Brink J A, Simeone J F, Mueller P R, Richter J M, Prien E L, Ferrucci J T
Department of Radiology, Massachusetts General Hospital, Boston 02114.
AJR Am J Roentgenol. 1988 Nov;151(5):927-31. doi: 10.2214/ajr.151.5.927.
The criteria by which patients are selected for new, nonsurgical forms of gallstone therapy will influence the use of these techniques. We estimated the number of patients with gallbladder stones who are potentially suitable for extracorporeal shock-wave lithotripsy according to the current Food and Drug Administration protocol for the United States trials of the Dornier gallbladder lithotriptor. Exclusion criteria include patients with (1) more than three stones, (2) stones less than 0.5 cm or more than 3.0 cm in diameter, (3) radiopaque stones, and (4) a nonfunctioning gallbladder. The gallbladder contents in 100 consecutive patients undergoing cholecystectomy were analyzed according to the number, size, and calcium content of the stones as determined by specimen radiographs. Because none of these patients underwent preoperative oral cholecystography, an estimated percentage of functioning gallbladders was taken from the literature. Preoperative symptoms were not considered in determining a patient's eligibility for gallbladder lithotripsy. On the basis of these criteria, we estimated that 85% of our surgical patients would have been excluded from extracorporeal shock-wave lithotripsy according to the current Food and Drug Administration protocol for the Dornier gallbladder lithotriptor.
选择患者接受新的非手术性胆结石治疗的标准将影响这些技术的应用。我们根据美国食品药品监督管理局（Food and Drug Administration）针对多尼尔胆囊碎石机（Dornier gallbladder lithotriptor）美国试验的现行方案，估算了可能适合体外冲击波碎石术的胆囊结石患者数量。排除标准包括患有以下情况的患者：（1）结石超过三块；（2）直径小于0.5厘米或大于3.0厘米的结石；（3）不透射线的结石；（4）无功能的胆囊。根据标本X光片确定的结石数量、大小和钙含量，对100例连续接受胆囊切除术的患者的胆囊内容物进行了分析。由于这些患者均未进行术前口服胆囊造影，因此从文献中获取了估计的有功能胆囊的百分比。在确定患者是否适合胆囊碎石术时，未考虑术前症状。基于这些标准，我们估计，根据美国食品药品监督管理局针对多尼尔胆囊碎石机的现行方案，我们的手术患者中有85%会被排除在体外冲击波碎石术之外。
