Pelagotti F, Cecchi M, Messori A
Laboratorio SIFO di Farmacoeconomia, U.O. Farmacia, Drug Information Center, Azienda Ospedaliera Careggi, viale Morgagni 85, 50134 Florence, Italy.
J Clin Pharm Ther. 2003 Jun;28(3):191-6. doi: 10.1046/j.1365-2710.2003.00480.x.
Gabexate mesylate has been proposed as a therapeutic or prophylactic agent in a variety of diseases (e.g. disseminated intravascular coagulation, prophylaxis of pancreatic damage and acute pancreatitis), but its clinical effectiveness is still unclear. As the drug is widely used in Italy, we conducted an observational study to determine the pattern of prescription of gabexate in Italian hospitals and to assess the outcome of patients with acute pancreatitis when this treatment is given. An updated meta-analysis of the use of the drug is also presented.
From 20 May to 20 July 2001, all consecutive patients admitted to 13 Italian hospitals were enrolled. The following information was recorded from each patient: indication for the use of gabexate, total dose and duration of gabexate administration, need for surgical treatment and outcome of hospitalization (alive or dead). In the patient subgroup with acute pancreatitis, the outcome data of our observational study were compared with those reported by the randomized trials (RCTs) previously published. For this purpose, the survival data of the RCTs were summarized in an updated meta-analysis.
A total of 170 patients were enrolled in the study. The main clinical indications were acute pancreatitis in 88 cases (52%) and prophylaxis of pancreatic damage in 62 cases (36%). At the end of the study, 80 of the 88 patients treated for acute pancreatitis (91%) were alive and eight (9%) had died. In the subgroup of patients with necrotic-haemorrhagic pancreatitis (n = 10), six died during the observation period. Our meta-analysis showed that gabexate mesylate did not improve survival in comparison with placebo. The meta-analytic odds ratio was 0.70 (95% CI: 0.45-1.09).
The study described the pattern of use of gabexate mesylate in Italian hospitals and provided information on the outcome of the subgroup treated for acute pancreatitis. A meta-analysis of current data from RCTs, together with our findings, indicates that gabexate mesylate does not significantly improve survival in acute pancreatitis.
甲磺酸加贝酯已被提议作为多种疾病的治疗或预防药物（如弥散性血管内凝血、预防胰腺损伤和急性胰腺炎），但其临床疗效仍不明确。由于该药物在意大利广泛使用，我们开展了一项观察性研究，以确定甲磺酸加贝酯在意大利医院的处方模式，并评估给予该治疗时急性胰腺炎患者的治疗结果。同时还呈现了该药物使用的最新荟萃分析。
2001年5月20日至7月20日，纳入了意大利13家医院收治的所有连续患者。记录每位患者的以下信息：使用甲磺酸加贝酯的指征、甲磺酸加贝酯的总剂量和给药持续时间、手术治疗需求以及住院结局（存活或死亡）。在急性胰腺炎患者亚组中，将我们观察性研究的结局数据与先前发表的随机试验（RCT）报告的数据进行比较。为此，在最新的荟萃分析中总结了RCT的生存数据。
共170例患者纳入研究。主要临床指征为急性胰腺炎88例（52%）和预防胰腺损伤62例（36%）。研究结束时，88例接受急性胰腺炎治疗的患者中有80例（91%）存活，8例（9%）死亡。在坏死性出血性胰腺炎患者亚组（n = 10）中，观察期内有6例死亡。我们的荟萃分析表明，与安慰剂相比，甲磺酸加贝酯并未改善生存率。荟萃分析的优势比为0.70（95%可信区间：0.45 - 1.09）。
该研究描述了甲磺酸加贝酯在意大利医院的使用模式，并提供了急性胰腺炎治疗亚组的结局信息。对RCT当前数据的荟萃分析以及我们的研究结果表明，甲磺酸加贝酯在急性胰腺炎中并未显著改善生存率。
