新加良附颗粒配合化疗治疗进展期胃癌临床研究

Treatment of advanced gastric cancer with Xinjia Liangfu Granules combined with chemotherapy

目的观察新加良附颗粒配合化疗治疗进展期胃癌的临床疗效。方法采用前瞻性随机对照多中心的临床试验方法,并通过中央(网上)随机法将符合III/IV期胃癌患者42例随机分为对照组、治疗组,治疗组选择标准化疗方案配合新加良附颗粒治疗,对照组单纯接受化疗,治疗过程中2组均同时给予最佳对症支持治疗,分别观察4个化疗周期,在入组当天及各周期末记录症状与体征记分、卡氏评分、疼痛数字评分法评分、病灶大小、血尿常规、肝肾功能、心电图等指标。结果新加良附颗粒配合化疗组21例,单纯化疗组20例,脱落1例,研究结果显示:(1)治疗组在临床症状与体征的改善方面明显优于对照组,具有统计学意义,P<0.005。治疗组对胃脘疼痛、胸腹胀满、畏寒肢冷、食欲不振等症状有改善作用,具有统计学意义,P<0.05。(2)治疗组总体健康状况的改善明显优于对照组,具有统计学意义,P<0.05。(3)治疗组较对照组虽有更高的临床缓解率,但无统计学意义,P>0.05。(4)新加良附颗粒在临床应用过程中,具有良好的安全性。结论新加良附颗粒具有改善进展期胃癌患者临床症状,提高患者生活质量,减轻化疗毒副反应等作用,临床应用安全有效。

Objective To observe the clinical efficacy of Xinjia Liangfu （Modified Galangal and Cyperus） Granules on advanced gastric cancer. Methods The patients with stage Ⅲ/Ⅳ gastric cancer （n = 42 ） were randomly divided into control group and treatment group by applying prospective randomized controlled multi-center clinical trial method. The treatment group was treated with standard chemotherapy regimens combined with Xinjia Liangfu Granules, and control group, with only chemotherapy regimens. During the therapeutic course, 2 groups were given the best supportive care and observed for 4 cycles of chemotherapy. The scores of symptoms and signs, Kamofsky performance status （KPS）, pain numerical rating scale, tumor size and indexes of blood and urine routine tests, liver and renal functions and electrocardiogram were recorded on the day of grouping and at the end of each cycle of chemotherapy. Results There were 21 cases in treatment group, 20 in control group and 1 case was missed. The trial results showed that the relief of symptoms and signs was significant superior in treatment group to that in control group （P 〈 0. 005 ）. The symptoms of stomach pain, abdominal distension and pain, fearing of cold, cold limbs and loss of appetite were relieved in treatment group （P 〈 0.05 ）. The improvement of total physical condition were superior in treatment group to that in control group （P 〈 0.05 ）. The treatment group had higher clinical remission rate compared with control group but the difference had no statistical significance （ P 〉 0.05 ）. Xinjia Liangfu Granules had a higher safety in clinical administration. Conclusion Xinjia Liangfu Granules has the effects of relieving symptoms, improving quality of life and reducing toxic and side effects of chemotherapy, and it is safe and effective in clinic.