Assessment of long-term intravesical hyaluronic acid, chondroitin sulfate and combination therapy for patients with bladder pain syndrome

Mete Özkıdık
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引用次数: 12

Abstract

Introduction The aim of this study was to evaluate the efficacy, safety and tolerability of intravesical hyaluronic acid (HA), chondroitin sulfate (CS) and combination therapies (HA+CS) for patients with bladder pain syndrome (BPS) – interstitial cystitis (IC) during a 24 months follow-up period. Material and methods The study was conducted with a prospective, randomized and double-blinded design. A total of 72 patients were divided into three groups as HA, CS and combination group. Outpatient visits were performed at the begining of the study and at every 3rd month thereafter. Both objective parameters included in 3 day micturition diary such as number of micturitions per 24 hours, volume voided in each micturition and self-reported questionnaires such as Patient Perception of Bladder Condition Scale, Visual Analog Scale, Pain Urgency Frequency Questionnaire, Interstitial Cystitis Symptom and Problem Index, Health Related Quality of Life (HRQoL) were used to assess the efficacy of three different agents. Safety was defined as any adverse event beginning or worsening in the study and reported in each visit. Results All groups showed a significant improvement both in the parameters included in the 3 day micturition diary and self-reported questionnaires compared to the baseline values or scores recorded at the beginning of the study. Our primary end point was improvement in HRQoL score. The combination therapy was superior to both of the monotherapies in terms of improvement in HRQoL score and the difference was statistically significant (p = 0.02). Conclusions Combination therapy provides better results than the monotherapies to obtain symptomatic relief in patients with BPS/IC. Meta-analysis of different well-designed studies are required for more definitive results.
膀胱内注射透明质酸、硫酸软骨素及联合治疗膀胱疼痛综合征的疗效评价
本研究的目的是评估膀胱内透明质酸(HA)、硫酸软骨素(CS)和联合治疗(HA+CS)对膀胱疼痛综合征(BPS) -间质性膀胱炎(IC)患者的疗效、安全性和耐受性,随访24个月。材料与方法本研究采用前瞻性、随机、双盲设计。将72例患者分为HA组、CS组和联合组。在研究开始时和之后每3个月进行一次门诊访问。采用3 d排尿日记中的客观参数(如每24小时排尿次数、每次排尿量)和自述问卷(如患者膀胱状况感知量表、视觉模拟量表、疼痛急迫性频率问卷、间质性膀胱炎症状和问题指数、健康相关生活质量(HRQoL))来评估3种不同药物的疗效。安全性定义为在研究中开始或恶化的任何不良事件,并在每次访问中报告。结果与研究开始时记录的基线值或分数相比,所有组在3天排尿日记和自我报告问卷中的参数均有显著改善。我们的主要终点是HRQoL评分的改善。联合治疗在HRQoL评分改善方面优于单药治疗,差异有统计学意义(p = 0.02)。结论联合治疗对BPS/IC患者的症状缓解效果优于单药治疗。需要对不同设计良好的研究进行荟萃分析,以获得更明确的结果。
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