[關(guān)鍵詞]
[摘要]
目的 系統(tǒng)評價復(fù)方丹參滴丸聯(lián)合化學(xué)藥治療對行經(jīng)皮冠狀動脈介入術(shù)(PCI)后的冠心病患者不良心血管事件及心臟功能的影響。方法 通過中國學(xué)術(shù)期刊全文數(shù)據(jù)庫(CNKI)、萬方數(shù)據(jù)知識服務(wù)平臺(Wanfang Data)、維普中文期刊全文數(shù)據(jù)庫(VIP)、中國生物醫(yī)學(xué)文獻(xiàn)服務(wù)系統(tǒng)(SinoMed)、PubMed、Cochrane Library、Embase、Web of Science 8個數(shù)據(jù)庫檢索復(fù)方丹參滴丸治療冠心病患者PCI術(shù)后的臨床隨機對照試驗(RCTs),檢索時限從建庫至2023年10月31日。使用Cochrane手冊中的Cochrane風(fēng)險測試偏倚工具來評估納入研究的質(zhì)量,Review Manager 5.4軟件對結(jié)果進(jìn)行分析。結(jié)果 最終納入26項RCTs,總樣本量3 384例,包括治療組1 692例、對照組1 692例。Meta分析結(jié)果顯示:在主要結(jié)局方面,與對照組比較,治療組可顯著減少心絞痛復(fù)發(fā)[RR=0.27,95% CI (0.16,0.45),P<0.000 01]、再發(fā)非致死性心肌梗死[RR=0.30,95% CI (0.15,0.60),P=0.000 7]、心律失常[RR=0.75,95% CI (0.62,0.90),P=0.002]、心力衰竭[RR=0.36,95% CI (0.21,0.60),P<0.000 1]、再次血運重建[RR=0.18,95% CI (0.05,0.66),P=0.01]、支架內(nèi)再狹窄[RR=0.23,95% CI (0.10,0.57),P=0.001]的發(fā)生;同時,與對照組比較,治療組能夠顯著提高左室射血分?jǐn)?shù)(LVEF)[MD=4.13,95% CI (3.62,4.64),P<0.000 01],降低左心室舒張末期內(nèi)徑[MD=-3.71,95% CI (-4.37,-3.05),P<0.000 01]、降低N末端腦利鈉肽前體[MD=-325.48,95% CI (-629.97,-21.00),P=0.04],但不能改善B型腦利鈉肽[MD=-185.90,95% CI (-413.12,-41.31),P=0.11]。在次要結(jié)局方面,與對照組比較,治療組能夠改善心指數(shù)、每搏輸出量、左室收縮末期內(nèi)徑,差異具有統(tǒng)計學(xué)意義(P<0.05)。在不良反應(yīng)方面,2組間的不良反應(yīng)發(fā)生率無統(tǒng)計學(xué)差異(P>0.05)。結(jié)論 復(fù)方丹參滴丸聯(lián)合化學(xué)藥治療能夠減少冠心病PCI術(shù)后患者的主要不良心血管事件發(fā)生率、改善患者心功能,且不會增加不良反應(yīng)的發(fā)生風(fēng)險,安全性良好。
[Key word]
[Abstract]
Objective To systematically review the effect of Compound Danshen Dropping Pills (CDDP) combined with chemical drug on adverse cardiovascular events and cardiac function for patients with coronary heart disease after percutaneous coronary intervention (PCI). Methods Randomized controlled trials (RCTs) on CDDP in the treatment for patients with coronary heart disease after PCI were searched until October 31, 2023, through eight electronic databases:The CNKI, Wanfang, VIP, SinoMed, Pubmed, Cochranelibrary, Embase, Web of Science. This study used the Cochrane Risk Test bias tool in the Cochrane Handbook to assess the quality of the methodology. Review Manager 5.4 was used to analyze the results. Results A total of 26 RCTs were ultimately selected, with a total sample size of 3384 cases, including 1 692 cases in the treatment group and 1 692 cases in the control group. The Meta-analysis revealed significant reductions in the treatment group compared to the control group for primary outcomes, including angina pectoris recurrence [RR=0.27, 95%CI (0.16, 0.45), P< 0.000 01], recurrent nonfatal myocardial infarction [RR=0.30, 95% CI (0.15, 0.60), P=0.000 7], arrhythmia [RR=0.75, 95%CI (0.62, 0.90), P=0.002], heart failure [RR=0.36, 95%CI (0.21, 0.60), P< 0.000 1], revascularization [RR=0.18, 95%CI (0.05, 0.66), P=0.01], and stent restenosis [RR=0.23, 95%CI (0.10, 0.57), P=0.001]. Compared to the control group, the treatment group significantly increased LVEF [MD=4.13, 95%CI (3.62, 4.64), P< 0.000 01], decreased LVEDD [MD=-3.71, 95%CI (-4.37,-3.05), P< 0.000 01], and reduced NT-proBNP levels [MD=-325.48, 95%CI (-629.97,-21.00), P=0.04]. However, there was no significant improvement in BNP levels [MD=-185.90, 95%CI (-413.12,-41.31), P=0.11]. Regarding secondary outcomes, the treatment group demonstrated significant improvements in CI, SV, and LVESD compared to the control group (P< 0.05). In terms of adverse reactions, there was no statistically significant difference in the incidence of adverse reactions between the two groups (P > 0.05). Conclusion The application of CDDP combined with chemical drug for the treatment of patients after PCI could reduce the occurrence of major adverse cardiovascular events (MACE), improve cardiac function in a safe and reliable manner.
[中圖分類號]
R286.2;R969.3
[基金項目]
國家青年科學(xué)基金資助項目(No.82200349)、廣東省基礎(chǔ)與應(yīng)用基礎(chǔ)研究基金面上項目(2022A1515011647)