β七叶皂苷钠注射液联合布美他尼注射液治疗急性脑梗死伴脑水肿的临床研究

Clinical trial of β-aescin sodium injection combined with bumetanide injection in the treatment of acute cerebral infarction with cerebral edema

目的观察β七叶皂苷钠注射液联合布美他尼注射液治疗急性脑梗死伴脑水肿患者的临床疗效及安全性。方法将98例急性脑梗死伴脑水肿患者随机分为对照组49例和试验组49例。对照组予以20%甘露醇注射液每次250mL,qd,静脉滴注;试验组在对照组治疗的基础上,予以β七叶皂苷钠注射液每次20 mg,qd,静脉滴注+布美他尼注射液每次2 mg,qd,静脉注射。2组患者均持续治疗7~10 d。比较2组患者的临床疗效、超氧化物歧化酶(SOD)、白细胞介素-6(IL-6)、肿瘤坏死因子-α(TNF-α),以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为85.71%(42例/49例)和67.35%(33例/49例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的SOD分别为(64.71±8.19)和(59.65±8.52)k U·L^(-1),IL-6分别为(54.03±7.53)和(65.49±6.93)ng·L^(-1),TNF-α分别为(8.59±0.89)和(9.54±1.00)ng·L^(-1),差异均有统计学意义(均P<0.05)。试验组发生的药物不良反应主要有高血糖、电解质紊乱和尿检异常,对照组发生的药物不良反应主要有电解质紊乱和尿检异常。试验组和对照组的总药物不良反应发生率分别为14.29%和12.24%,差异无统计学意义(P>0.05)。结论β七叶皂苷钠注射液联合布美他尼注射液治疗急性脑梗死伴脑水肿患者的临床疗效确切,其能够有效地改善氧化应激状态和炎症因子水平,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of β - aescin sodium injection combined with bumetanide injection in the treat- ment of acute cerebral infarction with cerebral edema. Methods Ninety -eight patients of acute cerebral infarction with cerebral edema were randomly divided into control and treatment groups with 49 cases per group. Control group was given 20% mannitol injection 250 mL per time, qd, intravenous infusion. Treatment group was treated with β- aescin sodium injection 20 mg per time, qd, intravenous infusion bumetanide injection 2 mg per time, qd, intravenous injection, on the basis of control group. Two groups were treated for 7 - 10 days. The cli- nical efficacy, superoxide dismutase （ SOD ）, interleukin - 6 （ IL - 6 ） , tumor necrosis factor - a（ TNF - a ） and adverse drug reactions were compared between two groups. Results After treatment, the total effec- tive rates of treatment and control groups were 85.71% （42 cases/49cases） and 67.35 % （33 cases/49 cases） with significant difference （P 〈 0. 05 ）. After treatment, the main indexes in treatment and control groups were compared： SOD were （64. 71 ±8. 19） and （59.65 ±8.52）kU ·L-1, IL-6 were （54.03±7.53） and （65.49 ±6.93）ng · L-l, TNF-a were （8.59 ±0.89） and （9.54 ±1. 00）ng ·L-1, the differences were statistically significant （ all P 〈 0. 05 ）. The adverse drug reactions in treatment group were hyperglyce- mia, electrolyte disorder and urinalysis abnormality, which in control group were electrolyte disorder and urinalysis ab- normality. The total incidences of adverse drug reactions in treatment and control groups were 14.29% and 12. 24% without significant difference （P 〉 0. 05）. Conclusion - aescin sodium injection combined with bumetanide injec- tion has a definitive clinical efficacy in the treatment of acute cerebral infarction with cerebral edema, which can effec- tively improve the level of oxidative stress and inflammatory factors, without increasing the incidence of adverse drug reactions.