冠心舒通胶囊临床疗效及安全性系统评价结果分析

A Systematic Review of Clinical Researches of Guanxinshutong Capsule

目的:对冠心舒通胶囊研究文献进行系统评价,以期对其疗效和安全性进行全面认识。方法:采用系统评价方法,检索国内外中英文文献,包括CNKI、万方、Medline电子数据库,时间设定为本药应用以来到2013年4月。由2名评价者筛选文献并分别评价研究质量后讨论。采用metaanlyst3.13进行合并分析。结果共筛选出22篇临床对照研究,其中11项临床对照研究计1708名心绞痛及冠心病门诊与住院患者纳入meta分析,仅1项研究描述了随机方法,其它均未提及随机方法、分配隐藏及盲法。结果:11项心绞痛及冠心病疗效评估合并RR为1.189(95%CI:1.130-1.253);该药对PCI术后心绞痛复发研究表明,试验组加用后对血脂异常有益;心绞痛发作次数与硝酸甘油用量差别有统计学意义;室性早搏用药后,胸闷、气短、头晕的好转优于心律平组,对心率、血脂、血流、血胆固醇、血浆纤维蛋白原有影响。主要不良反应为恶心、胃肠道不适等,为轻微可逆反应。结论:冠心舒通胶囊对心绞痛及冠心病的治疗有效,对其它疾病治疗文献较少,但现有证据支持有益。少数患者有不良反应,主要为恶心和胃肠道不适。

Objective： To review the research findings about Guanxinshutong capsule in order to have a comprehensive understanding of its efficacy and safety.Methods： Systematic review was applied to English and Chinese literatures from the beginning of Guanxinshutong capsule application to April 2013 were comprehensively retrieved in databases including CNKI, Wanfang and Medline. Two evaluators screened the literatures, made the quality evaluation. Metaanlyst 3.13 was used.Results： 22 screened papers were all controlled clinical studies, including 11 controlled clinical study of 1708 patients with angina pectoris and coronary heart disease. Only 1 study described its random method. The combined RR is 1.189 （95% CI： 1.130 1.253）. The drug showed efficacy in dyslipidemia in patients with postoperative recurrence of angina after PCI. There were significant difference inanginal attack times and nitroglycerin consumption. Chest tightness, shortness of breath, dizziness in patients with ventricular premature beat were improved compared to Xinlvping group. Heart rate, blood lipid level, blood flow, blood cholesterol level, blood plasmafibrinogen level were also affected. Adverse reactions such as nausea and gastrointestinal discomfort were mild and reversible.Conclusion： Guanxinshutong capsule is effective in the treatment of angina and coronary heart disease （CHD）. For other diseases, literatures were little, but the current evidence showed beneficial in some aspects. A few patients had adverse reactions as nausea and gastrointestinal discomfort.