胍法辛缓释剂在成人注意缺陷多动障碍中的安全性和疗效：一项开放标签、长期、3 期扩展研究。
Safety and efficacy of guanfacine extended-release in adults with attention-deficit/hyperactivity disorder: an open-label, long-term, phase 3 extension study.
机构信息
Department of Psychiatry, Showa University School of Medicine, 6-11-11 Kita Karasuyama, Setagaya-ku, Tokyo, 157-8577, Japan.
Aiiku Counselling Office, Aiiku Research Institute, Imperial Gift Foundation Boshi-Aiiku-Kai, Tokyo, Japan.
出版信息
BMC Psychiatry. 2020 Oct 2;20(1):485. doi: 10.1186/s12888-020-02867-8.
BACKGROUND
To assess the safety and efficacy of long-term administration of guanfacine extended-release (GXR) in adults with attention-deficit/hyperactivity disorder (ADHD).
METHODS
In this open-label, long-term, phase 3 extension study in Japan, 150 patients transitioned from a double-blind trial, and 41 newly enrolled patients received once daily GXR (starting dose 2 mg/day, maintenance dose 4-6 mg/day) for 50 weeks. Primary outcome measures were the frequency and nature of treatment-emergent adverse events (TEAEs); secondary outcome measures included the change from week 0 in ADHD Rating Scale IV with Adult Prompts (ADHD-RS-IV; Japanese version) total and subscale scores, Conners' Adult ADHD Rating Scales (CAARS), Clinical Global Impression-Improvement (CGI-I) and Patient Global Impression-Improvement (PGI-I) scales, and quality of life (QoL) and executive functioning measures.
RESULTS
Of all patients, 94.2% (180/191) reported ≥1 TEAE and 19.9% (38/191) discontinued because of a TEAE. Most TEAEs were mild to moderate in severity; there were two serious TEAEs and no deaths. Commonly reported TEAEs (≥10% of patients) were somnolence, thirst, nasopharyngitis, decreased blood pressure, postural dizziness, bradycardia, malaise, constipation, and dizziness. Mean changes from week 0 in ADHD-RS-IV total and subscale scores and CAARS subscale scores were significantly improved in former placebo or GXR patients and new patients at last observation (p < .0001), and the percentage of patients with very much or much improved CGI-I and PGI-I scores increased.
CONCLUSIONS
There were no major safety concerns during long-term GXR administration in adults with ADHD. After long-term treatment, patients had significant improvements from baseline in ADHD symptoms, QoL, and executive functioning.
TRIAL REGISTRATION
Japan Primary Registries Network ( https://rctportal.niph.go.jp/en/ ): JapicCTI-163232, registered 04/21/2016.
背景
评估胍法辛缓释剂（GXR）在成人注意缺陷多动障碍（ADHD）患者中的长期安全性和疗效。
方法
在日本这项开放标签、长期、3 期扩展研究中，150 名患者从双盲试验转入，41 名新入组患者接受每日一次 GXR（起始剂量 2mg/天，维持剂量 4-6mg/天）治疗 50 周。主要疗效指标为治疗出现的不良事件（TEAE）的频率和性质；次要疗效指标包括 ADHD 评定量表-IV 与成人提示（ADHD-RS-IV；日本版）总分和各分量表评分、Conners 成人 ADHD 评定量表（CAARS）、临床总体印象-改善（CGI-I）和患者总体印象-改善（PGI-I）量表、生活质量（QoL）和执行功能的变化。
结果
所有患者中，94.2%（180/191）报告≥1 次 TEAE，19.9%（38/191）因 TEAE 停药。大多数 TEAEs 为轻至中度，有 2 例严重 TEAEs，无死亡。报告≥10%患者的常见 TEAEs（按发生频率降序排列）为嗜睡、口渴、鼻咽炎、血压降低、体位性头晕、心动过缓、不适、便秘和头晕。在前安慰剂或 GXR 患者和新患者的最后观察时，ADHD-RS-IV 总分和各分量表评分以及 CAARS 各分量表评分较基线显著改善（p<0.0001），CGI-I 和 PGI-I 评分非常或明显改善的患者比例增加。
结论
在 ADHD 成人长期 GXR 治疗期间，未发现重大安全性问题。经过长期治疗，患者的 ADHD 症状、QoL 和执行功能均有显著改善。
试验注册
日本主要注册处网络（https://rctportal.niph.go.jp/en/）： JapicCTI-163232，于 2016 年 4 月 21 日注册。
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