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多沙唑嗪作为一种随机临床试验中远端输尿管结石的药物排石疗法的疗效初步研究。

Preliminary study of efficacy of doxazosin as a medical expulsive therapy of distal ureteric stones in a randomized clinical trial.

机构信息

Section of Urology, Department of Surgery, Aga Khan University, Karachi, Pakistan.

出版信息

Urology. 2010 Jun;75(6):1285-8. doi: 10.1016/j.urology.2009.10.069. Epub 2010 Feb 26.

Abstract

OBJECTIVES

To assess the clinical efficacy of doxazosin as the medical-expulsive therapy for distal ureterolithiasis.

METHODS

A total of 65 patients with a symptomatic 4-7 mm distal ureteral stone were included in the study. Patients were randomized to 1 of the 2 treatment groups. Group 1 (n=32 patients) was the control group and received diclofenac sodium 50 mg for their pain and group 2 (n=33 patients) received doxazosin (2 mg daily at the night) along with diclofenac sodium 50 mg. The treatment duration was until stone expulsion or 28 days, whichever come first. The primary endpoint of the study was the stone expulsion rate. The secondary endpoints included time to stone expulsion, use of analgesics, and number of emergency room visits, hospitalizations, and drug side effects. Statistical analyses were performed using chi-square test and Fisher exact test.

RESULTS

Both groups were comparable in terms of demographic, clinical, and stone-related parameters. Stone expulsion rate was significantly higher in the treatment group (38% for group 1 and 70% for group 2, P=.009) while the expulsion time was significantly lesser in group 2 patients (P=.005). During the treatment period, we observed significant differences between the 2 groups in the number of pain episodes and analgesic used (P=.0001). None of the patients in either groups reported adverse drug-related events.

CONCLUSIONS

Doxazosin significantly improves stone expulsion and is associated with decreased colic frequency and use of analgesia. It is also well tolerated with no adverse drug-related events.

摘要

目的

评估多沙唑嗪作为医学排石疗法治疗远端输尿管结石的临床疗效。

方法

本研究共纳入 65 例有症状的 4-7mm 远端输尿管结石患者。患者随机分为 2 组治疗。第 1 组(n=32 例)为对照组,给予双氯芬酸钠 50mg 缓解疼痛;第 2 组(n=33 例)给予多沙唑嗪(每晚 2mg)联合双氯芬酸钠 50mg。治疗持续至结石排出或 28 天,以先到者为准。研究的主要终点是结石排出率。次要终点包括结石排出时间、镇痛药使用情况以及急诊就诊、住院和药物不良反应的次数。统计分析采用卡方检验和 Fisher 确切概率法。

结果

两组在人口统计学、临床和结石相关参数方面具有可比性。治疗组的结石排出率显著更高(第 1 组为 38%,第 2 组为 70%,P=.009),而第 2 组患者的排出时间明显更短(P=.005)。在治疗期间,我们观察到两组在疼痛发作次数和镇痛药使用方面存在显著差异(P=.0001)。两组均无患者报告与药物相关的不良反应事件。

结论

多沙唑嗪显著提高结石排出率,并降低绞痛发作频率和镇痛药使用量。它具有良好的耐受性,无药物相关不良反应。

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