注射用七叶皂苷钠联合盐酸尼卡地平注射液治疗高血压脑出血患者的临床研究  

Clinical trial of sodium aescinate injection combined with nicardipine hydrochloride injection in the treatment of patients with hypertensive intracerebral hemorrhage

作　　者：方泽波[1] 侯玉清[2] 谢晋国[2] FANG Ze - bo 1a, HOU Yu - qing 1b, XIE Jin - guo 1b(1.a Department of Pharmacy; b. Department of Cardiovascular Medicine, Nanfang Hospital, Southern Medical University, Guangzhou 510515, Chin)

机构地区：[1]南方医科大学南方医院药材科,广州510515 [2]南方医科大学南方医院心血管内科,广州510515

出　　处：《中国临床药理学杂志》2018年第6期618-621,共4页The Chinese Journal of Clinical Pharmacology

基　　金：2011年广东省科技计划基金资助项目(20110316)

摘　　要：目的观察注射用七叶皂苷钠联合盐酸尼卡地平注射液治疗高血压脑出血患者的临床疗效和安全性。方法入选86例高血压脑出血患者,随机分为对照组43例和试验组43例。对照组给予盐酸尼卡地平注射液0.5~5μg·min^(-1)·kg^(-1),静脉滴注;试验组在对照组的基础上给予注射用七叶皂苷钠10 mg,静脉滴注,每天1次。比较2组患者治疗前后残留血量、脑水肿体积、血钙、血肌酸酐、水通道蛋白(AQP)水平、长谷川痴呆量表评分、美国国立卫生院卒中量表(NIHSS)评分、Barthel评分和药物不良反应发生情况。结果治疗后,试验组的残留血量、脑水肿体积分别为(6.36±0.65),(11.54±1.36)mL,对照组分别为(10.08±1.33),(17.22±1.15)mL,差异均有统计学意义(均P<0.05)。试验组的血钙水平为(3.15±0.42)mmol·L^(-1),对照组为(2.14±0.22)mmol·L^(-1),差异有统计学意义(P<0.05)。试验组的血肌酸酐、AQP-1、AQP-4水平分别为(62.77±6.67)μmol·L^(-1),(3.07±0.38)μg·mL^(-1),(43.17±4.83)μg·mL^(-1);对照组分别为(73.76±8.03)μmol·L^(-1),(5.94±0.54)μg·mL^(-1),(82.08±5.92)μg·mL^(-1),差异均有统计学意义(均P<0.05)。试验组的长谷川痴呆量表评分、Barthel评分、NIHSS分别为(36.11±3.44),(93.16±0.71),(6.34±0.77)分;对照组分别为(28.75±3.02),(81.65±1.58),(11.58±1.51)分,差异均有统计学意义(均P<0.05)。试验组出现皮疹1例,咳嗽1例,消化道反应2例,急性肾损伤2例,药物不良反应发生率为13.95%(6例/43例);对照组出现皮疹2例,咳嗽2例,消化道反应1例,急性肾损伤3例,药物不良反应率为18.60%(8例/43例),差异无统计学意义(P>0.05)。结论注射用七叶皂苷钠联合盐酸尼卡地平注射液治疗高血压脑出血患者的临床疗效较好,安全性较高,能有效改善患者血钙、血肌酸酐及AQP水平。Objective To evaluate the clinical effect of sodium aescinate injection combined with nicardipine hydroehloride injection in the treatment of patients with hypertensive intracerebral hemorrhage. Methods Eight- six patients with hypertensive intracerebral hemor- rhage were randomly divided into control group （n = 43 ） and treatment group （ n = 43 ）. Control group was treated with nicardipine hydrochloride injection 0. 5 -5 μg·min-1·kg-1. Patients in treatment group were treated with sodium aescinate injection 10 mg on the basis of control group, qd, intravenous infusion. Residual blood volume, volume of cerebral edema, serum calcium, serum creatinine, levels of aquaporin （AQP）, Hasegawa dementia scale, National Institute of Health Stroke Scale （NIHSS） score, Barthel score and adverse drug reactions were compared between the two groups. Results After treatment, the residual blood volume and brain edema volume in treatment group were （6.36 ± 0. 65 ） and （11. 54 ± 1.36 ） mL, had significant difference with those in control group, which were （ 10. 08 ± 1.33 ） and （ 17.22 ± 1.15 ） mL （ all P 〈0. 05 ）. The levels of serum calcium in treatment group and control group were （3.15 ± 0. 42 ）, （ 2. 14 ± 0. 22 ） mmol · L-1, with significant difference （ P 〈 0. 05 ）. The serum total creatinine and AQP -I and AQP -4 levels in treatment group were （62. 77±6. 67）μmol· L-1, （3.07 ±0. 38） μg·mL-1, （43.17 ± 4.83 ） μg · mL-1, had significant difference with those in control group, which were （73.76 ± 8.03 ） μmol · L- 1, （5.94 ＋ 0. 54） μg · mL -1 and （ 82. 08 ±5.92） μg · mL - 1 （ all P 〈 0. 05 ）. The Haseg- awa dementia scale, Barthel score and NIHSS in treatment group were 36. 11 ±3.44, 93. 16 ±0. 71,6. 34±0. 77, had significant difference with those in control group, which were 28.75±3.02, 81.65± 1.58, 11.58 ±1.51 （all P 〈 0. 05 ）. In treatment group, there were 1 case of rash, 1 case of cough, 2 cases of digesti

关 键 词：注射用七叶皂苷钠 盐酸尼卡地平注射液 高血压 脑出血 

分 类 号：R972.4[医药卫生—药品]