Schoenfeld P
Division of Gastroenterology, University of Michigan School of Medicine and Veterans Affairs Center for Excellence in Health Services Research, Ann Arbor, MI 48105, USA.
Aliment Pharmacol Ther. 2004 Feb 1;19(3):263-9. doi: 10.1111/j.1365-2036.2004.01864.x.
In the USA, tegaserod is contraindicated in patients with a history of bowel obstruction, abdominal adhesions or symptomatic gall-bladder disease due to a non-significant difference in abdominal surgery between tegaserod-using and placebo-using patients in Phase III trials.
To calculate the incidence of abdominal and pelvic surgery in tegaserod-using and placebo-using patients in randomized controlled trials and to assess the possible association between medication and surgery, using pre-specified criteria in a blind adjudication procedure.
Primary study selection criteria included: (i) randomized controlled trial; (ii) comparison of tegaserod vs. placebo; and (iii) results reporting the incidence of abdominal and pelvic surgery. A panel of experts in epidemiology and functional bowel disorders reviewed the history of each patient who underwent surgery. Experts were blind with regard to whether patients used tegaserod or placebo. Using pre-specified criteria, experts rated the likelihood of an association between medication use and surgery.
Thirteen randomized controlled trials (n =9857 patients) met the primary study selection criteria. No significant difference in the incidence of abdominal/pelvic surgery was identified between tegaserod-using and placebo-using patients: pelvic surgery, 0.16% vs. 0.19% (P = 0.80); abdominal surgery (non-cholecystectomy), 0.15% vs. 0.19% (P = 0.61); cholecystectomy, 0.13% vs. 0.03% (P = 0.17); total abdominal/pelvic surgery, 0.44% vs. 0.41% (P = 1.00). Post-adjudication, there was no significant difference in the incidence of abdominal/pelvic surgery between tegaserod-using and placebo-using patients.
Data from randomized controlled trials demonstrate a similar incidence of abdominal/pelvic surgery in tegaserod-using and placebo-using patients.
在美国，由于在III期试验中使用替加色罗和使用安慰剂的患者腹部手术方面无显著差异，因此肠梗阻、腹部粘连或有症状胆囊疾病史的患者禁用替加色罗。
采用预先设定的标准并通过盲法判定程序，计算随机对照试验中使用替加色罗和使用安慰剂的患者进行腹部和盆腔手术的发生率，并评估药物与手术之间可能存在的关联。
主要研究选择标准包括：（i）随机对照试验；（ii）替加色罗与安慰剂的比较；（iii）报告腹部和盆腔手术发生率的结果。一组流行病学和功能性肠病专家审查了每位接受手术患者的病史。专家们对患者使用的是替加色罗还是安慰剂并不知情。专家们根据预先设定的标准，对药物使用与手术之间关联的可能性进行评分。
13项随机对照试验（n = 9857例患者）符合主要研究选择标准。使用替加色罗和使用安慰剂的患者在腹部/盆腔手术发生率方面未发现显著差异：盆腔手术，0.16%对0.19%（P = 0.80）；腹部手术（非胆囊切除术），0.15%对0.19%（P = 0.61）；胆囊切除术，0.13%对0.03%（P = 0.17）；腹部/盆腔手术总计，0.44%对0.41%（P = 1.00）。判定后，使用替加色罗和使用安慰剂的患者腹部/盆腔手术发生率无显著差异。
随机对照试验数据表明，使用替加色罗和使用安慰剂的患者腹部/盆腔手术发生率相似。
