目的:确定西洛多辛-他达拉非与西洛多辛-伐地那非在治疗输尿管远端结石的耐受性和疗效方面的最佳联合治疗方案。
方法:这种前瞻性,双盲,随机临床试验包括140例输尿管远端结石患者,随机分为两组:I组(n=67)接受西洛多辛8mg每日一次联合他达拉非5mg每日一次,和II组(n=68)接受西洛多辛8mg,每日一次,与伐地那非10mg,每日一次。主要结果是联合疗法的耐受性,通过不良事件的发生率进行评估。次要结果包括结石排出率,驱逐时间,以及对镇痛药的需要.
结果:两种联合疗法均表现出相似的疗效,结石排出率无显著差异(70.1%与67.6%,P=0.754),驱逐时间(两组均为19±3天,P=0.793),和镇痛需求(P>0.05)。然而,西洛多辛-他达拉非联合用药的不良事件发生率显著降低,在头痛方面有显著差异(23.9%vs.57.4%,P<0.001),头晕(32.8%vs.60.3%,P=0.001),和肠胃不适(9%vs.66.2%,P<0.001),和其他不良影响。任何不良事件的总发生率在西洛多辛-他达拉非组显著较低(88.1%vs.98.5%,P=0.017)。
结论:西洛多辛-他达拉非和西洛多辛-伐地那非治疗输尿管远端结石均有效。然而,西洛多辛-他达拉非联合用药与不良事件发生率显著降低相关,使它成为患者更容易接受的选择。
OBJECTIVE: To determine the optimum combination therapy of Silodosin-
Tadalafil versus Silodosin-Vardenafil in terms of both tolerability and efficacy for the management of distal ureteric stones.
METHODS: This prospective, double blinded, randomized clinical trial included 140 patients with distal ureteric stones, randomized into two groups: Group I (n = 67) received Silodosin 8 mg once daily combined with
Tadalafil 5 mg once daily, and Group II (n = 68) received Silodosin 8 mg once daily combined with Vardenafil 10 mg once daily. The primary outcome was the tolerability of the combination therapies, assessed through the incidence of adverse events. Secondary outcomes included stone expulsion rate, expulsion time, and the need for analgesics.
RESULTS: Both combination therapies demonstrated similar efficacy, with no significant differences in stone expulsion rate (70.1% vs. 67.6%, P = 0.754), expulsion time (19 ± 3 days for both groups, P = 0.793), and analgesic requirements (P > 0.05). However, the Silodosin-
Tadalafil combination showed a significantly lower occurrence of adverse events, with notable differences in headache (23.9% vs. 57.4%, P < 0.001), dizziness (32.8% vs. 60.3%, P = 0.001), and gastrointestinal upset (9% vs. 66.2%, P < 0.001), and other adverse effects. The overall occurrence of any adverse event was significantly lower in the Silodosin-
Tadalafil group (88.1% vs. 98.5%, P = 0.017).
CONCLUSIONS: Both Silodosin-
Tadalafil and Silodosin-Vardenafil therapies are effective in managing distal ureteric stones. However, the Silodosin-Tadalafil combination is associated with a significantly lower incidence of adverse events, making it a more tolerable option for patients.