坦索罗辛对梦魇症的治疗效果:一项随机、双盲、安慰剂对照、交叉试验研究。

IF 1.7 Q3 PHARMACOLOGY & PHARMACY Drug Research Pub Date : 2024-02-01 Epub Date: 2024-01-18 DOI:10.1055/a-2226-3604
Negin Naderifar, Elnaz Roohi, Ali Sharifi, Nemat Jaafari, Farshad Hashemian
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引用次数: 0

摘要

噩梦障碍与功能障碍、痛苦和生活质量低下有关;然而,针对这种使人衰弱的障碍的药物疗法研究结果不一。据报道,非选择性α1受体阻滞剂哌唑嗪可有效治疗创伤后应激障碍相关噩梦。坦索罗辛对阻断α1A和α1D肾上腺素受体具有更高的亲和力,我们旨在研究坦索罗辛在治疗噩梦障碍方面的疗效。我们进行了一项随机、双盲、交叉、安慰剂对照试验研究。患者被随机分配接受坦索罗辛 0.4 毫克,每天一次或安慰剂,为期四周。经过两周的冲淡期后,他们被交叉分配到另一组,再接受为期四周的药物或安慰剂治疗。恶梦频率和强度的测量采用干扰性梦境和恶梦严重程度指数(DDNSI)。同时还进行了血压测量。根据方案分析,服用坦索罗辛后,DDNSI评分平均值有所下降,并呈显著统计学趋势(p=0.065,d=0.236)。意向治疗分析结果显示,用药后 DDNSI 评分有显著差异(p=0.030,d=0.651)。此外,使用安慰剂后,DDNSI 分数也明显下降。然而,意向治疗分析表明,使用安慰剂前后的差异无统计学意义(0.064,d=0.040)。坦索罗辛可能对治疗梦魇症有效。不过,建议进一步开展更大规模的临床试验,以明确坦索罗辛和α1亚型在恶梦药物治疗中的有效性。
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Therapeutic Effects of Tamsulosin in Nightmare Disorder: A Randomized, Double Blind, Placebo-Controlled, Cross-Over, Pilot Study.

Nightmare disorder is associated with functional impairment, distress, and low quality of life; however, studies on pharmacotherapy of this debilitating disorder yielded mixed results. Prazosin, a non-selective α1 blocker is reported to be effective in treatment of post-traumatic stress disorder-related nightmares. We aimed at investigating therapeutic effects of tamsulosin which has higher affinity for blocking α1A and α1D adrenoceptors in treatment of nightmare disorder. A randomized, double blind, cross-over, placebo-controlled pilot study was conducted. Patients were randomly assigned to receive Tamsulosin 0.4 mg once daily or placebo for period of four weeks. Following a 2-week wash-out period, they were crossed over to the other group and received drug or placebo for duration of 4 additional weeks. Nightmare frequency and intensity measurements were carried out using Disturbing Dreams and Nightmares Severity Index (DDNSI). Blood pressure measurements were also performed. According to per protocol analysis, mean DDNSI scores decreased following administration of tamsulosin and a statistical trend towards significance was reported (p=0.065, d=0.236). Results of intention to treat analysis showed significant difference in DDNSI scores after drug use (p=0.030, d=0.651). Additionally, DDNSI scores dropped significantly following placebo use. However, intention to treat analysis showed no statistically significant difference pre and post placebo period (0.064, d=0.040). Tamsulosin may be effective in treatment of nightmare disorder. However, further larger clinical trials are recommended to clarify the effectiveness of tamsulosin and α1 subtypes in pharmacotherapy of nightmares.

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来源期刊
Drug Research
Drug Research PHARMACOLOGY & PHARMACY-
CiteScore
3.50
自引率
0.00%
发文量
67
期刊介绍: Drug Research (formerly Arzneimittelforschung) is an international peer-reviewed journal with expedited processing times presenting the very latest research results related to novel and established drug molecules and the evaluation of new drug development. A key focus of the publication is translational medicine and the application of biological discoveries in the development of drugs for use in the clinical environment. Articles and experimental data from across the field of drug research address not only the issue of drug discovery, but also the mathematical and statistical methods for evaluating results from industrial investigations and clinical trials. Publishing twelve times a year, Drug Research includes original research articles as well as reviews, commentaries and short communications in the following areas: analytics applied to clinical trials chemistry and biochemistry clinical and experimental pharmacology drug interactions efficacy testing pharmacodynamics pharmacokinetics teratology toxicology.
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