复方浙贝颗粒辅助化疗改善难治性急性白血病患者症状的临床观察

目的观察复方浙贝颗粒辅助化疗对难治性急性白血病患者KPS评分与症状的影响。方法将235例难治性急性白血病患者随机进行药品编号及患者人组，分为治疗组合对照组，采用随机双盲、安慰剂对照、多中心临床试验的方法，分别在在标准化疗方案实施前3天加服复方浙贝颗粒或安慰剂，均每次1袋，每日2次，连续j4天，以一个标准化疗疗程为治疗周期，观察治疗前后患者KPS评分与症状的变化。结果临床症状中仅有发热症状在访视点三减基线2组比较差异有统计学意义（P=043），提示复方浙贝颗粒辅助化疗对发热症状有一定的改善作用。结论复方浙贝颗粒联合化疗药能够改善难治性急性白血病患者的临床症状。

Clinical observation on effects of adjuvant chemotherapy with Fritillary Thunbergii Bulb Complex Granules on symptoms of Refractory Acute Leukemia patients

Objective To observe impacts of adjuvant chemotherapy with Fritillary Thunbergii Bulb Complex Granules （FTBCG） on KPS and symptoms in patients with Refractory Acute Leukemia （RAL）.Methods The multicenter randomized placebo-controlled double-blind clinical trial was applied. With RAL patients as research objective, the changes of KPS and symptoms were observed before and after treatment. Drug identification number and patient assignment were randomized during the trial. 3 days before application of standard chemotherapy, FTBCG or placebo was added, once a bag, twice a day for continuous 14 days. One session of standard chemotherapy was taken as treatment course, and the therapeutic effect was assessed after treatment. Results Among clinical symptoms, compared between groups only difference of fever was significantly different, indicating adjuvant chemotherapy of FTBCG had some improvement on fever. Conclusion The FTBCG could improve clinical symptoms of RAL patients and improve their life quality.