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.
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。