不同剂量阿托伐他汀对慢性硬膜下血肿的疗效及安全性评价

Efficacy and Safety Evaluation of Different Doses of Atorvastatin in the Treatment of Chronic Subdural Hematoma

目的:观察不同剂量的阿托伐他汀对慢性硬膜下血肿(CSDH)患者的临床疗效和安全性。方法:选择2013年6月-2015年5月我院CSDH患者128例,按照随机数字表法分为观察组(n=62)和对照组(n=66)。所有患者均给予常规的脑细胞营养治疗;对照组患者给予阿托伐他汀钙片20 mg,po,qd;观察组患者给予阿托伐他汀钙片40 mg,po,qd。两组患者均连续治疗6个月。观察两组患者的临床疗效、神经功能缺损评分标准(CSS)及日常生活能力量表(ADL)评分、血肿量和血清炎症因子[超敏C反应蛋白(hs-CRP)、基质金属蛋白酶9(MMP-9)、白细胞介素6(IL-6)和肿瘤坏死因子α(TNF-α)]水平,记录治疗过程中的不良反应及治疗后6个月内的复发率。结果:观察组患者脱落2例,对照组患者脱落6例,最终纳入统计的合格病例为120例,两组各60例。观察组患者总有效率(88.3%)明显优于对照组(73.3%),差异有统计学意义(P<0.05)。治疗后1、3、6个月,两组患者CSS评分、血肿量和血清hs-CRP、MMP-9、IL-6、TNF-α水平明显降低,ADL评分明显升高,且观察组患者上述指标改善程度明显优于对照组,差异均有统计学意义(P<0.05)。两组患者各项不良反应的发生率比较,差异均无统计学意义(P>0.05)。对照组患者的复发率(13.3%)明显高于观察组(3.3%),差异有统计学意义(P<0.05)。结论:阿托伐他汀40 mg的日剂量对CSDH患者的临床疗效更好、复发率更低,且安全性良好。

OBJECTIVE：To observe the clinical efficacy and safety of different doses of atorvastatin in the treatment of chronic subdural hematoma（CSDH）.METHODS：One hundred and tweaty-eighie CSDH patients selected from our hospital during Jun.2013-May 2015 were divided into observation group（n=62） and control group（n = 66） in accordance with random number table.Both groups were given conventional treatment of brain cell nutrition.Control group received Atorvastatin tablet 20 mg,po,qd;observation group received Atorvastatin tablet 40 mg,po,qd.Both groups were treated for 6 months.Clinical efficacy,CSS and ADL score,hematoma volume,the levels of serum inflammatory factors（hs-CRP,MMP-9,IL-6,TNF-α） were observed in 2groups.ADR was recorded during treatment and recurrence rate was also recorded.RESULTS：2 patients withdrew from observation group and 6 from control group.Finally,120 patients met the criteria were included,with 60 cases in each group.Total response rate of observation group（88.3%） was significantly better than that of control group（73.3%）,with statistical significance（P〈0.05）.After 1,3,6 months of treatment,CSS score,hematoma volume,the serum levels of hs-CRP,MMP-9,IL-6 and TNF-α in 2 groups were significantly decreased,while ADL score was increased significantly;the improvement of above indexes in observation group was significantly better than in control group,with statistical significance（P〈0.05）.There was no statistical significance in the incidence of ADR between 2 groups（P〉0.05）.The recurrence rate of control group（13.3%） was significantly higher than that of observation group（3.3%）,with statistical significance（P〈0.05）.CONCLUSIONS：Daily dose of shows atorvastatin 40 mg better therapeutic efficacy and lower recurrence rate in the treatment of CSDH with good safety.