复方丹参/丹参注射液辅助治疗慢性肺心病急性加重期随机试验的系统评价
http://www.100md.com
中医循证医学
李芳1 李廷谦2 马建昕2
(1.四川大学临床医学院 2.四川大学华西医院中西医结合科 成都 610041)
摘要：目的 评价丹参/复方丹参注射液辅助治疗慢性肺心病急性加重期的疗效和安全性。设计 随机对照临床试验时Cochrane 系统评价。方法 搜集比较加用丹参或复方丹参注射液与单纯采用常规治疗对慢性肺心病急性加重期患期患者的随机对照临床试验。无语种限制。纳入试验的质量用Jadad记分表评价。结果 符合纳入标准的论文共有30篇，均为小文发表，治疗组疗效症状评分的合并效应量RR(相对危险度)为1.20，95%CI(95%可信区间)为1.15-1.26。血液流变学指标多数因异质性明而不能进行合并计算，由于报道病死率、血小板聚集、氧化物脱氧化物指标的纳入试%太少，不能得出有推广意义的结论。结论 根据本系统评价，加用丹参/复方丹参注射液辅助治疗慢性肺心病急性加重期患者，对提高疗效尚无肯定结论，在改善血液流变性及体内氧化物/抗氧化物失衡方面，也不能得出可靠的结论。由于试验的方法学质量普遍较低，所选用的实验室指标变异较大，且缺乏与患者生活质量密切相关的指标及一些重要的长期结局指标，目前无足够的证据支持其应用于临床治疗，尚需要设计更加合理、严格执行的大样本随机试验。
, 百拇医药
关键词: 丹参注射液 复方丹参注射液 慢性肺心病急性加重期 随机临床试验 Cochrane系统评价 Meta-分析
Salviae Miltiorrhizae for Chronic ocr Pulmonale: A Systematic Review
LI Fang1, LI Ting-qian2, MA Jian-xin
(1.School of Clinical Medicine of Sichuan University
2.The Department of Integrated Traditional Chinese and Western M edicine
, 百拇医药
West China Hospital of Sichuan Unvisersity, Chengdu 610041, China)
ABSTRACT: Objective To evaluate evaluate the efficacy and safety of Salviae miltiorrhizae Injection (include Danshen Injection and Fufang Danshen Injection) for chronic Cor Pulmonale. Design A systematic review of randomized clinical trials. Methods Randomzied trials comparing Salviae miltiorrhizae Injection plus routine treatment versus routing treatment alone were identified by electronic and manual searches. No blinding and language limitationswere applied. The Jadad scale assessed the methodological quality of trials. Results Thirty randomized trials (n＝2161) were identified. The methdoIogical quality of all trials included was low. The combined results (RR and 95%CI) of symptom scores was 1.20 (1015,1026) Because of the significant heterogeneity, many other markers of the blood rheology can not be combined. The reason for heterogeneity should include the differences among cases and studies. Because of lacking enough studies, the conclusions about mortality and oxidants/antioxidants markers were not strong. Only a few studies had reported adverse events. Conclusions Based in the review, Salviae miltiorrhizae Infection may have positive effect on symptom scores in patients with chronic Cor pulmonale. But for mortality, the markers of blood rheology and oxidants/there is no reliable conclusion.However, the evidence is not strong due to the general low methodological quality, the variations among studies and experimental markers themselves, and lacking of more relevant and important marders. Further large trials are needed.
Key words: Red Rage Root Injection; chronic Cor pulmonale; systematic review;andomized clinical trials; Meta-analysis, http://www.100md.com
(1.四川大学临床医学院 2.四川大学华西医院中西医结合科 成都 610041)
摘要：目的 评价丹参/复方丹参注射液辅助治疗慢性肺心病急性加重期的疗效和安全性。设计 随机对照临床试验时Cochrane 系统评价。方法 搜集比较加用丹参或复方丹参注射液与单纯采用常规治疗对慢性肺心病急性加重期患期患者的随机对照临床试验。无语种限制。纳入试验的质量用Jadad记分表评价。结果 符合纳入标准的论文共有30篇，均为小文发表，治疗组疗效症状评分的合并效应量RR(相对危险度)为1.20，95%CI(95%可信区间)为1.15-1.26。血液流变学指标多数因异质性明而不能进行合并计算，由于报道病死率、血小板聚集、氧化物脱氧化物指标的纳入试%太少，不能得出有推广意义的结论。结论 根据本系统评价，加用丹参/复方丹参注射液辅助治疗慢性肺心病急性加重期患者，对提高疗效尚无肯定结论，在改善血液流变性及体内氧化物/抗氧化物失衡方面，也不能得出可靠的结论。由于试验的方法学质量普遍较低，所选用的实验室指标变异较大，且缺乏与患者生活质量密切相关的指标及一些重要的长期结局指标，目前无足够的证据支持其应用于临床治疗，尚需要设计更加合理、严格执行的大样本随机试验。
, 百拇医药
关键词: 丹参注射液 复方丹参注射液 慢性肺心病急性加重期 随机临床试验 Cochrane系统评价 Meta-分析
Salviae Miltiorrhizae for Chronic ocr Pulmonale: A Systematic Review
LI Fang1, LI Ting-qian2, MA Jian-xin
(1.School of Clinical Medicine of Sichuan University
2.The Department of Integrated Traditional Chinese and Western M edicine
, 百拇医药
West China Hospital of Sichuan Unvisersity, Chengdu 610041, China)
ABSTRACT: Objective To evaluate evaluate the efficacy and safety of Salviae miltiorrhizae Injection (include Danshen Injection and Fufang Danshen Injection) for chronic Cor Pulmonale. Design A systematic review of randomized clinical trials. Methods Randomzied trials comparing Salviae miltiorrhizae Injection plus routine treatment versus routing treatment alone were identified by electronic and manual searches. No blinding and language limitationswere applied. The Jadad scale assessed the methodological quality of trials. Results Thirty randomized trials (n＝2161) were identified. The methdoIogical quality of all trials included was low. The combined results (RR and 95%CI) of symptom scores was 1.20 (1015,1026) Because of the significant heterogeneity, many other markers of the blood rheology can not be combined. The reason for heterogeneity should include the differences among cases and studies. Because of lacking enough studies, the conclusions about mortality and oxidants/antioxidants markers were not strong. Only a few studies had reported adverse events. Conclusions Based in the review, Salviae miltiorrhizae Infection may have positive effect on symptom scores in patients with chronic Cor pulmonale. But for mortality, the markers of blood rheology and oxidants/there is no reliable conclusion.However, the evidence is not strong due to the general low methodological quality, the variations among studies and experimental markers themselves, and lacking of more relevant and important marders. Further large trials are needed.
Key words: Red Rage Root Injection; chronic Cor pulmonale; systematic review;andomized clinical trials; Meta-analysis, http://www.100md.com