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中药对中年女性间质性膀胱炎的临床疗效:一项随机对照试验方案

The clinical effect of traditional chinese medicine on middle-aged women with Interstitial Cystitis: Protocol for a randomized controlled trial.

作者信息

Liu Yahong, Zhang Pingan, Liu Mengyu, Liu Xiaohe, Liu Ruijia, Yu Xudong, Deng Sheng, Si Hongmei, Sun Bei

机构信息

The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, Shaanxi, P.R. China.

Chengde Medical University, Chengde, Hebei, China.

出版信息

Medicine (Baltimore). 2020 Apr;99(14):e19673. doi: 10.1097/MD.0000000000019673.

Abstract

INTRODUCTION

Interstitial cystitis (IC), as a common disease in urology, is prolonged and repeated. IC has caused great harm to the patient's physical and psychological. Traditional Chinese medicine (TCM) is characterized by overall concepts and dialectical treatment. It provides clinicians with safer and more reliable alternatives in terms of clinical prescriptions and prepared medicines, and also improves the quality of life of patients with IC. Therefore, in this study, we will use the research method of randomized controlled trials to explore the effects of TCM combined with western medicine on renal function and urine metabolism on middle-aged women with IC.

METHODS/DESIGN: Use randomized controlled trials. According to the proposed diagnostic, inclusion, and exclusion criteria. Sixty patients with interstitial bladder inflammation that met the criteria were randomized into a treatment group and a control group of 30 cases each. The intervention group was treated with integrated traditional Chinese and western medicine. The control group was given conventional Western medicine treatment. The course of treatment is 8 weeks. Interstitial bladder inflammation symptoms score (ICS worker), problem score (worker CPI), pelvic pain and urinary urgency symptoms, and urodynamics were used as the evaluation criteria.

DISCUSSION

This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of TCM for patients with IC.

TRIAL REGISTRATION

ClinicalTrials.gov, ChiCTR2000029971, Registered on 17 February 2020.

摘要

引言

间质性膀胱炎(IC)是泌尿外科的常见疾病,病程迁延且反复,对患者身心造成极大伤害。中医以整体观念和辨证论治为特点,在临床处方和制剂方面为临床医生提供了更安全可靠的选择,也提高了IC患者的生活质量。因此,本研究将采用随机对照试验的研究方法,探讨中西医结合对中年IC女性患者肾功能及尿液代谢的影响。

方法/设计:采用随机对照试验。依据拟定的诊断、纳入及排除标准。将60例符合标准的间质性膀胱炎患者随机分为治疗组和对照组,每组30例。干预组采用中西医结合治疗。对照组给予西医常规治疗。疗程为8周。以间质性膀胱炎症状评分(ICS评分)、问题评分(CPI评分)、盆腔疼痛及尿急症状、尿动力学作为评价指标。

讨论

本试验可能为中医治疗IC患者的临床有效性、安全性及成本效益提供依据。

试验注册

ClinicalTrials.gov,ChiCTR2000029971,于2020年2月17日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8e5f/7440324/11228f2f95f1/medi-99-e19673-g001.jpg

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