Efficacy, Side Effects, and Monitoring of Oral Cyclosporine in Interstitial Cystitis-Bladder Pain Syndrome.
Efficacy, Side Effects, and Monitoring of Oral Cyclosporine in Interstitial Cystitis-Bladder Pain Syndrome.
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DOI：
10.1016/j.urology.2017.05.016
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发表时间：
2017-09
期刊：
影响因子：
2.1
通讯作者：
Shoskes DA
中科院分区：
文献类型：
--
作者：
Crescenze IM;Tucky B;Li J;Moore C;Shoskes DA
评价口服环孢素A（CyA）治疗难治性间质性膀胱炎/膀胱疼痛综合征（IC/BPS）的疗效，并通过药物浓度和肾功能监测评估其安全性。至少2次既往治疗失败的IC/BPS患者入组口服CyA的开放标签研究。以3 mg/kg剂量开始给药，每日两次，持续3个月。根据副作用和早晨给药后2小时测量的药物水平调整剂量（C2）。主要终点为3个月时总体反应评估（GRA）显著或中度改善或间质性膀胱炎症状指数（ICSI）或间质性膀胱炎问题指数（ICPI）改善> 50%。26例患者中有22例完成了3个月随访; 18例完成了研究后评价。中位症状持续时间为66个月（12 - 336）。3个月时，GRA改善31%（8/26），ICSI改善15%（4/26），ICPI改善19%（5/26）。Hunner病变（HL）可预测ICSI的改善（OR = 15.4; 95%CI：1.7 - 224.6，p = 0.01），75%（3/4）的应答者患有HL。2例患者因高血压或血糖升高退出研究。3个月时平均核肾小球滤过率下降（98.9 ± 31.6 vs. 84.2 ± 25.5 ml/min/1.73 m2，p = 0.01），停药后恢复至基线水平。C2水平与症状无关，但允许11例患者减少剂量。根据AUA指南，环孢霉素A对部分难治性IC/BPS患者有效。HL患者更有可能受益。监测C2而不是谷水平可导致剂量降低，从而最大限度地减少毒性。
To evaluate the efficacy of oral Cyclosporine A (CyA) in treatment of refractory interstitial cystitis/bladder pain syndrome (IC/BPS) and assess safety using drug level and renal function monitoring. Patients with IC/BPS who failed at least 2 prior treatments were enrolled in an open-label study of oral CyA. Medication was started at 3 mg/kg divided twice daily for 3 months. Dose was adjusted based on side effects and drug level measured 2 hours after the morning dose (C2). Primary end point was marked or moderate improvement of global response assessment (GRA) or >50% improvement on the Interstitial Cystitis Symptom Index (ICSI) or Interstitial Cystitis Problem Index (ICPI) at 3 months. Twenty-two of 26 patients completed 3-month follow-up; 18 completed the post-study evaluation. Median symptom duration was 66 months (12–336). At 3 months 31%(8/26) improved by GRA, 15%(4/26) had >50% improvement in ICSI, 19% (5/26) in ICPI. Hunner’s lesions (HL) predicted improvement in ICSI (OR=15.4; 95%CI:1.7–224.6, p=0.01) with 75%(3/4) of responders having HL. Two patients withdrew due to hypertension or elevated serum glucose. Mean nuclear glomerular filtration rate declined at 3 months (98.9±31.6 vs. 84.2±25.5 ml/min/1.73m2, p=0.01) and reversed to baseline after treatment discontinuation. C2 levels did not correlate with symptoms but allowed dose reduction in 11 patients. Per AUA guidelines Cyclosporine A can be effective in a proportion of patients with refractory IC/BPS. Patients with HL are more likely to benefit. Monitoring of C2 rather than trough levels, can lead to dose reduction thereby minimizing toxicity.
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影响因子：
6.6
作者：
Sairanen, J;Forsell, T;Ruutu, MJ
通讯作者：
Ruutu, MJ
影响因子：
6.6
作者：
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影响因子：
6.6
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DOI：
10.1016/j.juro.2011.03.132
发表时间：
2011-08
期刊：
The Journal of urology
影响因子：
--
作者：
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通讯作者：
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影响因子：
2.1
作者：
Forrest, John B.;Nickel, J. Curtis;Moldwin, Robert M.
通讯作者：
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