灯盏花素注射液治疗不稳定型心绞痛的疗效与安全性:系统评价与Meta分析
[Efficacy and safety of breviscapine injection in treatment of unstable angina pectoris: systematic review and Meta-analysis].
作者信息
Zhi Ying-Jie, Zhao Jun, Zhao Hui, Yu Dan-Dan
机构信息
Institute of Basic Research Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing 100700, China.
出版信息
Zhongguo Zhong Yao Za Zhi. 2018 Oct;43(19):3940-3955. doi: 10.19540/j.cnki.cjcmm.20180611.009.
To systematically evaluate the efficacy and safety of breviscapine injection in the treatment of unstable angina pectoris (UAP). Eight electronic databases and clinical trials registries were searched to collect randomized controlled trials on breviscapine injection in the treatment of UAP. According to the evaluation standards in Cochrane Handbook 5.1, two independent reviewers screened out the literature, extracted data and assessed the quality of the studies included. RevMan 5.3 software was used for Meta quantitative analysis and corresponding description analysis. A total of 36 studies involving 3 058 patients were included, 1 552 cases in the trial group, 1 506 cases in the control group, 1 846 males and 1 212 females. All the clinical studies showed a low quality. Meta-analysis results showed that the combination of breviscapine injection and conventional therapy was superior to conventional therapy in angina pectoris efficacy (RRangina pectoris efficacy=1.29, 95%CI[1.23,1.35],<0.000 01;RRECG1=1.25,95%CI[1.12,1.38],<0.000 1;RRECG2=1.38,95%CI[1.27,1.49],<0.000 01); descriptive analysis of a single study showed that the efficacy of combination of breviscapine injection and conventional therapy was superior to that of conventional therapy alone. In respect of hemorheology, the combination of breviscapine injection and conventional therapy was better than conventional therapy in lowering LBV and EAI (MDLBV=-1.27,95%CI[-1.55,-0.99],<0.000 01;MDEAI=-0.38,95%CI[-0.60,-0.16],=0.000 6), as well as in lowering WBV and HCT in the descriptive analysis of single study. In respect of blood lipid, the combination of breviscapine injection and conventional therapy was better than conventional therapy in lowering TC, TG and LDL-C (MDTC=-0.30,95%CI[-0.51,-0.10],=0.003;MDTG=-0.32,95%CI[-0.77,0.13],=0.16;MDLDL-C=-0.45,95%CI[-0.76,-0.14],=0.004). In reducing the frequency of angina attacks, heart rate, high sensitive C-reactive protein and improving exercise tolerance, the combination of breviscapine injection and conventional therapy was also superior to the conventional therapy alone (MDFAP=-3.30,95%CI[-4.06,-2.54],< 0.000 01;MDHR=-9.38,95%CI[-12.78,-5.98],=0.000 2;MDhs-CRP=-0.56,95%CI[-0.85,-0.27],=0.000 2;MDET=0.88,95%CI[0.41,1.35],=0.000 2). The main adverse reactions in the two groups included headache, dizziness, palpitations, nausea, abdominal distension, skin pruritus, flushes and allergic reactions in the study. The safety of breviscapine injection needs to be further studied and clarified because of the combination of drugs and the incomplete information reported in the original study. The current evidence suggested that the combination of breviscapine injection and conventional therapy had certain advantages in curative effect for the treatment of UAP. Due to the low quality of the study and its own shortcomings, it is necessary to design more rigorous, high-quality, multi-center randomized double-blind controlled trials to increase the strength of the evidence.
系统评价灯盏花素注射液治疗不稳定型心绞痛(UAP)的疗效和安全性。检索8个电子数据库及临床试验注册库,收集灯盏花素注射液治疗UAP的随机对照试验。根据Cochrane Handbook 5.1中的评价标准,由两名独立评价员筛选文献、提取数据并评估纳入研究的质量。采用RevMan 5.3软件进行Meta定量分析及相应的描述性分析。共纳入36项研究,涉及3058例患者,试验组1552例,对照组1506例,男性1846例,女性1212例。所有临床研究质量均较低。Meta分析结果显示,灯盏花素注射液联合常规治疗在心绞痛疗效方面优于常规治疗(RR心绞痛疗效 = 1.29,95%CI[1.23, 1.35],P < 0.000 01;RR心电图改善1 = 1.25,95%CI[1.12, 1.38],P < 0.000 1;RR心电图改善2 = 1.38,95%CI[1.27, 1.49],P < 0.000 01);单研究描述性分析显示,灯盏花素注射液联合常规治疗的疗效优于单纯常规治疗。在血液流变学方面,灯盏花素注射液联合常规治疗在降低低切变率(LBV)和红细胞聚集指数(EAI)方面优于常规治疗(MDLBV = -1.27,95%CI[-1.55, -0.99],P < 0.000 01;MDEAI = -0.38,95%CI[-0.60, -0.16],P = 0.000 6),单研究描述性分析还显示在降低全血高切黏度(WBV)和红细胞压积(HCT)方面也有优势。在血脂方面,灯盏花素注射液联合常规治疗在降低总胆固醇(TC)、甘油三酯(TG)和低密度脂蛋白胆固醇(LDL-C)方面优于常规治疗(MDTC = -0.30,95%CI[-0.51, -0.10],P = 0.003;MDTG = -0.32,95%CI[-0.77, 0.13],P = 0.16;MDLDL-C = -0.45,95%CI[-0.76, -0.14])。在减少心绞痛发作次数、心率、高敏C反应蛋白及提高运动耐量方面,灯盏花素注射液联合常规治疗也优于单纯常规治疗(MDFAP = -3.30,95%CI[-4.06, -2.54],P < 0.000 01;MDHR = -9.38,95%CI[-12.78, -5.98],P = 0.000 2;MDhs-CRP = -0.56,95%CI[-0.85, -0.27],P = 0.000 2;MDET = = 0.88,95%CI[0.41, 1.35],P = 0.000 2)。两组主要不良反应包括头痛、头晕、心悸、恶心、腹胀、皮肤瘙痒、潮红及过敏反应。由于药物联合使用及原始研究报告信息不完整,灯盏花素注射液的安全性有待进一步研究明确。目前证据表明,灯盏花素注射液联合常规治疗在治疗UAP的疗效方面有一定优势。鉴于研究质量较低及其自身不足,有必要设计更严谨、高质量、多中心随机双盲对照试验以增强证据强度。