一项评估按需口服普瑞巴林（150mg 和 75mg）治疗早泄的疗效和耐受性的双盲、安慰剂对照、随机临床试验。

A Double Blind, Placebo Controlled, Randomized Trial to Evaluate the Efficacy and Tolerability of On-Demand Oral Pregablin (150 mg and 75 mg) in Treatment of Premature Ejaculation.

机构信息

Dermatology and Venereology Department, Faculty of Medicine, Al Azhar University, Cairo, Egypt.

出版信息

J Sex Med. 2020 Mar;17(3):442-446. doi: 10.1016/j.jsxm.2019.12.014. Epub 2020 Jan 22.

DOI:10.1016/j.jsxm.2019.12.014

PMID:31982359

Abstract

INTRODUCTION

Although premature ejaculation (PE) is a common sexual dysfunction, the available options for PE treatment remain unsatisfactory.

AIM

To evaluate the effect of on-demand oral pregabalin on the intravaginal ejaculation latency time (IELT).

METHOD

We conducted a multiarm double-blinded placebo-controlled randomized clinical trial that enrolled 120 patients with PE who were divided equally into 3 groups (A, B, and C). 4 patients were excluded, 39 patients received 150 mg pregabalin (group A), 39 patients received 75 mg pregabalin (group B), and 38 patients received placebo (group C). All patients were encouraged to engage in sexual relations twice per week for 2 weeks and to take the medication 1-2 hours before sexual intercourse. A stopwatch was used to evaluate IELT.

MAIN OUTCOME MEASURE

The main outcome measure are the improvement of IELT and the reported adverse events.

RESULTS

IELT significantly improved in patients who received 150 mg pregabalin, but there was no change in the other groups.

CLINICAL IMPLICATIONS

Most PE patients showed a significant improvement after receiving on-demand pregabalin (150 mg).

STRENGTH & LIMITATIONS: The strength of this study is that it is the first randomized controlled trial to evaluate the efficacy of pregabalin in treatment of PE. The main limitations were the small number of patients, IELT was the only primary outcome of the study, and the pregabalin cap can be identified by the patient.

CONCLUSION

Oral pregabalin seems to be a promising drug for additional evaluation as a new treatment for PE. More studies are needed to evaluate the suitable dose, duration, timing, and its safety profile. El Najjar MR, El Hariri M, Ramadan A, et al. A Double Blind, Placebo Controlled, Randomized Trial to Evaluate the Efficacy and Tolerability of On-Demand Oral Pregablin (150 mg and 75 mg) in Treatment of Premature Ejaculation. J Sex Med 2020;17:442-446.

摘要

简介

尽管早泄（PE）是一种常见的性功能障碍，但现有的 PE 治疗选择仍不尽如人意。

目的

评估按需口服普瑞巴林对阴道内射精潜伏期时间（IELT）的影响。

方法

我们进行了一项多臂双盲安慰剂对照随机临床试验，共纳入 120 例 PE 患者，平均分为 3 组（A、B 和 C 组）。排除 4 例患者后，39 例患者接受 150mg 普瑞巴林（A 组），39 例患者接受 75mg 普瑞巴林（B 组），38 例患者接受安慰剂（C 组）。所有患者均被鼓励每两周进行两次性行为，并在性交前 1-2 小时服用药物。使用秒表评估 IELT。

主要观察指标

主要观察指标为 IELT 的改善情况和报告的不良反应。

结果

接受 150mg 普瑞巴林治疗的患者 IELT 显著改善，但其他两组无变化。

临床意义

大多数 PE 患者接受按需普瑞巴林治疗后均有显著改善。

局限性

本研究的优势在于，它是第一项评估普瑞巴林治疗 PE 疗效的随机对照试验。主要局限性是患者数量较少，研究的主要结果仅为 IELT，且患者可识别普瑞巴林胶囊。

结论

口服普瑞巴林似乎是一种很有前途的药物，可进一步评估作为治疗 PE 的新方法。需要更多的研究来评估其合适的剂量、持续时间、时机和安全性。El Najjar MR、El Hariri M、Ramadan A 等。一项双盲、安慰剂对照、随机试验，评估按需口服普瑞巴林（150mg 和 75mg）治疗早泄的疗效和耐受性。J 性医学 2020；17：442-446。