生脉注射液预防透析相关性低血压的系统评价
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摘要
目的本研究对近年来发表的临床随机试验进行了系统评价,评估生脉注射液对透析相关性低血压的预防作用,并进行药物安全性评价。方法电子检索既往发表的相关临床的随机对照试验,电子检索Cochrane CochraneCentral Register of ControlLed Trials (Central)及中国临床试验注册中心系统(ChiCTR)。检索MEDLINE、EMBASE、中国生物医学文献数据库(CBMdisk)、中文科技期刊全文数据库(VIP)等数据库。检索时间从1990年1月至2018年1月。评估文献质量,对可以合并的数据采用Revman 5.2进行Meta分析。结果纳入8个随机对照试验,共包含300名患者,共观察透析治疗例次为4328次。Meta分析显示:①纳入研究的8项研究因为异质性分析显示,各项研究之间存在异质性:Heterogeneity:Chi~2=30.84,df=6 (P<0.0001);I2=81%,各项研究之间的数据不能合并;②排除临床异质性明显的研究后对其余4项研究的结果进行合并,Meta结果显示,生脉注射液组在预防透析相关性低血压上有明显的作用,[OR 0.37,95%(0.26,0.52)];③患者治疗前后的平均动脉压进行Meta分析后显示,生脉注射液组相较对照组的平均动脉压升高,其差异有统计学意义[OR1.41,95%CI(1.35,1.48)];④患者治疗后的心率比较,差异无统计学意义[OR-0.91,95%CI(-1.04,-0.77)];⑤综合纳入的研究,未发现有针对生脉注射液在治疗中的严重不良反应的报道,亦未发现生脉注射液对患者的血压,心率等存在影响,同时,目前亦无证据证明生脉注射液对患者的长期生存质量及终点事件的发生存在影响。结论生脉注射液具有预防透析相关性低血压的作用,透析开始阶段静滴生脉注射液可明显升高患者透析治疗时的平均动脉压水平,且对心率的影响不明显。目前尚无证据证明生脉注射液对维持性透析患者的死亡率及终点事件存在影响。
Objective to evaluate preventive effect of Shengmai injection on dialysis-related hypotension and evaluate safety of Shengmai injection based on clinical randomized trials published in recent years. Methods retrieve clinical randomized controlled trials published, Cochrane Cochrane Central Register of Controlled Led Trials(Central)and China Clinical Trial Register(ChiCTR) electronically. Search MEDLINE, EMBASE, CBMdisk, VIP and other databases with retrieval time ranged from January 1990 to January 2018. Evaluate quality of literature and carry on meta-analysis with Revman 5.2 for data that can be merged. Results 8 randomized controlled trials included involves300 patients, with total 4328 dialysis cases observed. Meta-analysis showed: ① heterogeneity analysis of 8 studies showed heterogeneity existed among studies: Chi2= 30.84, df = 6(P< 0.0001); I~2= 81%. Data between studies could not be merged; ② results of other four studies were merged after excluding studies with obvious clinical heterogeneity. Meta results showed Shengmai injection group has obvious effect on preventing dialysis-related hypotension,[OR 0.37,95%(0.26,0.52)];③ Meta-analysis of mean arterial pressure before and after treatment showed, mean arterial pressure of Shengmai injection group was higher than control group, and difference showed statistical significance, [OR 1.41, 95%CI(1.35, 1.48)]; ④ heart rate difference after treatment showed no statistical significance, [OR-0.91, 95% CI(-1.04,-0.77)];⑤ comprehensive study found no reports of serious adverse reactions of Shengmai injection in treatment, and Shengmai injection affecting blood pressure, heart rate of patients. At the same time, there is no evidence Shengmai injection has effect on long-term life quality and endpoint events of patients. Conclusion Shengmai injection has functions of preventing dialysis-related hypotension. Intravenous drip of Shengmai injection at dialysis beginning stage can increase average arterial pressure level of patients significantly, with not obvious effect on heart rate. At present, there is no evidence Shengmai injection has effect on mortality and end-point events of maintenance dialysis patients.
Objective to evaluate preventive effect of Shengmai injection on dialysis-related hypotension and evaluate safety of Shengmai injection based on clinical randomized trials published in recent years. Methods retrieve clinical randomized controlled trials published, Cochrane Cochrane Central Register of Controlled Led Trials(Central)and China Clinical Trial Register(ChiCTR) electronically. Search MEDLINE, EMBASE, CBMdisk, VIP and other databases with retrieval time ranged from January 1990 to January 2018. Evaluate quality of literature and carry on meta-analysis with Revman 5.2 for data that can be merged. Results 8 randomized controlled trials included involves300 patients, with total 4328 dialysis cases observed. Meta-analysis showed: ① heterogeneity analysis of 8 studies showed heterogeneity existed among studies: Chi2= 30.84, df = 6(P< 0.0001); I~2= 81%. Data between studies could not be merged; ② results of other four studies were merged after excluding studies with obvious clinical heterogeneity. Meta results showed Shengmai injection group has obvious effect on preventing dialysis-related hypotension,[OR 0.37,95%(0.26,0.52)];③ Meta-analysis of mean arterial pressure before and after treatment showed, mean arterial pressure of Shengmai injection group was higher than control group, and difference showed statistical significance, [OR 1.41, 95%CI(1.35, 1.48)]; ④ heart rate difference after treatment showed no statistical significance, [OR-0.91, 95% CI(-1.04,-0.77)];⑤ comprehensive study found no reports of serious adverse reactions of Shengmai injection in treatment, and Shengmai injection affecting blood pressure, heart rate of patients. At the same time, there is no evidence Shengmai injection has effect on long-term life quality and endpoint events of patients. Conclusion Shengmai injection has functions of preventing dialysis-related hypotension. Intravenous drip of Shengmai injection at dialysis beginning stage can increase average arterial pressure level of patients significantly, with not obvious effect on heart rate. At present, there is no evidence Shengmai injection has effect on mortality and end-point events of maintenance dialysis patients.
引文
[1]王质刚.血液净化学[M].第二版.北京:北京科学技术出版社,2003.
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[4]Furlan A D,Pennick V,Bombardier C,et al.2009 updated method guidelines for systematic reviews in the Cochrane Back Review Group[J].Spine,2009,34(18):1929-1941.
[5]吕贵东,刘玉霞.生脉注射液治疗老年维持性血液透析患者低血压的临床研究[J].长春中医药大学学报,2009,(04):490-491.
[6]喻红.生脉注射液治疗透析相关性低血压36例疗效观察[J].中国医药导报,2009,(08):63-64.
[7]郑淑婷,李娜,侯波.生脉注射液联合50%葡萄糖治疗老年透析相关性低血压[J].临床误诊误治,2009,(02):34-36.
[8]周世菊.生脉注射液防治血液透析中低血压的临床观察[J].中国中西医结合急救杂志,2007,(02):120.
[9]赵巧萍,吕宏云,卢巧英.生脉注射液防治血液透析中低血压的临床观察[J].浙江中医药大学学报,2009,(03):362-363.
[10]蒋鹏志,江红,贾卫红,等.生脉治疗血液透析中症状性低血压临床观察[J].黑龙江医药,2012,(02):280-281.
[11]高小玲,廖元江,郭勇,等.生脉注射液、盐酸米多君防治血液透析中顽固性低血压的疗效观察[J].重庆医学,2010,(06):730-731.
[12]赵虎康.生脉注射液防治血液透析相关性低血压的疗效观察[D].北京中医药大学,2007.
[13]赵菁华,钱小平,胡琦,等.生脉注射液对血压双向调节的临床观察[J].中国中医急症,2004,13(6)B367-368.
[2]Dheenan S,Henrich W L.Preventing dialysis hypotension:Acomparison of usual protective maneuvers[J].Kidney Intern ational,2001,60(2):802-803.
[3]Kopple J D.National Kidney Foundation K/DOQIClinic al Prac tice Guidelines for Nutrition in Chronic Renal Failure[J].American Journal of Kidney Diseases the Official Journal of the National Kidney Foundation,2001,37(1):S66-S70.
[4]Furlan A D,Pennick V,Bombardier C,et al.2009 updated method guidelines for systematic reviews in the Cochrane Back Review Group[J].Spine,2009,34(18):1929-1941.
[5]吕贵东,刘玉霞.生脉注射液治疗老年维持性血液透析患者低血压的临床研究[J].长春中医药大学学报,2009,(04):490-491.
[6]喻红.生脉注射液治疗透析相关性低血压36例疗效观察[J].中国医药导报,2009,(08):63-64.
[7]郑淑婷,李娜,侯波.生脉注射液联合50%葡萄糖治疗老年透析相关性低血压[J].临床误诊误治,2009,(02):34-36.
[8]周世菊.生脉注射液防治血液透析中低血压的临床观察[J].中国中西医结合急救杂志,2007,(02):120.
[9]赵巧萍,吕宏云,卢巧英.生脉注射液防治血液透析中低血压的临床观察[J].浙江中医药大学学报,2009,(03):362-363.
[10]蒋鹏志,江红,贾卫红,等.生脉治疗血液透析中症状性低血压临床观察[J].黑龙江医药,2012,(02):280-281.
[11]高小玲,廖元江,郭勇,等.生脉注射液、盐酸米多君防治血液透析中顽固性低血压的疗效观察[J].重庆医学,2010,(06):730-731.
[12]赵虎康.生脉注射液防治血液透析相关性低血压的疗效观察[D].北京中医药大学,2007.
[13]赵菁华,钱小平,胡琦,等.生脉注射液对血压双向调节的临床观察[J].中国中医急症,2004,13(6)B367-368.
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