生血宝合剂治疗非小细胞肺癌患者化疗后白细胞减少症210例多中心随机、双盲对照临床研究  

Shengxuebao Heji (生血宝合剂) in Treating Leukopenia after Chemotherapy in Patients with Non-small Cell Lung Cancer:A Multi-centered,Randomized,Double-blind Controlled Trial of 210 Cases

作　　者：何斌[1] 杨宇飞[1] 褚亚军 刘红娜 张颖[3] 傅敏 于雁[5] 孙立哲[6] 闫明亮 李曾 曹凤军[9] 赵君慧[10] 徐志巧 谢卫红 王俊生[13] 杨晓庆[14] 李守富 

机构地区：[1]中国中医科学院西苑医院,北京市海淀区西苑操场1号100091 [2]清华德人西安幸福制药有限公司 [3]四川大学华西医院 [4]重庆市中西医结合医院 [5]哈尔滨医科大学附属肿瘤医院 [6]陕西中医药大学第二附属医院 [7]咸阳市中心医院 [8]三二○一医院 [9]十堰市人民医院 [10]青海大学附属医院 [11]开封市中心医院 [12]漯河市中医院 [13]安阳市肿瘤医院 [14]邯郸市中医院 [15]北京康派特医药科技开发有限公司

出　　处：《中医杂志》2017年第9期763-767,共5页Journal of Traditional Chinese Medicine

基　　金：陕西省科技统筹创新工程计划(2015KTZDSF02-05-01)

摘　　要：目的评价生血宝合剂治疗非小细胞肺癌化疗引起的白细胞减少症的有效性。方法采用随机双盲、平行对照、多中心临床试验的方法,将非小细胞肺癌化疗后白细胞减少症患者随机分为治疗组210例,对照组70例。在下一次化疗前1天开始治疗组予生血宝合剂,每次15 ml,每日3次;对照组给予安多霖胶囊,每次4粒,每日3次。两组疗程均为3周。观察两组患者治疗前后外周血白细胞计数变化及分级、中医证候疗效及单项症状疗效、Karnofsky评分。结果两组治疗后外周血白细胞数计数均高于治疗前(P<0.05),且治疗组治疗后及治疗前后差值高于对照组(P<0.05)。治疗组治疗后Ⅱ度、Ⅲ度及Ⅳ度白细胞减少总发生率(2.85%)低于对照组(4.29%)(P<0.05)。治疗组中医证候疗效总有效率为88.1%,对照组为60.00%,治疗组优于对照组(P<0.05)。治疗组神疲乏力、头晕目眩、心悸气短、烦躁不安单项症状疗效均优于对照组(P<0.05)。结论生血宝合剂能有效防治非小细胞肺癌化疗引起的白细胞减少症,改善化疗后患者癌因性疲乏。Objective To evaluate the efficacy of Shengxuebao Heji（ 生血宝合剂） in treating leukopenia induced by chemotherapy for non-small cell lung cancer（ NSCLC）. Methods The trial was randomized,double-blind,parallel controlled and multi-centered. The patients with leukopenia after chemotherapy for NSCLC were randomized into the treatment group（ 210 cases） and the control group（ 70 cases）. The treatment group was administered Shengxuebao Heji 15 ml,three times each day on one day before the next round of chemotherapy,while the control group was given Anduolin Capsule（ 安多霖胶囊） 4 capsules,three times each day. Both groups were treated for 3weeks. The researchers observed the change of peripheral white blood cell amount and leukopenia grading before and after treatment,as well as the efficacy of Chinese medicine syndrome,the efficacy of single symptom and Karnofsky score. Results After treatment,the peripheral white blood cell amount increased than that before treatment in both groups（ P〈0. 05）. And the peripheral white blood cell amount after treatment in the treatment group was higher than that in the control group,so was the difference before and after treatment（ P〈0. 05） in the treatment group. After treatment,the incidence of Ⅱ,Ⅲ and Ⅳ degree of leukopenia in the treatment group（ 2. 85%） was lower than that in the control group（ 4. 29%,P〈0. 05）. The overall response rate of Chinese medicine syndrome in the treatment group（ 88. 1%） was significantly better than that in the control group（ 60. 00%,P〈0. 05）. The efficacy of single symptom,such as fatigued spirit and lack of strength,dizziness,palpitations and shortness of breath and dysphoria,in the treatment group was better than that in the control group（ P〈0. 05）. Conclusion Shengxuebao Heji could prevent and treat the leukopenia after chemotherapy for NSCLC and improve the cancer-related fatigue after chemotherapy.

关 键 词：非小细胞肺癌 化疗 白细胞减少症 生血宝合剂 癌因性疲乏 

分 类 号：R734.2[医药卫生—肿瘤]