Peking University HuiLongGuan Clinical Medical School, Beijing Huilongguan Hospital, Beijing, People's Republic of China.
The Mental Health Center of Hebei Province, Baoding, People's Republic of China.
BMC Psychiatry. 2023 Mar 15;23(1):166. doi: 10.1186/s12888-023-04588-0.
Ziprasidone mesylate injection is an atypical antipsychotic drug which is recently approved in China. In combination with its oral formulation, sequential therapy with ziprasidone brings new interventions to patients with agitation in the acute phase of schizophrenia. The purpose of this 7-day multicenter study conducted in China was to evaluate the efficacy and safety of ziprasidone sequential treatment through intramuscular/oral routes in agitated patients with schizophrenia.
A total of 95 patients were enrolled from three centers in this study. The study duration was 7 days. In the first 3 days, subjects were administered an intramuscular injection of ziprasidone 10-40 mg daily and started sequentially with oral ziprasidone 40-80 mg at dinner (or lunch) from the day of the last intramuscular injection. In the following 4 days, according to the severity of the symptoms and the drug response, 120-160 mg of ziprasidone was orally administered daily. In total, six visits were scheduled to assess the Positive and Negative Syndrome Scale (PANSS), the Behavioral Activity Rating Scale (BARS), the Clinical Global Impression of Severity (CGI-S), and Improvement (CGI-I) scores throughout the procedure. Lastly, adverse events were recorded during treatment.
Out of the 95 patients that were enrolled, 83 cases were effectively completed. Visits 3, 4, 6, PANSS, and PANSS-excited component (PANSS-EC) subscale points, and Visit 2-Visit 6 viewpoints, BARS scale points, and baseline scores denote a progressive downward trend (P < 0.001). In this study, 62 adverse events were reported. The most common adverse events were extrapyramidal symptoms (EPS) (23 cases) and excessive sedation(10 cases), and 13 cases of prolonged QTc interval were reported.
Ziprasidone IM demonstrated significant and rapid reduction in agitation, and sequential oral formulation keep stability and continuation of the treatment can further ensure efficacy. Ziprasidone sequential therapy may provide a new approach to acute agitation in schizophrenic patients.
The Chinese Clinical Trials Registry; URL: https://www.chictr.org.cn : ChiCTR-OIC-16007970.
甲磺酸齐拉西酮注射液是一种新型抗精神病药物，最近在中国获得批准。与口服制剂联合使用，齐拉西酮序贯治疗为精神分裂症急性期激越患者带来了新的干预手段。本项在中国进行的为期 7 天的多中心研究旨在评估肌内/口服途径使用齐拉西酮序贯治疗激越精神分裂症患者的疗效和安全性。
本研究共纳入 3 个中心的 95 例患者。研究持续 7 天。前 3 天，受试者每天接受 10-40mg 齐拉西酮肌内注射，末次肌内注射日晚餐（或午餐）时开始序贯口服齐拉西酮 40-80mg。随后 4 天，根据症状严重程度和药物反应，每天口服齐拉西酮 120-160mg。共安排 6 次就诊，以评估阳性和阴性症状量表（PANSS）、行为活动评定量表（BARS）、临床总体印象严重程度（CGI-S）和改善（CGI-I）评分。最后，记录治疗期间的不良事件。
95 例患者中，83 例有效完成。就诊 3、4、6 时、PANSS 总分和兴奋因子分（PANSS-EC）、就诊 2-6 时、BARS 总分和基线评分呈逐渐下降趋势（P<0.001）。本研究共报告 62 例不良事件。最常见的不良事件是锥体外系症状（EPS）（23 例）和过度镇静（10 例），报告 13 例 QTc 间期延长。
齐拉西酮肌内注射能迅速显著减轻激越，口服制剂序贯治疗可保持疗效稳定和治疗的连续性，进一步确保疗效。齐拉西酮序贯治疗可能为精神分裂症患者的急性激越提供一种新的治疗方法。
中国临床试验注册中心；网址：https://www.chictr.org.cn：ChiCTR-OIC-16007970。
