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首页> 外文期刊>BJU international >A real-life multicentre clinical practice study to evaluate the efficacy and safety of intravesical chondroitin sulphate for the treatment of interstitial cystitis.
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A real-life multicentre clinical practice study to evaluate the efficacy and safety of intravesical chondroitin sulphate for the treatment of interstitial cystitis.

机译：一项现实生活中的多中心临床实践研究，旨在评估硫酸软骨素硫酸盐治疗间质性膀胱炎的有效性和安全性。

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OBJECTIVE: To report a multicentre, community based open-label study designed to assess the efficacy and safety of intravesical sodium chondroitin sulphate in the treatment of patients with the clinical diagnosis of interstitial cystitis (IC). Chondroitin sulphate is a naturally occurring glycosaminoglycan (GAG) in the bladder mucus layer and changes in this GAG have been implicated in the pathogenesis of IC, and small single-centre studies have suggested that intravesical chondroitin sulphate may have efficacy in IC. PATIENTS AND METHODS: Patients with IC were treated with sodium chondroitin sulphate (Uracyst, Stellar Pharmaceuticals Inc., London ON, Canada) solution 2.0% via urinary catheter weekly for 6 weeks and then monthly for 16 weeks for a total of 10 treatments. The primary efficacy endpoint was the percentage of responders to treatment as indicated by a marked or moderate improvement on a seven-point patient Global Response Assessment (GRA) scale at week 10 (4 weeks after the initial six treatments) compared with baseline. A major secondary efficacy endpoint (durability) was the percentage of responders on the GRA scale after 10 treatments. Additional secondary efficacy objectives were differences from baseline in Patient Symptom/Problem Index scores over the course of the treatment compared with baseline. RESULTS: In all, 47% of the 53 enrolled patients with long standing moderately severe IC (mean [SD, range] diagnosis of IC 3.0 [3.4, 0.1-16] years; duration of symptoms 9.2 [9.2, 1-39] years; baseline symptom score 14.2 [3.2]) were responders at week 10. At 24 weeks, 60% were responders. There was a statistically and clinically significant decrease in the mean (SD) symptom and bother scores from baseline at 10 weeks and 24 weeks, at 9.0 (4.3) and 8.1 (5.0), respectively (P < 0.001). There were no significant safety issues during the study. CONCLUSIONS: This multicentre community based real-life clinical practice study suggests that intravesical chondroitin sulphate may have an important role in the treatment of IC and validates the rationale for a randomized placebo-controlled trial.
机译：目的：报告一项基于社区的多中心开放标签研究，旨在评估膀胱内硫酸软骨素钠在临床诊断为间质性膀胱炎（IC）的患者中的疗效和安全性。硫酸软骨素是膀胱粘液层中的一种天然存在的糖胺聚糖（GAG），该GAG的变化与IC的发病机制有关，小型的单中心研究表明，膀胱内硫酸软骨素可能对IC有疗效。病人和方法：IC病人每周通过导尿管用硫酸软骨素钠（Uracyst，Stellar制药公司，伦敦，加拿大）溶液2.0％进行治疗，每周6周，然后每月16周，共10次治疗。主要疗效终点是治疗的反应者百分比，与基线相比，在第10周（最初的6种治疗后4周），七点患者总体反应评估（GRA）量表的显着或中度改善表明。次要功效终点（耐久性）是10次治疗后GRA量表上应答者的百分比。其他次级功效目标是与基线相比，治疗过程中患者症状/问题指数评分与基线的差异。结果：总共53例长期中度严重IC患者（平均[SD，范围]诊断为IC 3.0 [3.4，0.1-16]年;症状持续时间9.2 [9.2，1-39]年）中有47％ ;基线症状评分14.2 [3.2]）是在第10周时的反应者。在24周时，有60％是反应者。在10周和24周时，平均（SD）症状和打扰得分与基线相比有统计学和临床​​显着性降低，分别为9.0（4.3）和8.1（5.0）（P <0.001）。在研究过程中没有重大的安全问题。结论：该基于多中心社区的现实生活临床实践研究表明，膀胱内硫酸软骨素可能在IC的治疗中起重要作用，并验证了随机安慰剂对照试验的理由。

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