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双氯芬酸联合生长抑素预防内镜下逆行胰胆管造影术后胰腺炎:一项随机双盲安慰剂对照试验

发布日期:2014-1-29 12:40:08 文章来源:Endoscopy 作者次数:1206
    双氯芬酸联合生长抑素预防内镜下逆行胰胆管造影术后胰腺炎:一项随机双盲安慰剂对照试验

    P. Katsinelos1, K. Fasoulas1, G. Paroutoglou2, G. Chatzimavroudis1, A. Beltsis1, S. Terzoudis1, T. Katsinelos3, E. Dimou3, C. Zavos4, A. Kaltsa2, J. Kountouras4

    1希腊塞萨洛尼基亚里士多德大学G. Gennimatas总医院内镜和活动性组

    2希腊拉里萨塞萨利大学医院消化科

    3希腊塞萨洛尼基亚里士多德大学药学系

    4希腊塞萨洛尼基Ippokration医院亚里士多德大学第二诊所医学系

    背景和研究目的:胰腺炎是治疗性内镜逆行胰胆管造影术(ERCP)最常见的并发症,而且人们已提出许多药物预防性方法,尽管这不是毫无争议的。本研究目的是探讨双氯芬酸与生长抑素联合疗法对降低内镜逆行胰胆管造影术后胰腺炎(PEP)发生频率和严重程度的影响。

    患者和方法:在两所三级转诊中心进行了一项前瞻性、双盲、安慰剂对照试验,该实验纳入的540例符合条件的患者被随机分为两组,一组(A组)接受双氯芬酸和生长抑素联合疗法,即于内镜逆行胰胆管造影术前3060分经直肠给予双氯芬酸100mg,之后以0.25mg/h给予生长抑素,连续6小时;另一组(B组)给予安慰剂和生理盐水,该安慰剂是一种与双氯芬酸具有相同外观的栓剂。在行ERCP前和术后6小时与24小时,对患者进行临床评估,并测定血清中淀粉酶水平。运用规范化的标准诊断PEP的严重性,并对其进行评分。前瞻性记录不良反应。

    结果:两组PEP人口数据、ERCP检查结果和手术风险因子差异无统计学意义。急性胰腺炎的总发病率为7.2%。接受联合疗法的患者PEP发病率显著低于对照组患者(4.7%10.4%P = 0.015)。在多元分析中,急性胰腺炎史(P = 0.001),胰腺一级和一级以外的分支混浊(P = 0.008)和无药物预防(P = 0.023)被认为是PEP的独立风险因素。

    结论:虽然双氯芬酸和生长抑素联合预防性疗法有希望降低PEP发生频率,但在得出明确结论之前,仍需进一步的大型比较性研究来证实我们的研究结果。

     

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    Combination of diclofenac plus somatostatin in the prevention of post-ERCP pancreatitis: a randomized, double-blind, placebo-controlled trial

    P. Katsinelos1, K. Fasoulas1, G. Paroutoglou2, G. Chatzimavroudis1, A. Beltsis1, S. Terzoudis1, T. Katsinelos3, E. Dimou3, C. Zavos4, A. Kaltsa2, J. Kountouras4

    1Department of Endoscopy and Motility Unit, G. Gennimatas General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece

    2Department of Gastroenterology, University HospitalofThessaly, Larissa,Greece

    3Department of Pharmacy, AristotleUniversityofThessaloniki,Thessaloniki,Greece

    4Department of Medicine, Second Medical Clinic, Aristotle University of Thessaloniki, Ippokration Hospital, Thessaloniki, Greece

    Background and study aims: Pancreatitis is the most common complication of therapeutic endoscopic retrograde cholangiopancreatography (ERCP), and many pharmacoprophylactic approaches have been suggested, though not without controversy. The aim was to investigate the impact of combined therapy with diclofenac plus somatostatin on reducing the frequency and severity of post-ERCP pancreatitis (PEP).

    Patients and methods: A prospective, double-blind, placebo-controlled trial was conducted in two tertiary referral centers, with 540 eligible patients randomized to receive either combined therapy with diclofenac 100 mg rectally 30 to 60 minutes before ERCP plus somatostatin 0.25 mg/h for 6 hours (group A), or a placebo suppository identical in appearance to the diclofenac along with saline solution (group B). Patients were clinically evaluated and serum amylase levels were determined before ERCP and at 6 and 24 hours post-procedure. Standardized criteria were used to diagnose and grade the severity of PEP. Adverse events were recorded prospectively.

    Results: There were no statistical differences between the groups regarding demographic data, ERCP findings, and procedure risk factors for PEP. The overall incidence of acute pancreatitis was 7.2 %. The PEP rate was significantly lower in the patients who received the combination therapy than in controls (4.7 % vs. 10.4 %, P = 0.015). Previous history of acute pancreatitis (P = 0.001), pancreatic opacification of first-class branches and beyond (P = 0.008), and absence of pharmacoprophylaxis (P = 0.023) were identified as independent risk factors for PEP in multivariate analysis.

    Conclusion: Although combined prophylactic therapy with diclofenac plus somatostatin was promising in reducing frequency of PEP, further comparative large-scale studies are needed to confirm our findings before definitive conclusions can be drawn.

     

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