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硝酸甘油软膏对痔切除术后疼痛影响的随机、前瞻性、双盲、安慰剂对照试验

Randomized, prospective, double-blind, placebo-controlled trial of effect of nitroglycerin ointment on pain after hemorrhoidectomy.

作者信息

Wasvary H J, Hain J, Mosed-Vogel M, Bendick P, Barkel D C, Klein S N

机构信息

Department of Colon and Rectal Surgery, William Beaumont Hospital, Royal Oak, MI 48067, USA.

出版信息

Dis Colon Rectum. 2001 Aug;44(8):1069-73. doi: 10.1007/BF02234622.

Abstract

PURPOSE

Fissure-in-ano is characterized by pain, bleeding, and internal anal sphincter hypertonicity. Spasm of the internal sphincter also plays a role in hemorrhoidal disease and may be a source of anal pain after hemorrhoid surgery. Inducing sphincter relaxation with a nitroglycerin ointment has shown promise in healing anal fissures and relieving symptoms of pain. Our study attempts to test the hypothesis that topical nitroglycerin applied to the perianal region is beneficial in reducing pain after hemorrhoidectomy.

METHODS

After hemorrhoidectomy 39 patients were randomly assigned to receive 0.2 percent nitroglycerin ointment (n = 19) or placebo (n = 20). Ointments were applied to the perianal region three times daily for seven days. Patients were prescribed hydrocodone bitartrate to take as needed. Visual analog scales were used to measure postoperative pain intensity and ointment benefits. Patients completed questionnaires to record medication morbidity and number of prescribed or nonprescribed medications taken.

RESULTS

Patients using nitroglycerin had less pain and greater benefit from ointment than those did in the placebo group, but differences were not significant. Narcotic use was higher in the placebo group when considered on a daily basis, but was statistically significant on the second postoperative day only (P < 0.05). Morbidity from ointment application was significantly higher in the nitroglycerin group (P < 0.002) and included a headache in 8 of 19 patients. Nonsteroidal anti-inflammatory drugs and acetaminophen were not prescribed, but were taken more frequently in nitroglycerin patients (P < 0.0003).

CONCLUSION

Perianal application of 0.2 percent nitroglycerin ointment after hemorrhoidectomy significantly reduced narcotic requirements on the second postoperative day. Headaches and a subsequent need for nonnarcotic medications may limit benefits of nitroglycerin.

摘要

目的

肛裂的特征为疼痛、出血和肛门内括约肌张力亢进。内括约肌痉挛在痔病中也起作用,并且可能是痔疮手术后肛门疼痛的一个来源。使用硝酸甘油软膏诱导括约肌松弛已显示出在愈合肛裂和缓解疼痛症状方面的前景。我们的研究试图检验以下假设:将硝酸甘油局部应用于肛周区域对减轻痔切除术后的疼痛有益。

方法

痔切除术后,39例患者被随机分配接受0.2%硝酸甘油软膏(n = 19)或安慰剂(n = 20)。软膏每天3次涂抹于肛周区域,共7天。患者按需要服用酒石酸氢可酮。采用视觉模拟量表测量术后疼痛强度和软膏疗效。患者完成问卷以记录药物不良反应及服用的处方药或非处方药数量。

结果

使用硝酸甘油的患者比安慰剂组患者疼痛更轻,从软膏中获益更大,但差异不显著。按每日计算,安慰剂组的麻醉药使用量更高,但仅在术后第二天具有统计学意义(P < 0.05)。硝酸甘油组软膏应用的不良反应显著更高(P < 0.002),19例患者中有8例出现头痛。未开具非甾体抗炎药和对乙酰氨基酚,但硝酸甘油组患者服用得更频繁(P < 0.0003)。

结论

痔切除术后在肛周应用0.2%硝酸甘油软膏可在术后第二天显著减少麻醉药需求。头痛以及随后对非麻醉性药物的需求可能会限制硝酸甘油的益处。

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