Prospective, randomized, double-blind study of safety and tolerability of intravesical resiniferatoxin (RTX) in interstitial cystitis (IQ
Prospective, randomized, double-blind study of safety and tolerability of intravesical resiniferatoxin (RTX) in interstitial cystitis (IQ
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DOI：
10.1007/s00192-005-1307-4
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发表时间：
2005-07-01
影响因子：
1.8
通讯作者：
Tu, LM
中科院分区：
文献类型：
--
作者：
Chen, TYH;Corcos, J;Tu, LM
目的：评价树脂毒素(RTX)膀胱内注射治疗间质性膀胱炎(IC)的安全性和耐受性。材料和方法：IC患者膀胱内注入含安慰剂、0.05 mU M和0.10 mU RTX的试验液50毫升。测定了RTX及其降解物9-，13-，14-邻苯乙酸酯的血药浓度。治疗后即刻采血，行膀胱镜检查。在治疗前、治疗后4周和12周进行症状评估，采用疼痛VAS指标、排尿日记和O‘Leary的IC症状/问题指数进行评估。结果：在观察的22例患者中(0.10 mU RTX组10例，0.05 mU RTX组8例，安慰剂组4例)，最常见的不良事件是滴注时的疼痛(80.0%，87.5%，25.0%)。没有严重不良反应的报道。结论：在IC患者中，膀胱内注射RTX与重要的耐受性问题有关，但在0.10微米和0.05微米时是安全的。
Objective: To determine the safety and tolerability of intravesical resiniferatoxin (RTX) in interstitial cystitis (IC) patients. Materials and Methods: IC patients were instilled with 50 cc of test solution containing either placebo, 0.05 mu M or 0.10 mu M RTX in the bladder. Plasma concentration of RTX and its degradant resiniferonol 9-, 13-, 14-orthophenylacetate was measured. Immediate post-treatment blood sampling and cystoscopy were performed. Symptoms were evaluated before treatment, at 4- and at 12-week follow-ups, using VAS indicator for pain, voiding diary, and O'Leary's IC symptom/problem indices. Results: Among 22 patients observed (ten in 0.10 mu M RTX, eight in 0.05 mu M RTX, and four in placebo groups), the most commonly reported adverse event was pain during instillation (80.0%, 87.5%, and 25.0%). No serious adverse events were reported. Conclusions: Use of intravesical RTX in IC patients is associated with important tolerability issues but safe at 0.10 mu M and 0.05 mu M.