Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, No. 16 Nanxiaojie, Dongzhimen Nei, Beijing, 100700, China.
Department of Cardiology, The First Hospital of Changsha, No.311 Yingpan Road, Changsha, 410005, Hunan, China.
J Ethnopharmacol. 2022 Feb 10;284:114794. doi: 10.1016/j.jep.2021.114794. Epub 2021 Oct 31.
Danhong injection (DHI)，which is extracted from Salviae miltiorrhizae and Flos carthami，has been widely prescribed to patients with unstable angina pectoris (UAP) in China. However, a high quality clinical trial is needed.
To determine whether DHI can relieve symptoms of transient myocardial ischemia in patients with unstable angina pectoris.
A double-blind, placebo-controlled, randomized clinical trial was conducted in nine hospitals in China. Inpatients with UAP with blood stasis syndrome (BSS) were randomized 1:1 to receive DHI or placebo. The primary outcome was improvement rate in the quantification score of angina pectoris. Secondary outcomes included blood stasis syndrome scale, nitrates use, electrocardiogram recordings, PCI procedures, Seattle Angina Questionnaire (SAQ) and biochemical indexes.
160 participants were enrolled and 159 were analyzed. There was no significant difference in primary outcome as compared with control group at the end of 7-day treatment, but significant difference at 28-day follow up (70.53% [95% CI, 59.97-81.09%] and 54.34% [95% CI, 42.68-65.99%]; P = 0.0423). The BSS score was significantly lower in the DHI group than that in the control group at day 28 (6.49 [6.96] vs 10.53 [9.07], P = 0.0034). In addition, DHI was significantly superior to placebo in the angina stability score of SAQ (91.10 [17.37] versus 78.21 [22.08], P < 0.001). There were no significant differences in other secondary outcome measures.
A small decrease in the total effective rate and an increase in the angina stability score were observed 28 days after implementation of DHI in UAP with a total blood stasis syndrome score decrease, but the efficacy was not observed at day 7. The findings support that DHI may potentially relieve clinical symptoms and can benefit angina stability.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT02007187.
丹红注射液（DHI）是从丹参和红花中提取的，已广泛用于中国不稳定型心绞痛（UAP）患者的治疗。然而，仍需要高质量的临床试验来进一步验证。
确定丹红注射液是否能缓解不稳定型心绞痛患者短暂性心肌缺血的症状。
在中国九家医院进行了一项双盲、安慰剂对照、随机临床试验。将符合血瘀证的 UAP 住院患者按 1:1 随机分配至丹红注射液或安慰剂组。主要结局为心绞痛量化评分的改善率。次要结局包括血瘀证量表、硝酸酯类药物使用、心电图记录、PCI 程序、西雅图心绞痛问卷（SAQ）和生化指标。
共纳入 160 名参与者，其中 159 名完成分析。与对照组相比，在 7 天治疗结束时，主要结局无显著差异，但在 28 天随访时差异显著（70.53%[95%CI，59.97-81.09%]和 54.34%[95%CI，42.68-65.99%]；P=0.0423）。DHI 组在第 28 天的血瘀证评分显著低于对照组（6.49[6.96]与 10.53[9.07]，P=0.0034）。此外，DHI 在 SAQ 的心绞痛稳定评分方面明显优于安慰剂（91.10[17.37]与 78.21[22.08]，P<0.001）。其他次要结局指标无显著差异。
在 UAP 血瘀证总积分降低的情况下，实施丹红注射液治疗 28 天后，总有效率略有下降，心绞痛稳定评分增加，但在第 7 天未观察到疗效。研究结果支持丹红注射液可能具有缓解临床症状和改善稳定性的潜力。
