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锦葵对前列腺癌患者放疗后尿路毒性的预防作用:一项多中心、双盲、随机临床试验。

Preventive effect of Malva on urinary toxicity after radiation therapy in prostate cancer patients: A multi-centric, double-blind, randomized clinical trial.

作者信息

Mofid Bahram, Rezaeizadeh Hossein, Jaladat Amir Mohammad, Atarzadeh Fatemeh, Moeini Reihane, Motevalian Abbas, Mosalaie Ahmad, Farhan Farshid, Rakhsha Afshin, Kashi Amir Shahram Yousefi

机构信息

Associate Professor, Shohada-e-Tajrish Hospital, Department of Radiation Oncology, Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

M.D, Ph.D. of Traditional Persian Medicine, Assistant Professor, Department of Traditional Persian Medicine, School of traditional Medicine, Tehran University of Medical Science, Tehran, Iran.

出版信息

Electron Physician. 2015 Sep 16;7(5):1220-6. doi: 10.14661/1220. eCollection 2015 Sep.

DOI:10.14661/1220
PMID:26435820
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4590556/
Abstract

BACKGROUND

For patients receiving external beam radiation therapy (EBRT) after radical prostatectomy as adjuvant treatment or patients receiving EBRT as definitive treatment, partial irradiation of the urinary bladder is common. Many of such patients experience some degree of radiation-induced cystitis during or after EBRT. There is currently no efficient treatment for preventing radiation cystitis.

OBJECTIVE

The aim of this study was to evaluate the effectiveness of one of the safe mucilaginous herbs (Malva) in preventing radiation-induced dysuria in patients who are undergoing EBRT for prostate cancer.

METHODS

From April 2013 to August 2014, 68 patients were randomized into two groups using four block randomization, 34 to the drug (Malva) group and 34 to the placebo group. Of the 68 patients who began the study, 60 completed it. They were instructed to use the medication, i.e., Malva or the placebo, three times a day for six weeks. They were followed by a physician every two weeks for eight weeks, and urinary function was assessed in each visit by asking questions based on the Visual Prostate Symptom Score (VPSS) and a dysuria severity score. The changes in the VPSS and dysuria severity score between baseline and each follow-up visit were compared between the two groups in the study using repeated measures analysis of variance (ANOVA) and t-tests.

RESULTS

The median age of the 68 patients was 66. Twenty-one of 27 patients in the control group (77.7%) suffered from dysuria, while dysuria was detected in 23 of 33 patients (69.6%) who received Malva (odds ratio=2.70 for dysuria). After two weeks, four weeks, and six weeks of treatment with Malva, dysuria due to EBRT was milder in the treatment group than in the control group, and the differences were statistically significant (p = 0.005, p = 0.004, p = 0.001, respectively).

CONCLUSION

To the best of our knowledge, our study is the first study to assess the protective effect of a mucilaginous herb (Malva) against urinary toxicity induced by EBRT. The positive results of this study warrant further studies in this field.

摘要

背景

对于接受前列腺癌根治术后外照射放疗(EBRT)作为辅助治疗的患者或接受EBRT作为确定性治疗的患者,膀胱部分照射很常见。许多此类患者在EBRT期间或之后会经历一定程度的放射性膀胱炎。目前尚无预防放射性膀胱炎的有效治疗方法。

目的

本研究旨在评估一种安全的黏液性草药(锦葵)对接受前列腺癌EBRT患者预防放射性排尿困难的有效性。

方法

2013年4月至2014年8月,采用四次区组随机化将68例患者随机分为两组,34例进入药物(锦葵)组,34例进入安慰剂组。在开始研究的68例患者中,60例完成了研究。他们被指示每天服用药物(即锦葵或安慰剂)三次,持续六周。医生每两周对他们进行随访八周,并在每次随访时根据视觉前列腺症状评分(VPSS)和排尿困难严重程度评分通过提问来评估排尿功能。在研究中,使用重复测量方差分析(ANOVA)和t检验比较两组在基线和每次随访之间VPSS和排尿困难严重程度评分的变化。

结果

68例患者的中位年龄为66岁。对照组27例患者中有21例(77.7%)出现排尿困难,而接受锦葵治疗的33例患者中有23例(69.6%)出现排尿困难(排尿困难的优势比=2.70)。使用锦葵治疗两周、四周和六周后,治疗组因EBRT导致的排尿困难比对照组轻,差异具有统计学意义(分别为p = 0.005、p = 0.004、p = 0.001)。

结论

据我们所知,我们的研究是第一项评估黏液性草药(锦葵)对EBRT引起的泌尿毒性保护作用的研究。本研究的阳性结果值得在该领域进一步开展研究。

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Botanicals: an alternative remedy to radiotherapy-induced dysuria.植物药:放疗引起的排尿困难的替代疗法。
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Flavonoids as prospective compounds for anti-cancer therapy.类黄酮作为抗癌治疗的有前景的化合物。
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Bioactivity of malva sylvestris L., a medicinal plant from iran.玛尔维莎草(Malva sylvestris L.)的生物活性,一种来自伊朗的药用植物。
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Enteric-coated, highly standardized cranberry extract reduces risk of UTIs and urinary symptoms during radiotherapy for prostate carcinoma.肠溶性、高度标准化的蔓越莓提取物可降低前列腺癌放射治疗期间尿路感染和尿路症状的风险。
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