Lander Elliot B, See Jackie R
Nanologix Research LLC Las Vegas, Nevada, USA.
Am J Clin Exp Urol. 2014 Jul 12;2(2):145-8. eCollection 2014.
We determined the effect of intravesical instillation of pentosan polysulfate encapsulated in liposomes for refractory interstitial cystitis patients. This was an open label uncontrolled study. Subjects were recruited from a private urology practice. Inclusion criteria included patients who met NIDDK criteria for Interstitial Cystitis (IC) and who were responding poorly to conventional treatments. Exclusion criteria included evidence of a urinary tract infection, bladder cancer, or other forms of chronic cystitis. Patients received 400 mg of Pentosan Polysulfate (PP) encapsulated into liposomes as an intravesical instillation performed every 2 weeks for 3 months. Baseline and post treatment outcome measures were obtained that included the O'Leary-Sant Interstitial Cystitis Symptom and Problem Questionnaire and the Pelvic Pain and Urgency/Frequency Patient symptom Scale tests. A total of 37 instillations were used and no adverse events occurred. Clinically significant decreases in symptom scores greater than 50% were seen in virtually all outcome measures at 3 month follow up. All subjects reported remarkable subjective improvement in pain symptoms marked by decreased use of narcotics and increased enjoyment of daily activities. No patients developed systemic symptoms or poor tolerance of the instillations. Intravesical Pentosan Polysulfate encapsulated into liposomes can significantly decrease frequency, urgency, pain and improve quality of life for two months after deployment. Additional studies are needed to determine cellular effects of glycosaminoglycan restoration, ideal doses, dosing intervals, safety and cost-effectiveness of this therapy.
我们确定了脂质体包裹的聚多卡醇膀胱灌注对难治性间质性膀胱炎患者的疗效。这是一项开放标签的非对照研究。受试者来自一家私立泌尿外科诊所。纳入标准包括符合美国国立糖尿病、消化和肾脏疾病研究所(NIDDK)间质性膀胱炎(IC)标准且对传统治疗反应不佳的患者。排除标准包括尿路感染、膀胱癌或其他形式慢性膀胱炎的证据。患者接受每2周进行一次、为期3个月的脂质体包裹的400毫克聚多卡醇膀胱灌注。获取了基线和治疗后的结果指标,包括奥利里 - 桑特间质性膀胱炎症状与问题问卷以及盆腔疼痛与尿急/尿频患者症状量表测试。总共进行了37次灌注,未发生不良事件。在3个月的随访中,几乎所有结果指标的症状评分均出现了大于50%的临床显著下降。所有受试者均报告疼痛症状有显著主观改善,表现为麻醉剂使用减少以及日常活动乐趣增加。没有患者出现全身症状或对灌注耐受性差的情况。脂质体包裹的膀胱内聚多卡醇在灌注后两个月可显著降低尿频、尿急、疼痛并改善生活质量。需要进一步研究以确定糖胺聚糖恢复的细胞效应、理想剂量、给药间隔、安全性以及该疗法的成本效益。