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植物树脂没药在痔疮治疗中的临床评估:一项随机对照试验。

Clinical Evaluation of Commiphora Mukul, a Botanical resin, in the Management of Hemorrhoids: A randomized controlled trial.

作者信息

Yousefi Mahdi, Mahdavi Mohammad Reza Vaez, Hosseini Seyed Mousalreza, Bahrami Abdollah, Davati Ali, Kamalinejad Mohammad, Faghihzadeh Sograt

机构信息

Department of Traditional Iranian Medicine, Faculty of Medicine, Shahed University, Tehran, Iran.

出版信息

Pharmacogn Mag. 2013 Oct;9(36):350-6. doi: 10.4103/0973-1296.117832.

Abstract

BACKGROUND

Hemorrhoids complaint is one of the most common problems in most society, especially in Asian countries. Current drug treatment protocols cannot cure the disease, and they are palliative. According to Persian traditional medicine, Commiphora Mukul (CM) resin is a medication choice.

AIM

This randomized study was undertaken to evaluate the efficacy and safety of crude CM resin compared to a combination of lactolose and anti-hemorrhoid (LandA) in patients with uncomplicated hemorrhoids grade 1 and 2.

MATERIALS AND METHODS

This trial was carried out on 99 patients with hemorrhoids, in Ghaem and Imam Reaza Hospitals of the Mashhad University of Medical Sciences, Iran. They randomly received CM 3 g/d for 4 weeks (as study group) or LandA (Lactolose syrup in laxative dose for 1 month and anti-hemorrhoid suppository daily for 10 days) as control group. Subjective and objectives variables including painful defecation, flatulence, constipation, gastro-esophageal reflux (GER), dyspepsia, proctorrhagia, anal protrusion, and colonoscopic grading were assessed before, immediately after, and 4 weeks after the treatment period. An intent-to-treat analysis was used. Safety was assessed with evaluation of clinical adverse effects by common toxicity criteria version 4.0. Forty-nine patients were assigned randomly to receive LandA and 50 to receive CM. After 4 weeks, flatulence, dyspepsia, GER, and colonoscopic grading scores significantly decreased in study group, whereas in control group constipation, painful defecation, and proctorrhagia showed better but not significant improvement. After 4-weak follow-up, the rate of constipation, and proctorrhagia also showed significantly improvement in study group. Constipation and proctorrhagia in control group recurred significantly in 4-week follow-up than after the treatment, whereas this recurrence in test group was not seen.

CONCLUSION

CM was more effective than LandA in 4-week treatment of patients with uncomplicated hemorrhoids grade 1 and 2.

摘要

背景

痔疮问题是大多数社会中最常见的问题之一,尤其是在亚洲国家。目前的药物治疗方案无法治愈该疾病,只能起到缓解作用。根据波斯传统医学,没药树脂是一种治疗选择。

目的

本随机研究旨在评估粗制没药树脂与乳糖醇和抗痔疮药(LandA)联合用药相比,对1级和2级单纯性痔疮患者的疗效和安全性。

材料与方法

本试验在伊朗马什哈德医科大学的加姆医院和伊玛目礼萨医院对99例痔疮患者进行。他们被随机分为两组,一组每天服用3克没药树脂,持续4周(作为研究组),另一组服用LandA(缓泻剂量的乳糖醇糖浆服用1个月,每天使用抗痔疮栓剂10天)作为对照组。在治疗前、治疗后即刻以及治疗后4周评估主观和客观变量,包括排便疼痛、肠胃胀气、便秘、胃食管反流(GER)、消化不良、便血、肛门脱垂和结肠镜分级。采用意向性分析。根据常见毒性标准第4.0版评估临床不良反应来评估安全性。49例患者被随机分配接受LandA治疗,50例接受没药树脂治疗。4周后,研究组的肠胃胀气、消化不良、GER和结肠镜分级评分显著降低,而对照组的便秘、排便疼痛和便血虽有改善但不显著。4周随访后,研究组的便秘和便血发生率也显著改善。对照组的便秘和便血在4周随访时比治疗后显著复发,而试验组未出现这种复发情况。

结论

在对1级和2级单纯性痔疮患者进行4周治疗时,没药树脂比LandA更有效。

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