PDF(Pubmed)
Abstract：
BACKGROUND: Urologic guidelines recommend perioperative instillation of chemotherapy after transurethral resection of bladder tumor (TURBT) to decrease tumor recurrence, yet implementation of this recommendation is partial due to associated morbidity. Hypertonic saline destroys cells by osmotic dehydration and might present a safer alternative.
OBJECTIVE: To evaluate the safety of 3% hypertonic saline (Hypersal) intravesical instillation following TURBT in rats and in humans.
METHODS: In 8 rats whose bladders were electrically injured, intravesical blue-dyed Hypersal was administered. We measured serum sodium levels before and after instillation and pathologically evaluated their pelvic cavity for signs of inflammation or blue discoloration. Twenty-four patients were recruited to the human trial (NIH-NCT04147182), 15 comprised the interventional and 10 the control group (one patient crossed over). Hypersal was given postoperatively. Serum sodium was measured before, 1 hour and 12-24 hours after instillation. Adverse effects were documented and compared between the groups.
RESULTS: In rats, average sodium levels were 140.0 mEq/L and 140.3 mEq/L before and following instillation, respectively. Necropsy revealed no signs of inflammation or blue discoloration. In humans the average plasma sodium levels were 138.6 mEq∖L, 138.8 mEq∖L and 137.7 mEq∖L before, 1 hour and 12-24 hours after instillation, respectively. During the postoperative follow-up there was one case of fever. A month after the surgery, dysuria was reported by 5 patients while urgency and hematuria were reported by one patient each. The most severe adverse events were grade 2 on the Clavien-Dindo scale. Adverse events were similar in the control group.
CONCLUSIONS: Hypersal instillation is safe and tolerable immediately after TURBT.
OBJECTIVE: To evaluate the safety of 3% hypertonic saline (Hypersal) intravesical instillation following TURBT in rats and in humans.
METHODS: In 8 rats whose bladders were electrically injured, intravesical blue-dyed Hypersal was administered. We measured serum sodium levels before and after instillation and pathologically evaluated their pelvic cavity for signs of inflammation or blue discoloration. Twenty-four patients were recruited to the human trial (NIH-NCT04147182), 15 comprised the interventional and 10 the control group (one patient crossed over). Hypersal was given postoperatively. Serum sodium was measured before, 1 hour and 12-24 hours after instillation. Adverse effects were documented and compared between the groups.
RESULTS: In rats, average sodium levels were 140.0 mEq/L and 140.3 mEq/L before and following instillation, respectively. Necropsy revealed no signs of inflammation or blue discoloration. In humans the average plasma sodium levels were 138.6 mEq∖L, 138.8 mEq∖L and 137.7 mEq∖L before, 1 hour and 12-24 hours after instillation, respectively. During the postoperative follow-up there was one case of fever. A month after the surgery, dysuria was reported by 5 patients while urgency and hematuria were reported by one patient each. The most severe adverse events were grade 2 on the Clavien-Dindo scale. Adverse events were similar in the control group.
CONCLUSIONS: Hypersal instillation is safe and tolerable immediately after TURBT.
摘要：
背景：泌尿外科指南建议在经尿道膀胱肿瘤电切术（TURBT）后围手术期滴注化疗以减少肿瘤复发，然而,由于相关的发病率,这项建议的实施是部分的.高渗盐水通过渗透性脱水破坏细胞，可能是一种更安全的选择。
目的：评估TURBT后3％高渗盐水（Hypersal）膀胱内滴注在大鼠和人类中的安全性。
方法：在8只膀胱电损伤的大鼠中，给予膀胱内蓝色染色的Hypersal。我们测量了滴注前后的血清钠水平，并对其盆腔进行了病理评估，以确定炎症或蓝色变色的迹象。24名患者被招募到人体试验（NIH-NCT04147182），15包括介入组,10包括对照组(一名患者交叉)。术后给予超声检查。之前测量血清钠，滴注后1小时和12-24小时。记录不良反应，并在组间进行比较。
结果：在大鼠中，滴注前后的平均钠水平为140.0mEq/L和140.3mEq/L，分别。尸检显示没有炎症或蓝色变色的迹象。在人类中，平均血浆钠水平为138.6mEqL，138.8mEqL和137.7mEqL之前，滴注后1小时和12-24小时，分别。术后随访有1例发热。手术后一个月,5例患者报告排尿困难，尿急和血尿各1例。最严重的不良事件在Clavien-Dindo量表上为2级。对照组的不良事件相似。
结论：TURBT后立即滴注是安全且可耐受的。
目的：评估TURBT后3％高渗盐水（Hypersal）膀胱内滴注在大鼠和人类中的安全性。
方法：在8只膀胱电损伤的大鼠中，给予膀胱内蓝色染色的Hypersal。我们测量了滴注前后的血清钠水平，并对其盆腔进行了病理评估，以确定炎症或蓝色变色的迹象。24名患者被招募到人体试验（NIH-NCT04147182），15包括介入组,10包括对照组(一名患者交叉)。术后给予超声检查。之前测量血清钠，滴注后1小时和12-24小时。记录不良反应，并在组间进行比较。
结果：在大鼠中，滴注前后的平均钠水平为140.0mEq/L和140.3mEq/L，分别。尸检显示没有炎症或蓝色变色的迹象。在人类中，平均血浆钠水平为138.6mEq
结论：TURBT后立即滴注是安全且可耐受的。
