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 随机对照临床试验的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,均为中文发表。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显不能进行合并计算。由于报道病死率、血小板聚集、氧化物/抗氧化物指标的纳入试验太少,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。
Objective To 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 limitations were applied. The Jadad scale assessed the methodological quality of trials. Results Thirty randomized trials (n = 2 161) were identified. The methodological quality of all trials included was low. The combined results (RR and 95% CI) of symptom scores was 1.20(1.15, 1.26). 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 Injection may have positive effect on symptom scores in patients with chronic Cor pulmonale. But for mortality, the markers of blood rheology and oxidants/antioxidants, 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 markers. Further large trials are needed.
出处
《中国循证医学杂志》
CSCD
2002年第3期152-161,共10页
Chinese Journal of Evidence-based Medicine
