Holm-Bentzen M, Jacobsen F, Nerstrøm B, Lose G, Kristensen J K, Pedersen R H, Krarup T, Feggetter J, Bates P, Barnard R
J Urol. 1987 Sep;138(3):503-7. doi: 10.1016/s0022-5347(17)43241-1.
Painful bladder disease, sensory bladder disease, chronic abacterial cystitis and interstitial cystitis are ill-defined conditions of unknown etiology and pathogenesis, and, therefore, they are without any rational therapy. Pathogenetic theories concerning defects in the epithelium and/or mucous surface coat (including glycosaminoglycans) of the bladder, and theories concerning immunological disturbances predominate. Sodium pentosanpolysulfate (Elmiron) acts by substituting a defective glycosaminoglycan layer and inhibits complement reactions in inflammatory processes. We compared sodium pentosanpolysulfate versus placebo in a prospective double-blind, clinically controlled multicenter trial of 115 patients with painful bladder disease. Two protocols were used. Protocol A included 43 patients with clinically and pathologically anatomically verified interstitial cystitis (28 or more mast cells per mm.2), and protocol B included 72 patients with a painful bladder and unspecific histological findings. The patients were randomized to receive either sodium pentosanpolysulfate (200 mg. twice daily) or placebo capsules for 4 months. Before and after the trial the patients were evaluated with symptom grading, urodynamics and cystoscopy with distension and deep bladder biopsies. The results showed no difference between the pre-trial and post-trial values in the sodium pentosanpolysulfate and placebo groups in both protocols in regard to symptoms, urodynamic parameters, cystoscopic appearance and mast cell counts. A significant increase in the cystoscopically determined bladder capacity in the sodium pentosanpolysulfate group in protocol A was found. We conclude that no statistically or clinically significant effect of sodium pentosanpolysulfate was found compared to placebo in patients with painful bladder disease.
疼痛性膀胱疾病、感觉性膀胱疾病、慢性非细菌性膀胱炎和间质性膀胱炎是病因和发病机制不明的界定不清的病症，因此，它们没有任何合理的治疗方法。关于膀胱上皮和/或黏膜表面涂层（包括糖胺聚糖）缺陷的发病机制理论以及关于免疫紊乱的理论占主导地位。聚磺苯乙烯钠（爱若华）通过替代有缺陷的糖胺聚糖层起作用，并抑制炎症过程中的补体反应。我们在一项针对115例疼痛性膀胱疾病患者的前瞻性双盲、临床对照多中心试验中比较了聚磺苯乙烯钠与安慰剂的效果。使用了两种方案。方案A包括43例经临床和病理解剖学证实的间质性膀胱炎患者（每平方毫米有28个或更多肥大细胞），方案B包括72例有疼痛性膀胱且组织学检查结果不特异的患者。患者被随机分配接受聚磺苯乙烯钠（每日两次，每次200毫克）或安慰剂胶囊，为期4个月。在试验前后，通过症状分级、尿动力学检查以及膀胱扩张和膀胱深部活检的膀胱镜检查对患者进行评估。结果显示，在两种方案中，聚磺苯乙烯钠组和安慰剂组在症状、尿动力学参数、膀胱镜检查外观和肥大细胞计数方面，试验前和试验后的数值均无差异。在方案A的聚磺苯乙烯钠组中，膀胱镜测定的膀胱容量有显著增加。我们得出结论，在疼痛性膀胱疾病患者中，与安慰剂相比，未发现聚磺苯乙烯钠有统计学或临床显著效果。
