加味升血贴对化疗所致肿瘤患者血液学毒性的预防作用——138例双盲随机对照临床研究  

The Protection of Jiawei Shengxue Plaster (加味升血贴) on Hematologic Toxicity Caused by Tumor Chemotherapy: a Double-Blind,Randomize-Controlled Clinical Trail of 138 Cases

作　　者：富琦[1] 梁姗姗[1] 王皓[1] 杨国旺[1] 韩冬[1] 王笑民[1] FU Qi;LIANG Shanshan;WANG Hao;YANG Guowang;HAN Dong;WANG Xiaomin(Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, lO0010)

机构地区：[1]首都医科大学附属北京中医医院

出　　处：《中医杂志》2018年第14期1214-1218,共5页Journal of Traditional Chinese Medicine

摘　　要：目的评价加味升血贴预防恶性肿瘤患者化疗所致血液学毒性的疗效及安全性。方法采用随机、对照、双盲、双模拟的研究设计,将138例符合条件的患者分为治疗组和对照组各69例。治疗组应用加味升血贴贴脐治疗,每日1贴;同时口服利可君片模拟剂,每次30 mg,每日3次。对照组口服利可君片,每次30 mg,每日3次;同时予加味升血贴模拟剂,每日1贴。化疗第1天开始用药,连续治疗14天,观察期为21天。分别于治疗前后不同时间检测血常规指标、生活质量评分、中医症状评分、体重、KPS评分及安全性指标。结果与治疗前比较,治疗组血小板计数在治疗7、14天,对照组在治疗4、7、14、21天均明显下降(P<0.01);两组白细胞计数在第7、14天均明显下降(P<0.05或P<0.01)。与对照组比较,治疗组治疗21天时白细胞及红细胞计数均明显升高(P<0.05)。与对照组比较,治疗组治疗21天生活质量评分明显提高(P<0.05)。与治疗前比较,治疗组治疗21天,腹胀、神疲乏力症状评分较治疗前明显降低(P<0.05或P<0.01);对照组治疗7天食欲减退评分及治疗21天神疲乏力评分明显升高(P<0.05);两组治疗7天及21天恶心呕吐评分均明显升高(P<0.05或P<0.01)。与对照组比较,治疗组治疗21天反酸、神疲乏力评分明显下降(P<0.05或P<0.01)。治疗前后两组体重、KPS评分及安全性指标均未见明显改变(P>0.05)。结论加味升血贴对肿瘤患者化疗所致血液学毒性具有一定的保护作用,同时可提高患者生活质量,减轻化疗所致的神疲乏力、腹胀症状并且安全可靠。Objective To evaluate the efficacy and safety of the treatment model of Jiawei Shengxue Plaster（ 加味升血贴） on protection of hematologic toxicities in the malignant tumor chemotherapy. Methods In the prospective study,randomized controlled,double blind,double dummy clinical trail was designed. A total of 138 patients with malignant tumor were randomly divided into two groups,with 69 cases for each group. The observation group was treated with modified blood rising plaster once a day and simultaneous oral leucogen,30 mg each time,3 times a day.The control group was treated with leucogen,30 mg each time,3 times a day. At the same time Jiawei Shengxue Plaster simulation agent was added once a day. The treatment was started on the first day of chemotherapy,and was continued for 14 days. The observation period was 21 days. Before and after treatment,blood routine,symptoms score,life quality score,body weight,KPS score and the safety were observed. Results Compared with before treatment,the platelet counts of the treatment group were reduced on the 7 th,14 th day of treatment,and on the 4 th,7 th,14 th,and 21 th day of the treatment group（ P〈0. 01）; the white blood cell counts of the two groups were significantly decreased on the 7 th and 14 th day（ P〈0. 05 or P〈0. 01）. Compared with the control group,the leucocyte and red blood cell counts were significantly increased in the treatment group on the 21 st day（ P〈0. 05）. Compared with the control group on the 21 st day,the quality of life score in the treatment group was significantly increased（ P〈0. 05）.Compared with before treatment,in the treatment group on the 21 st day,the symptoms of bloating and fatigue caused by fatigue were significantly lower than those before treatment（ P〈0. 05 or P〈0. 01）; the score of appetite loss on the 21 st day and fatigue score on the 7 the day in treatment group were significantly higher than in the control group（ P〈0. 05）; The nausea and vomiting scores of both groups were significantl

关 键 词：恶性肿瘤 血液学毒性 加味升血贴 化疗 白细胞计数 红细胞计数 

分 类 号：R730.5[医药卫生—肿瘤]