注射用丹参多酚酸盐联合常规西药治疗急性脑梗死有效性和安全性的系统评价
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摘要
目的:系统评价中药注射剂注射用丹参多酚酸盐联合常规西药治疗急性脑梗死的临床疗效和安全性。方法:检索中文科技期刊全文数据库、中国医用信息资源系统、万方数据库及PubMed等数据库,检索时限为2000—2017年,查阅注射用丹参多酚酸盐治疗急性脑梗死的随机对照试验(对照组患者采用常规西药治疗,观察组患者在对照组基础上加用注射用丹参多酚酸盐)。根据Cochrane系统评价方法对纳入的文献进行方法学质量评价,应用RevMan 5.2软件进行文献荟萃分析(Meta分析)。结果:共纳入14篇文献,Meta分析结果显示,观察组患者的总有效率(RR=1.29,95%CI=1.19～1.41,P<0.000 1)、神经功能缺损评分(MD=-3.84,95%CI=-4.73～-2.95,P<0.000 01)、日常生活活动能力(MD=12.88,95%CI=8.66～17.10,P<0.000 01)、C反应蛋白水平(MD=-2.81,95%CI=-5.29～-0.34,P=0.03)及各项血液动力学指标水平(P<0.05)均明显优于对照组,差异均有统计学意义。两组患者均无严重不良反应,安全性好。结论:基于目前的临床证据,注射用丹参多酚酸盐联合常规西药治疗急性脑梗死疗效显著,优于单纯常规西药治疗,能降低近期致残率,且较安全。由于本研究纳入的文献数量少、质量不高,上述结论仍需更多大样本、多中心且随访时间长的临床随机、双盲对照试验进一步验证。
OBJECTIVE: To systematically evaluate the efficacy and safety of salvianolate injection combined with conventional western medicine in the treatment of acute cerebral infarction. METHODS: CNKI, China Medical Information Resource System, Wanfang data base and PubMed were retrieved to collect the randomized controlled trial(RCT) of salvianolate injection combined with conventional western medicine in the treatment of acute cerebral infarction(the control group was treated with conventional western medicine, and the observation group received salvianolate injection on the basis of the control group), the retrieval time was from 2000 to 2017. Methodological quality of the included literature was assessed by using the Cochrane systematic evaluation method, and meta-analysis was performed using the RevMan 5.2 software. RESULTS: A total of 14 literature were included. Meta-analysis showed that the total effective rate(RR=1.29,95%CI=1.19-1.41,P<0.000 1), neurological impairment score(MD=-3.84,95%CI=-4.73--2.95,P<0.000 01), daily living ability(MD=12.88,95%CI=8.66-17.10,P<0.000 01), and C-reactive protein level(MD=-2.81,95%CI=-5.29--0.34,P=0.03) and all hemodynamic indexes(P<0.05) in the observation group were significantly better than those in the control group, and the differences were statistically significant. There were no severe adverse drug reactions in both groups and the safety was higher. CONCUSIONS: Based on the current clinical evidence, the efficacy of salvianolate injection combined with conventional western medicine in the treatment of acute cerebral infarction is significantly better than conventional western medicine alone, which can reduce the recent morbidity rate and has higher safety. Due to the small number and low quality of the literature included in this study, the above conclusions still need to be further verified by more large samples, multi-center clinical randomized, double-blind controlled trials with long follow-up time.
OBJECTIVE: To systematically evaluate the efficacy and safety of salvianolate injection combined with conventional western medicine in the treatment of acute cerebral infarction. METHODS: CNKI, China Medical Information Resource System, Wanfang data base and PubMed were retrieved to collect the randomized controlled trial(RCT) of salvianolate injection combined with conventional western medicine in the treatment of acute cerebral infarction(the control group was treated with conventional western medicine, and the observation group received salvianolate injection on the basis of the control group), the retrieval time was from 2000 to 2017. Methodological quality of the included literature was assessed by using the Cochrane systematic evaluation method, and meta-analysis was performed using the RevMan 5.2 software. RESULTS: A total of 14 literature were included. Meta-analysis showed that the total effective rate(RR=1.29,95%CI=1.19-1.41,P<0.000 1), neurological impairment score(MD=-3.84,95%CI=-4.73--2.95,P<0.000 01), daily living ability(MD=12.88,95%CI=8.66-17.10,P<0.000 01), and C-reactive protein level(MD=-2.81,95%CI=-5.29--0.34,P=0.03) and all hemodynamic indexes(P<0.05) in the observation group were significantly better than those in the control group, and the differences were statistically significant. There were no severe adverse drug reactions in both groups and the safety was higher. CONCUSIONS: Based on the current clinical evidence, the efficacy of salvianolate injection combined with conventional western medicine in the treatment of acute cerebral infarction is significantly better than conventional western medicine alone, which can reduce the recent morbidity rate and has higher safety. Due to the small number and low quality of the literature included in this study, the above conclusions still need to be further verified by more large samples, multi-center clinical randomized, double-blind controlled trials with long follow-up time.
引文
[1] 张晓雷,陈俊华,郭春霞,等.丹参多酚酸盐的药理作用研究[J].世界临床药物,2013,34(5):292-297.
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[8] 张震,尹泽黎,刘育进.丹参多酚酸盐治疗急性脑梗死患者的疗效观察[J].湖南师范大学学报:医学版,2010,7(1):65-67.
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[10] 张琼,陈书艳.丹参多酚酸盐治疗急性脑缺血的临床研究[J].实用药物与临床,2013,16(2):114-116.
[11] 吉佩忠,罗仲秋,王春革.丹参多酚酸盐治疗急性缺血性脑卒中的疗效[J].药学服务与研究,2010,10(1):4,17,20.
[12] 李燕,周倩.丹参多酚酸盐治疗老年急性脑梗死患者的疗效观察[J].宁夏医学杂志,2015,37(12):1120-1121.
[13] 王红权,赵姝丽.丹参多酚酸盐治疗脑梗死对脑血流动力学及神经功能与日常生活能力的影响[J].中国实用神经疾病杂志,2016,19(14):64-66.
[14] 贺亚龙,高焱,郭晓贤.丹参多酚酸治疗急性脑梗死的临床研究[J].现代药物与临床,2016,31(9):1354-1359.
[15] 吕志威,吕远,杨炯,等.依达拉奉联合注射用丹参多酚酸盐治疗急性脑梗塞的临床疗效[J].中医临床研究,2017,9(19):63-64.
[16] 张艳霞,刘玉清,张娟,等.丹参多酚酸盐联合依达拉奉治疗急性脑梗死对照研究[J].中国实用神经疾病杂志,2017,20(19):67-70.
[17] 李曼,刘丙营,潘东.丹参多酚酸盐联合依达拉奉治疗急性缺血性脑卒中临床研究[J].中国药业,2017,26(1):74-77.
[2] 各类脑血管病诊断要点[J].中华神经科杂志,1996,29(6):379-380.
[3] 脑卒中患者临床神经功能缺损程度评分标准(1995)[J].中华神经科杂志,1996,29(6):381-383.
[4] 康康,冀书娟,李浩.丹参多酚酸对急性脑梗死患者运动和认知功能的影响分析[J].河南医学研究,2016,25(2):326-327.
[5] 王珲,王琴,戚妹,等.丹参多酚酸盐对脑梗塞患者脑血流动力学的影响[J].海南医学,2015,26(6):794-796.
[6] 郝绍江,安慧娟.丹参多酚酸盐治疗急性脑梗死的疗效观察[J].中西医结合心脑血管病杂志,2012,10(9):1076-1077.
[7] 裴媛,周贺伟.丹参多酚酸盐治疗急性脑梗死的临床效果及应用价值分析[J].中国实用医药,2016,11(21):156-157.
[8] 张震,尹泽黎,刘育进.丹参多酚酸盐治疗急性脑梗死患者的疗效观察[J].湖南师范大学学报:医学版,2010,7(1):65-67.
[9] 宋欢欢.丹参多酚酸盐治疗急性脑缺血的临床观察[J].医学研究,2016,24(6):184.
[10] 张琼,陈书艳.丹参多酚酸盐治疗急性脑缺血的临床研究[J].实用药物与临床,2013,16(2):114-116.
[11] 吉佩忠,罗仲秋,王春革.丹参多酚酸盐治疗急性缺血性脑卒中的疗效[J].药学服务与研究,2010,10(1):4,17,20.
[12] 李燕,周倩.丹参多酚酸盐治疗老年急性脑梗死患者的疗效观察[J].宁夏医学杂志,2015,37(12):1120-1121.
[13] 王红权,赵姝丽.丹参多酚酸盐治疗脑梗死对脑血流动力学及神经功能与日常生活能力的影响[J].中国实用神经疾病杂志,2016,19(14):64-66.
[14] 贺亚龙,高焱,郭晓贤.丹参多酚酸治疗急性脑梗死的临床研究[J].现代药物与临床,2016,31(9):1354-1359.
[15] 吕志威,吕远,杨炯,等.依达拉奉联合注射用丹参多酚酸盐治疗急性脑梗塞的临床疗效[J].中医临床研究,2017,9(19):63-64.
[16] 张艳霞,刘玉清,张娟,等.丹参多酚酸盐联合依达拉奉治疗急性脑梗死对照研究[J].中国实用神经疾病杂志,2017,20(19):67-70.
[17] 李曼,刘丙营,潘东.丹参多酚酸盐联合依达拉奉治疗急性缺血性脑卒中临床研究[J].中国药业,2017,26(1):74-77.