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西洛多辛对性功能不良反应存在安慰剂效应:一项随机对照试验。

Silodosin Has Nocebo Effect on Sexual Adverse Effects: A Randomized Controlled Trial.

作者信息

Sertkaya Zulfu, Ozkaya Fatih

机构信息

Clinic of Urology, Memorial Dicle Hospital, Diyarbakır, Turkey.

Department of Urology, Atatürk University School of Medicine, Erzurum, Turkey.

出版信息

Eurasian J Med. 2019 Oct;51(3):277-279. doi: 10.5152/eurasianjmed.2019.19139.

Abstract

OBJECTIVE

Nocebo effect is known in patients refered to side effects of drugs that cause more side effects than expected. Side effects on sexual function have been reported in about 60% of patients using silodosin. To investigate whether there was nocebo effect of silodosin in the side effects on sexual function.

MATERIALS AND METHODS

Between May 2014 and March 2017, 129 moderate-to-severe LUTS patients were included in the study. For the patients, PSA (ng/mL), prostate volume (cc), uroflowmetry test IIEF-15 and IPSS questionnaires were filled at the time of before and after treatment. Patients were divided into two groups, referred to as side effects that was mentioned and not mentioned. After 3 months control, all patients were asked whether they had sexual side effects. It was analyzed whether there was significantly differences between two groups.

RESULTS

The groups were compared in terms of the frequency of androgenic side effects, low semen volume was 40.9% in Group 1 and 22.2% in Group 2 (p=0.04). Anejaculation rates were 6% and 4%, respectively (p=0.12); loss of libido and erectile dysfunction were observed in one patient in both groups (p=0.42). There was no statistically significant difference between the groups for anejaculation, decreased libido and erectile dysfunction. 9 patients (7%) who left medication due to side effects were excluded from the study.

CONCLUSION

In patients, mentioned about the sexual side effects, low semen volume was seen more frequantly, but anejaculation, decreased libido and erectile dysfunction were same. Therefore, be informed about the side effects before treatment is a matter of debate.

摘要

目的

在因药物副作用前来就诊且副作用比预期更多的患者中存在反安慰剂效应。使用西洛多辛的患者中约60%报告有性功能方面的副作用。本研究旨在调查西洛多辛在性功能副作用方面是否存在反安慰剂效应。

材料与方法

2014年5月至2017年3月期间,129例中重度下尿路症状患者纳入本研究。患者在治疗前后分别填写前列腺特异性抗原(ng/mL)、前列腺体积(cc)、尿流率检查、国际勃起功能指数-15(IIEF-15)和国际前列腺症状评分(IPSS)问卷。患者被分为两组,即被告知副作用组和未被告知副作用组。3个月后进行随访,询问所有患者是否有性方面的副作用。分析两组之间是否存在显著差异。

结果

比较两组雄激素相关副作用的发生率,第1组低精液量发生率为40.9%,第2组为22.2%(p = 0.04)。两组的无射精率分别为6%和4%(p = 0.12);两组各有1例患者出现性欲减退和勃起功能障碍(p = 0.42)。两组在无射精、性欲减退和勃起功能障碍方面无统计学显著差异。9例(7%)因副作用停药的患者被排除在研究之外。

结论

在被告知性副作用的患者中,低精液量出现得更频繁,但无射精、性欲减退和勃起功能障碍的情况相同。因此,治疗前告知患者副作用这一做法仍存在争议。

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