难治性急性白血病化疗联合复方浙贝颗粒疗效及药物安全性的临床研究  

Efficacy and drug safety of chemotherapy combined with Compound Zhebei Granules(CZBG)in refractory acute leukemia

作　　者：吕鹏 石凤芹[1] 潘一鸣 陈信义[1] 侯丽[1] Lyu Peng;Shi Fengqin;Pan Yiming;Chen Xinyi;Hou Li(Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine,Beijing 100700)

机构地区：[1]北京中医药大学东直门医院,北京100700

出　　处：《现代中医临床》2020年第3期27-32,共6页Modern Chinese Clinical Medicine

基　　金：北京市科技计划“十病十药研发”项目(No.Z151100003815027);国家科技支撑计划资助项目(No.2006BAI04A18)。

摘　　要：目的观察复方浙贝颗粒联合化疗治疗难治性急性白血病患者的药物安全性及有效性。方法采用随机双盲、安慰剂对照、多中心临床试验方法,并通过中央(网上)随机将2007年4月-2009年12月入组的238例符合难治性急性白血病诊断标准患者随机分对照与治疗2组。临床试验结束后,经核实剔除3例不符合入组标准患者,脱落38例,经两次揭盲确定治疗组(化疗方案联合复方浙贝颗粒,每次1袋,每日2次)98例,对照组(化疗方案加安慰剂,每次1袋,每日2次)99例。2组均在1个化疗疗程结束后统计疗效及药物安全性资料。结果完全缓解(CR)、CR+部分缓解(PR)分别为33.67%、52.04%(治疗组)与24.24%、37.37%(对照组),有统计学意义(P<0.05),治疗组CR、CR+PR分别较对照组提高9.43%与14.67%;1个化疗疗程结束后,化疗联合复方浙贝颗粒与单纯化疗相比,未增加患者血液、肝、肾、皮肤及周围神经毒性(P>0.05),具有降低胃炎分度,保护白细胞的作用趋势(P>0.05),能降低化疗导致粒细胞减少的毒性反应分级(P<0.05)。结论复方浙贝颗粒联合化疗能够提高难治性急性白血病1个疗程的化疗缓解率;在协同增效的同时,未增加患者血液、肝肾、皮肤及周围神经毒性,且具有降低胃炎分度、保护白细胞的作用趋势,能降低化疗导致粒细胞减少的毒性反应。Objective To observe the effects and safety of Compound Zhebei Granules(CZBG)in combination with chemotherapy in the treatment of refractory acute leukemia.Methods A randomized,double-blind,placebo-controlled,multicenter clinical trial was conducted in which 238 patients who met the diagnostic criteria for refractory acute leukemia were assigned to the control group and treatment group by using a central(online)randomized method.After the end of the clinical trial,3 patients who did not meet the inclusion criteria were removed and 38 patients were shedding.There were 98 patients in the treatment group(chemotherapy regimen combined with CZBG,1 bag each time,twice a day)and 99 patients in the control group(chemotherapy plus placebo,1 bag each time,twice a day).Both groups were statistically evaluated for efficacy and drug safety at the end of one chemotherapy session.Results Complete remission(CR)and complete remission plus partial remission(CR+PR)were 33.67%and 52.04%for the treatment group,and 24.24%and 37.37%for the control group,respectively.The difference was statistically significant(P<0.05).As compared with the control group,CR and CR+PR in the treatment group increased by 9.43%and 14.67%,respectively.After the end of one chemotherapy treatment session,as compared with chemotherapy alone,in the chemotherapy combined with CZBG group,toxicity to the blood,liver,kidney,skin and peripheral neurotoxicity were not elevated(P>0.05).CZBG showed a tendency to reduce the index of gastritis and protect white blood cells(P>0.05),which reduced the grading of chemotherapy-induced toxic reactions of decreased granulocytes(P<0.05).Conclusions CZBG combined with chemotherapy can improve chemotherapy response in refractory acute leukemia after one course of treatment;it does not increase the blood,liver,kidney,skin and peripheral neurotoxicity of patients,but with synergistic effects.In addition,it may reduce gastritis and protect white blood cells and it can reduce neutropenia caused by chemotherapy.

关 键 词：难治性急性白血病 复方浙贝颗粒 化疗缓解率 药物安全性 

分 类 号：R259[医药卫生—中西医结合]