国产美罗培南与进口亚胺培南/西司他丁预防重症急性胰腺炎腹腔感染的随机对照研究

目的:评价国产美罗培南对重症急性胰腺炎患者腹腔感染预防的有效性和安全性。方法:采用随机、双盲、对照开放试验。临床确诊重症急性胰腺炎的患者随机分为试验组与对照组,试验组应用国产美罗培南500mg,tid,对照组应用进口亚胺培南/西司他丁500mg,tid,疗程均为7～14d。记录2组患者生命体征、急性生理学与慢性健康状况评分Ⅱ(APACHEⅡ)评分、血常规、肝肾功能以及恶心、呕吐、腹痛、腹胀等,统计患者感染发生率及死亡率。结果:试验组与对照组均有28例患者纳入本研究,各有27、25例可进行疗效评价,各组有25例可进行安全性评价。腹腔感染发生率试验组为14.8%,对照组为16.0%(P>0.05);不良反应发生率试验组为20.0%,对照组为24.0%(P>0.05)。结论:在重症急性胰腺炎预防性应用抗菌药物治疗中,单用国产美罗培南可达到进口亚胺培南/西司他丁同样的效果。

Randomized Controlled Trial of Domestic Meropenem and Imported Imipenem/Cilastatin in the Prevention of Abdominal Infection of Severe Acute Pancreatitis

OBJECTIVE: To evaluate the efficacy and safety of domestic meropenem in the prevention of abdominal infection in patients with severe acute pancreatitis. METHODS: Randomized double-blind controlled trails were adopted. Patients with severe acute pancreatitis were randomly divided into trial group and control group. Trial group received domestic meropenem 500 mg t.i.d. for 7～14 days, and control group received imported imipenem/cilastatin 500 mg t.i.d. for 7～14 days. Their vital signs, APACHEⅡ score, blood routine, liver function and renal function, as well as objective signs such as nausea, vomiting, abdominal pain and distension were recorded. The mortality and incidence ofinfection were analyzed statistically. RESULTS: 28 patients of trial group and control group were enrolled respectively. 27 patients of trial group and 25 patients of control group could receive curative effect evaluation, and 25 patients in each group could receive safety evaluation. The incidences of abdominal infection in trial group and control group were 14.8% and 16.0% respectively (P>0.05). The incidences of adverse drug reaction in trial group and control group were 20.0% and 24.0% respectively (P>0.05). CONCLUSION: Domestic meropenem has the same effect as imported imipenem/cilastatin in the prophylactic antibiotics treatment of severe acute pancreatitis.