新型75毫克西地那非口腔崩解膜对勃起功能及性生活质量的影响：一项观察性研究的见解
Effect of the new 75-mg orodispersible film of sildenafil on erection and sexual quality of life: insights from an observational study.
作者信息
Sansone Andrea, Frangione Valeria, Lanzarotti Arturo, Cocci Andrea, Ceruti Carlo, De Sio Marco, Imbimbo Ciro, Mirone Vincenzo, Schips Luigi, Terrone Carlo, Jannini Emmanuele A
机构信息
Section of Endocrinology and Medical Sexology (ENDOSEX), University of Rome Tor Vergata, Rome, Italy.
IBSA Institut Biochimique SA, Pambio-Noranco, Switzerland.
出版信息
Sex Med. 2023 Mar 1;11(2):qfac007. doi: 10.1093/sexmed/qfac007. eCollection 2023 Apr.
BACKGROUND
The newly devised orodispersible film (ODF) of sildenafil is the first phosphodiesterase type 5 inhibitor (PDE5i) available in a 75-mg dose. This intermediate dose and the particular properties of the ODF formulation can improve the clinical management of erectile dysfunction (ED) patients.
AIM
We investigated the effects of the sildenafil ODF 75-mg dose on both sexual quality of life and erectile function based on the results from an observational study in daily practice in Italy.
METHODS
This study was a post hoc analysis of results from an observational, real-life study carried out in ED patients at 6 treatment centers in Italy. All subjects were asked to take the prescribed dose of sildenafil ODF at inclusion (visit 1) and to return for a control visit (visit 2) to confirm or adapt the prescribed dose after a minimum of 4 weeks. An end of study control visit (visit 3) was performed after additional 4 weeks.
OUTCOMES
Erectile function, assessed by the International Index of Erectile Function-Erectile Function (IIEF-EF) domain; sexual quality of life, measured using the sexual quality of life instrument for men (SQoL-M).
RESULTS
Among the 36 subjects initially recruited for the 75-mg dose, 5 patients dropped out of the study (2 at visit 2 and 3 at visit 3), none of whom due to treatment inefficacy or serious adverse events. At visit 2, the mean (SD) IIEF-EF scores significantly increased (∆ = 7.97 [4.71], < 0.0001) as SQoL-M scores also did (∆ = 10.76 [10.46], < 0.0001). At visit 3, IIEF-EF and SQoL-M scores were still significantly improved compared to baseline (∆ = 10.64 [7.01], < 0.0001, and ∆ = 18.15 [12.32], < 0.0001, respectively). By ANCOVA, we found no significant effects for age, BMI, previous use of PDE5i, presence of metabolic comorbidities, or smoking habits on study outcomes at both visits 2 and 3.
CLINICAL IMPLICATION
The new 75-mg ODF sildenafil formulation is a safe and effective treatment for ED, significantly improving both erectile function and sexual quality of life in patients undergoing treatment.
STRENGTHS AND LIMITATIONS
This is the first study assessing the efficacy of the sildenafil ODF 75-mg dose in a real-life setting. However, the small sample size, possible underlying cultural factors, and limited availability of clinically relevant data may have affected the reliability of our results.
CONCLUSION
The use of the 75 mg ODF formulation for sildenafil represents an effective and safe novel treatment option for ED patients.
背景
新研制的西地那非口腔崩解片（ODF）是首个有75毫克剂量的5型磷酸二酯酶抑制剂（PDE5i）。这一中等剂量以及ODF剂型的特殊性质能够改善勃起功能障碍（ED）患者的临床治疗。
目的
基于在意大利日常实践中的一项观察性研究结果，我们调查了75毫克剂量的西地那非ODF对性生活质量和勃起功能的影响。
方法
本研究是对在意大利6个治疗中心的ED患者中进行的一项观察性、现实生活研究结果的事后分析。所有受试者在纳入研究时（第1次就诊）被要求服用规定剂量的西地那非ODF，并在至少4周后返回进行对照就诊（第2次就诊）以确认或调整规定剂量。在另外4周后进行研究结束时的对照就诊（第3次就诊）。
结果
在最初招募的36名接受75毫克剂量治疗的受试者中，5名患者退出研究（2名在第2次就诊时退出，3名在第3次就诊时退出），均非因治疗无效或严重不良事件。在第2次就诊时，国际勃起功能指数-勃起功能（IIEF-EF）领域的平均（标准差）得分显著增加（∆ = 7.97 [4.71]，< 0.0001），男性性生活质量量表（SQoL-M）得分也显著增加（∆ = 10.76 [10.46]，< 0.0001）。在第3次就诊时，与基线相比，IIEF-EF和SQoL-M得分仍显著改善（分别为∆ = 10.64 [7.01]，< 0.0001，以及∆ = 18.15 [12.32]，< 0.0001）。通过协方差分析，我们发现在第2次和第3次就诊时，年龄、体重指数、既往使用PDE5i、存在代谢合并症或吸烟习惯对研究结果均无显著影响。
临床意义
新的75毫克ODF西地那非制剂是一种治疗ED的安全有效的方法，能显著改善接受治疗患者的勃起功能和性生活质量。
优点和局限性
这是第一项在现实生活环境中评估75毫克剂量西地那非ODF疗效的研究。然而，样本量小、可能存在的潜在文化因素以及临床相关数据的可用性有限可能影响了我们结果的可靠性。
结论
使用75毫克ODF剂型的西地那非对ED患者而言是一种有效且安全的新治疗选择。
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