Özkıdık Mete
Clinic of Urology, Yerköy State Hospital, Yozgat, Turkey.
Cent European J Urol. 2019;72(3):270-275. doi: 10.5173/ceju.2019.0007. Epub 2019 Sep 16.
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.
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 3 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.
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).
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.
本研究的目的是评估膀胱内注射透明质酸(HA)、硫酸软骨素(CS)及联合疗法(HA+CS)对膀胱疼痛综合征(BPS)-间质性膀胱炎(IC)患者在24个月随访期内的疗效、安全性和耐受性。
本研究采用前瞻性、随机、双盲设计。共72例患者分为HA组、CS组和联合治疗组。在研究开始时及之后每3个月进行一次门诊随访。使用3天排尿日记中的客观参数,如每24小时排尿次数、每次排尿量,以及自我报告问卷,如膀胱状况患者感知量表、视觉模拟量表、疼痛-尿急-频率问卷、间质性膀胱炎症状与问题指数、健康相关生活质量(HRQoL),来评估三种不同药物的疗效。安全性定义为研究期间开始或恶化并在每次随访中报告的任何不良事件。
与研究开始时记录的基线值或分数相比,所有组在3天排尿日记中的参数和自我报告问卷方面均有显著改善。我们的主要终点是HRQoL评分的改善。联合治疗在HRQoL评分改善方面优于两种单一疗法,差异具有统计学意义(p = 0.02)。
联合治疗比单一疗法能为BPS/IC患者提供更好的症状缓解效果。需要对不同设计良好的研究进行荟萃分析以获得更确切的结果。