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首页> 外文期刊>Journal of Clinical Pharmacy and Therapeutics >An improved dosage regimen of sertraline hydrochloride in the treatment for premature ejaculation: An 8-week, single-blind, randomized controlled study followed by a 4-week, open-label extension study
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An improved dosage regimen of sertraline hydrochloride in the treatment for premature ejaculation: An 8-week, single-blind, randomized controlled study followed by a 4-week, open-label extension study

机译：盐酸舍曲林盐酸盐治疗早泄的改良剂量方案：一项为期8周，单盲，随机对照研究，随后为期4周的开放标签延伸研究

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What is known and objective This study aimed at evaluating the safety and efficacy of an improved dosage regimen of sertraline in patients with premature ejaculation (PE) and to examine whether the premature ejaculation diagnostic tool (PEDT) can be used as a measure of treatment response in these patients. Methods A total of 218 PE patients were randomized into control (n = 61) and treatment (n = 157) groups to receive mycelium of cordyceps sinensis C4 and sertraline 50 mg daily for 8 weeks, respectively. Following this blinded stage, sixty-three patients chose to take sertraline 100 mg daily for an additional 4-week period, and 80 other patients continued treatment with sertraline 50 mg. Main outcome measures include intravaginal ejaculatory latency time (IELT), PEDT score and Clinical Global Impression of Change (CGIC) score. Results At weeks 4 and 8, mean IELT of patients who subsequently chose to take 100 mg of sertraline was significantly lower than that of patients who continued taking 50 mg of sertraline, although the IELT value was comparable between the two groups of patients at baseline. However, with an additional 4-week treatment, the mean IELT increased significantly more in the 100-mg group than in the 50-mg continuation group. Similar results were also obtained in the analyses of the PEDT and CGIC scores. Both regimens were well tolerated, and relapse rate did not differ significantly between the two groups. What is new and conclusion These findings suggest that PE patients not responding to an 8-week treatment with sertraline 50 mg can benefit from an additional 4-week treatment with sertraline 100 mg and that the PEDT may be a valid measure of treatment response in PE patients. The study is aimed at evaluating the safety and efficacy of an improved dosage regimen of sertraline in patients with premature ejaculation (PE) and to examine whether the Premature Ejaculation Diagnostic Tool (PEDT) can be used as a measure of treatment response in these patients. Main outcome measures include intravaginal ejaculatory latency time (IELT), PEDT score and Clinical Global Impression of Change (CGIC) score. The findings suggest that PE patients not responding to an 8-week treatment with sertraline 50 mg can benefit from an additional 4-week treatment with sertraline 100 mg and that the PEDT may be a valid measure of treatment response in PE patients.
机译：已知和客观的本研究旨在评估改良舍曲林剂量方案对早泄（PE）患者的安全性和有效性，并研究是否可以将早泄诊断工具（PEDT）用作治疗反应的量度在这些患者中。方法将218例PE患者随机分为对照组（n = 61）和治疗组（n = 157），分别接受冬虫夏草C4菌丝体和舍曲林50mg的菌丝体，共8周。在这个盲目的阶段之后，六十三名患者选择每天服用100 mg舍曲林，持续另外的4周时间，其他80名患者继续接受舍曲林50 mg的治疗。主要结局指标包括阴道内射精潜伏时间（IELT），PEDT评分和临床整体变化印象（CGIC）评分。结果在第4周和第8周，尽管两组基线患者的IELT值相当，但随后选择服用100 mg舍曲林的患者的IELT显着低于继续服用50 mg舍曲林的患者的IELT。但是，如果再进行4周治疗，则100 mg组的平均IELT升高要比50 mg连续组的IELT显着增加。在PEDT和CGIC得分的分析中也获得了类似的结果。两种方案均耐受良好，两组的复发率无显着差异。新发现和结论这些发现表明，对舍曲林50 mg的8周治疗无效的PE患者可以再接受舍曲林100 mg的4周治疗，并且PEDT可能是对PE的有效治疗反应的有效指标耐心。这项研究旨在评估舍曲林改良剂量方案对早泄（PE）患者的安全性和有效性，并研究是否可以将早泄诊断工具（PEDT）用作这些患者治疗反应的量度。主要结局指标包括阴道内射精潜伏时间（IELT），PEDT评分和临床整体变化印象（CGIC）评分。研究结果表明，对舍曲林50 mg的8周治疗无反应的PE患者可以从舍曲林100 mg的4周治疗中获益，并且PEDT可能是衡量PE患者治疗反应的有效指标。

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