薏苡仁油注射液用于32例老年急性髓系白血病围诱导化疗期患者疗效观察
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摘要
目的评价联合应用薏苡仁油注射液对老年急性髓系白血病(AML)(非M3)围诱导化疗期患者1个诱导疗程后临床缓解率的影响。方法以2009年1月—2016年1月北京中医药大学东直门医院住院的老年(≥60岁)AML患者为研究对象,根据住院期间有无联合应用薏苡仁油注射液分为联合治疗组(观察组)及单纯化疗组(对照组)2组,比较2组临床缓解率、中医症状体征疗效及药物安全性。结果 1个诱导疗程后,观察组完全缓解(CR)13例(40.6%)、部分缓解(PR)5例(15.6%),对照组CR 7例(30.4%)、PR 5例(21.8%),2组间差异均无统计学意义(均P>0.05);观察组骨髓原始细胞比4.5(21.0),对照组为9.0(15.5),2组间差异无统计学意义(P>0.05)。1个诱导疗程后,观察组中医证候疗效总有效率62.5%,对照组为17.4%,2组间差异有统计学意义(P<0.01);在复发难治病例中,观察组中医证候疗效总有效率77.2%,对照组为20.0%,2组间差异亦有统计学意义(P<0.01)。1个诱导疗程后,观察组心脏、肝脏、肾脏毒性反应发生率分别为18.7%、31.2%、12.5%,对照组分别为34.8%、21.7%、8.7%,2组间差异均无统计学意义(均P>0.05)。结论老年AML(非M3)围诱导化疗期联合应用薏苡仁油注射液可以提高缓解率,降低患者骨髓原始细胞比,以复发难治患者作用更明显。薏苡仁油注射液不但能改善患者中医症状、体征,还可能具有减轻患者化疗相关性心脏不良反应的作用。
Objective To evaluate the complete remission rates in elderly AML(M3 excluded)patients during peri-induction chemotherapy period after receiving one course of combined treatment of induction chemotherapy and Yiyiren Oil injection.Methods Elderly inpatients(≥60 years old) in Dongzhimen Hospital from January 2009 to January 2016 were the subjects,and based on whether Yiyiren Oil injection was incorporated in the patients' treatment regimen or not during hospitalization,these cases were divided into two groups:those who received Yiyiren Oil injection were categorized into the combined treatment group,while those who did not were placed in the simple treatment group.The clinical remission rate,TCM symptoms,sign effect and drug safety between the two groups were compared.Results After one course of induction,complete remission was seen in 13 cases(40.6 %)and partly remission in 5 cases(15.6 %)in the treatment group,and complete remission was seen in 7 cases(30.4 %)and partly remission in 5 cases(21.8 %)in the control group,the differences between the two groups were not statistically significant(P>0.05).Bone marrow blast percentages was 4.5 in the treatment group and 9.0 in the control group.The total effect rate of TCM syndrome was 77.2 % in the treatment group,and 20.0 % in the control group,and the difference between the two groups was not statistically significant(P>0.05).The incidence of heart,liver,and kidney toxicity after one course of induction therapy was18.7 %,31.2 %,and 12.5 % in the treatment group and 34.8 %,21.7 %,and 8.7 % in the control group respectively.The differences between the two groups were not statistically significant(P>0.05).Conclusion Combined treatment regimen with induction chemotherapy and Yiyiren Oil injection has the effects for elderly AML(M3 excluded)patients in increasing remission rate,lower bone marrow blast percentage,more prominently in refractory or relapsed AML.Yiyiren Oil Injection has the effect of reducing chemotherapy-related cardiotoxicity in elderly patients with AML without increasing liver and kidney toxicity.
Objective To evaluate the complete remission rates in elderly AML(M3 excluded)patients during peri-induction chemotherapy period after receiving one course of combined treatment of induction chemotherapy and Yiyiren Oil injection.Methods Elderly inpatients(≥60 years old) in Dongzhimen Hospital from January 2009 to January 2016 were the subjects,and based on whether Yiyiren Oil injection was incorporated in the patients' treatment regimen or not during hospitalization,these cases were divided into two groups:those who received Yiyiren Oil injection were categorized into the combined treatment group,while those who did not were placed in the simple treatment group.The clinical remission rate,TCM symptoms,sign effect and drug safety between the two groups were compared.Results After one course of induction,complete remission was seen in 13 cases(40.6 %)and partly remission in 5 cases(15.6 %)in the treatment group,and complete remission was seen in 7 cases(30.4 %)and partly remission in 5 cases(21.8 %)in the control group,the differences between the two groups were not statistically significant(P>0.05).Bone marrow blast percentages was 4.5 in the treatment group and 9.0 in the control group.The total effect rate of TCM syndrome was 77.2 % in the treatment group,and 20.0 % in the control group,and the difference between the two groups was not statistically significant(P>0.05).The incidence of heart,liver,and kidney toxicity after one course of induction therapy was18.7 %,31.2 %,and 12.5 % in the treatment group and 34.8 %,21.7 %,and 8.7 % in the control group respectively.The differences between the two groups were not statistically significant(P>0.05).Conclusion Combined treatment regimen with induction chemotherapy and Yiyiren Oil injection has the effects for elderly AML(M3 excluded)patients in increasing remission rate,lower bone marrow blast percentage,more prominently in refractory or relapsed AML.Yiyiren Oil Injection has the effect of reducing chemotherapy-related cardiotoxicity in elderly patients with AML without increasing liver and kidney toxicity.
引文
[1] 樊文娟,姜中兴.老年急性髓系白血病的治疗现状[J].河南医学研究,2014,23(1):149-152.
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[10] 刘珂.中西医结合治疗急性白血病的疗效[J].江苏医药,2015,41(7):831-832.
[11] 窦慧丽,刘宝山.中医药干预白血病围化疗期临床研究概述[J].中医杂志,2011,52(9):797-799.
[12] 于晓原,高巧梅,牛进宝,等.中医药在恶性肿瘤综合治疗中的伦理价值[J].中国医学伦理学,2010,13(6):26-27.
[13] 赵永辰,陈信义,高月平,等.多药耐药相关蛋白表达与急性白血病证效关系研究[J].中华中医药杂志,2006,9(2l):566-567.
[14] Young JC,Sook YL.Cytotoxicity and Multidrug-Resistance Reversing Activity of Extracts from Gamma-Irradiated Coix lachryma-jobi L.var.ma-yuen Stapf Seed[J].J Korean Soc Food Sci Nutr,2005,34(5):613-618.
[15] 董庆华,郑树,吕庆华.薏苡仁油注射液对多药耐药人白血病细胞株作用的实验研究[J].实用肿瘤杂志,2002,17(1):24-26.
[16] 吕鹏,张雅月,李蕊白,等.中医药在急性髓系白血病(非M3)围诱导化疗期的应用与研究进展[J].北京中医药,2017,36(10):955-959.
[17] Miyawaki S,Ohtake S,Fujisawa S,et al.A randomized comparison of 4 courses of standard dose multiagent chemotherapy versus 3 courses of high-dose cytarabine alone in post-remission therapy for acute myeloid leukemia in adults:the JALSG AML 201 study[J].Blood,2011,117(8):2366-2372.
[2] Buchner T,Berdel WE,Haferlach C,et al.Age-related risk profile and chemotherapy dose response in acute myeloid leukemia:a study by the German Acute Myeloid Leukemia Cooperative Group[J].J Clin Oncol,2009,27(1):61-69.
[3] 张之南,沈悌.血液病诊断及疗效标准[M].3版.北京:科学出版社,2007.
[4] 中华医学会血液学分会白血病淋巴瘤学组.复发难治性急性髓系白血病中国诊疗指南(2017年版)[J].中华血液学杂志,2017,38(3):183-184.
[5] 戴维斯,李小平.肿瘤支持治疗学[M].北京:北京大学医学出版社,2013.
[6] 郑筱萸.中药新药临床研究指导原则(试行)[M].北京:中国医药科技出版社,2002.
[7] 皋文君,刘砚燕,袁长蓉.国际肿瘤化疗药物不良反应评价系统—通用不良反应术语标准4.0版[J].肿瘤,2012,32(2):142-144.
[8] Oran B,Weisdorf DJ.Survival for older patients with acute myeloid leuke-mia:a population-based study[J].Haematologica,2012,97(12):1916-1924.
[9] 王珺,陈信义,董青,等.难治性急性白血病中西医诊疗研究进展[J].世界中医药,2013,8(8):979-984.
[10] 刘珂.中西医结合治疗急性白血病的疗效[J].江苏医药,2015,41(7):831-832.
[11] 窦慧丽,刘宝山.中医药干预白血病围化疗期临床研究概述[J].中医杂志,2011,52(9):797-799.
[12] 于晓原,高巧梅,牛进宝,等.中医药在恶性肿瘤综合治疗中的伦理价值[J].中国医学伦理学,2010,13(6):26-27.
[13] 赵永辰,陈信义,高月平,等.多药耐药相关蛋白表达与急性白血病证效关系研究[J].中华中医药杂志,2006,9(2l):566-567.
[14] Young JC,Sook YL.Cytotoxicity and Multidrug-Resistance Reversing Activity of Extracts from Gamma-Irradiated Coix lachryma-jobi L.var.ma-yuen Stapf Seed[J].J Korean Soc Food Sci Nutr,2005,34(5):613-618.
[15] 董庆华,郑树,吕庆华.薏苡仁油注射液对多药耐药人白血病细胞株作用的实验研究[J].实用肿瘤杂志,2002,17(1):24-26.
[16] 吕鹏,张雅月,李蕊白,等.中医药在急性髓系白血病(非M3)围诱导化疗期的应用与研究进展[J].北京中医药,2017,36(10):955-959.
[17] Miyawaki S,Ohtake S,Fujisawa S,et al.A randomized comparison of 4 courses of standard dose multiagent chemotherapy versus 3 courses of high-dose cytarabine alone in post-remission therapy for acute myeloid leukemia in adults:the JALSG AML 201 study[J].Blood,2011,117(8):2366-2372.