Manfredi Celeste, Spirito Lorenzo, Calace Francesco Paolo, Balsamo Raffaele, Terribile Marco, Stizzo Marco, Romano Lorenzo, Napolitano Luigi, Califano Gianluigi, Cirillo Luigi, Fusco Giovanni Maria, Rosati Claudia, Quattrone Carmelo, Sciorio Carmine, Creta Massimiliano, Longo Nicola, De Sio Marco, Arcaniolo Davide
Urology Unit, Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli", 80131 Naples, Italy.
Urology Unit, AORN Ospedali dei Colli, Monaldi Hospital, 80131 Naples, Italy.
Pathophysiology. 2022 Jul 13;29(3):365-373. doi: 10.3390/pathophysiology29030028.
Intravesical chemotherapy may cause chemical cystitis and related lower urinary tract symptoms (LUTS). The aims of this study were to evaluate the efficacy and safety of an oral preparation of hyaluronic acid (HA), chondroitin sulfate (CS), curcumin, and quercetin (Ialuril® Soft Gels) to reduce the severity of LUTS in patients with a history of bladder cancer (BCa) undergoing intravesical chemotherapy. We designed a monocentric, randomized, double-blind, placebo-controlled pilot trial. Patients referred to our institute between November 2016 and March 2018 were enrolled. All subjects had non-muscle-invasive BCa and received intravesical chemotherapy with mitomycin C (MMC). Patients were randomized 1:1 in two groups (intervention vs. control). All subjects underwent oral administration (Ialuril® Soft Gels or placebo) starting one week before the first weekly instillation and ending 30 days after the last one, subsequently starting one week before each monthly instillation and ending 14 days after it. International prostate symptom score (IPSS) and 0-100 visual analogue scale (VAS) were used to assess the efficacy of the treatment. Adverse events were also described. Patients were evaluated at baseline and after 1, 4, 7, and 13 months of intravesical chemotherapy. A total of 34 patients were enrolled. The median IPSS score was significantly lower in the intervention group compared to the control group at 4 (13 vs. 17 points; p = 0.038), 7 (10 vs. 18 points; p < 0.001), and 13 (10 vs. 17 points; p = 0.002) months. The median VAS score was significantly lower in the intervention group compared to the control group at 7 (22 vs. 37 points; p = 0.021) and 13 (20 vs. 35 points; p = 0.024) months. No AE specifically related to supplement or placebo was recorded. Oral formulation of HA, CS, quercetin, and curcumin could be an effective and safe supportive therapy against chemical cystitis in patients receiving intravesical chemotherapy for BCa.
膀胱内化疗可能会导致化学性膀胱炎及相关下尿路症状（LUTS）。本研究旨在评估口服透明质酸（HA）、硫酸软骨素（CS）、姜黄素和槲皮素制剂（Ialuril®软胶囊）对减轻膀胱癌（BCa）患者接受膀胱内化疗时LUTS严重程度的疗效和安全性。我们设计了一项单中心、随机、双盲、安慰剂对照的试点试验。纳入了2016年11月至2018年3月期间转诊至我院的患者。所有受试者均患有非肌层浸润性BCa，并接受了丝裂霉素C（MMC）膀胱内化疗。患者按1:1随机分为两组（干预组与对照组）。所有受试者在首次每周灌注前一周开始口服（Ialuril®软胶囊或安慰剂），并在最后一次灌注后30天结束，随后在每次每月灌注前一周开始口服，并在灌注后14天结束。采用国际前列腺症状评分（IPSS）和0 - 100视觉模拟量表（VAS）评估治疗效果。同时描述了不良事件。在膀胱内化疗的基线期以及1、4、7和13个月后对患者进行评估。共纳入34例患者。在第4个月（13分对17分；p = 0.038）、第7个月（10分对18分；p < 0.001）和第13个月（10分对17分；p = 0.002）时，干预组的IPSS中位数得分显著低于对照组。在第7个月（22分对37分；p = 0.021）和第13个月（20分对35分；p = 0.024）时，干预组的VAS中位数得分显著低于对照组。未记录到与补充剂或安慰剂特别相关的不良事件。HA、CS、槲皮素和姜黄素的口服制剂可能是一种有效且安全的辅助治疗方法，可用于接受BCa膀胱内化疗患者的化学性膀胱炎治疗。
