通心络胶囊对PCI术后无复流患者心肌微灌注的影响以及远期疗效与安全性

doi:10.3969/j.issn.1004-583X.2021.02.007

摘要/Abstract

摘要：

目的探讨通心络对经皮冠状动脉介入术(percutaneous coronary intervention, PCI)术后无复流患者心肌微灌注的影响以及其远期安全性与有效性。方法将128例PCI术后无复流患者,按随机法分为2组,对照组(n=63)接受规范化药物治疗,治疗组(n=65)在规范化药物治疗基础上口服通心络胶囊。比较两组基线临床情况,术中手术操作情况、术后7天、30天、90天炎性以及氧化应激指标、心功能指标、心肌声学造影图像和心肌微灌注情况,随访24个月不良心脏事件(MACE)以及患者因使用通心络胶囊所致不良反应。结果治疗组高敏C反应蛋白(hs-CRP)、丙二醛(MDA)在术后各时间节点均明显低于对照组,至术后30天差异有统计学意义(P<0.05);超氧化物歧化酶(SOD)均高于对照组,至术后30天差异有统计学意义(P<0.05); 30天时行心肌声学造影检查,与对照组相比,治疗组心肌灌注显像时间低,造影计分指数高, A·β 值高,90天时差异更为明显(P<0.05)。两组术后7天、30天、90天时左心室射血分数(LVEF)水平随时间递升,左室收缩末容积指数(LVESVI)、室壁运动积分指数(WMSI)水平随时间递降,治疗组各项心功能指标均优于对照组(P<0.05)。与对照组相比,治疗组24个月MACE事件发生率明显降低(P<0.05),随访24个月通心络胶囊未导致明显药物不良反应。结论无复流患者尽早使用通心络胶囊可降低炎症反应,抑制氧化应激,增加心肌微灌注,提高心功能,进而改善患者预后,且长期观察具有良好的安全性。

关键词: 无复流现象, 通心络胶囊, 心肌再灌注, 心肌声学造影, 氧化性应激

Abstract:

Objective To explore the effects of Tongxinluo Capsules on myocardial microperfusion in patients with percutaneous coronary intervention (PCI) free of reflow and corresponding long-term safety. Methods One hundred and twenty eight patients free of reflow after PCI were randomly divided into two groups by random grouping method, the patients in control group(n=63) received standardized medications, and those in treatment group(n=65) received oral Tongxinluo Capsules based on standardized medications. Baseline clinical conditions, intraoperative surgical operations as well as changes in inflammatory and oxidative stress indicators(hs-CRP, SOD, MDA), cardiac function indicators and myocardial contrast echocardiography images on the 7th day, 30th day and 90th day after surgery, 24 months follow-up of MACE events as well as adverse reactions caused by the use of Tongxinluo Capsules of patients in two groups were compared. Results Highly sensitive C-reactive protein(hs-CRP) and malondialdehyde(MDA) of treatment group at post-operative time node were significantly lower than those of control group, and the differences in two groups till post-operative 30 days were statistically significant, the superoxide dismutase(SOD) of treatment group was higher than those of control group(P<0.05); Myocardial contrast echocardiography was performed on the 30th day, the patients in treatment group were found to have low myocardial perfusion imaging time, high contrast score indexes, and high A·β value when compared to those in the control group, and the difference was even greater on the 90th day(P<0.05); LVEF level of patients in two groups escalated over time, and the level of LVESVI and WMSI decreased over time. The heart function indexes of treatment group were better than those of control group at each time points(P<0.05). The 24-month MACE event rate of treatment group was significantly lower compared to those of control group(P<0.05). No serious adverse drug reactions caused by Tongxinluo capsules were found after 24 months follow-up. Conclusion Early use of Tongxinluo Capsule in patients free of reflow after PCI can reduce inflammation, inhibit oxidative stress, improve myocardial microperfusion and cardiac function, and further enhance patient prognosis, and long-term follow-up shows Tongxinluo Capsule delivers good safety.

Key words: reflow-free phenomenon, tongxinluo capsules, myocardial reperfusion, myocardial contrast echocardiography, oxidative stress

中图分类号:

R542.22

贺娜, 李敏娴, 张旗, 许芳, 张晨峰, 宋达. 通心络胶囊对PCI术后无复流患者心肌微灌注的影响以及远期疗效与安全性[J]. 临床荟萃, 2021, 36(2): 129-133.

He Na, Li Minxian, Zhang Qi, Xu Fang, Zhang Chenfeng, Song Da. Effects of Tongxinluo Capsules on myocardial microperfusion in patients free of reflow after PCI and long-term efficacy and safety[J]. Clinical Focus, 2021, 36(2): 129-133.

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链接本文: https://huicui.hebmu.edu.cn/CN/10.3969/j.issn.1004-583X.2021.02.007

https://huicui.hebmu.edu.cn/CN/Y2021/V36/I2/129

图/表 5

参考文献 15

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项目	治疗组(n=65)	对照组(n=63)	t/χ²值	P值
年龄(岁)	59.28± 15.92	60.58± 16.97	0.447	0.656
男[例(%)]	42(64.61)	40(63.49)	0.018	0.893
高血压[例(%)]	39(60.00)	41(65.08)	0.352	0.553
BMI(kg/m²)	25.66±2.98	26.91±3.13	2.315	0.022
高脂血症[例(%)]	35(53.85)	38(60.32)	0.547	0.460
吸烟[例(%)]	37(56.92)	32(50.79)	0.484	0.487
AMI[例(%)]	48(73.85)	42(66.67)	0.79	0.374
糖尿病[例(%)]	32(49.23)	36(57.14)	0.804	0.370
高尿酸血症[例(%)]	37(56.92)	28(44.44)	1.993	0.158

项目	治疗组(n=65)	对照组(n=63)	t/χ²值	P值
年龄(岁)	59.28± 15.92	60.58± 16.97	0.447	0.656
男[例(%)]	42(64.61)	40(63.49)	0.018	0.893
高血压[例(%)]	39(60.00)	41(65.08)	0.352	0.553
BMI(kg/m²)	25.66±2.98	26.91±3.13	2.315	0.022
高脂血症[例(%)]	35(53.85)	38(60.32)	0.547	0.460
吸烟[例(%)]	37(56.92)	32(50.79)	0.484	0.487
AMI[例(%)]	48(73.85)	42(66.67)	0.79	0.374
糖尿病[例(%)]	32(49.23)	36(57.14)	0.804	0.370
高尿酸血症[例(%)]	37(56.92)	28(44.44)	1.993	0.158

项目	治疗组(n=65)	对照组(n=63)	t/χ²值	P值
急诊PCI[例(%)]	45(69.23)	37(58.73)	1.532	0.216
球囊扩张时间(s)	49.48±17.35	52.71±15.98	1.095	0.276
无复流TIMI分级[例(%)]
0	0(0.00)	0(0.00)
1	18(27.69)	25(39.68)	1.73	0.188
2	47(71.31)	38(61.32)
病变血管数[例(%)]
单支	28(43.08)	18(28.57)
双支	21(32.31)	32(50.79)	4.737	0.094
三支	16(24.61)	13(20.64)
植入支架数[例(%)]
PTCA	10(17.04)	9(14.84)
1个	33(54.07)	23(58.59)	3.483	0.323
2个	18(22.96)	24(17.97)
3个	4(5.93)	7(8.59)
病变血管[例(%)]
LM	6(5.08)	8(6.61)
LAD	68(57.63)	56(46.28)	3.371	0.338
LCX	24(20.34)	28(23.14)
RCA	20(16.95)	29(23.97)
应用IABP[例(%)]	6(9.23)	3(4.76)	0.977	0.323
应用临时起搏器[例(%)]	2(3.08)	4(6.35)	0.767	0.381
血栓抽吸[例(%)]	10(15.38)	14(22.22)	0.982	0.322

项目	治疗组(n=65)	对照组(n=63)	t/χ²值	P值
急诊PCI[例(%)]	45(69.23)	37(58.73)	1.532	0.216
球囊扩张时间(s)	49.48±17.35	52.71±15.98	1.095	0.276
无复流TIMI分级[例(%)]
0	0(0.00)	0(0.00)
1	18(27.69)	25(39.68)	1.73	0.188
2	47(71.31)	38(61.32)
病变血管数[例(%)]
单支	28(43.08)	18(28.57)
双支	21(32.31)	32(50.79)	4.737	0.094
三支	16(24.61)	13(20.64)
植入支架数[例(%)]
PTCA	10(17.04)	9(14.84)
1个	33(54.07)	23(58.59)	3.483	0.323
2个	18(22.96)	24(17.97)
3个	4(5.93)	7(8.59)
病变血管[例(%)]
LM	6(5.08)	8(6.61)
LAD	68(57.63)	56(46.28)	3.371	0.338
LCX	24(20.34)	28(23.14)
RCA	20(16.95)	29(23.97)
应用IABP[例(%)]	6(9.23)	3(4.76)	0.977	0.323
应用临时起搏器[例(%)]	2(3.08)	4(6.35)	0.767	0.381
血栓抽吸[例(%)]	10(15.38)	14(22.22)	0.982	0.322

组别	例数	hs-CRP(mg/L)			MDA(mg/L)			SOD(U/L)
组别	例数	术后7天	术后30天	术后90天	术后7天	术后30天	术后90天	术后7天	术后30天	术后90天
对照组	63	10.93±3.22	8.24±2.72	5.57±1.53	6.38±2.73	5.45±2.26	4.77±1.66	50.1±8.48	71.85±9.64	115.22±11.41
治疗组	65	11.13±2.91	7.73±2.23	4.06±0.93	6.30±3.11	5.01±2.32	4.07±2.02	49.82±9.94	89.51±9.11	132.15±12.13
组间		F=3.58 P<0.05			F=3.22 P<0.05			F=5.26 P<0.01
时点间		F=6.23 P<0.01			F=4.53 P<0.05			F=6.88 P<0.01
组间·时点间		F=27.89 P<0.01			F=22.23 P<0.01			F=32.29 P<0.01