麝香通心滴丸对PCI术后患者慢血流的临床证据评价

Clinical Evidence Evaluation of Shexiang Tongxin Dropping Pill for Slow Blood Flow after PCI

目的:系统评价麝香通心滴丸对PCI术后患者慢血流的有效性及安全性,为PCI术后慢血流患者的临床治疗提供证据或为进一步研究设计提供依据。方法:以"麝香通心"、"PCI"、"经皮冠状动脉介入治疗"、"shexiangtongxin"、"shexiang tongxin"、"percutaneous coronary intervention"等为检索词,计算机检索Pubmed、Cochrane library、CNKI、CBM等数据库,并辅以手工检索获得随机对照临床试验(RCT)、系统评价、回顾性病例分析、病例对照研究等方面的相关文献,采用Cochrane风险评估工具及NOS评分量表对文献质量进行评价;参照2001年牛津证据分级与推荐意见强度标准对文献证据等级进行鉴定。结果:最终纳入RCT3篇、病例对照试验1篇,包括335例患者。本研究结果显示:(1)冠状动脉慢血流患者经麝香通心滴丸治疗后患者血管血栓溶解频数、心脏射血分数、TIMI血流均显著高于治疗前(P <0.05);(2)经麝香通心滴丸治疗后临床症状显效率为97.8%,高出治疗组11.1%;(3)治疗期间麝香通心滴丸组患者均未有不良反应出现。结论:麝香通心滴丸对PCI术后慢血流患者的有效性及安全性较好,但是由于PCI术后患者服用麝香通心滴丸的剂量、方法、周期以及PCI术后慢血流临床研究选取结局指标均尚未统一,建议临床研究可以针对给药剂量及术前、术后给药等不同给药时机的选择开展更多高质量、多中心的前瞻性随机对照实验为其临床应用提供更多强有力的的证据支持。

Objective: To evaluate the efficacy and safety of Shexiang Tongxin dropping pill(ShXT) in the treatment ofslow blood flow after PCI(Percutaneous Transluminal Coronary Intervention), and to provide evidence for clinicaltreatment of patients with slow blood flow after PCI or to provide evidence for further research and design. Methods: "Shexiang Tongxin", "PCI", "percutaneous coronary intervention", "shexiangtongxin", "shexiang tongxin", "percutaneouscoronary intervention" were used as key words. Randomized controlled clinical trial(RCT), system evaluation,retrospective case analysis and case-control trials of randomized controlled clinical trials were searched in the databasesof Pubmed, Cochrane, web of science, CNKI, WIP, CBM, and other databases. Cochrane risk assessment tool and NOSrating scale were used to evaluate the quality of literature, and the classification of literature evidence was evaluatedaccording to Oxford criteria of evidence classification and recommended opinion strength in 2001. Results: A total of 3 articles of RCT related to the subject were selected, including 1 case control trial, including 335 patients. The resultsshowed that:(1) The frequency of thrombolysis, heart ejection fraction and TIMI blood flow in patients with slow coronaryartery flow after treatment with Shexiang Tongxin dropping pills were significantly higher than those before treatment.(P < 0.05).(2) After treatment with Shexiang Tongxin dropping pills, the effective rate of clinical symptoms was 97.8%,which was higher than that of the treatment group 11.1%.(3) There were no adverse reactions in the ShXT group duringthe treatment period. Conclusion: The efficacy and safety of Shexiang Tongxin dropping pills for patients with slow bloodflow after PCI were good. However, the dosage, method, period and outcome of the clinical study of slow blood flow afterPCI were not uniform because of the dosage, method, period of taking Shexiang Tongxin dropping pills in patients afterPCI. It is suggested that the clinical study should be aimed at the choice of different dosages before and after theadministration of drugs. The multicenter prospective randomized controlled trial can provide more evidence for itsclinical application.