汉防己甲素辅助治疗复发难治急性白血病临床研究

目的 探讨汉防己甲素辅助治疗复发难治急性白血病(M3除外)的疗效及安全性.方法 分析2015年1月至2017年12月江苏省6家三级甲等医院收治的复发难治急性白血病(M3除外)患者58例,根据患者是否服用受试药物分为汉防己甲素辅助标准化疗方案组(治疗组,17例)和标准化疗方案组(对照组,41例).治疗组于化疗前5天加用汉防己甲素,每天4 mg/kg,连续口服5d后立即化疗;对照组采用标准化疗方案.对比分析两组的临床疗效及安全性.结果 治疗组中完全缓解(CR)、部分缓解(PR)、未缓解(NR)分别为5、3和9例,总有效(CR+PR)率为47.06％(8/17);对照组中CR、PR、NR分别为14、10和17例,总有效率为58.54％(24/41).两组总有效率比较,差异无统计学意义(x2=0.64,P=0.424).两组不同性别患者疗效比较,差异均无统计学意义(均P＞0.05).病程为6～11个月时,两组间疗效比较,差异有统计学意义(P=0.041).两组间治疗前后骨髓白血病细胞比例、白细胞计数、血小板计数、红细胞计数及血红蛋白比较,差异均无统计学意义(均P＞0.05).两组患者临床安全性指标(尿、粪常规,肝、肾功能及心电图)比较,差异均无统计学意义(均P＞ 0.05).结论 汉防己甲素对病程较短的复发难治急性白血病患者(M3除外)辅助化疗效果更佳.在化疗时加用汉防己甲素的临床疗效尚不能认为优于单纯化疗.

Clinical study on tetrandrine in adjuvant treatment of relapsed/refractory acute leukemia

Objective To analyze the efficacy and safety of tetrandrine in the adjuvant treatment of relapsed/refractory acute leukemia (except M3).Methods A total of 58 patients with relapsed/refractory acute leukemia (except M3) admitted to six tertiary hospitals in Jiangsu Province from January 2015 to December 2017 were included in this study.The tetrandrine-adjuvant standard chemotherapy regimen and standard chemotherapy regimen were given to treatment and control groups respectively.There were 17 and 41 patients in treatment and control groups.The treatment group was given tetrandrine for 5 days before the use of standard chemotherapy.The dose of tetrandrine was 4 mg ·kg-1 ·d-1,and patients had continuous oral administration of 5 days.After that,the patients in the treatment group started chemotherapy immediately.On the other side,the control group received standard chemotherapy without any other multidrug reversal medicine.Then the clinical efficacy and safety outcomes in both groups were analyzed.Results In the treatment group,5,3,and 9 cases achieved complete remission (CR),partial remission (PR),and nonremission (NR) respectively,and the total effective (CR+PR) rate was 47.06 ％ (8/17);in the control group,14,10,and 17 cases achieved CR,PR,and NR,and the total effective rate was 58.54 ％ (24/41).There was no significant difference in the total effective rate between the two groups (x2 =0.64,P =0.424).There was no significant difference in the efficacy between the two groups of patients with different genders (P ＞ 0.05).When the disease duration was 6-11 months,the difference of efficacy between the two groups was statistically significant (P =0.041).There was no significant difference in the proportion of myeloid leukemia cells,white blood cell count,platelet count,red blood cell count,and hemoglobin between the two groups before and after treatment (all P ＞ 0.05).There was no significant difference in clinical safety indicators (urine,faecal routine,liver and kidney function,and electrocardiogram) between the two groups (all P ＞ 0.05).Conclusions Tetrandrine is more effective in patients with relapsed/refractory acute leukemia (except M3) with shorter duration of disease.Compared with chemotherapy alone,the clinical efficacy of adding tetrandrine in chemotherapy cannot be considered superior to the former.