中成药辅助治疗心绞痛的网状Meta分析和汇总评价

发布时间：2018-02-21 15:23

本文关键词： 冠心病心绞痛网状Meta分析汇总评价中成药注射液　出处：《昆明医科大学》2017年硕士论文　论文类型：学位论文

【摘要】：目的比较14种注射用中成药(Chinese patent medicine,CPM)分别与常规抗心绞痛治疗(routine anti-angina treatment,RT)的西药结合使用时对心绞痛(angina pectoris,AP)患者具有的相对疗效和安全性。方法检索4个中文和4个英文数据库,按照严格的纳入和排除标准,筛选出合格的系统评价(systematic review,SR)和随机对照试验(randomized controlled trial,RCT),在进行质量评价之后,分别进行定性和定量合成分析。定量合成分析采用网状Meta分析(network meta-analysis,NMA)和敏感性分析等方法,并在软件 Stata 12.0、WinBUGS 1.4 和 Microsoft Excel 2013中完成。结果一共纳入14篇SR(总样本量为20579例)用于定性合成分析,一共纳入的152篇RCT(总样本量为15644例)进行定量合成分析。纳入14篇SR的质量和SR中的证据质量总体上较低。纳入152篇RCT的疗程较短(均小于等于42天)。没有足够的数据用于定量分析心血管事件这一结局指标。相关的NMA和敏感性分析显示:就心绞痛症状改善而言,这5种干预[丹红注射液(Dan Hong Injection,DHI)+RT、黄芪注射液(Astragalus Membranceus Injection,AMEI)+RT、大株红景天注射液(Sofren Injection,SOI)+RT、参麦注射液(Shenmai Injection,SMI)+RT 和葛根素注射液(Puerarin Injection,PUI)+RT]的 SUCRA(the surface under the cumulative ranking curve)值相对其他10种干预[RT、红花黄色素注射液(Safflower Yellow Injection,SYI)+RT、丹参川芎嗪注射液(Danshen Chuanxiongqin Injection,DCI)+RT、冠心宁注射液(Guanxinning Injection,GXNI)+RT、灯盏细辛注射液(Dengzhan Xixin Injection,DXI)+RT、复方丹参注射液(Compound Danshen Injection,CDI)+RT、生脉注射液(Shengmai Injection,SGMI)+RT、参芎注射液(Shenxiong Injection,SXI)+RT、参附注射液(Shenfu Injection,SFI)+RT和苦碟子注射液(Kudiezi Injection,KDZI)+RT]的SUCRA值较大,且结果具有稳健性;而这5种干预(DHI+RT、AMEI+RT、SOI+RT、SMI+RT 和 PUI+RT)在改善心绞痛症状上差异无统计学意义。漏斗图提示存在一定的发表偏倚。纳入的14篇SR中,14种CPM均未导致严重不良反应和受试者因不良反应而退出试验的情况;未能比较14种CPM之间的相对安全性。结论这5种干预措施(DHI+RT、AMEI+RT、SOI+RT、SMI+RT 和 PUI+RT)在改善心绞痛症状方面优于其他10种干预措施,同时这5种干预措施具有相似的疗效。但考虑到研究的不足之处,此结果用于临床实践时应该谨慎。未来的RCT研究应该延长其临床试验疗程,并在研究中详细报告不良反应发生情况以及相关的重要临床结局(如心血管事件等),以便评价不同CPM注射制剂与RT结合时治疗AP的相对安全性和远期获益。未来也需要对不同类型的AP(如稳定型AP或不稳定型AP)人群进行RCT研究,以得到更加精准的临床证据。未来的SR或MA应该参照PRISMA指南来实施,以提高其质量。
[Abstract]:Objective to compare the relative efficacy and safety of 14 kinds of Chinese patent medicine for injection in combination with routine anti-angina pectoris anti-angina treatment in patients with angina pectoris. Methods four Chinese and four English databases were searched. According to the strict inclusion and exclusion criteria, the qualified systematic review system (SRS) and randomized controlled trialants (RCTs) were screened, and after the quality evaluation was carried out, Qualitative and quantitative synthetic analysis were carried out respectively. Quantitative synthesis analysis was performed by network meta-analysis (NMA) and sensitivity analysis. Software Stata 12.0, WinBUGS 1.4 and Microsoft Excel 2013. Results 14 SRs (total sample size of 20579 cases) were included for qualitative synthesis analysis. A total of 152RCTs (total sample size of 15644 cases) were analyzed by quantitative synthetic analysis. The quality of 14 SRs and the quality of evidence in SRs were lower in general, and the course of treatment was shorter (all less than 42days) in RCT (all less than 42 days). The data were used to quantify cardiovascular events as an outcome indicator. Related NMA and sensitivity analysis showed that in terms of improved angina symptoms, The SUCRA(the surface under the cumulative ranking curvevalues of these five interventions [Dan Hong injection Dan Hong injection DHIRT, Astragalus Membranceus injection AMEI] RTT, large strain Rhodiola injection Sofren injection SMI RT, Shenmai injection Shenmai injection Smi RT and Puerarin injection Puerarin injection Puerarin injection Puerarin injection Puerarin injection Puerarin injection Puerarin cumulative ranking curvecompared with the other 10 dry ones. Safflower Yellow injection (Syi) RTT, Danshen Chuanxiongqin injection (DCI) RTT, Guanxinning injection Guanxinning injection GXNIRT, Dengzhan Xixin injection DXI) RTT, compound Danshen Danshen injection injection CDI), Shengmai injection Shengmai injection SGMIRT, Shenshinning injection GXNIRT, Dengzhan Xixin injection DXI) RTT, Safflower Yellow injection Syi RTT, Danshen Chuanxiongqin injection DXI RTT, Guanxinning injection Guanxinning injection Guanxinning injection GXNIRT, Dengzhan Xixin injection DXI) RTT, Safflower Yellow injection Safflower injection Syi RTT, Shengmai injection Shengmai injection SGMIT. The SUCRA values of Shenxiong injection (SXI), Shenfu injection (SFIRT) and Kudiezi injection (KDZIRT) were higher. The results are robust. However, there was no significant difference between these five interventions in ameliorating angina pectoris symptoms. Funnel graph showed that there was a certain publication bias. None of 14 CPM in the 14 SRs included did not result in serious adverse reactions and severe adverse reactions. The withdrawal of the participants from the test due to adverse reactions; The relative safety of 14 kinds of CPM could not be compared. Conclusion these five intervention measures are superior to the other 10 intervention measures in improving angina pectoris symptoms. At the same time, these five interventions have similar efficacy. However, in view of the shortcomings of the study, this result should be used carefully in clinical practice. Future RCT studies should extend its clinical trial course. The incidence of adverse reactions and related important clinical outcomes (such as cardiovascular events, etc.) were reported in detail in order to evaluate the relative safety and long-term benefits of different CPM injection agents combined with RT in the treatment of AP in the future. RCT studies are also needed for different types of APs, such as stable or unstable APs. For more accurate clinical evidence, future SR or MA should be implemented with reference to the PRISMA guidelines to improve their quality.
【学位授予单位】：昆明医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R541.4

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