Tang Shuang, Zhang Dan, Han Shuang, Chen Ya-Hong, Ma Bao-Nan, Liu Chuan-Xin, Zhang Chen-Ning
School of Traditional Chinese Materia Medica, Beijing University of Chinese Medicine Beijing 100029, China.
State Key Laboratory of Antitoxic Drugs and Toxicology, Beijing Key Laboratory of Neuropsychopharmacology, Institute of Toxicology, Academy of Military Medicine, Academy of Military Sciences Beijing 100850, China.
Zhongguo Zhong Yao Za Zhi. 2021 Jan;46(1):237-246. doi: 10.19540/j.cnki.cjcmm.20200701.501.
To systematically evaluate the clinical efficacy and safety of Danhong Injection combined with conventional therapy in improving diabetes mellitus complicated with coronary heart disease. Based on the online literature database(CNKI, Wanfang, VIP, PubMed, Web of Science, Cochran Library), the Chinese and English papers about the randomized controlled trial(RCT) of Danhong Injection in the treatment of diabetes mellitus complicated with coronary heart disease were searched comprehensively from the establishment of the databases to January 1, 2020. The papers were screened strictly according to the inclusion and exclusion criteria. Based on Jadad scale, the risk assessment of literature was carried out, and Meta-analysis was performed by STATA 12.0 software. Seventeen RCTs were included, involving 1 453 patients. The results of Meta-analysis showed that the combination of Danhong Injection and conventio-nal treatment could improve the clinical comprehensive effective rate(RR=1.47, 95%CI[1.38, 1.58], P<0.000 1), electrocardiogram(ECG) efficiency(RR=1.30, 95%CI[1.16, 1.46], P<0.000 1), efficiency of the angina pectoris(RR=1.41, 95%CI[1.25, 1.58], P<0.000 1), cholesterol level(SMD=-1.05, 95%CI[-1.95,-0.16], P=0.02), low-density lipoprotein(LDL) level(SMD=-0.50, 95%CI[-0.79,-0.21], P<0.000 1), coronary angina attack frequency(SMD=-3.71, 95%CI[-4.05,-3.36], P<0.000 1) and duration of angina pectoris(SMD=-2.96, 95%CI[-3.25,-2.66], P<0.000 1), with statistically significant differences. But the differences in fasting plasma glucose(FPG)(SMD=-0.19, 95%CI[-0.45, 0.08], P=0.16), plasma glucose of two hours after meal(2 hPG)(SMD=0.19, 95%CI[-0.11, 0.49], P=0.22), and high-density lipoprotein(HDL) level(SMD=0.10, 95%CI[-0.30, 0.49], P=0.62) after treatment were not statistically significant. Compared with the control group, there was no significant difference in adverse reactions(SMD=-2.96, 95%CI[-3.25,-2.66], P=0.75). The existing evidence shows that the combination of Western medicine and Danhong Injection can improve the clinical effect for diabetes mellitus complicated with coronary heart disease and has no obvious adverse reactions. However, due to the low level of overall literature evidence, high risk and some kind of publication bias, it still needs more high-quality randomized controlled trials and low-bias studies for further verification.
系统评价丹红注射液联合常规治疗改善糖尿病合并冠心病的临床疗效及安全性。基于在线文献数据库(中国知网、万方、维普、PubMed、Web of Science、Cochrane图书馆),全面检索从各数据库建库至2020年1月1日关于丹红注射液治疗糖尿病合并冠心病的随机对照试验(RCT)的中英文论文。严格按照纳入与排除标准进行文献筛选。基于Jadad量表进行文献风险评估,并用STATA 12.0软件进行Meta分析。共纳入17项RCT,涉及1453例患者。Meta分析结果显示,丹红注射液联合常规治疗可提高临床综合有效率(RR=1.47,95%CI[1.38,1.58],P<0.000 1)、心电图(ECG)有效率(RR=1.30,95%CI[1.16,1.46],P<0.000 1)、心绞痛有效率(RR=1.41,95%CI[1.25,1.58],P<0.000 1)、胆固醇水平(SMD=-1.05,95%CI[-1.95,-0.16],P=0.02)、低密度脂蛋白(LDL)水平(SMD=-0.50,95%CI[-0.79,-0.21],P<0.000 1)、冠状动脉心绞痛发作频率(SMD=-3.71,95%CI[-4.05,-3.36],P<0.000 1)和心绞痛持续时间(SMD=-2.96,95%CI[-3.25,-2.66],P<0.000 1),差异有统计学意义。但治疗后空腹血糖(FPG)(SMD=-0.19,95%CI[-0.45,0.08],P=0.16)、餐后2小时血糖(2hPG)(SMD=0.19,95%CI[-0.11,0.49],P=0.22)和高密度脂蛋白(HDL)水平(SMD=0.10,95%CI[-0.30,0.49],P=0.62)的差异无统计学意义。与对照组相比,不良反应差异无统计学意义(SMD=-2.96,95%CI[-3.25,-2.66],P=0.75)。现有证据表明,西药联合丹红注射液可提高糖尿病合并冠心病的临床疗效,且无明显不良反应。然而,由于总体文献证据水平较低、风险较高且存在某种发表偏倚,仍需要更多高质量的随机对照试验和低偏倚研究进行进一步验证。