盐酸哌甲酯控释片治疗注意缺陷多动障碍疗效观察

Effectiveness of oral osmotic-methylphenidate in treatment of attention deficit hyperactivity disorder in children

摘要:

目的：盐酸哌甲酯是目前治疗注意缺陷多动障碍（ADHD）的首选药物。以往多使用传统的速释哌甲酯片，现已研制出渗透泵控释的哌甲酯，并且已在我国上市使用。该研究对盐酸哌甲酯控释片对ADHD的治疗疗效及安全性进行评价。方法：将99例ADHD儿童按随机原则分为哌甲酯控释片组与速释哌甲酯片组。接受6周治疗观察，采用主要疗效评定指标（SNAP-IV家长评定量表）及次要疗效评定指标(IVA-CPT）进行疗效评定。结果：共50例患儿完成6周治疗，哌甲酯控释片组治疗有效率（83.3%）、完全缓解率（44%）均高于速释哌甲酯组（有效率75%、完全缓解率25%），两组治疗6周前后各量表分值与基线值相比差异均有显著性（P＜0.01），两组间各量表分值变化的平均值差异无显著性。两组治疗期间不良事件发生率相似。结论： 哌甲酯控释片用于ADHD治疗安全有效，且每日只需1次服药，用药方便。

Abstract:

ObjectiveMethylphenidate is recommended as a first-line modality for treating attention deficit hyperactivity disorder (ADHD). In the past, immediate release methylphenidate (IR-MPH) was used for ADHD. Now oral osmotic-methylphenidate (OROS-MPH) is used for ADHD in China. This study was designed to investigate the efficacy and safety of OROS-MPH for treatment of ADHD in children. MethodsNinety-nine children with ADHD were randomly administered with OROS-MPH (18 mg/time, once daily) and IR-MPH (5 mg/ time, twice or three times per day). After 6 weeks of treatment, the therapeutic effects were evaluated by the SNAP-IV and the IVA-CPT. ResultsFifty patients completed the 6-week treatment. The effective rate (83.3% vs 75%) and the complete remission rate (44% vs 25%) in the OROS-MPH treatment group were higher than that in the IR-MPH treatment group. There were statistically significant differences in the SNAP-IV and IVA-CPT scores before and after treatment in the two groups (P＜0.01). The two groups had a similar incidence of side effects during treatment.ConclusionsOROS-MPH for the treatment of ADHD is effective and safe in children, and its once-daily administration is more convenient.