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

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。

Objective Methylphenidate 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. Methods Ninety-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. Results Fifty 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. Conclusions OROS-MPH for the treatment of ADHD is effective and safe in children, and its once-daily administration is more convenient.