本文關(guān)鍵詞： 冠心病 心絞痛 網(wǎng)狀Meta分析 匯總評(píng)價(jià) 中成藥 注射液　出處：《昆明醫(yī)科大學(xué)》2017年碩士論文　論文類(lèi)型：學(xué)位論文

【摘要】：目的比較14種注射用中成藥(Chinese patent medicine,CPM)分別與常規(guī)抗心絞痛治療(routine anti-angina treatment,RT)的西藥結(jié)合使用時(shí)對(duì)心絞痛(angina pectoris,AP)患者具有的相對(duì)療效和安全性。方法檢索4個(gè)中文和4個(gè)英文數(shù)據(jù)庫(kù),按照嚴(yán)格的納入和排除標(biāo)準(zhǔn),篩選出合格的系統(tǒng)評(píng)價(jià)(systematic review,SR)和隨機(jī)對(duì)照試驗(yàn)(randomized controlled trial,RCT),在進(jìn)行質(zhì)量評(píng)價(jià)之后,分別進(jìn)行定性和定量合成分析。定量合成分析采用網(wǎng)狀Meta分析(network meta-analysis,NMA)和敏感性分析等方法,并在軟件 Stata 12.0、WinBUGS 1.4 和 Microsoft Excel 2013中完成。結(jié)果一共納入14篇SR(總樣本量為20579例)用于定性合成分析,一共納入的152篇RCT(總樣本量為15644例)進(jìn)行定量合成分析。納入14篇SR的質(zhì)量和SR中的證據(jù)質(zhì)量總體上較低。納入152篇RCT的療程較短(均小于等于42天)。沒(méi)有足夠的數(shù)據(jù)用于定量分析心血管事件這一結(jié)局指標(biāo)。相關(guān)的NMA和敏感性分析顯示:就心絞痛癥狀改善而言,這5種干預(yù)[丹紅注射液(Dan Hong Injection,DHI)+RT、黃芪注射液(Astragalus Membranceus Injection,AMEI)+RT、大株紅景天注射液(Sofren Injection,SOI)+RT、參麥注射液(Shenmai Injection,SMI)+RT 和葛根素注射液(Puerarin Injection,PUI)+RT]的 SUCRA(the surface under the cumulative ranking curve)值相對(duì)其他10種干預(yù)[RT、紅花黃色素注射液(Safflower Yellow Injection,SYI)+RT、丹參川芎嗪注射液(Danshen Chuanxiongqin Injection,DCI)+RT、冠心寧注射液(Guanxinning Injection,GXNI)+RT、燈盞細(xì)辛注射液(Dengzhan Xixin Injection,DXI)+RT、復(fù)方丹參注射液(Compound Danshen Injection,CDI)+RT、生脈注射液(Shengmai Injection,SGMI)+RT、參芎注射液(Shenxiong Injection,SXI)+RT、參附注射液(Shenfu Injection,SFI)+RT和苦碟子注射液(Kudiezi Injection,KDZI)+RT]的SUCRA值較大,且結(jié)果具有穩(wěn)健性;而這5種干預(yù)(DHI+RT、AMEI+RT、SOI+RT、SMI+RT 和 PUI+RT)在改善心絞痛癥狀上差異無(wú)統(tǒng)計(jì)學(xué)意義。漏斗圖提示存在一定的發(fā)表偏倚。納入的14篇SR中,14種CPM均未導(dǎo)致嚴(yán)重不良反應(yīng)和受試者因不良反應(yīng)而退出試驗(yàn)的情況;未能比較14種CPM之間的相對(duì)安全性。結(jié)論這5種干預(yù)措施(DHI+RT、AMEI+RT、SOI+RT、SMI+RT 和 PUI+RT)在改善心絞痛癥狀方面優(yōu)于其他10種干預(yù)措施,同時(shí)這5種干預(yù)措施具有相似的療效。但考慮到研究的不足之處,此結(jié)果用于臨床實(shí)踐時(shí)應(yīng)該謹(jǐn)慎。未來(lái)的RCT研究應(yīng)該延長(zhǎng)其臨床試驗(yàn)療程,并在研究中詳細(xì)報(bào)告不良反應(yīng)發(fā)生情況以及相關(guān)的重要臨床結(jié)局(如心血管事件等),以便評(píng)價(jià)不同CPM注射制劑與RT結(jié)合時(shí)治療AP的相對(duì)安全性和遠(yuǎn)期獲益。未來(lái)也需要對(duì)不同類(lèi)型的AP(如穩(wěn)定型AP或不穩(wěn)定型AP)人群進(jìn)行RCT研究,以得到更加精準(zhǔn)的臨床證據(jù)。未來(lái)的SR或MA應(yīng)該參照PRISMA指南來(lái)實(shí)施,以提高其質(zhì)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.
【學(xué)位授予單位】：昆明醫(yī)科大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類(lèi)號(hào)】：R541.4

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