目的 系统评价活血化瘀法中药复方治疗慢性阻塞性肺疾病(Chronic obstructive pulmonary disease,COPD)合并肺动脉高压(Pulmonary hypertension,PH)的有效性及安全性.方法 计算机检索CNKI、Wanfang Data、VIP Database、CBM、PubMed、Web of science、Embase、Cochrane Library 中英文数据库自建库至 2023 年 4 月 30日期间,活血化瘀法治疗COPD合并PH的随机对照试验,并提取数据,采用Revman 5.3软件进行Meta分析与系统评价,其安全性指标用不良反应发生率来评价.结果 共纳入文献42篇,涉及患者3558例,实验组活血化瘀法联合西医常规治疗组1794例,对照组西医常规治疗组1764例.Meta分析结果显示:与对照组比较,实验组提高临床有效率[RR=1.26,95％CI(1.21,1.31),P＜0.0001];改善患者缺氧、二氧化碳潴留:血氧分压(Arterial partial pressure of oxygen,PaO2)[SMD=0.92,95％CI(0.60,1.24),P＜0.0001]、二氧化碳分压(Arterial partial pressure of carbon dioxide,PaCO2)[SMD=-0.97,95％CI(-1.41,-0.52),P＜0.0001]、动脉血氧饱和度(Arterial oxygen sat-uration,SaO2)[MD=2.36,95％CI(0.92,3.80),P=0.001];降低肺循环压力:肺动脉收缩压(Pulmonary artery sys-tolic pressure,PASP)[MD=-4.55,95％CI(-5.60,-3.51),P＜0.0001];改善临床症状,提高运动耐量:6 min 步行距离(6-minute walking distance,6MWD)[MD=51.00,95％CI(39.80,62.19),P＜0.0001]、证候总评分[MD=-2.91,95％CI(-3.52,-2.31),P＜0.0001]、改良英国医学研究委员会呼吸困难量表(Modified British medical research council dyspnea scores,mMRC)评分[MD=-0.82,95％CI(-0.89,-0.76),P＜0.0001]和慢阻肺患者自我评估测试(COPD assessment test,CAT)问卷[MD=-6.49,95％CI(-12.74,-0.25),P=0.04];提高血清一氧化氮(Nitric oxide,NO)[.SMD=0.83,95％CI(0.35,1.32),P=0.0007]等方面有优势;但在不良反应发生率方面无显著差异[RR=1.50,95％CI(0.44,5.11),P=0.52].结论 活血化瘀法中药复方联合西医常规治疗COPD合并PH具有较好的临床疗效,能显著提高临床有效率、改善患者缺氧、二氧化碳潴留,改善临床症状,提高运动耐量,降低肺循环压力等.但在安全性方面尚待进一步研究,未来仍需更多严谨高质量RCT研究来验证.
Meta-Analysis of Efficacy and Safety of TCM Compound of Promoting Blood Cir-culation and Removing Stasis in Treatment of Chronic Obstructive Pulmonary Dis-ease Complicated with Pulmonary Arterial Hypertension
Objective To systematically evaluate the efficacy and safety of traditional Chinese medicine(TCM)compound of promoting blood circulation and removing stasis in the treatment of chronic obstructive pulmonary disease(COPD)complicated with pulmonary arterial hypertension(PH).Methods CNKI,Wanfang Data,VIP Database,CBM,PubMed,Web of Science,Embase,and Cochrane Library Chinese and English databases were searched by computer from their establishment to April 30,2023.The randomized controlled trials(RCTs)about TCM compound of promoting blood circulation and removing stasis in the treatment of COPD complicated with PH were searched,and data were extracted.Meta-analysis and systematic review were performed using Revman 5.3 software.The safety index was evaluated by the incidence of adverse reactions.Results A total of 42 pieces of literature were included,involving 3 558 patients,including 1 794 pa-tients in the experimental group receiving TCM compound of promoting blood circulation and removing stasis and conven-tional western medicine treatment and 1 764 patients in the control group receiving conventional western medicine treat-ment.The Meta-analysis results showed that compared with the control group,the experimental group enhanced clinical efficacy[RR=1.26,95％CI(1.21,1.31),P＜0.000 1]and improved patients'hypoxia and carbon dioxide retention:ar-terial partial pressure of oxygen(PaO2)[SMD=0.92,95％CI(0.60,1.24),P＜0.000 1],arterial partial pressure of car-bon dioxide(PaCO2)[SMD=-0.97,95％CI(-1.41,-0.52),P＜0.000 1],and arterial oxygen saturation(SaO2)[MD=2.36,95％CI(0.92,3.80),P=0.001].Pulmonary circulation pressure:pulmonary artery systolic pressure(PASP)[MD=-4.55,95％CI(-5.60,-3.51),P＜0.000 1]was decreased.Clinical symptoms and exercise toler-ance:6-minute walking distance(6MWD)[MD=51.00,95％CI(39.80,62.19),P＜0.000 1],total syndrome score[MD=-2.91,95％CI(-3.52,-2.31),P＜0.000 1],modified British medical research council dyspnea scores(mMRC)[MD=-0.82,95％CI(-0.89,-0.76),P＜0.000 1],and COPD patient assessment test(CAT)question-naire[MD=-6.49,95％CI(-12.74,-0.25),P=0.04]were improved.It had advantages in improving serum nitric oxide(NO)[SMD=0.83,95％CI(0.35,1.32),P=0.000 7]and other aspects.However,there was no significant statisti-cal difference in the incidence of adverse reactions[RR=1.50,95％CI(0.44,5.11),P=0.52].Conclusion TCM com-pound of promoting blood circulation and removing stasis combined with conventional western medicine has good clinical efficacy in the treatment of COPD complicated with PH.It can significantly improve clinical effective rate,hypoxia,carbon dioxide retention,clinical symptoms of patients,and exercise tolerance and reduce pulmonary circulation pressure.Howev-er,further studies on its safety are needed,and more high-quality RCTs are required for verification in the future.
Traditional Chinese MedicinePromoting Blood Circulation and Removing StasisChronic Obstructive Pulmonary DiseasePulmonary Arterial HypertensionMeta-Analysis
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万方数据
