Holmskov Mathilde, Storebø Ole Jakob, Moreira-Maia Carlos R, Ramstad Erica, Magnusson Frederik Løgstrup, Krogh Helle B, Groth Camilla, Gillies Donna, Zwi Morris, Skoog Maria, Gluud Christian, Simonsen Erik
Psychiatric Research Unit, Region Zealand Psychiatry, Slagelse, Denmark.
Child and Adolescent Psychiatric Department, Region Zealand, Denmark.
PLoS One. 2017 Jun 15;12(6):e0178187. doi: 10.1371/journal.pone.0178187. eCollection 2017.
To study in more depth the relationship between type, dose, or duration of methylphenidate offered to children and adolescents with attention deficit hyperactivity disorder and their risks of gastrointestinal adverse events based on our Cochrane systematic review.
We use data from our review including 185 randomised clinical trials. Randomised parallel-group trials and cross-over trials reporting gastrointestinal adverse events associated with methylphenidate were included. Data were extracted and quality assessed according to Cochrane guidelines. Data were summarised as risk ratios (RR) with 95% confidence intervals (CI) using the inverse variance method. Bias risks were assessed according to domains. Trial Sequential Analysis (TSA) was used to control random errors. Eighteen parallel group trials and 43 cross-over trials reported gastrointestinal adverse events. All trials were at high risk of bias. In parallel group trials, methylphenidate decreased appetite (RR 3.66, 95% CI 2.56 to 5.23) and weight (RR 3.89, 95% CI 1.43 to 10.59). In cross-over trials, methylphenidate increased abdominal pain (RR 1.61, 95% CI 1.27 to 2.04). We found no significant differences in the risk according to type, dose, or duration of administration. The required information size was achieved in three out of four outcomes.
Methylphenidate increases the risks of decreased appetite, weight loss, and abdominal pain in children and adolescents with attention deficit hyperactivity disorder. No differences in the risks of gastrointestinal adverse events according to type, dose, or duration of administration were found.
基于我们的Cochrane系统评价，更深入地研究给予患有注意力缺陷多动障碍的儿童和青少年的哌甲酯类型、剂量或持续时间与其胃肠道不良事件风险之间的关系。
我们使用了来自我们评价的包括185项随机临床试验的数据。纳入报告与哌甲酯相关的胃肠道不良事件的随机平行组试验和交叉试验。根据Cochrane指南提取数据并进行质量评估。使用逆方差法将数据总结为风险比（RR）及95%置信区间（CI）。根据不同领域评估偏倚风险。采用试验序贯分析（TSA）控制随机误差。18项平行组试验和43项交叉试验报告了胃肠道不良事件。所有试验均存在较高的偏倚风险。在平行组试验中，哌甲酯会降低食欲（RR 3.66，95%CI 2.56至5.23）和体重（RR 3.89，95%CI 1.43至10.59）。在交叉试验中，哌甲酯会增加腹痛（RR 1.61，95%CI 1.27至2.04）。我们发现根据给药类型、剂量或持续时间，风险无显著差异。四个结局中有三个达到了所需的信息规模。
哌甲酯会增加患有注意力缺陷多动障碍的儿童和青少年出现食欲下降、体重减轻和腹痛的风险。未发现根据给药类型、剂量或持续时间，胃肠道不良事件风险存在差异。
