扶正固本颗粒治疗晚期结直肠癌合并贫血的临床研究

目的 观察扶正固本颗粒治疗晚期结直肠癌合并贫血的临床疗效和安全性.方法 选取105例经组织病理学证实的晚期结直肠癌合并贫血的气血两虚证患者为研究对象,采用随机数字表法将其随机分为临床试验组(西医基础治疗+扶正固本颗粒)35例,阳性药物对照组(西医基础治疗+复方阿胶浆)35例和空白对照组(西医基础治疗)35例.分析比较3组患者治疗5周(35 d)前后的中医症状疗效、贫血程度和生活质量评分.结果临床试验组和阳性药物对照组患者治疗后神疲乏力、纳呆食少和头晕目眩症状明显改善,症状积分明显低于本组治疗前水平和对照组的治疗后水平,差异有统计学意义(P﹤0.01);临床试验组和阳性药物对照组的中医症状疗效总有效率分别为51.4％和57.1％,均高于空白对照组的总有效率28.6％,差异有统计学意义(P﹤0.05).临床试验组患者治疗后,贫血程度和生活质量方面的有效率分别为80.0％和54.3％,均有所改善,和空白对照组比较,差异有统计学意义(P﹤0.05),且无药物相关死亡.结论 扶正固本颗粒治疗晚期结直肠癌合并贫血的临床疗效显著,且安全性好,值得临床推广.

Clinical observation of Fuzheng Guben granules in the treatment of patients with advanced colorectal cancer and anemia

Objective To evaluate the efficacy and safety of Fuzheng Guben granules in patients with advanced colorectal cancer and anemia. Method 105 patients with advanced colorectal cancer and anemia, who were observed with symptoms of qi and blood deficiency, were included and randomized as study group (which was treated with conven-tional western therapy and Fuzheng Guben granules, n=35), positive therapy group (western therapy and Fufang Ejiao Ji-ang, n=35) and control group (western medicine therapy group, n=35). The three groups of patients were analyzed for the TCM efficacy, degree of anemia and quality of life before and 5 weeks (35 d) after treatment. Result In study group and positive therapy group, the symptoms of fatigue, decreased appetite, and dizziness were significantly improved, and the symptom scores were obviously decreased after treatment (P<0.01), an overall response rate for TCM symptoms of 51.4％and 57.1％were observed in study group and positive therapy group, and were significantly higher than that in con-trol group at 28.6％ (P<0.05). The response rate for degree of anemia and quality of life was improved for patients in study group at 80.0％and 54.3％, respectively, and was significantly better than those observed in control group (P<0.05). And there was no drug-related death. Conclusion Fuzheng Guben granules is safe and effective in the treatment of pa-tients with advanced colorectal cancer and anemia, which is clinically applicable.