中西医结合运动康复辅助治疗冠心病PCI术后患者有效性和安全性的Meta分析

Effectiveness and Safety of Integrated Rehabilitation Exercises of Traditional Chinese and Western Medicine for Coronary Heart Disease after Percutaneous Coronary Intervention: A Systematic Review and Meta-analysis

目的系统评价中西医结合运动康复辅助治疗冠心病经皮冠状动脉介入治疗(PCI)术后患者的有效性和安全性,为其临床运用提供证据。方法检索中国知网、万方数据库、维普网、中国生物医学文献数据库,以及MEDLINE、Cochrane Library、EMbase外文数据库,检索时间自建库起至2020年4月30日。纳入的文献研究对象为冠心病PCI术后患者,根据干预措施分为治疗组(在常规基础治疗的同时联合中西医结合运动康复治疗)和对照组(仅采用常规基础治疗),常规基础治疗为标准化药物治疗、健康宣教,中西医结合运动康复包括有氧运动、阻抗训练、太极拳、八段锦等,干预时间为3个月及以上,结局指标包括主要不良心血管事件(MACE)发生率、左室射血分数(LVEF)值、6分钟步行距离、峰值摄氧量、无氧阈摄氧量、运动代谢当量。采用Cochrane系统评价手册的偏倚风险评估工具对依据纳入研究进行方法学质量评价,使用Rev Man 5.3软件对结局指标进行Meta分析,并同时评价安全性。结果共纳入22项研究,共2085例患者,纳入的研究总体方法学质量一般。Meta分析结果显示:与对照组比较,治疗组可减少冠心病PCI术后患者MACE发生率[OR=0.36,95%CI(0.24~10.52),P<0.01],提高LVEF值[MD=18.74,95%CI(14.33~23.14),P<0.01],增加6分钟步行距离[MD=18.74,95%CI(14.33~23.14),P<0.01],改善峰值摄氧量[MD=2.33,95%CI(1.85~2.82),P<0.01]和无氧阈摄氧量[MD=2.17,95%CI(1.59~2.75),P<0.01],提高运动代谢当量[MD=0.95,95%CI:(0.63~1.28),P<0.01],疗效优势明显,仅有2项研究报告了安全性指标。结论中西医结合运动康复辅助治疗可降低冠心病PCI术后患者MACE事件,提高心肺功能,增加运动耐力,疗效肯定,且无严重不良反应,但仍需高质量的随机对照试验进一步验证。

Objective To evaluate the effectiveness and safety of integrated rehabilitation exercises of traditional Chinese and Western medicine(IRE) in the treatment of coronary heart disease(CHD) after percutaneous coronary intervention(PCI), and to provide evidence for its clinical application. Methods Databases including CNKI, Wanfang, VIP, Sinomed, MEDLINE, Cochrane Library, and Embase were searched from their inception dates to April 30 th, 2020. Randomized controlled trials(RCTs) comparing IRE plus conventional treatment versus conventional treatment alone following PCI in treatment of CHD were included. Conventional treatments were standardized drugs and health education, while IRE included aerobic exercise, impedance training, Taiji, Baduanjin, and others. The interventions lasted at least three months. The outcomes were incidence of major adverse cardiovascular events(MACE), left ventricular ejection fraction(LVEF) value, 6-minute walking distance(6 MWD), peak oxygen uptake(peak VO2), anaerobic threshold(AT), and metabolic equivalent(MET). The Cochrane bias of risk tool was used to evaluate the methodological quality of the included studies. RevMan 5.3 software was used to perform Meta-analyses. Results Twenty-two RCTs involving 2085 patients were included. The overall methodological quality of the included studies was moderate. Results from meta-analyses showed that compared to control group, the IRE group significantly reduced the incidence of MACE in CHD patients after PCI(OR=0.36, 95%CI 0.24 to 10.52, P<0.01), increased LVEF value(MD=18.74, 95%CI 14.33 to 23.14, P<0.01), increased 6 MWD(MD=18.74, 95%CI 14.33 to 23.14, P<0.01), improved peak VO2(MD=2.33, 95%CI 1.85 to 2.82, P<0.01) and AT(MD=2.17, 95%CI 1.59 to 2.75, P<0.01), and increased MET(MD=0.95, 95%CI 0.63 to 1.28, P<0.01). Only two trials reported safety outcomes. Conclusion IRE following PCI has effects in decreasing incidence of MACE, improving cardiopulmonary function, and increasing exercise endurance in patients with CHD, and there are no serious adverse events;however, highly qualified RCTs are still needed for further verification.