Venneman Niels G, Besselink Marc G H, Keulemans Yolande C A, Vanberge-Henegouwen Gerard P, Boermeester Marja A, Broeders Ivo A M J, Go Peter M N Y H, van Erpecum Karel J
Gastrointestinal Research Unit, Department of Gastroenterology, University Medical Center Utrecht, The Netherlands.
Hepatology. 2006 Jun;43(6):1276-83. doi: 10.1002/hep.21182.
Ursodeoxycholic acid (UDCA) and impaired gallbladder motility purportedly reduce biliary pain and acute cholecystitis in patients with gallstones. However, the effect of UDCA in this setting has not been studied prospectively. This issue is important, as in several countries (including the Netherlands) scheduling problems result in long waiting periods for elective cholecystectomy. We conducted a randomized, double-blind, placebo-controlled trial on effects of UDCA in 177 highly symptomatic patients with gallstones scheduled for cholecystectomy. Patients were stratified for colic number in the preceding year (<3: 32 patients; > or =3: 145 patients). Baseline postprandial gallbladder motility was measured by ultrasound in 126 consenting patients. Twenty-three patients (26%) receiving UDCA and 29 (33%) receiving placebo remained colic-free during the waiting period (89 +/- 4; median [range]: 75[4-365] days) before cholecystectomy (P = .3). Number of colics, non-severe biliary pain, and analgesics intake were comparable. A low number of prior colics was associated with a higher likelihood of remaining colic-free (59% vs. 23%, P < .001), without effects on the risk of complications. In patients evaluated for gallbladder motility, 57% were weak and 43% were strong contractors (minimal gallbladder volume > respectively < or = 6 mL). Likelihood to remain colic-free was comparable in strong and weak contractors (31% vs. 33%). In weak contractors, UDCA decreased likelihood to remain colic-free (21% vs. 47%, P = .02). In the placebo group, 3 preoperative and 2 post-cholecystectomy complications occurred. In contrast, all 4 complications in the UDCA group occurred after cholecystectomy. In conclusion, UDCA does not reduce biliary symptoms in highly symptomatic patients. Early cholecystectomy is warranted in patients with symptomatic gallstones.
熊去氧胆酸（UDCA）和胆囊运动功能受损据称可减轻胆结石患者的胆绞痛和急性胆囊炎。然而，UDCA在此情况下的效果尚未进行前瞻性研究。这个问题很重要，因为在几个国家（包括荷兰），由于安排问题导致择期胆囊切除术的等待时间很长。我们对177例计划进行胆囊切除术的高度症状性胆结石患者进行了一项关于UDCA效果的随机、双盲、安慰剂对照试验。患者根据前一年的绞痛次数进行分层（<3次：32例患者；≥3次：145例患者）。在126例同意的患者中，通过超声测量基线餐后胆囊运动功能。在胆囊切除术之前的等待期（89±4；中位数[范围]：75[4 - 365]天），23例（26%）接受UDCA治疗的患者和29例（33%）接受安慰剂治疗的患者保持无绞痛状态（P = 0.3）。绞痛次数、非严重胆绞痛和镇痛药摄入量相当。既往绞痛次数少与保持无绞痛状态的可能性较高相关（59%对23%，P < 0.001），对并发症风险无影响。在评估胆囊运动功能的患者中，57%为弱收缩者，43%为强收缩者（最小胆囊体积分别>或≤6 mL）。强收缩者和弱收缩者保持无绞痛状态的可能性相当（31%对33%）。在弱收缩者中，UDCA降低了保持无绞痛状态的可能性（21%对47%，P = 0.02）。在安慰剂组，发生了3例术前和2例胆囊切除术后并发症。相比之下，UDCA组的所有4例并发症均发生在胆囊切除术后。总之，UDCA不能减轻高度症状性患者的胆绞痛症状。有症状的胆结石患者应尽早进行胆囊切除术。
