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中西医结合疗法对心力衰竭患者长期临床结局的影响:一项纳入394例患者的真实世界研究

Effect of Integrative Chinese and Western Medicine Therapy on Long-Term Clinical Outcomes in Patients with Heart Failure: A Real-World Study Including 394 Patients.

作者信息

Wang Zihan, Zhang Jin, Zhang Gaoyu, Lan Tianyi, Sun Ziyi, Lu Xiaoyan, Huang Li, Li Lin

机构信息

Beijing University of Chinese Medicine, Beijing, China.

Department of Integrative Cardiology, China-Japan Friendship Hospital, Beijing, China.

出版信息

Evid Based Complement Alternat Med. 2022 Sep 13;2022:2001397. doi: 10.1155/2022/2001397. eCollection 2022.

Abstract

OBJECTIVE

To explore the effect of integrative Chinese and Western medicine therapy on the clinical outcomes of patients with heart failure.

METHODS

This is a retrospective cohort study in the real world. Patients were divided into "conventional therapy" and "integrative therapy" groups according to treatment modality. The occurrence of cardiovascular events (CVE) was determined during follow-up. Survival curves were plotted, and survival analysis was performed using Cox regression to report survival in both groups. Further subgroup tests were performed as sensitivity analyses. A Markov model was constructed to predict patients with distant heart failure conditions based on real follow-up data.

RESULTS

Based on diagnostic criteria, 394 patients with heart failure were included. The integrative therapy group had ( = 181) older patients (=0.005), higher proportion of renal insufficiency ( < 0.001), higher creatinine (=0.040), hypersensitive C-reactive protein (=0.007), N-terminal pro-B type natriuretic peptide (=0.019) levels, more patients in cardiac function class IV (=0.004), and longer hospital days (=0.003) than the conventional therapy group ( = 213). Survival was better in the integrative therapy group than in the conventional therapy group (log-rank < 0.001). Multifactorial Cox regression identified "conventional therapy" or "integrative therapy" as an independent factor affecting the risk of CVE in patients with heart failure, with the risk of CVE being lower in the integrative therapy group (HR = 0.322, 95% CI = 0.185-0.561). A subgroup analysis found no significant association between therapy modality and risk of CVE in older patients (age ≥65 years, =0.210) and those who had renal insufficiency (=0.062). The Markov model predicted better cardiac function in the integrative therapy group than in the conventional therapy group at all time points (all < 0.001).

CONCLUSION

In patients with heart failure, integrative therapy of Chinese and Western medicine had better long-term outcomes than conventional therapy. However, patients with advanced age and renal insufficiency had no significant advantage. . This trial is registered with China Clinical Trials Registry, ChiCTR2100050927, registered 8 September 2021, https://www.chictr.org.cn/showproj.aspx?proj=133451.

摘要

目的

探讨中西医结合疗法对心力衰竭患者临床结局的影响。

方法

这是一项真实世界的回顾性队列研究。根据治疗方式将患者分为“传统疗法”组和“综合疗法”组。在随访期间确定心血管事件(CVE)的发生情况。绘制生存曲线,并使用Cox回归进行生存分析以报告两组的生存率。进行进一步的亚组检验作为敏感性分析。基于实际随访数据构建马尔可夫模型以预测远期心力衰竭状况的患者。

结果

根据诊断标准,纳入394例心力衰竭患者。综合疗法组(n = 181)患者年龄较大(P = 0.005),肾功能不全比例较高(P < 0.001),肌酐水平较高(P = 0.040),超敏C反应蛋白水平较高(P = 0.007),N末端B型利钠肽原水平较高(P = 0.019),心功能IV级患者较多(P = 0.004),住院天数较长(P = 0.003),均高于传统疗法组(n = 213)。综合疗法组的生存率高于传统疗法组(对数秩检验P < 0.001)。多因素Cox回归确定“传统疗法”或“综合疗法”是影响心力衰竭患者CVE风险的独立因素,综合疗法组CVE风险较低(HR = 0.322,95%CI = 0.185 - 0.561)。亚组分析发现,在老年患者(年龄≥65岁,P = 0.210)和肾功能不全患者(P = 0.062)中,治疗方式与CVE风险之间无显著关联。马尔可夫模型预测,在所有时间点综合疗法组的心脏功能均优于传统疗法组(均P < 0.001)。

结论

在心力衰竭患者中,中西医结合疗法的长期结局优于传统疗法。然而,高龄和肾功能不全患者无显著优势。本试验在中国临床试验注册中心注册,注册号为ChiCTR2100050927,于2021年9月8日注册,https://www.chictr.org.cn/showproj.aspx?proj=133451。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dfdc/9489340/a35b56b17ef0/ECAM2022-2001397.001.jpg

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