参麦注射液对心脏瓣膜置换术后病人华法林抗凝治疗及炎性反应的影响

The Influence of Shenmai Injection on the Anticoagulation of Warfarin and Inflammatory Response in Patients Undergoing Cardiac Valve Replacement

目的观察参麦注射液对行体外循环(CPB)心脏瓣膜置换术(CVR)后病人华法林抗凝作用及炎性反应的影响。方法选择行CPB心脏瓣膜置换术病人90例,随机分为对照组和观察组,每组45例。两组均在术后服用华法林钠片,首日剂量4.5 mg^6.0mg,后每天服用2.5mg/d,根据国际标准化比值(INR)调整华法林钠剂量,使INR达1.8~2.5。观察组于术前10d使用参麦注射液20mL加入250mL生理盐水中静脉输注,每日1次。检测术后1d、4d和7d病人凝血酶时间(TT)、活化部分凝血酶时间(APTT)、凝血酶原时间(PT)、血浆纤维蛋白原(FIB)和INR。ELISA法检测术后1d、4d和7d病人血清肿瘤坏死因子α(TNF-α)、白介素6(IL-6)和超敏C反应蛋白(hs-CRP)水平。术后随访6个月,统计不良反应发生情况。结果术后1d、4d和7d,两组TT、APTT、PT、FIB水平比较差异无统计学意义(P>0.05);两组病人INR均在术后4d达到目标值,观察组术后4d、7dINR值显著高于对照组(P<0.05)。术后1d、4d和7d,观察组病人TNF-α、IL-6和hs-CRP水平显著低于对照组(P<0.05)。术后不良反应以出血症状为主,两组间不良反应发生率比较差异无统计学意义(P>0.05)。结论术前使用参麦注射液进行干预可有效降低行CPB心脏瓣膜置换术病人术后体内炎症水平,增强华法林抗凝治疗效果,且不会对病人凝血造成影响,同时并未增加并发症发生率。

Objective To observe the effects of Shenmai injection（SMI）on anticoagulation of warfarin and inflammatory response in patients undergoing cardiac valve replacement（CVR）under cardiopulmonary bypass（CPB）.Methods Ninety patients undergoing CVR under CPB were randomly divided into two groups：control group（n =45）treated with routine treatment of warfarin according to the International Standardization Ratio（INR）,and treatment group（n =45）treated with SMI from10 days before operation in the basis of routine treatment.The levels of thrombin time（PT）,activated partial thrombin time（APTT）,prothrombin time（PT）,plasma fibrinogen（FIB）and INR were measured at 1 day,4 days and 7 days after operation.The levels of serum tumor necrosis factor alpha（TNF-α）,interleukin-6（IL-6）and high-sensitivity C-reaction protein（hs-CRP）were measured by enzyme-linked immunosorbent assay（ELISA）at 1 day,4 days and 7 days after operation.The patients were followed up for 6 months and the adverse events were reported.Results There was no significant difference in TT,APTT,PT and FIB levels between two groups at 1 day,4 days and7 days after surgery（P 〉0.05）.The INR reached the target value in two groups on the 4 th day after operation.The INR in treatment group at 4 days and 7 days after operation was significantly higher than that in control group（P 〈0.05）.The levels of TNF-α,IL-6 and hs-CRP were significantly lower in treatment group than that in control group（P 〈0.05）.There was no significant difference in the incidence of complications between two groups（P 〉0.05）.Conclusion Preoperative intervention with SMI can effectively reduce the level of postoperative inflammation in patients undergoing CVR under CPB,and enhance the anticoagulant effect of warfarin without affecting the coagulation,and without increasing the incidence of complications.