Adwers J R
Biliary Center, Methodist Hospital, Omaha, Nebraska.
J Lithotr Stone Dis. 1990 Jul;2(3):199-204.
Early comparative data is now available from several different American Gallstone Lithotripsy, ("GSL") trials (Technomed, Dornier, and Medstone). While the 6-month gallbladder clearance results appear to be remarkably similar (36%-43% in less than 20-mm solitary stones), they do not appear to match the results obtained by the Munich group in their first 175 patients (63% clearance at 4-8 months). We review the currently available American data and describe our on-going national clinical trial with the Technomed Sonolith 3000 investigation. In this trial, patients are randomized to lithotripsy plus ursodiol (Actigall,¿ Ciba Geigy), or lithotripsy alone to determine the effect of oral bile salts on the gallbladder fragment clearance rate. To date, the early success rate is clearly better in the GSL plus ursodiol arm. Following one or two lithotripsy sessions, 62.1% of patients with solitary stones, 5-20 mm in size, have had fragmentation to 7 mm or less. In the same group, 39.1% of gallbladders are clear at 6 months. While the 6-month gallbladder clearance rate appears to be a reliable indicator of eventual gallbladder status it should not be regarded as the end point of therapy and it clearly does not represent the final efficacy rate for gallstone lithotripsy. A review of the results obtained from on-going American IDE trials is compared with the published German results using GSL and combination oral dissolution therapy.
目前已有来自美国几项不同的胆结石碎石术（“GSL”）试验（Technomed、多尼尔和Medstone）的早期比较数据。虽然6个月的胆囊清除结果似乎非常相似（直径小于20毫米的单发结石清除率为36%-43%），但这些结果似乎与慕尼黑研究小组在其首批175例患者中获得的结果（4-8个月时清除率为63%）不相符。我们回顾了目前可获得的美国数据，并描述了我们正在进行的使用Technomed Sonolith 3000的全国性临床试验。在该试验中，患者被随机分为碎石术加熊去氧胆酸（Actigall，® 汽巴-嘉基）组或单纯碎石术组，以确定口服胆汁盐对胆囊碎片清除率的影响。迄今为止，在GSL加熊去氧胆酸组中早期成功率明显更高。经过一或两次碎石术后，62.1%的直径为5-20毫米的单发结石患者的结石已破碎至7毫米或更小。在同一组中，39.1%的胆囊在6个月时已清除。虽然6个月的胆囊清除率似乎是最终胆囊状况的可靠指标，但它不应被视为治疗的终点，而且它显然不代表胆结石碎石术的最终有效率。将正在进行的美国IDE试验获得的结果与已发表的使用GSL和联合口服溶石疗法的德国结果进行了比较。
