS: 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). CONCLUSION: QXC can reduce the FR, prolong the ST, mST, mCFPT, and improve the QOF in patients with advanced colorectal carcinoma.