Maher J W, Summers R W, Dean T R, Swift J, Heitshusen D, Quinn G
Department of Surgery, University of Iowa College of Medicine, Iowa City.
Surgery. 1990 Oct;108(4):648-52; discussion 653-4.
One hundred thirty-three patients were entered into a randomized, double-blind, placebo-controlled trial of extracorporeal shock-wave lithotripsy for symptomatic gallstones versus extracorporeal shock-wave lithotripsy plus adjuvant litholytic therapy with ursodeoxycholic acid (UDCA). Six months after lithotripsy, patients receiving placebo were crossed over to UDCA therapy without unblinding the study. One hundred sixteen patients have completed 6 months of follow-up. Five patients were dropped from the study. Nine percent have required cholecystectomy (11 patients with biliary colic and 1 with acute cholecystitis). Ninety-one patients had a solitary stone (64 patients had stones less than or equal to 20 mm and 27 patients had stones greater than 20 mm in diameter), and 25 patients had two to three stones. Fifty percent were retreated. Cumulative stone-free rates at 6, 12, and 18 months were 26%, 39%, and 41%, respectively. At 6 months there was a significant advantage for patients treated with UDCA versus placebo (36% vs 17% were stone free) that had disappeared by 12 months (placebo-treated patients had received 6 months of UDCA). Patients with solitary stones equal to or less than 20 mm in diameter treated with UDCA had stone-free rates at 6, 12, and 18 months of 58%, 58%, and 62%, respectively, versus 27%, 56%, and 50%. The difference was significant only at the 6- month follow-up. Stone-free rates for patients with large solitary stones and multiple stones were very low. Extracorporeal shock-wave lithotripsy is both safe and effective therapy for treatment of symptomatic gallstones in patients with a solitary stone equal to or less than 20 mm in diameter. UDCA markedly improves the efficiency of the procedure and results in a stone-free gallbladder sooner.
133名患者进入了一项随机、双盲、安慰剂对照试验，该试验比较了体外冲击波碎石术治疗有症状胆结石与体外冲击波碎石术联合熊去氧胆酸（UDCA）辅助溶石治疗的效果。碎石术后6个月，接受安慰剂治疗的患者在不揭盲的情况下转而接受UDCA治疗。116名患者完成了6个月的随访。5名患者退出研究。9%的患者需要进行胆囊切除术（11例胆绞痛患者和1例急性胆囊炎患者）。91名患者有单个结石（64例结石直径小于或等于20mm，27例结石直径大于20mm），25名患者有两到三个结石。50%的患者接受了再次治疗。6个月、12个月和18个月时的累计无结石率分别为26%、39%和41%。6个月时，接受UDCA治疗的患者与接受安慰剂治疗的患者相比有显著优势（无结石率分别为36%和17%），但到12个月时这种优势消失了（接受安慰剂治疗的患者已接受了6个月的UDCA治疗）。直径小于或等于20mm的单个结石患者接受UDCA治疗后，6个月、12个月和18个月时的无结石率分别为58%、58%和62%，而接受安慰剂治疗的患者相应无结石率分别为27%、56%和50%。这种差异仅在6个月随访时具有统计学意义。大的单个结石和多个结石患者的无结石率非常低。体外冲击波碎石术是治疗直径小于或等于20mm的单个有症状胆结石患者的一种安全有效的治疗方法。UDCA显著提高了该治疗方法的效率，并能更快地使胆囊无结石。
