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考来烯胺软膏减少痔切除术后疼痛和排便疼痛的疗效:一项前瞻性、单中心、随机、双盲、安慰剂对照试验的结果。

Efficacy of cholestyramine ointment in reduction of postoperative pain and pain during defecation after open hemorrhoidectomy: results of a prospective, single-center, randomized, double-blind, placebo-controlled trial.

机构信息

Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, 18th Kilometer Farahabad Boulevard, 48175861, Sari, Mazandaran Province, Iran.

出版信息

World J Surg. 2013 Mar;37(3):657-62. doi: 10.1007/s00268-012-1895-3.

Abstract

BACKGROUND

The aim of the present study was to evaluate the efficacy of cholestyramine ointment (15 %) in reducing postoperative pain at rest and during defecation after open hemorrhoidectomy.

METHODS

A total of 91 patients with third and fourth degree hemorrhoids undergoing open hemorrhoidectomy were included in this prospective, double-blind, randomized controlled trial. The patients were randomly assigned to either cholestyramine ointment or placebo immediately after surgery, 12 h after surgery, and then every 8 h for 14 days. The primary outcomes were intensity of pain at rest and during defecation, measured with a visual analog scale, and the analgesic requirement, measured by amount of tramadol consumption.

RESULTS

The cholestyramine group had less postoperative pain than the placebo group at the 24th hour (1.84 ± 2.54 vs. 4.07 ± 3.35; P = 0.001) and 48th hour (0.18 ± 0.88 vs. 3.57 ± 3.45; P < 0.001) and less pain during defecation starting at the 48th hour (2.28 ± 2.96 vs. 4.77 ± 4.09; P = 0.001). Similarly, the average tramadol consumption at hours 24 and 48 was significantly lower for the cholestyramine group (5.32 ± 21.45 vs. 43.18 ± 61.56 mg at 24 h, and 4.48 ± 16.65 vs. 57.63 ± 65.47 mg at 48 h; P < 0.001). The only adverse event was pruritus, which had a lower frequency in the cholestyramine group but the difference was not significant until postoperative week 4 (P < 0.001).

CONCLUSIONS

Compared with placebo, cholestyramine ointment (15%) reduced postoperative pain at rest and on defecation, and consequently lowered the analgesic requirement after open hemorrhoidectomy.

摘要

背景

本研究旨在评估考来烯胺软膏(15%)在减轻痔切除术后静息和排便时疼痛的疗效。

方法

本前瞻性、双盲、随机对照试验纳入了 91 例接受痔切除术的 3 度和 4 度痔患者。患者在手术后立即、术后 12 小时以及之后每 8 小时随机分配至考来烯胺软膏或安慰剂组,共 14 天。主要结局为视觉模拟评分(VAS)评估的静息和排便时疼痛强度以及曲马多消耗量评估的镇痛需求。

结果

与安慰剂组相比,考来烯胺组在术后 24 小时(1.84±2.54 对 4.07±3.35;P=0.001)和 48 小时(0.18±0.88 对 3.57±3.45;P<0.001)时的术后疼痛较轻,且在术后 48 小时时排便时疼痛较轻(2.28±2.96 对 4.77±4.09;P=0.001)。同样,考来烯胺组在 24 小时和 48 小时时的平均曲马多消耗量显著降低(5.32±21.45 对 43.18±61.56 mg,4.48±16.65 对 57.63±65.47 mg;P<0.001)。唯一的不良反应是瘙痒,考来烯胺组的瘙痒发生率较低,但在术后第 4 周时差异无统计学意义(P<0.001)。

结论

与安慰剂相比,考来烯胺软膏(15%)可减轻痔切除术后的静息和排便时疼痛,并降低术后镇痛需求。

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