龟鹿二仙胶巴布剂治疗结直肠癌化疗后不良反应临床研究

Clinical Study on Adverse Reactions of Guiluerxianjiao Cataplasm to Treat with Colorectal Cancer after Chemotherapy

目的：观察龟鹿二仙胶巴布剂治疗78例Ⅲ-Ⅳ期结直癌患者FOLFIRI方案化疗后骨髓抑制的疗效,评价安全性及对中医症状积分的影响。方法：采用随机双盲、安慰剂对照的研究方法,将78例Ⅲ-Ⅳ期结直癌患者分为治疗组及对照组。两组均采用FOLFIRI方案化疗,治疗组随化疗开始同时使用龟鹿二仙胶巴布剂外敷神阙穴治疗,疗程为14 d;对照组使用安慰剂巴布剂,用法用量同治疗组。观察化疗开始后14 d内患者外周血白细胞、中性粒细胞及血小板计数,中医症状积分疗效指标,肝肾功能、皮肤不良反应等药物不良反应指标。结果：以化疗后第14天为观察节点,治疗组白细胞及中性粒细胞计数均显著高于对照组（P〈0.05）;中医症状积分显著低于对照组（P〈0.05）;两组患者肝肾功能指标及皮肤情况均未见明显异常。结论：龟鹿二仙胶巴布剂治疗Ⅲ-Ⅳ期结直肠癌患者FOLFIRI方案化疗后骨髓抑制疗效显著,安全性高。

Objective：To observe the clinical effects of Guiluerxianjiao Cataplasm to allay myelosuppression and TCM symptoms in- tegral after FOLFIRI chemotherapy with stage III - IV colorectal cancer,to further confirm the efficiency and security. Methods： The research adopted a prospective, randomized, double-blind, placebo-controlled method. It gathered 78 patients diagnosed of colorectal cancer to accept FOLFIRI chemotherapy and divded them into two groups, namely treatment group and control group. Treatment group uses Guiluerxianjiao Cataplasm from day 1 to day 14 with chemotherapy. Control group used the same method with placebo instead. Monitor blood cell count（ WBC NE PLT）, TCM symptoms integral, liver and kidney function, and observe skin reactions daily. Results ：The blood cell count on day 14 showed WBC and NE count were higher,with statistically significant difference （P 〈 0. 05 ）. The TCM symptoms integral on day 14 was lower than control group in treatment group, with statistically significant difference（P 〈 0.05 ） ; no obvious adverse reactions such as liver and kidney function damage and skin allergy were observed.Conclusion：Adjuvant treatment with Guiluerxianjiao Cataplasm is effective in reducing myelosuppression extent after FOLFIRI chemotherapy with stage III - IV colorectal cancer with no relevant adverse reactions being found during the research.