Objective:To evaluate the clinical efficacy and safety of Xueshuantong Injection(Lyophilized)(XST)in reducing residual inflammatory risk(RIR)in patients with unstable angina(UA).Methods:This was a randomized,double-bl...Objective:To evaluate the clinical efficacy and safety of Xueshuantong Injection(Lyophilized)(XST)in reducing residual inflammatory risk(RIR)in patients with unstable angina(UA).Methods:This was a randomized,double-blind,parallel-controlled multicenter trial.Patients with UA were recruited from Xiyuan Hospital and Guang'anmen Hospital of the China Academy of Chinese Medical Sciences between January 2024 and March 2025.Eligible participants were randomly assigned to the treatment group(XST 500 mg,30 cases)or the control group(XST 25 mg,30 cases)in a 1:1 ratio.Both groups received intravenous XST for 10 consecutive days along with standard medical therapy.The primary outcome was change in C-reactive protein(CRP)level from baseline to post-treatment.Secondary outcomes included changes in interleukin-6(IL-6),matrix metalloproteinase-9(MMP-9),high-mobility group box 1(HMGB1),vascular endothelial growth factor(VEGF),and von Willebrand factor(vWF),as well as the Canadian Cardiovascular Society(CCS)classification,and Chinese Medicine(CM)syndrome scores.Safety was evaluated by monitoring adverse event(AE)and performing laboratory tests of liver and kidney function before and after treatment.Results:A total of 59 patients completed the trial(30 in the treatment group and 29 in the control group).After treatment,the treatment group showed significantly greater reductions in CRP levels compared to the control group(P<0.01).In addition,the treatment group exhibited significantly improved IL-6,MMP-9,and HMGB1 levels,as well as CM symptom scores and CCS classification compared to the control group(all P<0.05).No serious adverse events were reported.Compared with the control group,the treatment group receiving XST showed greater improvements in RIR and clinical symptoms in UA patients with good safety and tolerability.Conclusion:XST shows potential to reduce RIR in patients with UA and may inform anti-inflammatory management.(Registration No.ITMCTR2025000552).展开更多
基金Supported by the Beijing Traditional Chinese Medicine Science and Technology Development Fund Project(No.BJZYYB-2023-53)the Capital Health Development Research Special Fund(No.2024-2-4173)。
文摘Objective:To evaluate the clinical efficacy and safety of Xueshuantong Injection(Lyophilized)(XST)in reducing residual inflammatory risk(RIR)in patients with unstable angina(UA).Methods:This was a randomized,double-blind,parallel-controlled multicenter trial.Patients with UA were recruited from Xiyuan Hospital and Guang'anmen Hospital of the China Academy of Chinese Medical Sciences between January 2024 and March 2025.Eligible participants were randomly assigned to the treatment group(XST 500 mg,30 cases)or the control group(XST 25 mg,30 cases)in a 1:1 ratio.Both groups received intravenous XST for 10 consecutive days along with standard medical therapy.The primary outcome was change in C-reactive protein(CRP)level from baseline to post-treatment.Secondary outcomes included changes in interleukin-6(IL-6),matrix metalloproteinase-9(MMP-9),high-mobility group box 1(HMGB1),vascular endothelial growth factor(VEGF),and von Willebrand factor(vWF),as well as the Canadian Cardiovascular Society(CCS)classification,and Chinese Medicine(CM)syndrome scores.Safety was evaluated by monitoring adverse event(AE)and performing laboratory tests of liver and kidney function before and after treatment.Results:A total of 59 patients completed the trial(30 in the treatment group and 29 in the control group).After treatment,the treatment group showed significantly greater reductions in CRP levels compared to the control group(P<0.01).In addition,the treatment group exhibited significantly improved IL-6,MMP-9,and HMGB1 levels,as well as CM symptom scores and CCS classification compared to the control group(all P<0.05).No serious adverse events were reported.Compared with the control group,the treatment group receiving XST showed greater improvements in RIR and clinical symptoms in UA patients with good safety and tolerability.Conclusion:XST shows potential to reduce RIR in patients with UA and may inform anti-inflammatory management.(Registration No.ITMCTR2025000552).
