复方苦参注射液联合同步放化疗治疗局部晚期直肠癌的临床研究

目的：探讨复方苦参注射液联合同步放化疗治疗局部晚期直肠癌方法，比较复方苦参注射液联合同步放化疗与单纯同步放化疗治疗晚期卣肠癌近期疗效及毒性反应。方法：局部晚期直肠癌60例，随机分成两组。同步放化组采用希罗达口服同时放疗；复方苦参注射液组（苦参组）采用同步放化疗，同时加用复方苦参注射液静脉滴注（复方苦参注射液10ml加入250ml氯化钠注射液中静脉滴注）。治疗计划结束后比较两组患者的毒副反应，治疗结束4周后比较两组患者的近期疗效。结果：苦参纰和同步放化疗组缓解率（CR＋PR）分别是86．7％（26／30）和70．0％（21／30）（P〈0．05）。苦参组和同步放化组部分毒性反应（白细胞及淋巴细胞减少、放射性直肠炎）比较有明显差异（P〈0．05）。结论：复方苦参注射液联合同步放化疗治疗局部晚期直肠癌可以提高患者近期疗效，减少毒副反应，值得进一步扩大研究及临床推广应用。

synchronous chemotherapy and radiotherapy with Composite Radix Sophora Flavescentis injection in locally advanced rectal cancer

Objective ： To investigate the effect of synchronous chemotherapy and radiotherapy with Composite Radix Sophora Flavescentis injection in treating locally advanced rectal cancer. Methods： 60 cases of inoperable locally advanced rectal cancer were randomized to the Composite Radix Sophora Flavescentis injection group and synchronous chemotherapy and radiotherapy group, chemotherapy and radiotherapy group were administrated by xeloda concurrent chemoradiotherapy. Composite Radix Sophora Flavescentis group were treated with the same way ,with Composite Radix Sophora Flavescentis injection 10 ml per day, observed the side effects after chemoradiotherapy and observed the overall response （ CR ＋ PR） rates 4 weeks after chemoradiotherapy. Results ： Composite Radix Sophora Flaves（.entis group and synchronous chemotherapy and radiotherapy group response rate were respectively 86.7% （ 26/30 ） and 70.0% （21/30） （ P 〈 0.05 ） ; part of the variance of toxicity （ the incidence of acute radiation proctitis） had significance between the two group（ P 〈 0. 05 ）. Conclusion： Synchronous chemotherapy and radiotherapy with Composite Radix Sophora Flavescentis injection could improve progression-free survival in locally advanced rectal cancer , and reduced the incidence rate of side effects.