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一种前瞻性研究间质性膀胱炎并证明戊聚糖多硫酸酯疗效的定量控制方法。

A quantitatively controlled method to study prospectively interstitial cystitis and demonstrate the efficacy of pentosanpolysulfate.

作者信息

Parsons C L, Benson G, Childs S J, Hanno P, Sant G R, Webster G

机构信息

University of California, San Diego.

出版信息

J Urol. 1993 Sep;150(3):845-8. doi: 10.1016/s0022-5347(17)35629-x.

DOI:10.1016/s0022-5347(17)35629-x
PMID:7688432
Abstract

A randomized, prospective, double-blind, placebo-controlled study was conducted at 7 clinical centers on 148 patients. Patients received orally either 100 mg. pentosanpolysulfate (a synthetic polysaccharide) 3 times per day or a placebo. Of the patients on drug therapy 32% showed significant improvement compared to 16% of those on placebo (p = 0.01). This study provides a model to assess this disease quantitatively in a prospective manner using a method whereby the patients globally assess their symptoms as either worse or improved by 0, 25, 50, 75 or 100%. Patients on drug therapy also experienced a significant decrease in pain and urgency (p = 0.04 and 0.01) on analogue scales when compared to placebo and also more drug patients showed an average increase of more than 20 ml. in voided volume than did placebo patients (p = 0.02). All adverse effects were minor, with 7 in the drug group and 10 in the placebo group. The results support the concept that some patients with the interstitial cystitis syndrome may have abnormal bladder surface glycosaminoglycans.

摘要

在7个临床中心对148名患者进行了一项随机、前瞻性、双盲、安慰剂对照研究。患者口服100毫克戊聚糖多硫酸盐(一种合成多糖),每日3次,或服用安慰剂。接受药物治疗的患者中,32%有显著改善,而服用安慰剂的患者中这一比例为16%(p = 0.01)。本研究提供了一个模型,以前瞻性的方式使用一种方法对这种疾病进行定量评估,即患者总体评估其症状是变差还是改善了0%、25%、50%、75%或100%。与安慰剂相比,接受药物治疗的患者在模拟量表上的疼痛和尿急也有显著减轻(p = 0.04和0.01),并且更多接受药物治疗的患者排尿量平均比安慰剂组患者增加超过20毫升(p = 0.02)。所有不良反应均较轻微,药物组有7例,安慰剂组有10例。结果支持这样一种观点,即一些间质性膀胱炎综合征患者可能存在膀胱表面糖胺聚糖异常。

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