新加良附颗粒配合化疗治疗晚期胃癌临床研究.docVIP

  新加良附颗粒配合化疗治疗晚期胃癌临床 研究 王婧1，田劭丹1，李元青2，叶霈志3，苏丽英4，芦殿荣5，陈信义1** 5 10 15 20 25 30 35 40 45 （1. 北京中医药大学东直门医院，北京，100700； 2. 北京大学肿瘤医院，北京，100142； 3. 中国医学科学院肿瘤医院，北京，100021； 4. 北京中医药大学第三附属医院，北京，100029； 5. 中国中医科学院望京医院，北京，100102） 摘要：目的：观察新加良附颗粒配合化疗治疗晚期胃癌的临床疗效。方法：采用前瞻性随机 对照的研究方法，将 42 例患者随机分为两组，其中，新加良附颗粒配合化疗组 21 例，单纯 化疗组 20 例，脱落 1 例，分别观察四个化疗周期，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 NRS 记分、病灶大小、血尿常规、肝肾功能、心电图等指标。结果： 研究结果显示：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， P0.005。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，P0.05。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，P0.05。 治疗组较对照组具有更高的临床缓解率，但无统计学意义，P0.05。新加良附颗粒在临 床应用过程中，具有良好的安全性。结论：新加良附颗粒可以改善化疗患者临床症状与体征， 提高生活质量，并对化疗具有一定的减毒增效作用，值得进一步研究。 关键词：中西医结合临床；临床疗效；胃癌；新加良附颗粒；晚期胃癌 中图分类号：R273；R735.2 A phase II clinical trial of modified Liang-fu granules combined with chemotherapy in treating advance gastric cancer WANG Jing1, TIAN Shaodan1, LI Yuanqing2, YE Peizhi3, SU Liying4, LU Dianrong5, CHEN Xinyi1 (1. Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100700; 2. Beijing Cancer Hospital, Peking University, Beijing, 100142; 3. Cancer Institute Hospital, Chinese Academy of Medical Sciences, Beijing, 100021; 4. The 3rd Clinical School Affiliated to Beijing University of Chinese Medicine, Beijing, 100029; 5. Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, 100102) Abstract: Objective: Modified Liang-Fu Granule (MLFG) is a Chinese medicine formula with claims for the treatment of severe gastric distress. This study is to observe the clinical efficacy of MLFG combined with chemotherapy in treating advanced gastric cancer. Methods: In this prospective randomized controlled clinical trial, all patients were randomly assigned to treatment group which received MLFG in addition to chemotherapy, or control group which got chemotherapy alone. Evaluation points were observed and recorded throughout four cycles of chemotherapy including signs and symptoms score, Karnofsky performance status, pain numerical rating scale, tumor size, blood