浙贝颗粒在难治性白血病围化疗期的临床应用研究

目的将基础研究成果应用于临床，评价浙贝颗粒辅助化疗在难治性急性白血病围化疗期的临床有效性与安全性。方法采用随机、双盲、多家医院同期对照临床研究方案，按照药物随机法将符合诊断标准的患者分为浙贝颗粒组与安慰剂对照组。所有入组病例均在化疗前3d给予观察药物或安慰剂，1个化疗疗程结束后进行临床疗效判定。结果按照临床研究方案能够进入统计学处理的患者138例，其中淅贝颗粒组72例，安慰剂对照组66例。疗效评定结果显示，浙贝颗粒组与对照组临床完全缓解率分别为36．8％、25．8％，总有效率分别为77．8％、53．0％。经统计学处理，差异有统计学意义（P〈0．05）。结论浙贝颗粒辅助化疗能够提高难治性急性白血病围化疗期临床疗效，并具有较好的临床用药安全性。

Clinical Application of Fritillaria thunbergh" Miq. Granule in Refractory Acute Leukemia during Perichemotherapy

Objective To translate the findings from fundamental research into clinical application and to evaluate the clinical efficiency and safety of Fritillaria thunbergu Miq. granule as adjunctive means of chemotherapy during peri chemotherapy of refractory acute leukemia. Methods Patients in multiple hospitals were randomly divided into two groups with Fritillaria thunbergii Miq. granule treatment or synchronous control at three days before chemotherapy respectively, according to random approaches for medical treatment. The clinical therapeutic effects were then determined after one course of treatment. Results According to the research project, 138 patients were analyzed statistically, 72 in FritiUaria thunbergii Miq. granule group and 66 in control group. The complete remission rate （CR） of Fritillaria thunbergii Miq. granule group and control group were 36.8% and 25.8% respectively, while the total effects were 77.8% and 53.0%, which was significantly different （P〈0.05）. Conclusion As an adjunctive means of chemotherapy, Fritillaria thunbergii Miq. granule promotes the clinical therapeutic effect during perichemotherapy of refractory acute leukemia safely.