[Clinical study on treatment of malignant neoplasms with Shenqi Fuzheng Injection and chemotherapy].
نویسندگان
چکیده
1 .1 纳入标准 (1)年龄 < 70 岁;(2)Karnofsky 活 动状况(Karnofs ky performance status, K PS)评分 > 60; (3)预计生存期 > 6 个月; (4)无化疗禁忌 症 ;(5)知情同意,依从性好,能连续完成 2 个疗程 的化疗。 1 .2 一般资料 2002 年 12 月~2004 年 5 月在我 院住院治疗且符合纳入标准的病理诊断明确的恶性 肿瘤患者,共 86 例,其中男 46 例,女 40 例;年龄 26~69 岁,平均 53 岁;其中肺癌 26 例, 大肠癌 22 例,鼻咽癌 16 例,乳腺癌 12 例,卵巢癌 6 例,恶 性淋巴瘤 4 例。 1 .3 病例分组 采用随机交叉试验设计,86 例患 者随机分为 A、B 两组。A 组 43 例,第 1 周期(对照 周期)给予化疗 1 个疗程,间歇 3~4 周,第 2 周期 (试验周期)给予参芪扶正注射液联合化疗 1 个疗 程;B 组 43 例,第 1 周期(试验周期)给予参芪扶正 注射液联合化疗 1 个疗程,间歇 3~4 周,第 2 周期 (对照周期)给予化疗 1 个疗程。 1 .4 治疗方法 化疗方案:肺癌:足叶乙甙 + 顺铂; 大肠癌:亚叶酸钙 + 氟尿嘧啶;鼻咽癌:氟尿嘧啶 + 顺铂;乳腺癌:环磷酰胺 + 阿霉素 + 氟尿嘧啶;恶性 淋巴瘤:环磷酰胺 + 长春新碱 + 阿霉素 + 强的松;卵 巢癌:环磷酰胺 + 阿霉素 + 顺铂。试验周期:参芪扶 正注射液(丽珠集团利民制药厂生产)联合化疗 1 个 疗程, 参芪 扶 正 注 射 液 250 ml / 次, 静 脉 滴 注, 1 次/ d,化疗前 3 d 开始,连续 10 d;对照周期:0 .9 % 氯化钠注射液作为参芪扶正注射液的对照药物,剂 量和用法同试验周期,同时予以化疗 1 个疗程。化 疗辅助药物恩丹西酮及静脉营养药物等,按临床需 要酌情使用。 1 .5 观察指标及疗效评定标准 1 .5 .1 化疗毒性反应 根据世界卫生组织抗癌药 物毒性反应标准评定,观察血液学毒性和胃肠道反 应等,其中临床症状和体征每日询问、检查并记录 1 次。自化疗开始后,血常规检查 1 次/ 4 d,至整个试 验完成。 1 .5 .2 中医症状改善评定标准 参照《中国常见恶 性肿瘤诊治规范》和《中药新药临床研究指导原则》, 每周 1 次观察神疲乏力、恶心呕吐、纳差、睡眠、腹 痛、腹泻、腹胀、自汗等症状及舌象、脉象等变化,对 · 4 8 · 中西医结合学报 2006 年 1 月第 4 卷第 1 期 Journ al of Chin ese In t egrat ive Me dicin e, Janu ary 2006, Vol .4, No .1
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ورودعنوان ژورنال:
- Zhong xi yi jie he xue bao = Journal of Chinese integrative medicine
دوره 4 1 شماره
صفحات -
تاریخ انتشار 2006