参芎葡萄糖注射液治疗脑血栓形成的有效性和安全性系统评价与Meta分析
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摘要
对参芎葡萄糖注射液治疗脑血栓形成的有效性和安全性进行系统评价。系统检索CNKI,Wan Fang,VIP,Sino Med,Cochrane Library,PubMed,EMbase,Web of Science,Clinical-Trials.gov,筛选出参芎葡萄糖注射液治疗脑血栓形成的随机对照试验(randomized controlled trial,RCT),并根据Cochrane Handbook 5. 1评价标准、工具和Rev Man 5. 3软件对最终纳入的研究进行Meta分析。采用GRADE系统(GRADE pro 3. 6. 1软件)对关键结局指标证据质量进行分级。共纳入25项研究,总样本量为2 286例,试验组1 144例,对照组1 142例。Meta分析结果显示:参芎葡萄糖注射液联合奥扎格雷治疗脑血栓形成总有效率优于奥扎格雷(RR=1. 26,95%CI[1. 20,1. 32],P<0. 000 01),常规治疗联合参芎葡萄糖注射液联合奥扎格雷治疗脑血栓形成总有效率优于常规治疗联合奥扎格雷(RR=1. 26,95%CI[1. 09,1. 46],P=0. 002),参芎葡萄糖注射液联合奥扎格雷能降低不良反应发生率(RR=0. 38,95%CI[0. 24,0. 60],P<0. 000 1),改善神经功能缺损情况(MD14 d=-7. 19,95%CI[-9. 16,-5. 22],P<0. 000 01; MD30 d=-5. 34,95%CI[-5. 85,-4. 83],P <0. 000 01; MD42 d=-7. 03,95%CI[-7. 79,-6. 28],P <0. 000 01; MD60 d=-6. 18,95%CI[-6. 55,-5. 81],P<0. 000 01; MD90 d=-4. 90,95%CI[-5. 74,-4. 06],P<0. 000 01),提高日常生活能力(MD=15. 00,95%CI[12. 20,17. 80],P<0. 000 01)。死亡率仅纳入1个研究,且样本量较小,需大样本进一步验证,不良反应主要为肺部感染、皮肤瘙痒、胃肠道反应等,均可耐受或消失,不影响治疗。基于现有数据和方法,参芎葡萄糖注射液联合奥扎格雷治疗脑血栓形成可提高总有效率,改善神经功能缺损情况,提高日常生活能力,无严重的不良反应。GRADE系统评估总有效率、死亡率、不良反应发生率证据质量级别为低级别。但纳入研究质量不高,需采用大样本、设计严谨、符合国际规范的临床试验方案提高证据质量级别。
To systematically evaluate the efficacy and safety of Shenxiong Glucose Injection in the treatment of cerebral thrombosis.Randomized controlled trials( RCTs) of Shenxiong Glucose Injection for cerebral thrombosis were screened out by searching CNKI,Wan Fang,VIP,Sino Med,Cochrane Library,PubMed,EMbase,and Web of Science in a systematic way,and the Meta-analysis on finally included studies was conducted by using Handbook 5. 1 evaluation criteria and tools and Rev Man 5. 3 software. GRADE system( GRADE pro 3. 6. 1) was used to grade the evidence quality of key outcome indicators. A total of 25 studies were included,with a total sample size of 2 286 cases,1 144 in the experimental group and 1 142 in the control group. The results of Meta-analysis showed that the total effective rate of Shenxiong Glucose Injection combined with ozagrel in the treatment of cerebral thrombosis was better than that of ozagrel alone( RR = 1. 26,95%CI [1. 20,1. 32],P<0. 000 01); the total effective rate of conventional treatment plus Shenxiong Glucose Injection and ozagrel for cerebral thrombosis was better than that of conventional treatment combined with ozagrel( RR = 1. 26,95%CI [1. 09,1. 46],P = 0. 002). In addition,Shenxiong Glucose Injection combined with ozagrel could reduce the incidence of adverse reactions( RR = 0. 38,95%CI [0. 24,0. 60],P < 0. 000 1),improve the neurological impairment( MD14 d=-7. 19,95% CI[-9. 16,-5. 22],P< 0. 000 1; MD30 d=-5. 34,95% CI [-5. 85,-4. 83],P < 0. 000 1; MD42 d=-7. 03,95% CI [-7. 79,-6. 28],P<0. 000 01; MD60 d=-6. 18,95%CI [-6. 55,-5. 81],P< 0. 000 01; MD90 d=-4. 90,95% CI [-5. 74,-4. 06],P<0. 000 01),and improve activities of daily living( ADL)( MD = 15. 00,95%CI [12. 20,17. 80],P<0. 000 01). The mortality was only included in one study,and the sample size was small,requiring to be further verified by a large sample size. The adverse reactions mainly included lung infection,skin pruritus,gastrointestinal reaction and so on,all of which could be tolerated or disappeared without affecting the treatment. Based on the available data and methods,Shenxiong Glucose Injection combined with ozagrel for cerebral thrombosis could improve the total effective rate,neurological impairment,and ability of daily living,with no serious adverse reactions. The evidence quality level of GRADE system was low in the evaluation of total effective rate,mortality and incidence of adverse reactions.However,the quality of the included researches was not high,requiring rigorously designed and internationally standardized clinical trials with a large sample size to improve the quality of evidence.
To systematically evaluate the efficacy and safety of Shenxiong Glucose Injection in the treatment of cerebral thrombosis.Randomized controlled trials( RCTs) of Shenxiong Glucose Injection for cerebral thrombosis were screened out by searching CNKI,Wan Fang,VIP,Sino Med,Cochrane Library,PubMed,EMbase,and Web of Science in a systematic way,and the Meta-analysis on finally included studies was conducted by using Handbook 5. 1 evaluation criteria and tools and Rev Man 5. 3 software. GRADE system( GRADE pro 3. 6. 1) was used to grade the evidence quality of key outcome indicators. A total of 25 studies were included,with a total sample size of 2 286 cases,1 144 in the experimental group and 1 142 in the control group. The results of Meta-analysis showed that the total effective rate of Shenxiong Glucose Injection combined with ozagrel in the treatment of cerebral thrombosis was better than that of ozagrel alone( RR = 1. 26,95%CI [1. 20,1. 32],P<0. 000 01); the total effective rate of conventional treatment plus Shenxiong Glucose Injection and ozagrel for cerebral thrombosis was better than that of conventional treatment combined with ozagrel( RR = 1. 26,95%CI [1. 09,1. 46],P = 0. 002). In addition,Shenxiong Glucose Injection combined with ozagrel could reduce the incidence of adverse reactions( RR = 0. 38,95%CI [0. 24,0. 60],P < 0. 000 1),improve the neurological impairment( MD14 d=-7. 19,95% CI[-9. 16,-5. 22],P< 0. 000 1; MD30 d=-5. 34,95% CI [-5. 85,-4. 83],P < 0. 000 1; MD42 d=-7. 03,95% CI [-7. 79,-6. 28],P<0. 000 01; MD60 d=-6. 18,95%CI [-6. 55,-5. 81],P< 0. 000 01; MD90 d=-4. 90,95% CI [-5. 74,-4. 06],P<0. 000 01),and improve activities of daily living( ADL)( MD = 15. 00,95%CI [12. 20,17. 80],P<0. 000 01). The mortality was only included in one study,and the sample size was small,requiring to be further verified by a large sample size. The adverse reactions mainly included lung infection,skin pruritus,gastrointestinal reaction and so on,all of which could be tolerated or disappeared without affecting the treatment. Based on the available data and methods,Shenxiong Glucose Injection combined with ozagrel for cerebral thrombosis could improve the total effective rate,neurological impairment,and ability of daily living,with no serious adverse reactions. The evidence quality level of GRADE system was low in the evaluation of total effective rate,mortality and incidence of adverse reactions.However,the quality of the included researches was not high,requiring rigorously designed and internationally standardized clinical trials with a large sample size to improve the quality of evidence.
引文
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[10]刘纲,丁碧云.参芎葡萄糖注射液治疗冠心病不稳定型心绞痛的Meta分析[J].中国中医急症,2016,25(2):272.
[11]王旭,杨淑梅,朱瑾,等.参芎葡萄糖注射液治疗冠心病心绞痛的系统性评价[J].新疆医科大学学报,2015,38(11):1420.
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[20]张俊圣,陈国良.分析急性脑血栓经参芎葡萄糖注射液联合奥扎格雷治疗的疗效[J].系统医学,2019,4(1):44.
[21]周征男.参芎葡萄糖注射液+奥扎格雷治疗急性脑血栓的临床效果[J].中国医药指南,2018,16(26):122.
[22]张迪.脑血栓形成采取参芎葡萄糖注射液联合奥扎格雷治疗的临床效果[J].中国医学工程,2018,26(5):52.
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