Efficacy and safety of Compound Huangdai Tablets combined with retinoic acid in treatment of patients with acute promyelocytic leukemia in maintenance phase
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摘要: 目的 探讨复方黄黛片联合维甲酸治疗急性早幼粒细胞白血病(APL)维持期患者的疗效及安全性。 方法 选取APL患者90例,随机分为对照组和观察组各45例。对照组采用维甲酸、亚砷酸序贯治疗,观察组采用复方黄黛片、维甲酸序贯疗法。比较2组的治疗效果、治疗前后血脂代谢水平以及不良反应发生率。 结果 2组无事件存活率、死亡率和复发率比较,差异无统计学意义(P>0.05)。治疗后, 2组总胆固醇(TC)、低密度脂蛋白胆固醇(LDL-C)及甘油三酯(TG)水平均显著增高(P<0.05),且观察组TC、LDL-C和TG水平均显著低于对照组(P<0.05)。对照组胃肠道不适、维甲酸综合征、肝肾功能损害、颅内压增高、头晕头痛和关节痛等不良反应的发生率均显著高于观察组(P<0.05)。 结论 与亚砷酸联合维甲酸相比,复方黄黛片联合维甲酸用于APL患者维持期治疗的疗效更佳,能够纠正机体血脂代谢异常状态。Abstract: Objective To explore the efficacy and safety of Compound Huangdai Tablets combined with retinoic acid in treatment of patients with acute promyelocytic leukemia(APL)in maintenance phase. Methods Ninety APL patients were selected and randomly divided into control group and observation group, with 45 cases in each group. The control group was treated with sequential therapy of retinoic acid and arsenious acid, while the observation group was treated with sequential therapy of Compound Huangdai Tablets and retinoic acid. The therapeutic effect, metabolism levels of blood lipid indexes before and after treatment, and the incidence of adverse reactions were compared between the two groups. Results There were no significant differences in event-free survival rate, mortality and recurrence rate between the two groups(P>0.05). After treatment, the levels of total cholesterol(TC), low density lipoprotein cholesterol(LDL-C)and triglyceride(TG)in both groups increased significantly(P<0.05), and the levels of TC, LDL-C and TG in the observation group were significantly lower than those in the control group(P<0.05). The incidence rates of adverse reactions such as gastrointestinal discomfort, retinoic acid syndrome, damage of liver and kidney function, increase of intracranial pressure, dizziness and headache and joint pain in the control group were significantly higher than those in the observation group(P<0.05). Conclusion Compared with therapy of arsenious acid combined with retinoic acid, the Compound Huangdai Tablets combined with retinoic acid has a better therapeutic effect in the treatment of patients with APL in maintenance phase, which can correct the abnormal metabolism of blood lipid indexes.
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