西地那非治疗EP的满意度调查

虽然全球已发表了许多有关西地那非(万艾可()治疗满意度方面的文章,但涉及女性伴侣性生活满意度的资料却很少。为此,国外学者Ichikawa T等进行了一项旨在了解男性勃起功能障碍(ED)患者口服西地那非治疗后,其女性性伴侣的满意度调查。共有98例男性ED患者的女性伴侣完成了有关治疗效果、性满意度和生活质量变化的调查表。调查结果表明:90%女性伴侣认为治疗有效;60%认为生活质量改善。大多数(66.7%)女性伴侣对西地那非治疗满意,仅20%不满意。只有20%女性伴侣担心是否有不良反应。由此提示,男性ED患者的女性性伴侣对口服西地那非具有相对较…     

他达拉非独特的时间顾虑收益

社会心理因素在勃起功能障碍(ED)的发病过程中占到了十分重要的地位。一种理想的治疗药物应能给患者及其伴侣带来满意的社会心理收益。"心理与人际关系量表"(PAIRS量表)既能评价ED对患者及其伴侣的心理及人际关系影响,又能预测ED患者对治疗的满意度。利用PAIRS量表对5型磷酸二酯酶(phosphodies-terasetype5,PDE5)抑制剂治疗ED的疗效进行评估,发现在降低ED患者性活动相关性时间顾虑方面,他达拉非明显优于西地那非和伐地那非。这也正是ED患者及其伴侣在临床治疗条件下偏好使用他达拉非的深层原因。与此相关的药物属性则是他达拉非长达36h的卓越疗效。     

勃起功能障碍治疗的研究:关注患者及其伴侣满意度

在临床实践中，勃起功能障碍（ED）患者及其伴侣对治疗的偏爱与满意度是影响治疗依从性的重要因素，Brock等在加拿大开展了一项多中心、前瞻性的观察试验，评估在日常临床中ED患者及其伴侣对他达拉非和西地那非治疗的偏爱和满意度。     

他达拉非、西地那非和伐地那非治疗6个月后的疗效和患者满意度：勃起功能障碍观察性研究（EDOS）

EDOS是一项在全欧开展，旨在评估勃起功能障碍（ED）男性患者在实际临床中接受6个月他达拉非、枸橼酸西地那非（西地那非）或盐酸伐地那非（伐地那非）治疗后健康状况的研究。研究中药物的疗效和患者满意度的评估指标为一些已经得到确认的问卷，如全球评估问卷（GAQ）、国际勃起功能指数（IIEF）、     

关于CONFIRMED研究中伐地那非与西地那非临床疗效的比较

CONFIRMED研究是完全遵循良好试验设计规范进行设计的一项研究。该研究是一项非劣性设计,主要目的是比较伐地那非与西地那非在治疗男性勃起功能障碍(ED)方面患者选择的倾向性,结果表明,总体倾向性伐地那非优于西地那非,尤其在总体满意度、性交满意度及伴侣关系满意度等方面显著优于西地那非。通过比较伐地那非与西地那非的结构,伐地那非的结构更具优势,其5型磷酸二酯酶(PDE5)选择性远远高于西地那非,这是伐地那非临床疗效优于西地那非的分子学基础。本研究提供了伐地那非优于西地那非的临床证据,进一步证实了伐地那非是对ED患者进行治疗的一线药物。     

患者及伴侣对万艾可治疗勃起功能障碍的满意度调查

万艾可是治疗勃起功能障碍（ED）的有效、安全的药物，患者及伴侣的满意度均很高。Lewis R等人进行的一项研究再次证明了，患者及其伴侣对万艾可治疗ED的高满意度。他们对247位各种病因引发的ED患者进行研究。在12个星期中对接受西地那非（25、50和100mg）治疗的患者与接受安慰剂治疗的患者进行比较。其主要疗效指标使用国际勃起功能指标（IIEF）中的问题3（有能力获得勃起）和问题4（有能力维持勃起）及3个通用的功效问题进行评价。同时首次运用EDITS（勃起功能障碍治疗满意度）问卷对患者及伴侣治疗后的满意度进行评估。     

针对于勃起功能障碍患者及其性伴侣的治疗满意度研究

在常规临床实践中，勃起功能障碍（ED）患者对治疗药物的选择偏好以及满意度是十分重要的，可能会影响到患者对治疗的依从性。本研究评估了ED患者及其性伴侣对他达拉非或西地那非（5型磷酸二酯酶抑制剂）两种治疗药物的选择偏好以及各自的满意度。本研究在加拿大进行，为一项多中心、前瞻性临床观察试验。     

多剂量伐地那非治疗男性勃起功能障碍的临床研究

目的评估不同剂量新型磷酸二酯酶5（PED5）抑制剂伐地那非治疗男性勃起功能障碍（ED）的有效性和安全性。方法采用随机、双盲、安慰剂平行对照、3个药物剂量（5、10和20mg）的方法，对88例ED患者进行为期12周的临床研究。结果伐地那非5mg、10mg和20mg组均能改善患者国际勃起功能指数（IIEF）中勃起功能部分的得分、患者日记中插入和保持勃起的成功率，改善程度优于安慰剂组。伐地那非20mg组对IIEF问卷中勃起功能部分得分的改善优于伐地那非5mg组。伐地那非组不良事件的发生率高于安慰剂组，但多为轻中度，且可自行缓解。结论伐地那非是治疗男性勃起功能障碍的安全、有效药物。     

他达拉非、西地那非和伐地那非治疗6月后的临床疗效和患者满意度研究:来自“勃起功能障碍观察性研究”(EDOS)的结果

为了评估服用他达拉非、枸橼酸西地那非（西地那非）或盐酸伐地那非（伐地那非）6个月患者的健康结果,在全欧洲范围内进行了一项观察性研究（EDOS研究）。在该研究中,用已获公认的以及最新的勃起功能问卷评估治疗的有效性以及患者满意度。同时用“心理学和人际关系量表”的短表（SF-PAIRS）对患者的行为、心理以及人际关系结果进行评估。     

来自女性角度的观察：患者伴侣对他达拉非的认识

为了评估勃起功能障碍（ED）患者及其女性伴侣对他达拉非治疗的反应和总体满意度，Ahhof等对4个为期12周的双盲、安慰剂对照的试验中的数据进行了相关研究，研究以患者性生活日记（SEP）为主要的评估工具。这些试验共纳入746例ED患者及其性伴侣，     

Early conceptual and linguistic development of a patient and partner treatment satisfaction scale (TSS) for erectile dysfunction

OBJECTIVE: To describe the early development of a pluri-language self-report questionnaire to assess male patients and their female partners' satisfaction with drug treatment for erectile dysfunction (ED). METHODS: This first development phase proceeded in several parts. Item generation followed literature review, hypothesized characteristics of the drug and in-depth interviews with patients and their partners. Perceptions and feelings related to ED and patients' expectations of treatment were explored. Items were generated simultaneously in 5 languages (American English, Canadian French, English, French and German). Content and face validity were empirically assessed by interviews with a few patients and partners in each country. Conceptual equivalence between languages was ascertained. RESULTS: The final content domains included satisfaction with: sexual spontaneity, quality of erection, quality of ejaculation, sexual pleasure, orgasm, confidence, reliability of treatment, side effects, convenience, overall satisfaction, conformity to treatment expectations and intent to continue use of drug. Cognitive debriefing with patients and partners found few issues with comprehension, however some words were considered problematic. The simultaneous development for the different languages allowed adaptation of the content at this stage and ensured consistency of all language versions. The final questionnaire consisted of 4 modules: unmedicated patient, medicated patient, unmedicated partner, and medicated partner modules. The questionnaire was then linguistically validated into 15 additional languages for further psychometric validation. CONCLUSIONS: The Treatment Satisfaction Scale (TSS) is a multi-facetted measure of patients' and partners' satisfaction with their sexual life relating to erectile dysfunction and intended for prospective use. Its simultaneous development for a variety of countries and languages has fostered true item equivalence across language versions. However, further work is needed to validate the TSS psychometrically, including identification of domains, test responsiveness and determination of appropriate scoring prior to its clinical use.     

The COUPLES-project: a pooled analysis of patient and partner treatment satisfaction scale (TSS) outcomes following vardenafil treatment

OBJECTIVE: To assess the influence of vardenafil on treatment satisfaction in men with erectile dysfunction (ED) and their female partners. PATIENTS AND METHODS: This was a pooled analysis of three randomized, double-blind, placebo-controlled, 12-week studies of flexible-dose vardenafil vs placebo, in men with ED for >/=6 months (n = 788) and their untreated female partners. Measures of efficacy included the Treatment Satisfaction Scale (TSS), International Index of Erectile Function, Erectile Function domain (IIEF-EF), and Sexual Encounter Profile (SEP) questions 2 and 3 (SEP-2, 'Were you able to insert your penis into your partner's vagina?'; and SEP-3, 'Did your erection last long enough for you to have sexual intercourse?'). In addition to the overall analysis, there was a subgroup analysis for potential moderators of response, e.g. whether patients who had undergone previous phosphodiesterase type 5 (PDE-5) treatment. RESULTS: At baseline, least-squares (LS) mean scores for all TSS domains were similar in the vardenafil and placebo groups. After 12 weeks of treatment, vardenafil significantly improved the LS mean score for all domains compared with placebo, among both patients and their female partners (P < 0.0001, 'last'-observation-carried- forward analysis). Absolute between- group differences in LS mean TSS scores (vardenafil - placebo) were: ease of erection (patients 23.4, partners 24.9), erectile function satisfaction (36.7 and 32.9), pleasure from sexual activity (23.0, 23.7), satisfaction with orgasm (27.6, 21.8), confidence to complete sexual activity (28.2, 32.5), and satisfaction with medication (37.4, 35.6). The benefits of vardenafil were greater in men who had undergone previous PDE-5-inhibitor treatment and men aged <45 years, while the overall pattern of benefit was similar in all examined subgroups. There were significant benefits with vardenafil in all other variables (IIEF-EF scores and positive response rates to SEP-2 and SEP-3). CONCLUSIONS: Vardenafil significantly improved treatment satisfaction in men with ED, and in their partners. The results provide further evidence of the validity of the TSS.     

The treatment satisfaction scale: a multidimensional instrument for the assessment of treatment satisfaction for erectile dysfunction patients and their partners

BACKGROUND: The development of the Treatment Satisfaction Scale (TSS) was previously reported (Kubin et al., 2004). OBJECTIVE: This article describes the psychometric validation process and psychometric properties (e.g., reliability, validity, and responsiveness) of TSS. METHODS: Initial patient and partner questionnaires were administered in a multi-national clinical trial. On the basis of exploratory analyses, iterative psychometric testing, and consideration of face validity and interpretability, the number of items was reduced, and six scales were constructed: "Satisfaction with Medication," "Ease with Erection," "Satisfaction with Erectile Function," "Pleasure from Sexual Activity," "Satisfaction with Orgasm," and either "Sexual Confidence" (for patients) or "Confidence in Completion" (for partners). RESULTS: Multi-item scales had good internal consistency reliability and concurrent validity with the IIEF. All patient scales and most partner scales were valid in relation to clinical criteria, and all tested scales were responsive to change over time. CONCLUSION: The TSS is brief, culturally valid, and the most comprehensive multidimensional measure of satisfaction with ED treatment for patients and their partners, and addresses some of the shortcomings of existing measures.     

Assessment of the efficacy of Viagra (sildenafil citrate) using the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS)

Treatment satisfaction is a predictor of long-term compliance in patients with erectile dysfunction (ED). We assessed patient satisfaction with and efficacy of Viagra (sildenafil citrate) using the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) and 3 global efficacy questions. Twenty-nine men with ED who had completed a prior study of MUSE (alprostadil) versus Caverject (alprostadil) took a 50-mg dose of Viagra 1 h preceding intercourse. Efficacy and patient satisfaction with Viagra were high. Satisfaction as measured by EDITS was highly correlated to patients' final ED treatment choice. This correlation could make EDITS useful in identifying long-term patient satisfaction, and thus of considerable clinical benefit.     

Comparable efficacy of once-daily versus on-demand vardenafil in men with mild-to-moderate erectile dysfunction: findings of the RESTORE study

BACKGROUND: Phosphodiesterase (type) 5 (PDE5) inhibitors are currently administered on demand for treatment of erectile dysfunction (ED). Once-daily dosing has been suggested to benefit patients. OBJECTIVE: To determine whether daily vardenafil use provides added clinical benefits to patients compared with on-demand dosing. DESIGN, SETTING, AND PARTICIPANTS: In this placebo-controlled, double-blind, multicentre parallel-group study, men with mild-to-moderate ED were randomised to 24 wk of treatment, followed by a 4-wk washout. INTERVENTION: Patients were randomised to receive once-daily vardenafil 10mg plus on-demand placebo for 12 or 24 wk, or once-daily placebo plus on-demand vardenafil 10mg for 24 wk. MEASUREMENTS: Primary efficacy variable was the between-group difference in change in International Index of Erectile Function-Erectile Function domain (IIEF-EF) score from baseline to end of washout. Secondary variables included change from baseline in proportion of positive respondents to Sexual Encounter Profile questions and in satisfaction with treatment as assessed with the Treatment Satisfaction Scale (TSS). RESULTS AND LIMITATIONS: LS mean changes from baseline in IIEF-EF scores were 2.02, 2.29, and 2.63 for vardenafil 12 wk once daily, 24 wk once daily, and 24 wk on demand, respectively. After washout, the trend was towards improved IIEF-EF scores in the on-demand group (20.58 [+/-0.96]) versus both once-daily groups (12 wk, 19.88 [+/-0.93]; 24 wk, 20.11 [+/-0.94]). Furthermore, there were no significant between-group differences in the percentage of patients with "normal" erectile function. TSS analyses demonstrated no significant differences between treatment groups. This study recruited patients with mild-to-moderate ED; therefore, the results may not be the same as in patients with severe ED. CONCLUSIONS: Once-daily vardenafil did not produce greater sustained effects on EF than on-demand vardenafil in men with mild-to-moderate ED, suggesting that daily dosing of PDE5 inhibitors does not produce sustained clinical benefits beyond cessation of treatment above those observed with on-demand administration.     

Vardenafil for the treatment of erectile dysfunction: a critical review of the literature based on personal clinical experience

OBJECTIVE: To critically review the literature on vardenafil in the treatment of erectile dysfunction while integrating the clinical findings with the personal experience of the authors. METHODS: Analysis of published full-length papers that were identified through Medline search from January 2000 through May 2004. Abstracts published in peer-reviewed journals from the same period were also considered. RESULTS: Efficacy, tolerability and safety, as reported in the peer-reviewed literature compares well with the authors' personal experience. Authors' personal observations include discussions on potency, selectivity, selection of initial dose, counselling for patients characteristically considered difficult-to-treat (diabetes, prostatectomy, depression), including the determination of the maximal efficacious dose and the possible role of daily dosing, optimisation of the use of vardenafil according to its pharmacokinetic and pharmacodynamic profiles (onset and reliability), and management of ED patients with or at risk for cardiovascular disease. CONCLUSIONS: Extensive experience with vardenafil as reported in peer reviewed literature confirms the important role of vardenafil in the management of patients with ED. The development of each physician's own experience with vardenafil is key to optimise overall satisfaction of this therapy by the patient and his partner.     

勃起功能障碍全球视点:从科学进展到伴侣的解决方案——第一届亚太地区研讨会纪要

2006年2月24～26日,第一届“勃起功能障碍(ED)全球视点:从科学进展到伴侣的解决方案”亚太地区研讨会在中国上海举行。会议就男性的性健康问题、尤其是勃起功能障碍(ED)的最新科学数据及其对女性伴侣的影响进行了广泛的探讨。主要内容包括ED患者及其伴侣与医生这3者之间交流的重要性,女性伴侣在患者寻求和坚持药物治疗中的作用,慢性疾病对性健康的影响,睾酮在ED中的作用,特殊人群的性健康,如何进行个体化治疗以及如何获得成功的治疗反应,磷酸二酯酶5(PDE5)抑制剂(尤其是伐地那非)治疗ED的显著疗效和安全性,以及亚洲地区ED的治疗现状等。     

The treatment of erectile dysfunction study: focus on treatment satisfaction of patients and partners

OBJECTIVE: To assess patient and partner preferences for, and satisfaction with, tadalafil or sildenafil (phosphodiesterase type 5 inhibitors) in routine clinical practice for treating erectile dysfunction (ED), as these are important outcomes that might influence treatment adherence. PATIENTS AND METHODS: In a multicentre, prospective observational trial in Canada, patients with ED were eligible if they planned to change treatment from tadalafil to sildenafil or vice versa. Data were collected at baseline and 4-12 weeks later (endpoint). Satisfaction was assessed using patient and partner versions of the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire. EDITS index scores range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction). RESULTS: Of 2425 patients, approximately 98% completed the study and 295 partners participated. When patients changed from sildenafil to tadalafil (1722 men) the mean EDITS index scores increased significantly for both patients (from 61.6 to 78.3) and partners (from 65.0 to 82.6; both P < 0.001). When patients changed from tadalafil to sildenafil (703 men), the mean EDITS index scores increased slightly but significantly for patients (from 68.8 to 70.2; P = 0.007) but not partners (from 76.8 to 68.9; P = 0.066). For the individual EDITS questions, mean scores increased significantly from baseline to endpoint on all questions for patients (all 11 questions; P < 0.001) and partners (all five questions; P < 0.001) in the sildenafil-to-tadalafil group, and in the tadalafil-to-sildenafil group, mean scores for patients decreased on nine of 11 questions (seven of nine significantly; P < 0.041) and mean scores for partners decreased on all five (two significantly; P < 0.049). For treatment preference, regardless of the change in treatment (i.e. sildenafil-tadalafil or tadalafil-sildenafil), a significantly higher percentage of patients and partners preferred tadalafil to sildenafil. CONCLUSIONS: These data indicate that patients with ED (and their partners) who changed from sildenafil to tadalafil treatment or vice versa in a routine clinical practice setting had higher treatment satisfaction when taking tadalafil than sildenafil, as assessed by most measures of EDITS. The higher treatment satisfaction with tadalafil might help to explain the greater preference for tadalafil compared with sildenafil in both patients and partners in this observational study.     

Improvement in erectile function on vardenafil treatment correlates with treatment satisfaction in both patients and their partners

OBJECTIVE: To evaluate the effect of vardenafil on both erectile function (EF) and treatment satisfaction (an aspect of quality of life) in men and their partners, as erectile dysfunction (ED) has a profound effect on patients' quality of life and that of their partners, and treatment for ED tends to be focused on improving functional measures of EF. PATIENTS, SUBJECTS AND METHODS: For this randomized, double-blind, placebo-controlled trial, men with ED for >6 months, according to the USA National Institutes of Health Consensus Statement, were recruited. In all, 611 patients were randomized to treatment with either vardenafil (10 mg for 4 weeks, titrated to preferred dose, 5, 10 or 20 mg, during the next 8 weeks, and maintained at preferred dose for the following 14 weeks), or placebo. RESULTS: At 18 weeks (primary endpoint), the mean improvement in the EF domain of International Index of EF (IIEF-EF) vs baseline was significantly greater with vardenafil than placebo (12.70 vs 1.69, P < 0.001). This was accompanied by significant benefits at 26 weeks and in various secondary variables relating to sexual satisfaction. Qualitative assessment of the treatment effect revealed three categories of importance to patients: effectiveness, confidence and quality of life. There were significant linear correlations between patients' EF and treatment satisfaction, and between patients' EF and their partners' treatment satisfaction. CONCLUSIONS: Functional improvements in response to vardenafil treatment are significantly correlated with treatment satisfaction for both patients with ED and their partners. These findings apply to patients with a wide range of baseline characteristics.