参附注射液治疗重症急性胰腺炎的临床研究

目的 探讨参附注射液治疗重症急性胰腺炎(SAP)的有效性、安全性及可能的机制.方法 收集2006年6月至2008年9月南京军区普通外科研究所58例SAP患者,按完全随机法分为常规治疗组28例和参附注射液组30例.参附注射液组在常规治疗基础上加用参附注射液50ml静脉滴注,每日1次,连用7 d.观察两组患者腹痛缓解时间、肠鸣音恢复时间和体温恢复时间;记录APACHEⅡ评分和Binder并发症积分;检测血清淀粉酶、IL-1β和TNF-α水平;统计并发症发生率、中转手术率、病死率和住院天数;观测两组与治疗相关的不良反应.结果 参附注射液组腹痛缓解时间、肠鸣音与体温恢复正常时间、平均住院天数分别为(5.3±2.8)d、(5.1±1.7)d、(7.1±2.4)d和(32.4±6.4)d;治疗后7 d的APACHEⅡ评分、Binder并发症积分分别为8.63±1.33和6.50±1.66;治疗7 d的血淀粉酶、IL-1β和TNF-α水平分别为(1152±576)U/L、(48.7±16.4)ng/ml和(199.3±53.3)ng/ml.均显著低于常规治疗组(P＜0.05或＜0.01).严重并发症发生12例次,中转手术率13.33%(4/30例),病死率0,无注射参附注射液相关不良反应.结论 参附注射液治疗SAP安全、有效,其作用机制可能与抑制炎症介质和细胞因子的过度释放、改善微循环障碍有关.

Shenfu injection in the treatment of severe acute pancreatitis

Objective To evaluate the efficacy,safety and the possible mechanism of shenfu injection (SFI)in the treatment of severe acute pancreatitis(SAP).Methods A total of fifty-eiSht patients with SAP admitted to Research Institute of General Surgery of Nanjing Military Command from June 2006 to September 2008 were randomized into the conventional group(n=28)and SFI group(n=30).Patients in SFI group were treated by plus SFI(50 ml per day for 7 days)on routine treatment.The time to pain ease,bowel sound recovery times,body temperature recovery time were observed;APACHE Ⅱ score,Binder point was calculated;serum amylase,TNF-α and IL-1β were measured.The complication rate,operation rate,mortality were analyzed.Results The duration of abdominal pain,recovery of bowel sound,body temperature,and mean hospital stay days in SFI group were 95.3±2.8)d,(5.1±1.7)d,(7.1±2.4)d and(32.4±6.4)d;7 days later the APACHE Ⅱ score,Binder point was 8.63±1.33 and 6.50±1.66.respectively;the serum levels of amylase,TNF-α,and IL-1β were(1152±576)U/L,(48.7±16.4)ns/na and(199.3±53.3)ng/ml,respectively.12 episodes of severe complication occurred,operation rate was 3.33%(4/30)and the mortality rate was 0%.All the parameters were statistically significantly lower than those in the conventional group(P＜0.05 or P＜0.01).There was no adverse event related to SFI.Conclusions SFI was safe and effective for SAP,and the mechanism may be related to inhibit over-release of inflammatory medium and cytokines,and improve microcirculation.