复方黄黛片治疗初诊急性早幼粒细胞白血病的Ⅱ期临床试验  

PhaseⅡclinical trial of compound Huangdai tablet in newly diagnosed acute promyelocytic leukemia

作　　者：复方黄黛片Ⅱ期临床试验协作组 钱林生[2] 赵耀中 

机构地区：[1]不详,天津300020 [2]中国医学科学院,中国协和医科大学血液学研究所,血液病医院

出　　处：《中华血液学杂志》2006年第12期801-804,共4页Chinese Journal of Hematology

摘　　要：目的进一步考察复方黄黛片治疗急性早幼粒细胞白血病(APL)的疗效和不良反应。方法通过区组、双盲双模、随机对照、多中心临床试验随机分组分出试验组和对照组。试验组:复方黄黛片,每次0．75～1．25 g,每日3次,根据胃肠道反应情况逐步加大剂量,到第10天,达到7．5 g／d,分3次服用。服复方黄黛片同时服用模拟全反式维甲酸胶囊每次10 mg,每日3次。对照组:模拟复方黄黛片每次0．75～1．25 g,每日3次,根据胃肠道反应情况逐步加大剂量,到第10天,达到7．5 g／d,分3次服用。服模拟复方黄黛片同时服用全反式维甲酸胶囊,每次10 mg,每日3次。试验组和对照组用药,达到完全缓解(CR)后停药。用药时间最长可延长到60 d。结果符合方案人群分析:试验组和对照组的CR率分别为96．7％和94．9％;意向治疗分析:试验组和对照组的CR率分别为80．8％和75．7％,差异无统计学意义(P>0．05)。试验组和对照组达CR所需时间,试验组[(48．95±8．97)d]长于对照组[(44．21±9．28)d],两组间差异有统计学意义。试验组和对照组治疗中不良反应发生率分别为39．7％和32．9％,两组差异无统计学意义。试验药物主要不良反应为胃肠道反应、皮疹、肝功能异常等;而对照药物不良反应主要为胃肠道反应,肌肉、关节、骨骼疼痛,皮疹以及发热等。结论复方黄黛片疗效和全反式维甲酸相近,对初治APL有较高的CR率和很好的耐受性。Objective To evaluate the curative and adverse effects of compound Huangdai tablet （CHDT） for treatment of acute promyelocytic leukemia （APL）. Methods A total of APL patients were randomly and double blindly distributed to test or control groups. In the test group, CHDT was administered 0.75 - 1. 25 g orally, three times a day, then gradually increased to 2.5 g, three times a day from the tenth day. Simulating all-trans retinoic acid （ATRA） capsule was given 10 mg orally, three times a day during the course of CHDT administration. In the control group, the simulating HDT was administered 0.75 - 1.25 g orally, three times a day, then gradually increased to 2.5 g, three times a day from the tenth day. All-trans retinoic acid （ATRA） was given 10 mg orally, three times a day during the simulating CHDT administration. Both groups stopped treatment on achieving complete remission （CR）. The longest treatment duration lasted for sixty days. Results The CR rates were 96.7% and 94.9% in test group and control group, respectively in per-protocol（PP） analysis. And were 80.8% and 75.7% respectively in intention-to-treat（IriS） analysis. The average time to achieving CR in test group [ （48.95 ±8.97） d] was significantly longer than in control group [ （44.21 ±9.28） d]. The incidence of adverse effects were 39.7% and 32.9% in test group and control group, respectively, being not significantly different. The major adverse effects included gastrointestinal symptoms, rash, liver disfunction, etc in test group, and gastrointestinal symptoms, pain in limb, rash, and pyrexia, etc in control group. Conclusion The curative effect of compound Huangdai tablet is no less than that of ATRA for newly diagnosed （APL）. It has a higher CR rate and better tolerance. Compound Huangdai tablets and ATRA are drugs with different therapeutic mechanism and applied conveniently. The compound Huangdai tablet is proved to be a new effective agent for APL treatment.

关 键 词：复方黄黛片 维甲酸 白血病 早幼粒细胞 急性 疗效 不良事件 

分 类 号：R733.71[医药卫生—肿瘤]