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前瞻性、随机、安慰剂对照、双臂研究,评估大蒜作为硫化氢供体与他达拉非联合给药对单独应用他达拉非反应不佳的勃起功能障碍患者的疗效 - 一项初步研究。

Prospective, randomized, placebo-controlled, two-arm study to evaluate the efficacy of coadministration of garlic as a hydrogen sulfide donor and tadalafil in patients with erectile dysfunction not responding to tadalafil alone - A pilot study.

机构信息

Department of Urology and Sexual Medicine, TSS Shripad Hegde Kadave Institute of Medical Sciences and PG Hospital, Sirsi, Uttara Kannada, Karnataka, India.

Department of Urology and Sexual Medicine, TSS Shripad Hegde Kadave Institute of Medical Sciences, Sirsi, Uttara Kannada, Karnataka, India.

出版信息

Indian J Pharmacol. 2024 Jul 1;56(4):242-247. doi: 10.4103/ijp.ijp_310_23. Epub 2024 Sep 10.

Abstract

OBJECTIVE

The objective is to evaluate the efficacy of coadministration of garlic (as a hydrogen sulfide [H2S] donor) and tadalafil for patients with ED using a placebo-controlled, prospective, randomized, two-arm pilot study in patients responding poorly to tadalafil alone.

MATERIALS AND METHODS

The patients with complaints of ED (with normal penile Doppler) who failed to maintain sustained improvement in erectile function with tadalafil were recruited after excluding those with comorbidities. The study sample was randomized into two groups. Group A received garlic 5 g twice a day orally and Group B received a placebo twice daily orally for 4 weeks. Both groups continued tadalafil 5 mg in the night for 4 weeks. Their erectile function was assessed at the beginning and at the end of 4 weeks using the International Index of Erectile Function (IIEF-EF), erectile function domain and compared. A value of P ≤ 0.05 was considered statistically significant.

RESULTS

Nineteen patients in Group A (mean age 37.5 ± 10.6 years) and 16 patients in Group B (mean age 39.6 ± 9.6 years) participated in the pilot study conducted from May 2022 to August 2022. The participants treated with garlic (as an H2S donor) as a coadministrant had statistically significant improvement in IIEF-EF score (P ≤ 0.0001) at the end of 4 weeks compared to placebo.

CONCLUSIONS

Garlic (as an H2S donor) as adjunctive therapy was beneficial in our study participants responding poorly to tadalafil alone.

摘要

目的

本研究旨在通过一项安慰剂对照、前瞻性、随机、双臂试验研究,评估大蒜(作为硫化氢 [H2S] 供体)与他达拉非联合用药治疗勃起功能障碍(ED)患者的疗效,这些患者对单独使用他达拉非反应不佳。

材料和方法

我们招募了勃起功能障碍(伴有正常阴茎多普勒)且对他达拉非治疗不能维持持续改善的患者,在排除合并症后,对这些患者进行了前瞻性、随机、双盲、安慰剂对照研究。研究样本被随机分为两组。A 组患者口服大蒜 5 g,每日 2 次;B 组患者每日口服安慰剂 2 次,疗程 4 周。两组患者在夜间均继续服用他达拉非 5 mg,疗程 4 周。在治疗开始和结束时使用国际勃起功能指数(IIEF-EF)评估患者的勃起功能,比较两组患者的勃起功能域。P 值≤0.05 被认为具有统计学意义。

结果

2022 年 5 月至 2022 年 8 月进行的这项试点研究共纳入 19 名 A 组患者(平均年龄 37.5±10.6 岁)和 16 名 B 组患者(平均年龄 39.6±9.6 岁)。与安慰剂相比,作为 H2S 供体的大蒜联合治疗在治疗 4 周后 IIEF-EF 评分有显著改善(P≤0.0001)。

结论

在本研究中,对单独使用他达拉非反应不佳的患者,大蒜(作为 H2S 供体)作为辅助治疗是有益的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a6ed/11483042/274349d98998/IJPharm-56-242-g001.jpg

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