| 引用本文:邢文龙1,2，尚菊菊1，刘红旭1，来晓磊1，张振民1，李思耐3，刘庆荣4，刘子豪2.参元益气活血胶囊干预缺血性心力衰竭患者生命质量的随机对照临床试验[J].世界中医药,2022,(07):. |
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| 参元益气活血胶囊干预缺血性心力衰竭患者生命质量的随机对照临床试验 |
| Shenyuan Yiqi Huoxue Capsules Interfere with Quality of Life of Patients with Ischemic Heart Failure:A Clinical Randomized Controlled Trial |
| 投稿时间：2021-11-17 |
| DOI：10.3969/j.issn.1673-7202.2022.07.021 |
| 中文关键词: 参元益气活血胶囊,参元丹,益气逐瘀法,缺血性心力衰竭,心力衰竭病,气虚血瘀证,生命质量,中医证候 |
| English Keywords:Shenyuan Yiqi Huoxue Capsules Shenyuan Pills Replenishing qi and resolving blood stasis Ischemic heart failure Heart failure Qi deficiency and blood stasis syndrome quality of life TCM syndrome |
| 基金项目:国家自然科学基金项目(82174106);国家自然科学基金面上项目(82174315);北京市属医院科研培育计划项目(Pz2021019);北京市医院管理局重点医学专业发展计划项目(ZYLX201817);中医药循证能力建设项目(2019XZZX-XXG001)——专科专病循证能力提升 |
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| 中文摘要: |
| 目的:探讨参元益气活血胶囊(SYYQ)改善缺血性心力衰竭(IHF)气虚血瘀证患者生命质量的临床疗效及安全性。方法:选取2021年1月1日至7月31日首都医科大学附属北京中医医院心血管科门诊收治的IHF气虚血瘀证患者71例作为研究对象，按照随机数字表法随机分为观察组(n=36)和对照组(n=35)。观察组在西药治疗基础上加用SYYQ,对照组仅给予西药治疗,疗程30 d,观察治疗前后明尼苏达心功能不全生命质量量表(MLHFQ)、中医证候积分、心力衰竭生物学标志物B型脑利尿钠肽(BNP)与超声心动指标(LVEDd、LVEF)、6 min步行距离试验(6 MWT)与呼吸困难评分(Borg)、30 d主要心血管事件(MACEs）及药物不良反应发生情况。结果:治疗后,观察组患者MLHFQ-体力、症状维度评分及总分低于对照组(P<0.05),情绪及经济维度评分与对照组比较差异无统计学意义(P>0.05);观察组中医证候积分低于对照组,总有效率及疗效指数高于对照组(P<0.05);观察组BNP水平低于对照组(P<0.05),LVEDd、LVEF与对照组比较差异无统计学意义(P>0.05);观察组患者6 MWT距离及提高幅度高于对照组,Borg评分低于对照组,Borg评分降低幅度高于对照组(P<0.05);2组患者MACEs事件发生率差异无统计学意义(P>0.05);观察期间2组均未见明显药物不良反应。结论:SYYQ具有在规范化治疗基础上进一步改善IHF气虚血瘀证患者生命质量、改善中医证候、降低BNP水平、提高运动耐量的临床疗效并且安全性较好。 |
| English Summary: |
| To explore the clinical efficacy and safety of Shenyuan Yiqi Huoxue Capsules(SYYQ) in improving the quality of life of ischemic heart failure(IHF) patients with qi deficiency and blood stasis syndrome.Methods:Seventy-one IHF patients with qi deficiency and blood stasis syndrome admitted to the Cardiovascular Department of Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University from January 1 to July 31，2021，were enrolled and divided into an SYYQ group(n=36) and a control group(n=35) by a random number table.All patients were treated with western medicine，while those in the SYYQ group received additional SYYQ.All patients were treated for 30 days.The Minnesota Living with Heart Failure Questionnaire(MLHFQ)，traditional Chinese medicine(TCM) syndrome scores，heart failure biomarker[B-type natriuretic peptide(BNP)]，and echocardiographic indicators(left ventricular end-diastolic dimension(LVEDd) and left ventricular ejection fraction(LVEF)]，6-minute walking test(6MWT)，dyspnea scale(Borg)，30-day major adverse cardiac events(MACEs)，and adverse drug events of the two groups before and after treatment were compared.Results:After treatment，the scores of strength and symptom in MLHFQ and the total score of the SYYQ group were lower than those of the control group(P<0.05)，and no statistical difference in the scores of emotional dimension and economic dimension was observed in the two groups(P>0.05).The TCM syndrome score in the SYYQ group was lower than that of the control group，and the total effective rate and curative effect index were higher than those of the control group(P<0.05).The BNP level of the SYYQ group was lower than that of the control group(P<0.05).There was no statistically significant difference in LVEDd and LVEF between the two groups(P>0.05).The 6MWT distance and the increased range of the SYYQ group were higher than those of the control group.The Borg score of the SYYQ group was lower than that of the control group，and the Borg score reduction was higher than that of the control group(P<0.05).There was no statistically significant difference in the incidence of MACEs between the two groups(P>0.05).No obvious adverse drug reactions occurred in both groups.Conclusion:On the basis of the standardized treatment，SYYQ can further improve the quality of life of IHF patients with qi deficiency and blood stasis syndrome，improve TCM syndromes，reduce BNP level，and improve exercise tolerance，with good safety. |
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