경피적 관상동맥중재술 후 스텐트 내 재협착 예방에 대한 심적환의 효과 : 무작위배정 대조 임상연구에 대한 체계적 문헌고찰 및 메타분석

Abstract

Objectives: This study aimed to evaluate the efficacy of compound Danshen dripping pills (CDDP) in preventing in-stent restenosis (ISR) after percutaneous coronary intervention (PCI) by reviewing domestic and international randomized controlled clinical trials (RCTs). Methods: A comprehensive search was conducted on 11 databases (Embase, PubMed, CNKI, Wanfang, CiNii, J-STAGE, ScienceON, KISS, OASIS, KTKP, and RISS) for RCTs using CDDP as an intervention after PCI from their inception to October 17, 2024. Studies that assessed ISR rates were selected based on predefined inclusion and exclusion criteria. The primary outcome was the ISR rate, while the secondary outcomes included recurrence rates of angina and myocardial infarction, revascularization rates, and mortality. Data were analyzed using Review Manager (RevMan) 5.4.1, and the quality of individual studies was assessed using Cochrane’s risk of bias (RoB) tool. Results: A total of 1750 studies were primarily searched, and eight studies were selected based on the inclusion and exclusion criteria after excluding duplicates. In the final eight studies, each experimental group (CDDP with conventional treatment group) received CDDP in addition to the corresponding intervention in the control group (conventional treatment group). The meta-analysis results showed that the incidences of ISR, recurrent angina, recurrent myocardial infarction, and repeat revascularization after PCI were significantly lower in the experimental group than in the control group (incidence of ISR : 8 studies, n=776, RR=0.21, 95% CI : 0.11-0.41, p<0.00001, I2=0%; recurrent angina : 5 studies, n=472, RR=0.22, 95% CI : 0.12-0.41, p<0.00001, I2=0%; recurrent myocardial infarction : 4 studies, n=284, RR=0.26, 95% CI : 0.07-1.03, p=0.05, I2=0%; repeat revascularization : 5 studies, n=564, RR=0.19, 95% CI : 0.07-0.55, p=0.002, I2=0%). The mortality rate showed no significant difference between the experimental group and the control group (4 studies, n=484, RR=1.95% CI : 0.14-7.01, p=1, I2=0%). The RoB assessment indicated that the included studies were generally of low quality. Conclusions: CDDP administration after PCI appears to be more effective in preventing ISR. However, further large-scale clinical studies with more refined designs and long-term follow-ups are required to confirm these findings.