Abu-Zidan Fikri M, Windsor John A
Department of Surgery, Faculty of Medicine and Health Sciences, United Arab Emirates University, Ain-Ain.
Eur J Surg. 2002;168(4):215-9. doi: 10.1080/11024150260102816.
The recent clinical trials of lexipafant in the treatment of acute pancreatitis were undertaken with considerable optimism. It was expected that this single agent anticytokine would reduce the morbidity and mortality of this disease. Published clinical trials of lexipafant (BB-882) in acute pancreatitis were retrieved by MEDLINE, EM Base, and Science Citation Index. The critical appraisal included the question asked, design of the study, group and selection of patients, results, and statistical analysis. The historical sequence of the trials and the impact of commerce on their performance were highlighted. Lexipafant did not reduce mortality in severe acute pancreatitis. Comparison between the trials is difficult because of changes in study groups and dose. The clinical trials were designed without the benefit of open discussion of the preliminary pharmacological studies. The results of the trials have not been communicated in an open, timely, and systematic manner, probably because of commercial constraints.
近期开展的关于来昔帕泛治疗急性胰腺炎的临床试验，是在满怀相当乐观的情绪下进行的。人们期望这种单一的抗细胞因子药物能够降低该疾病的发病率和死亡率。通过医学文献数据库（MEDLINE）、荷兰医学文摘数据库（EM Base）以及科学引文索引（Science Citation Index）检索了已发表的来昔帕泛（BB - 882）治疗急性胰腺炎的临床试验。批判性评价包括所提问题、研究设计、患者分组与选择、结果以及统计分析。强调了试验的历史顺序以及商业因素对试验实施的影响。来昔帕泛并未降低重症急性胰腺炎的死亡率。由于研究组和剂量的变化，各试验之间难以进行比较。这些临床试验的设计并未得益于对初步药理学研究的公开讨论。试验结果也未以公开、及时且系统的方式进行交流，这可能是由于商业限制所致。
