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丹红注射液对择期经皮冠状动脉介入治疗不稳定型心绞痛患者围术期心肌损伤及微循环阻力的影响:一项初步随机研究。

Effects of Danhong Injection () on Peri-Procedural Myocardial Injury and Microcirculatory Resistance in Patients with Unstable Angina Undergoing Elective Percutaneous Coronary Intervention: A Pilot Randomized Study.

机构信息

Department of Cardiology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, 100010, China.

Department of Cardiology, Fuwai Hospital, Beijing, 100037, China.

出版信息

Chin J Integr Med. 2021 Nov;27(11):846-853. doi: 10.1007/s11655-021-2872-1. Epub 2021 Jul 14.

DOI:10.1007/s11655-021-2872-1
PMID:34263442
Abstract

OBJECTIVE

To evaluate the effect of Danhong Injection (, DH) on the index of microcirculatory resistance (IMR) and myocardial injury in patients with unstable angina undergoing elective percutaneous coronary intervention (PCI).

METHODS

Seventy-eight patients with unstable angina were randomly divided into DH group (39 cases) and the control group (39 cases) during elective PCI. Randomization was performed using a random-number table. The DH group received DH at a dosage of 40 mL (mixed with 250 mL saline, covered by a light-proof bag, intravenous drip) during PCI and daily for 7 consecutive days, while the control group only received the same dosage of saline. Both groups received standardized treatment. The IMR and fractional flow reserve (FFR) were measured at maximal hyperemia before and after PCI. Myocardial markers, including myoglobin, creatine kinase (CK), creatine kinase MB (CK-MB), and coronary troponin T (cTnT) values were measured at baseline and 24 h after PCI.

RESULTS

Among the 78 patients enrolled, the baseline and procedural characteristics were similar between the two groups. There was no significant difference in pre-PCI myocardial markers and coronary physiological indexes between the two groups. However, post-PCI CK and CK-MB levels in the DH group were significantly lower than those in the control group (111.97 ± 80.97 vs. 165.47 ± 102.99, P=0.013; 13.08 ± 6.90 vs. 19.75 ± 15.49, P=0.016). Post-PCI myoglobin and cTNT-positive tend to be lower in the DH group than in the control group but did not reach statistical significance (88.07 ± 52.36 vs. 108.13 ± 90.94, P=0.52; 2.56% vs.7.69%, P=0.065). Compared with the control group, the post-IMR levels of the DH group tended to decrease, but there was no statistical difference (20.73 ± 13.15 vs. 26.37 ± 12.31, P=0.05). There were no statistical differences in post-FFR in both groups. The peri-procedural myocardial injury of the DH group was significantly lower than that of the control group (2.56% vs. 15.38%, P=0.025). During the 30-d follow-up period, no major adverse cardiovascular events occurred in either group.

CONCLUSION

This study demonstrated benefit of DH in reducing myocardial injury and potential preserving microvascular function in patients with unstable angina undergoing elective PCI.

摘要

目的

评价丹红注射液(DH)对择期经皮冠状动脉介入治疗(PCI)不稳定型心绞痛患者微循环阻力指数(IMR)和心肌损伤的影响。

方法

78 例不稳定型心绞痛患者在择期 PCI 期间随机分为 DH 组(39 例)和对照组(39 例)。采用随机数字表进行随机分组。DH 组在 PCI 期间和术后连续 7 天每天接受 40mL DH(混合在 250mL 生理盐水,避光袋覆盖,静脉滴注),对照组仅接受相同剂量的生理盐水。两组均接受标准化治疗。在 PCI 前后最大充血时测量 IMR 和血流储备分数(FFR)。在 PCI 前和 PCI 后 24 小时测量肌红蛋白、肌酸激酶(CK)、肌酸激酶同工酶(CK-MB)和冠状动脉肌钙蛋白 T(cTnT)等心肌标志物的值。

结果

78 例患者中,两组的基线和手术特征相似。两组间 PCI 前心肌标志物和冠状动脉生理指标无显著差异。然而,DH 组 PCI 后 CK 和 CK-MB 水平明显低于对照组(111.97±80.97 与 165.47±102.99,P=0.013;13.08±6.90 与 19.75±15.49,P=0.016)。DH 组 PCI 后肌红蛋白和 cTNT 呈阳性的趋势低于对照组,但未达到统计学意义(88.07±52.36 与 108.13±90.94,P=0.52;2.56%与 7.69%,P=0.065)。与对照组相比,DH 组的 IMR 术后水平趋于降低,但无统计学差异(20.73±13.15 与 26.37±12.31,P=0.05)。两组间的 FFR 术后无统计学差异。DH 组围手术期心肌损伤明显低于对照组(2.56%与 15.38%,P=0.025)。在 30 天随访期间,两组均未发生重大不良心血管事件。

结论

本研究表明,DH 可降低择期 PCI 不稳定型心绞痛患者的心肌损伤,可能有助于保护微血管功能。

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