五苓散治疗脑水肿疗效及安全性的Meta分析
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摘要
目的系统评价五苓散在脑水肿治疗中的疗效及安全性。方法计算机检索PubMed、Web of Science、CNKI、CBM、VIP及Wan Fang Data,检索时限均从各数据库建库至2018年3月,并辅助以手工检索,收集五苓散治疗脑水肿相关的临床随机对照试验(RCT)、半随机对照试验(quasi-RCT),采用Cochrane协作网系统评价方法进行评价,使用Revman5.3软件进行Meta分析。结果经筛选最终纳入11篇文献,共856例患者。Meta分析结果显示:1)五苓散联合常规治疗总有效率高于常规治疗[RR=1.18,95%CI(1.09,1.28),P=0.0001];亚组分析发现,治疗7～8 d时,两组有效率间无明显差异[RR=1.10,95%CI(0.96,1.25),P=0.16];而在治疗10 d[RR=1.29,95%CI(1.06,1.57),P=0.01]及14 d后[RR=1.20,95%CI(1.06,1.37),P=0.005],五苓散联合常规治疗均高于常规治疗;2)脑水肿体积方面,无论在治疗7 d[MD=-1.96,95%CI(-3.60,-0.32),P=0.02],10 d[MD=-2.63,95%CI(-3.35,-1.90),P <0.00001],还是14 d[MD=-2.51,95%CI(-3.77,-1.25),P <0.0001],五苓散联合常规治疗均优于常规治疗;3)格拉斯哥昏迷评分(GCS)显示,治疗7 d时,两组对GCS评分的改善效果相当[MD=0.71,95%CI(-0.19,1.60),P=0.12];而在治疗10 d[MD=1.45,95%CI(1.05,1.85),P <0.00001]及14 d后[MD=1.13,95%CI(0.85,1.40),P <0.00001]五苓散联合常规治疗均明显优于常规治疗;4)描述性分析结果显示,五苓散联合常规治疗不良反应较少。结论 1)五苓散治疗脑水肿具有一定疗效,且不良反应少,安全性较高。2)五苓散治疗脑水肿的疗效与其使用疗程的长短有关。3)由于现有文献数量及质量的限制,今后仍需纳入更多高质量的RCT研究为其提供更可靠的循证医学证据。
Objective: To assess the efficacy and safety of Wuling Powder on brain edema. Methods: All randomized controlled trials(RCTs) and quasi-randomized control trials(quasi-RCTs) about Wuling Powder on cerebral edema were collected by electronically searching PubMed,Web of Science,CNKI,CBM,VIP and WanFang Data from the earliest establishment time to March 2018. A meta-analysis of relevant data were performed with RevMan 5.3 software according to Cochrane system-atic review. Results: A total of 11 studies involving 856 patients were included. The baseline data was comparable in all trials. The results of meta-analysis showed that compared with the conventional treatment,the effective rate in the Wuling Powder treatment group could be enhanced [RR=1.18,95%CI(1.09,1.28),P = 0.0001],and subgroup analysis indicated that there was no significant difference when treated for 7 days or so in the two groups [RR=1.10,95%CI(0.96,1.25),P = 0.16],but when the course reached 10 days [RR=1.29,95%CI(1.06,1.57),P = 0.01] or 14 days [RR=1.20,95%CI(1.06,1.37),P =0.005],the efficiency of the treatment group was improved. When the course was 7 days [MD=-1.96,95%CI(-3.60,-0.32),P = 0.02],10 days [MD=-2.63,95%CI(-3.35,-1.90),P < 0.00001] or 14 days [MD=-2.51,95%CI(-3.77,-1.25),P < 0.0001],Wuling Powder combined with conventional treatment was superior to conventional treatment in the reduction of the volume of brain edema. In the terms of Glasgow coma scale,it was roughly equal between the two groups when patients were treated for 7 days [MD=0.71,95%CI(-0.19,1.60),P = 0.12]. However,the score of Wuling Powder group was significantly superior to conventional treatment group when the course was lasted for 10 days[MD=1.45,95%CI(1.05,1.85),P < 0.00001] and 14 days [MD=1.13,95%CI(0.85,1.40),P < 0.00001]. Moreover,the analysis results showed that lower rate of adverse effects in Wuling Powder group.Conclusion: Wuling Powder has a certain effect on brain edema with fewer adverse effects,which is related to the length of treatment course. Due to the quantity and quality of existing literature,more high-quality RCT studies should be included to provide more reliable evidence-based medical evidence in the future.
Objective: To assess the efficacy and safety of Wuling Powder on brain edema. Methods: All randomized controlled trials(RCTs) and quasi-randomized control trials(quasi-RCTs) about Wuling Powder on cerebral edema were collected by electronically searching PubMed,Web of Science,CNKI,CBM,VIP and WanFang Data from the earliest establishment time to March 2018. A meta-analysis of relevant data were performed with RevMan 5.3 software according to Cochrane system-atic review. Results: A total of 11 studies involving 856 patients were included. The baseline data was comparable in all trials. The results of meta-analysis showed that compared with the conventional treatment,the effective rate in the Wuling Powder treatment group could be enhanced [RR=1.18,95%CI(1.09,1.28),P = 0.0001],and subgroup analysis indicated that there was no significant difference when treated for 7 days or so in the two groups [RR=1.10,95%CI(0.96,1.25),P = 0.16],but when the course reached 10 days [RR=1.29,95%CI(1.06,1.57),P = 0.01] or 14 days [RR=1.20,95%CI(1.06,1.37),P =0.005],the efficiency of the treatment group was improved. When the course was 7 days [MD=-1.96,95%CI(-3.60,-0.32),P = 0.02],10 days [MD=-2.63,95%CI(-3.35,-1.90),P < 0.00001] or 14 days [MD=-2.51,95%CI(-3.77,-1.25),P < 0.0001],Wuling Powder combined with conventional treatment was superior to conventional treatment in the reduction of the volume of brain edema. In the terms of Glasgow coma scale,it was roughly equal between the two groups when patients were treated for 7 days [MD=0.71,95%CI(-0.19,1.60),P = 0.12]. However,the score of Wuling Powder group was significantly superior to conventional treatment group when the course was lasted for 10 days[MD=1.45,95%CI(1.05,1.85),P < 0.00001] and 14 days [MD=1.13,95%CI(0.85,1.40),P < 0.00001]. Moreover,the analysis results showed that lower rate of adverse effects in Wuling Powder group.Conclusion: Wuling Powder has a certain effect on brain edema with fewer adverse effects,which is related to the length of treatment course. Due to the quantity and quality of existing literature,more high-quality RCT studies should be included to provide more reliable evidence-based medical evidence in the future.
引文
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[13]李军.张学文教授论颅脑水瘀证治[J].中国中医急症,1993,2(5):209-210.
[14]倪诚.王琦教授从化气布津论五苓散制方思想及其运用心法[J].北京中医药大学学报,2011,34(10):699-701.
[15]马占峰,荔志云.从现代基础与临床研究探讨五苓散应用于创伤性脑水肿[J].中医药临床杂志,2016,28(5):623-626.
[16]刘泰,唐宇平,曾祥发,等.健神利水I号与醒脑消肿胶囊对血管源性脑水肿治疗作用的实验研究[J].中医杂志,2003,44(5):382-383.
[17]刘泰,唐宇平,吕晶.传统方剂五苓散加减后2种复方制剂对细胞毒性脑水肿的作用[J].中国临床康复,2006,10(11):53-55.
[18]张静,高淑娴.五苓散对脑出血大鼠TNF表达的影响[J].中国民族民间医药,2009,18(6):23.
[19]陈倩琪,潘赛英,高小平.五苓散联合重组人p53腺病毒注射液治疗恶性心包积液的临床疗效[J].实用心脑肺血管病杂志,2016,24(24):94-96.
[20]黄志强,丁庆学.肾气丸和五苓散联合西药治疗肝硬化腹水38例[J].光明中医,2015,30(7):1502-1503.
[21]方进民,孙淑贤.五苓散加味治疗膝关节创伤性滑膜炎36例[J].福建中医药,2015,46(6):41.
[22]高圣超,隆岚,廖丛娟.五苓散加味治疗顽固性湿疹疗效观察[J].现代中西医结合杂志,2016,25(30):3372-3374.
[2]程亚楠,周小平.五苓散临床应用研究综述[J].光明中医,2017,32(11):1674-1676.
[3]刘丰年.五苓散加味治疗颅脑损伤脑水肿的临床观察[D].南京:南京中医药大学,2014.
[4]谭伟斌.活血利水法治疗脑瘤术后水肿痰瘀互结证的疗效观察[D].广州:广州中医药大学,2015.
[5]李鑫,范经世,佟建洲,等.五苓散加味方治疗颅脑损伤脑水肿的疗效观察[J].中药药理与临床,2015,31(3):175-177.
[6]李星瑞,王爱梅,马聪文.加味五苓散治疗急性脑梗死后脑水肿的临床疗效观察[J].山西中医学院学报,2017,18(1):38-39.
[7]刘芳芳,王爱梅,张轩萍.中西医结合治疗脑水肿临床疗效观察[J].光明中医,2011,26(1):127-128.
[8]谢兴国,李妍妍,王立峰.五苓逐瘀汤治疗脑出血急性期临床研究[J].亚太传统医药,2016,12(12):126-127.
[9]袁鹰,常小芳,张晶.中药利水方治疗颅脑损伤后脑水肿患者45例[J].环球中医药,2016,9(10):1229-1231.
[10]翟瑞华,张钦朴,袁素萍,等.五苓散治疗脑水肿的疗效分析[J].中国卫生标准管理,2016,7(19):112-114.
[11]赵新军,张宇,周逸.中西医结合治疗脑外伤后脑水肿[J].实用中西医结合临床,2014,14(7):27-28.
[12]王跃.五苓散治疗颅脑损伤脑水肿的疗效观察[J].中国生化药物杂志,2017,37(6):124-128.
[13]李军.张学文教授论颅脑水瘀证治[J].中国中医急症,1993,2(5):209-210.
[14]倪诚.王琦教授从化气布津论五苓散制方思想及其运用心法[J].北京中医药大学学报,2011,34(10):699-701.
[15]马占峰,荔志云.从现代基础与临床研究探讨五苓散应用于创伤性脑水肿[J].中医药临床杂志,2016,28(5):623-626.
[16]刘泰,唐宇平,曾祥发,等.健神利水I号与醒脑消肿胶囊对血管源性脑水肿治疗作用的实验研究[J].中医杂志,2003,44(5):382-383.
[17]刘泰,唐宇平,吕晶.传统方剂五苓散加减后2种复方制剂对细胞毒性脑水肿的作用[J].中国临床康复,2006,10(11):53-55.
[18]张静,高淑娴.五苓散对脑出血大鼠TNF表达的影响[J].中国民族民间医药,2009,18(6):23.
[19]陈倩琪,潘赛英,高小平.五苓散联合重组人p53腺病毒注射液治疗恶性心包积液的临床疗效[J].实用心脑肺血管病杂志,2016,24(24):94-96.
[20]黄志强,丁庆学.肾气丸和五苓散联合西药治疗肝硬化腹水38例[J].光明中医,2015,30(7):1502-1503.
[21]方进民,孙淑贤.五苓散加味治疗膝关节创伤性滑膜炎36例[J].福建中医药,2015,46(6):41.
[22]高圣超,隆岚,廖丛娟.五苓散加味治疗顽固性湿疹疗效观察[J].现代中西医结合杂志,2016,25(30):3372-3374.