Prospective randomized controlled trial study of Luofengning granule in the treatment of unstable angina.

INTRODUCTION: Although the current western treatment plans for unstable angina (UA) has been optimized in past decades, UA still is a common phenotype of acute coronary syndrome and significantly influence the quality of life and endanger lives. In China, the clinical application of Chinese herb medicine is considered as an effective approach to treating UA and widely recognized by patients. In clinical practices, we found Luofengning granule (LFN-G) could improve clinical manifestations of patients with UA, but there is lack of rigorous proof of evidence-based medicine. This trial aims to further evaluate the efficacy of LFN-G in the treatment of UA. METHODS: A prospective, open-label, randomized, placebo-controlled clinical will be performed. A total of 60 patients diagnosed with UA will be randomly allocated to either the treatment group or the control group with a 1:1 ratio. The participants in the treatment group will receive LFN-G treatment and the participants in the control group will receive placebo. Meanwhile, both groups continue to undergo standard western medicine treatments. The duration of interventions is 4 weeks. The primary endpoint is the incidence of major cardiac adverse events, defined as a composite of recurrent angina, acute myocardial infarction (AMI), severe arrhythmia, heart failure, and cardiac death. Secondary outcomes include Seattle angina scale score, Chinese medicine syndromes and electrocardiograph (at weeks 0, 1, 2, 4), myocardial nuclides perfusion, measurement of wall motion score index and left ventricular ejection fraction, serum inflammation factors such as C-reactive protein, high sensitive-C-reactive protein, interleukin-6, matrix metalloproteinase-9, and so on (at weeks 0, 4). In addition, some biochemical indexes of blood and hematological indexes will be used to assess the safety of treatments. Any adverse effects of the treatment will be recorded. DISCUSSION: The results of this trial will provide compelling evidence of the efficacy and safety of LFN-G for treatment of UA and preliminarily reveal the potential mechanism of how LFN-G acts. Finally, it will widen treatment options for patients with UA.

Characteristics, Risk Factors, and Adverse Outcomes of Hyperkalemia in Acute-on-Chronic Liver Failure Patients.

BACKGROUND: Hyperkalemia is a serious complication in cirrhotic patients. However, the clinical characteristics, risk factors, and its impact on the outcomes in acute-on-chronic liver failure (ACLF) patients remain unclear. METHODS: We retrospectively recruited 650 ACLF patients in this study. The risk factors associated with hyperkalemia and its relationship with 90-day mortality were analyzed using multivariable regression models. RESULTS: Among 650 patients with ACLF, 12.2% (79/650) had hyperkalemia during hospitalization. Higher admission serum potassium levels and the presence of acute kidney injury (AKI) were independent risk factors for hyperkalemia. The prevalence rates of hyperkalemia in patients with and without AKI were 23.6% and 4.6%, respectively (P<0.001). Hyperkalemia was a predictor of mortality in AKI and non-AKI patients. The 90-day mortality rates in non-AKI patients with and without hyperkalemia were 44.4% and 24.7%, respectively (P<0.001), and in AKI patients with and without hyperkalemia were 80.3% and 56.6%, respectively (P<0.001). Hepatic encephalopathy (HE), gastrointestinal bleeding, AKI, hyperkalemia, elevated total bilirubin (TBIL) and international normalized ratio (INR) values, and higher Model for End-Stage Liver Disease (MELD) and chronic liver failure-sequential organ failure assessment (CLIF-SOFA) scores were independent risk factors for predicting the 90-day mortality in ACLF patients. CONCLUSIONS: Hyperkalemia increases the 90-day mortality in ACLF patients; hyperkalemia is associated with AKI. Patients with both AKI and hyperkalemia had the worst outcome.