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切除痔术后使用黄酮类和甲硝唑的益处:一项随机双盲临床试验。

Benefits of flavonoid and metronidazole use after excisional hemorrhoidectomy: a randomized double-blind clinical trial.

机构信息

Division of Coloproctology, Felicio Rocho Hospital, Belo Horizonte, Brazil.

Department of Surgery, Federal University of São João Del Rey School of Medicine, Divinopolis, Brazil.

出版信息

Tech Coloproctol. 2021 Aug;25(8):949-955. doi: 10.1007/s10151-021-02465-0. Epub 2021 May 31.

DOI:10.1007/s10151-021-02465-0
PMID:34057643
Abstract

BACKGROUND

Excisional hemorrhoidectomy remains the most effective treatment for a significant group of patients with hemorrhoids, despite the potential for postoperative pain. The purpose of this study was to evaluate the effects of flavonoid and metronidazole use in the postoperative period on patients undergoing excisional hemorrhoidectomy.

METHODS

A double-blind randomized clinical study was performed. Sixty-eight patients underwent excisional hemorrhoidectomy and were randomized into 4 groups of 17 patients each to receive double-placebo (G1), metronidazole plus placebo (G2), flavonoids plus placebo (G3) or metronidazole plus flavonoids (G4) in the postoperative period. A standard analgesic protocol was offered equally for all groups. Postoperative pain, bleeding, edema, pruritus and tenesmus were evaluated during the following three periods: from immediately after the operation until postoperative day (POD)7, from POD 8 to POD 14, and from POD 15 to POD 30. The patients were required to complete symptom questionnaires and to attend postoperative follow-up on PODs 7, 14 and 30. The effect of each drug was assessed for each symptom, and the groups were compared with each other and over time.

RESULTS

There was less severe pain in all postoperative periods in the groups using flavonoids (G3 and G4, both p < 0.0001), with an observed synergistic effect of flavonoids combined with metronidazole during the first 14 days after surgery (p < 0.0001). Flavonoid use was also associated with decreased bleeding (G3, p = 0.031 and G4, p = 0.016) between the first and second postoperative weeks CONCLUSIONS: The use of flavonoids alone and in combination with metronidazole resulted in a reduction of most symptoms, particularly pain, after excisional hemorrhoidectomy.

TRIAL REGISTRATION

The present study was registered in the SISNEP (document CAAE-0035.0.240.000-11), after approval by the research ethics committee (CEP) of the Hospital Felício Rocho (protocol nº393 / 11).

摘要

背景

尽管切除痔手术有潜在的术后疼痛,但对于一组有显著痔的患者来说,它仍然是最有效的治疗方法。本研究的目的是评估在切除痔手术后使用黄酮类化合物和甲硝唑对患者的影响。

方法

进行了一项双盲随机临床试验。68 名患者接受了切除痔手术,并随机分为 4 组,每组 17 名患者,分别接受术后双安慰剂(G1)、甲硝唑加安慰剂(G2)、黄酮加安慰剂(G3)或甲硝唑加黄酮(G4)。所有组都平等地提供了标准的镇痛方案。在以下三个时期评估术后疼痛、出血、水肿、瘙痒和里急后重:术后即刻至术后第 7 天(POD7)、术后第 8 天至第 14 天(POD14)和术后第 15 天至第 30 天(POD30)。患者需要填写症状问卷,并在 POD7、14 和 30 进行术后随访。评估每种药物对每种症状的效果,并对各组进行相互比较和随时间比较。

结果

使用黄酮类化合物的所有术后时期疼痛都较轻(G3 和 G4 均 p<0.0001),在手术后的前 14 天观察到黄酮类化合物与甲硝唑联合使用的协同作用(p<0.0001)。黄酮类化合物的使用还与术后第一至第二周的出血减少有关(G3,p=0.031;G4,p=0.016)。

结论

单独使用黄酮类化合物和联合使用甲硝唑可减少切除痔手术后的大多数症状,尤其是疼痛。

试验注册

本研究在获得 Hospital Felício Rocho 研究伦理委员会(CEP)批准(协议号 393/11)后,在 SISNEP(文件 CAAE-0035.0.240.000-11)中进行了注册。

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