麝香保心丸（MUSKARDIA）治疗稳定型冠心病合并糖尿病患者的有效性和安全性：一项随机临床试验的亚组分析。
Effectiveness and safety of Shexiang Baoxin Pill (MUSKARDIA) in patients with stable coronary artery disease and concomitant diabetes mellitus: a subgroup analysis of a randomized clinical trial.
机构信息
Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Department of Cardiology, Huashan Hospital, Fudan University, Shanghai 200040, China.
出版信息
Chin Med J (Engl). 2023 Jan 5;136(1):82-87. doi: 10.1097/CM9.0000000000002527.
BACKGROUND
Preliminary studies have indicated that Shexiang Baoxin Pill (MUSKARDIA) has a coronary artery dilation effect and increases the coronary blood flow, relieving the symptoms of angina. This study aimed to evaluate the benefit of MUSKARDIA on patients with stable coronary artery disease (CAD) and diabetes mellitus (DM).
METHODS
This was a subgroup analysis of a multicenter, randomized, placebo-controlled phase IV trial. CAD patients with a medical history of DM or baseline fasting blood glucose (FBG) ≥7.0 mmol/L were grouped according to the treatment (standard therapy plus MUSKARDIA or placebo). The primary outcome was major adverse cardiovascular events (MACEs), which was the composite outcome of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. The secondary outcome was the composite outcome of all-cause death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for unstable angina or heart failure, and coronary angioplasty.
RESULTS
MACEs occurred in 2.6% (9/340) and 4.8% (18/376) of patients in the MUSKARDIA and placebo groups, respectively ( P = 0.192). Secondary composite outcome was significantly less frequent with MUSKARDIA than with placebo (15.3% [52/340] vs . 22.6% [85/376], P = 0.017). Risk of MACEs (hazard ratio [HR] = 0.69, 95% confidence interval [CI]: 0.31-1.57) was comparable between two groups. In patients with uncontrolled DM (≥4 measurements of FBG ≥7 mmol/L in five times of follow-up), the risk of secondary outcome was significantly lower with MUSKARDIA (5/83, 6.0%) than with placebo (15/91, 16.5%) (HR = 0.35, 95%CI: 0.13-0.95).
CONCLUSION
As an add-on to standard therapy, MUSKARDIA shows a trend of reduced MACEs in patients with stable CAD and DM. Furthermore, MUSKARDIA may reduce the frequency of all-cause death, hospitalization, and coronary angioplasty in this population, especially in those with uncontrolled DM.
TRIAL REGISTRATION
ChiCTR.org.cn, ChiCTR-TRC-12003513.
背景
初步研究表明麝香保心丸（MUSKARDIA）具有扩张冠状动脉和增加冠状动脉血流量的作用，可缓解心绞痛症状。本研究旨在评估麝香保心丸对稳定型冠状动脉疾病（CAD）合并糖尿病（DM）患者的获益。
方法
这是一项多中心、随机、安慰剂对照的 IV 期试验的亚组分析。根据治疗（标准治疗加麝香保心丸或安慰剂），将有 DM 病史或基线空腹血糖（FBG）≥7.0mmol/L 的 CAD 患者分为两组。主要终点是主要不良心血管事件（MACEs），即心血管死亡、非致死性心肌梗死和非致死性卒中的复合终点。次要终点是全因死亡、非致死性心肌梗死、非致死性卒中、不稳定型心绞痛或心力衰竭住院以及冠状动脉介入治疗的复合终点。
结果
麝香保心丸组和安慰剂组分别有 2.6%（9/340）和 4.8%（18/376）的患者发生 MACEs（P=0.192）。麝香保心丸组的次要复合终点发生率明显低于安慰剂组（15.3%[52/340]比 22.6%[85/376]，P=0.017）。两组间 MACEs 的风险（风险比[HR]为 0.69，95%置信区间[CI]：0.31-1.57）相当。在未控制的 DM 患者（5 次随访中 FBG 有≥4 次≥7mmol/L）中，麝香保心丸组的次要终点发生率（5/83，6.0%）明显低于安慰剂组（15/91，16.5%）（HR 为 0.35，95%CI：0.13-0.95）。
结论
作为标准治疗的附加治疗，麝香保心丸可降低稳定型 CAD 合并 DM 患者的 MACEs 风险。此外，麝香保心丸可能降低此类患者的全因死亡、住院和冠状动脉介入治疗的频率，特别是在未控制的 DM 患者中。
试验注册
ChiCTR.org.cn，ChiCTR-TRC-12003513。
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