ObjectTo observe the clinical efficacy and safety of the combination therapy of atorvastatin and JiangZhi Decoction (ZJD) for primary hyperlipidemia (Tan Zhuo Zu E Zheng) and to analyze the interactions of drugs in hypolipidemic effect. MethodsA 2*2 factorial design, single-blind, stratified randomized controlled trial according to the level of lipid was conducted. Primary hyperlipidemia (Tan Zhuo Zu E Zheng) patients met the inclusion criteria were divided into 5 groups:ATV 10 mg group (group A), ATV 20 mg group (group B), ATV 10 mg+JZD group (group C), ATV 20 mg+JZD group (group D), JZD group (group E). After two weeks treatment, the efficacy and safety among the 5 groups were compared. ResultsA total of 92 patients were included, of which, 20 were in group A, 25 in group B, 21 in group C, 17 in group D, and 9 in group E. The results showed that:(1) There was no significant difference between group C and group B in the reduction of serum total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) (PTC=0.226, PLDL-C=0.818). (2) The results of 2*2 factorial analysis showed that, there was no significant interaction between TCM factor and western medicine factor (PTC=0.605, PLDL-C=0.843). (3) There were no significant differences in safety outcomes among 5 groups (all P values >0.05). ConclusionATV 10 mg+JZD and ATV 20 mg have a similar efficacy in reducing TC and LDL-C. There is no obvious interaction between JZD and ATV in hypolipidemic effect, and the combination therapy of ATV and JZD is safe.
Objective To analyze the characteristics and risk factors of hemorrhagic adverse events (AEs) associated with selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). Methods AEs reports with SSRIs/SNRIs as the primary suspected (PS) drugs from the first quarter of 2009 to the third quarter of 2024 in the FAERS database were extracted. Hemorrhagic AEs reports were screened using the MedDRA standard terminology (SMQ). Descriptive statistics were used to analyze patient characteristics, and signal detection was performed using the reporting odds ratio (ROR), proportional reporting ratio (PRR), and the polynomial gamma Poisson distribution reduction method (MGPS). Multiplicative and additive models were used to assess the interaction risk with antiplatelet/anticoagulant drugs. Results A total of 5 073 reports of hemorrhagic AEs associated with SSRIs (6.5%) and 2 740 reports related to SNRIs (4.1%) were included. The proportion of patients aged ≥65 years (P<0.001), the time-to-onset >90 days (P<0.001), reports from healthcare professionals (P<0.001), and serious adverse events (P<0.001) were higher. The gastrointestinal tract and central nervous system were the main bleeding sites for SSRIs, among which sertraline had the most signals for gastrointestinal adverse events, while the central nervous system had the fewest. All positive signals for SNRIs were associated with venlafaxine. Among AEs of various SSRIs/SNRIs combined with other drugs, the proportion of hemorrhagic AEs was higher in the combination with antiplatelet or anticoagulant drugs (P<0.001). Conclusion Hemorrhagic adverse events associated with SSRIs/SNRIs are mostly severe. In clinical practice, it is essential to implement proper pharmaceutical care, focusing on the bleeding risks associated with SSRIs/SNRIs use in elderly patients, those on long-term medication regimens, and patients concurrently using anticoagulants. Individualized medication regimens should be implemented based on the patient's underlying diseases and drug characteristics.