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评估一种创新黄酮类洗剂治疗痔疮患者的疗效和安全性:一项随机临床试验。

Evaluation of the efficacy and safety of an innovative flavonoid lotion in patients with haemorrhoid: a randomised clinical trial.

机构信息

Baqiyatallah Research Center for Gastroenterology and Liver Diseases (BRCGL), Clinical Sciences Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran.

Chemical Injuries Research Center, Systems Biology and Poisonings Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran (the Islamic Republic of).

出版信息

BMJ Open Gastroenterol. 2023 Aug;10(1). doi: 10.1136/bmjgast-2023-001158.

Abstract

OBJECTIVE

Haemorrhoids are one of the most common gastrointestinal and anal diseases. In olive oil and honey propolis, flavonoids have beneficial effects on improving vascular function and decreasing vascular resistance. In this study, we aimed to produce a combination of these two substances in the form of lotions and assess their healing and side effects in comparison with routine treatment, anti-haemorrhoid ointment (containing hydrocortisone and lidocaine).

DESIGN

In this randomised clinical trial study, 86 patients with grade 2 or more haemorrhoid degrees, diagnosed by colonoscopy, were divided into two groups, the case (n=44) and control (n=42). The case group was treated with flavonoid lotion, and the control group was treated with anti-haemorrhoid ointment two times per day for 1 month. Patients were followed weekly with history and physical examination. The data of the two groups were collected before and after the intervention and statistically analysed.

RESULTS

Post-treatment reduction in haemorrhoid grade was significant in the case group (p=0.02). This ratio was insignificant in the control group (p=0.139). Flavonoid lotion (p<0.05) significantly reduced the signs and symptoms of haemorrhoids more than anti-haemorrhoid ointment.

CONCLUSION

According to the results, flavonoid lotion can be an excellent alternative to topical chemical drugs, such as anti-haemorrhoid ointment, in treating haemorrhoid disease. Besides its effectiveness and safety, it can be easily manufactured and widely available to patien.

摘要

目的

痔疮是最常见的胃肠道和肛门疾病之一。在橄榄油和蜂蜜蜂胶中,类黄酮对改善血管功能和降低血管阻力有有益作用。在这项研究中,我们旨在将这两种物质以洗液的形式组合,并与常规治疗(含氢化可的松和利多卡因的痔疮膏)相比,评估其愈合和副作用。

设计

在这项随机临床试验研究中,86 名经结肠镜诊断为 2 度或以上痔疮程度的患者被分为两组,病例组(n=44)和对照组(n=42)。病例组使用黄酮类洗液治疗,对照组每天使用痔疮膏治疗两次,持续 1 个月。每周对患者进行病史和体格检查。收集两组干预前后的数据并进行统计分析。

结果

病例组治疗后痔疮等级的降低有统计学意义(p=0.02)。对照组(p=0.139)则无统计学意义。黄酮类洗液(p<0.05)在缓解痔疮症状和体征方面明显优于痔疮膏。

结论

根据结果,黄酮类洗液可以替代外用化学药物(如痔疮膏),成为治疗痔疮疾病的一种有效方法。除了有效性和安全性外,它还可以很容易地制造和广泛应用于患者。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2a6a/10441054/deffd6755c1b/bmjgast-2023-001158f01.jpg

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