RESUMEN
Background: Slow flow/no-reflow (SF-NR) during percutaneous coronary intervention (PCI) is associated with poor prognosis of patients with acute myocardial infarction (AMI). Currently, effective treatment is not available for SF-NR. Electroacupuncture (EA) has shown significant efficacy as an adjuvant therapy for many cardiovascular diseases by improving microcirculation and reducing ischemia-reperfusion injury. However, its effects on SF-NR in the AMI patients during PCI are not clear. This pilot trial aims to determine the efficacy of intraoperative EA in alleviating SF-NR in AMI patients undergoing PCI. Methods: This prospective, single-center, randomized controlled, pilot trial will recruit 60 AMI patients scheduled for PCI at the Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, China. The patients will be randomized in a 1:1 ratio into the EA or the control groups. Patients in the control group will undergo standard PCI. Patients in the EA group will undergo intraoperative electroacupuncture while undergoing standard PCI. Incidence of SF-NR is the primary outcome for this study. This study will also assess secondary outcomes including cardiac biomarkers, inflammatory biomarkers, pain and anxiety scores, electrocardiography parameters, traditional Chinese medicine (TCM) symptom score, and major adverse cardiovascular and cerebrovascular events (MACCE). All the included patients will undergo laboratory tests including routine blood tests, levels of electrolytes, as well as liver and renal function tests. Patients will be followed up for 1 month after the procedure. Discussion: This pilot trial will provide evidence for the potential benefits of intraoperative EA in improving microvascular perfusion and preventing or alleviating SF-NR during PCI in patients with AMI. If proven effective, intraoperative EA will provide a new and effective strategy against SF-NR and provide evidence for subsequent multicenter trials. Clinical Trial Registration: ClinicalTrials.gov, identifier (ChiCTR2300072265). Registered on 8 June 2023.
RESUMEN
OBJECTIVES: To evaluate the clinical value and safety of combined anesthesia of acupuncture-pharmacotherapy in pulmonary resection surgery. METHODS: The randomized controlled trials (RCTs) related to combined anesthesia of acupuncture-pharmacotherapy in pulmonary resection surgery were searched in PubMed, EMbase, Cochrane Library, Web of Science, SinoMed, CNKI, VIP database, Wanfang database, ClinicalTrials.gov, and the Chinese Clinical Trial Registry (http://www.chictr.org.cn/) from the inception of each database up to July 12, 2022. The methodological quality of the included studies was assessed using the Cochrane risk of bias tool, and Meta-analysis was conducted using RevMan5.4. RESULTS: A total of 33 RCTs were included, involving 2 526 participants. The Meta-analysis results showed that compared to conventional anesthesia, the patients receiving combined anesthesia of acupuncture-pharmacotherapy had more stable vital signs during surgery, reduced intraoperative fentanyl usage [SMD=-3.73, 95%CI(-5.28, -2.18), Z=4.72, P<0.000 01], decreased postoperative sufentanil consumption [MD=-20.85, 95%CI(-24.84, -16.86), Z=10.24, P<0.000 01], reduced total/effective presses of the postoperative patient-controlled analgesia pump [MD=-5.70, 95% CI(-9.04, -2.36), Z=3.35, P=0.000 8], lowered postoperative pain visual analogue scale (VAS) [MD=-1.63, 95%CI(-2.02, -1.23), Z=7.97, P<0.000 01], shorter length of postoperative hospital stay [MD=-1.14, 95%CI(-1.85, -0.43), Z=3.15, P=0.002], and higher levels of CD 4+ T lymphocytes, CD 8+ T lymphocytes, natural killer (NK) cell activity, and superoxide dismutase (SOD). Additionally, tumor necrosis factor-alpha (TNF-α), adrenaline and cortisol levels were decreased (P<0.05). No adverse events related to acupuncture or electrical stimulation were reported, and the incidence of postoperative complications was lower than that of conventional anesthesia [RR=0.47, 95%CI(0.36, 0.62), Z=5.36, P<0.000 01]. CONCLUSIONS: The combined anesthesia of acupuncture-pharmacotherapy in pulmonary resection surgery could improve anesthesia and analgesia effectiveness, reduce anesthesia drug usage, regulate immune responses, suppress stress reactions, and the safety is satisfactory. However, there is substantial heterogeneity among the included studies, and outcome measures vary widely. Further large-sample, high-quality, internationally standardized clinical trials are needed to clarify its clinical value and safety, providing reliable evidence for clinical practice.
