中药定清片联合化疗治疗急性白血病复发的临床研究

目的: 观察中药定清片联合化疗与单纯化疗比较治疗急性白血病复发患者的临床疗效. 方法: 采用随机对照研究方法, 将符合纳入标准的60例急性白血病复发病例分为2组, 每组30例. 分别给予定清片联合化疗(试验组)或单纯化疗(对照组)治疗, 观察比较两组治疗前后的骨髓缓解率、血常规变化、中医证候疗效、感染发生率和不良反应发生情况. 结果: 试验组获完全缓解13例、部分缓解6例, 总缓解率63.33%; 对照组获完全缓解12例、部分缓解5例, 总缓解率56.67%, 两组的骨髓总缓解率相比较无明显统计学差异(P＞0.05). 在治疗后, 试验组的白细胞和血小板计数高于对照组, 两者比较有统计学差异(P＜0.05). 在中医证候疗效方面, 试验组的总有效率86.6%, 明显高于对照组的66.7%(P＜0.05). 在疗后的感染发生率和不良反应发生情况比较中, 试验组低于对照组, 两组间比较均有统计学差异(P＜0.05). 结论: 中药定清片联合化疗治疗急性白血病复发患者, 在西医疗效上与单纯化疗组无明显差异, 但联合治疗更利于化疗后白细胞及血小板的恢复以及减少感染及相关并发症的产生, 所产生的不良反应也低于单纯化疗组; 在中医证候疗效上联合治疗也优于单纯化疗组.

Clinical study on treatment of the relapsed acute leukemia with traditional Chinese medicine Ding Qing tablet combined with chemotherapy

Objective: To examine the efficacy of traditional Chinese medicine Ding Qing tablets in combination with chemotherapy on the treatment of relapsed acute leukemia patients, compared with that of chemotherapy alone. Methods: 60 eligible relapsed acute leukemia patients were divided into 2 groups (30 in each group). The two groups were treated with Ding Qing tablets plus chemotherapy (trial group) and chemotherapy alone (control group), respectively. After intervention, differences in bone marrow remission rate, changes of blood biochemical parameters, improvements of TCM syndromes, infections occurrence and adverse reactions between two groups were recorded. Results: In trial group, complete remission (CR) was observed in 13 cases and partial remission (PR) in 6 cases, with a total response rate of 63.33%. In control group, there were 12 CR cases and 5 PR cases, with a total response rate of 56.67%. No significant difference was found in bone marrow remission rate (P>0.05), but higher white blood cell and platelet count, lower infection rate and lower incidence of adverse reactions were found in the trial group (all P<0.05). More patients in trial group showed improvements in TCM syndromes in comparison to those in control group (86.6% vs. 66.7%, P<0.05). Conclusion: The total response rate of the two regimens was similar in patients with relapsed acute leukemia. Compared with chemotherapy along, traditional Chinese medicine Ding Qing tablets plus chemotherapy showed a higher level of quicker white blood cell counts and platelet recovery, less adverse reactions, lower incidence of infection and related complications, as well as greater improvement in TCM syndromes.