西施泰与吡柔比星联合灌注减少膀胱灌注化疗所致膀胱并发症的多中心临床研究

目的 验证西施泰膀胱灌注减少非肌层浸润性膀胱癌TURBt术后灌注化疗并发症的疗效和安全性.方法 对120例符合入选/排除标准患者进行多中心、随机、空白对照的疗效和安全性临床研究.患者均先行TURBt,之后观察组联合灌注吡柔比星和西施泰,对照组仅灌注吡柔比星.以膀胱疼痛直观模拟分级(VAS)评分为主要疗效指标,以血尿、膀胱刺激症状为次要疗效指标,严密观察不良事件、实验室检查、治疗前后生命体征的变化,评价其疗效和安全性. 结果 2组患者人口学特征与基线资料相似,具有可比性.观察组治疗前后VAS评分差值和改善率分别为2.24±1.70与(92.92±14.76)%,对照组分别为0.70±1.82与(20.59±87.34)%,2组比较差异均有统计学意义(P＜0.01);2组VAS总分变化值差异也有统计学意义,并且2组VAS评分灌注前后改善率的比较从访视2开始差异就有统计学意义.观察组尿频次数从治疗前的(9.06±4.09)次减少至(6.69±2.89)次,对照组从(8.85±3.32)次增加至(10.15±4.40)次,组间比较差异有统计学意义(P＜0.01).观察组夜尿次数从治疗前的(2.88±1.74)次减少至(1.47±1.62)次,对照组从(3.22±2.30)次减少至(2.91±1.73)次,差异亦有统计学意义(P＜0.01).2组治疗前后尿急、排尿困难及血尿方面的改善不明显,未发现与西施泰有关的不良事件. 结论西施泰与化疗药物联合灌注能明显改善膀胱灌注化疗患者VAS评分状况,迅速、持续缓解患者的膀胱疼痛,并改善患者尿频与夜尿症状,提高患者生活质量.VAS评分高的患者改善效果更明显.西施泰与化疗药联合灌注安全性与临床耐受性良好.

Abstract：

Objective To verify the efficacy and safety of intravesical instillation of Cystistat in reducing complications caused by intravesical chemotherapy after TUR-BT in non-muscle invasive bladder cancer patients. Methods One hundred and twenty patients who met the inclusion/exclusion criteria were enrolled into this multi-centered, randomized and blank controlled clinical study. Selected patients were randomized into the observation group and control group. TUR-BT was carried out in both groups followed by pirarubicin (THP) and Cystistat intravesical instillation in the observation group, and THP intravesical instillation alone in control group. Visual analog scale (VAS) was used as the primary efficacy variable. The secondary efficacy variables were assessments of hematuria and bladder irritation symptoms. Adverse events, laboratory tests and changes of vital signs before and after treatment were strictly observed during observation to evaluate the efficacy and safety of Cystistat.Results Demographics and baseline characteristics were comparable in both groups. The differences and the improvement rate of VAS score in the 2 groups were significant, both P＜0.01. The changes of VAS score and the improvement rate before and after treatment were (2. 24±1.70) and (92. 92±14.76) % in observation group and (0. 70±1.82) and (20. 59±87.34)% in control group respectively. According to the covariance analysis, there were significant differences in changes of VAS score between the observation group and the control group. Also, the improvement rate of VAS score was significant from visit 2. The urine frequency decreased from 9.06±4.09 to 6. 69±2.89 in observation group and increased from 8. 85±3. 32 to 10. 15±4.40 in control group, P＜0.01. There were also significant differences in changes of nocturia before and after treatment between these two groups (P＜0.01), the nocturia decreased from 2. 88±1.74 to 1. 47±1.62 in observation group and 3. 22±2.30 to 2.91±1.73 in control group, respectively. The changes of WHO assessment for hematuria,urgency and dysuria were not significantly different between the 2 groups. No Cystistat related adverse event was observed. Conclusions Cystistat combined instillation can significantly improve the VAS score of patients with chemotherapeutic agent instillation. Relief of bladder pain, frequency and nocturia are more rapidly and more durable in Cystistat combined instillation group. The improvement is more effective in patients with a high VAS score. Cystistat instillation with chemotherapeutics agents is both well tolerated and safe.

Combination of Cystistat and pirarubicin intravesical instillation in reducing intravesical chemotherapy complications: a multi-center clinical study

Objective To verify the efficacy and safety of intravesical instillation of Cystistat in reducing complications caused by intravesical chemotherapy after TUR-BT in non-muscle invasive bladder cancer patients. Methods One hundred and twenty patients who met the inclusion/exclusion criteria were enrolled into this multi-centered, randomized and blank controlled clinical study. Selected patients were randomized into the observation group and control group. TUR-BT was carried out in both groups followed by pirarubicin (THP) and Cystistat intravesical instillation in the observation group, and THP intravesical instillation alone in control group. Visual analog scale (VAS) was used as the primary efficacy variable. The secondary efficacy variables were assessments of hematuria and bladder irritation symptoms. Adverse events, laboratory tests and changes of vital signs before and after treatment were strictly observed during observation to evaluate the efficacy and safety of Cystistat.Results Demographics and baseline characteristics were comparable in both groups. The differences and the improvement rate of VAS score in the 2 groups were significant, both P＜0.01. The changes of VAS score and the improvement rate before and after treatment were (2. 24±1.70) and (92. 92±14.76) % in observation group and (0. 70±1.82) and (20. 59±87.34)% in control group respectively. According to the covariance analysis, there were significant differences in changes of VAS score between the observation group and the control group. Also, the improvement rate of VAS score was significant from visit 2. The urine frequency decreased from 9.06±4.09 to 6. 69±2.89 in observation group and increased from 8. 85±3. 32 to 10. 15±4.40 in control group, P＜0.01. There were also significant differences in changes of nocturia before and after treatment between these two groups (P＜0.01), the nocturia decreased from 2. 88±1.74 to 1. 47±1.62 in observation group and 3. 22±2.30 to 2.91±1.73 in control group, respectively. The changes of WHO assessment for hematuria,urgency and dysuria were not significantly different between the 2 groups. No Cystistat related adverse event was observed. Conclusions Cystistat combined instillation can significantly improve the VAS score of patients with chemotherapeutic agent instillation. Relief of bladder pain, frequency and nocturia are more rapidly and more durable in Cystistat combined instillation group. The improvement is more effective in patients with a high VAS score. Cystistat instillation with chemotherapeutics agents is both well tolerated and safe.