摘要
目的系统评价丹红注射液与复方丹参注射液比较治疗冠心病心绞痛的疗效与安全性。方法计算机检索MEDLINE、EMbase、CBM、CNKI、维普及万方数据库(2007.01～2010.07),并手工检索相关期刊与会议论文,纳入丹红注射液治疗冠心病心绞痛的随机对照试验(RCT),按照纳入与排除标准选择试验、评价质量和提取有效数据,而后采用RevMan 4.3软件进行Meta分析。结果共纳入27个RCT,包括3030例患者,其方法学质量评价均为B级。Meta分析结果显示:①心绞痛发作有效率:丹红注射液组高于复方丹参组[OR=3.84,95%C(I3.03,4.88),P<0.00001];②心电图复查有效率:丹红注射液组优于复方丹参组[OR=1.98,95%CI(1.44,2.66),P<0.00001];③ST段缺血情况改善:丹红注射液组在NST[WMD=0.78,95%CI(0.42,1.14),P<0.0001]和∑ST[WMD=0.45,95%CI(0.32,0.57),P<0.00001]方面均优于复方丹参组;④血液流变学指标改善:丹红注射液组均优于复方丹参组;⑤不良反应:丹红注射液组与复方丹参组差异无统计学意义[OR=0.64,95%CI(0.33,1.25),P=0.19]。结论现有研究表明,丹红注射液能有效改善冠心病心绞痛患者心肌ST段缺血和各项血液流变学指标,使患者心电图复查有效率显著提高,并最终显著降低心绞痛发作率,且安全性更高。但由于本系统评价纳入研究证据强度不高,且样本量小,故上述结论尚需更多高质量RCT进一步验证。
Objective To assess the efficacy and safety of Dan Hong injection for patients with angina pectoris compared with compound salvia injection as the control group.Methods Databases were electronically searched from MEDLINE,EMbase,CBM,CNKI,VIP,and Wanfang Data（January,2007 to July,2010）,and reference lists of all papers identified were also checked.Randomized controlled trials（RCTs） of the effect of Dan Hong injection on angina pectoris were identified and assessed according to the Cochrane Handbook for Systematic Reviews of Interventions and then RevMan 4.3 was used to undertake Meta analysis.Results Twenty-seven trials involving 3 030 patients were included.Meta-analysis showed that：a） Compared with compound salvia injection,Dan Hong injection was capable of significantly decreasing the angina incidence（OR=3.84,95% CI 3.03 to 4.88,P0.00001）;b） Dan Hong injection was capable of significantly improving ECG review effectiveness compared with compound salvia injection（OR=1.98,95% CI 1.44 to 2.66,P0.00001）;c） Dan Hong injection was obviously superior to compound salvia injection in improving the NST（WMD=0.78,95%CI 0.42 to 1.14,P0.0001） and ∑ST（WMD=0.45,95%CI 0.32 to 0.57,P0.00001）;and d） Dan Hong injection was able to obviously improve the hemorheology index after angina pectoris;Meta-analyses of eight trials in which adverse events were reported showed that no significant difference was found between Dan Hong injection and salvia injection（OR=0.64,95%CI 0.33 to 1.25,P=0.19）.Conclusion Dan Hong injection can effectively improve the ST segment ischemia and hemorheology index after angina pectoris,significantly increase the effectiveness of electrocardiogram reviews and eventually significantly reduce the recurrence rate of angina,and appears to be much safer.Further high quality RCTs are required to provide reliable evidence on the treatment of patients with angina pectoris.
出处
《中国循证医学杂志》
CSCD
2011年第1期57-63,共7页
Chinese Journal of Evidence-based Medicine
