麝香通心滴丸改善痰热血瘀证稳定性心绞痛患者：一项多中心、随机、双盲、安慰剂对照试验。
Shexiang Tongxin Dropping Pill Improves Stable Angina Patients with Phlegm-Heat and Blood-Stasis Syndrome: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.
作者信息
Zhao Ying-Qiang, Xing Yong-Fa, Zou Ke-Yong, Jiang Wei-Dong, Du Ting-Hai, Chen Bo, Yang Bao-Ping, Qu Bai-Ming, Wang Li-Yue, Gong Gui-Hong, Sun Yan-Ling, Wang Li-Qi, Zhou Gao-Feng, Dong Yu-Gang, Chen Min, Zhang Xue-Juan, Yang Tian-Lun, Zhang Min-Zhou, Zhao Ming-Jun, Deng Yue, Xiao Chang-Jiang, Wang Lin, Wang Bao-He
机构信息
Department of Cardiology, the Second Affiliated Hospital of Tianjin University of Chinese Medicine, Tianjin, 300143, China.
Department of Cardiology, Nanshi Hospital of Nanyang, Nanyang, Henan Province, 473000, China.
出版信息
Chin J Integr Med. 2025 Jun 13. doi: 10.1007/s11655-025-4014-7.
OBJECTIVE
To evaluate the efficacy and safety of Shexiang Tongxin Dropping Pill (STDP) in treating stable angina patients with phlegm-heat and blood-stasis syndrome by exercise duration and metabolic equivalents.
METHODS
This multicenter, randomized, double-blind, placebo-controlled clinical trial enrolled stable angina patients with phlegm-heat and blood-stasis syndrome from 22 hospitals. They were randomized 1:1 to STDP (35 mg/pill, 6 pills per day) or placebo for 56 days. The primary outcome was the exercise duration and metabolic equivalents (METs) assessed by the standard Bruce exercise treadmill test after 56 days of treatment. The secondary outcomes included the total angina symptom score, Chinese medicine (CM) symptom scores, Seattle Angina Questionnaire (SAQ) scores, changes in ST-T on electrocardiogram and adverse events (AEs).
RESULTS
This trial enrolled 309 patients, including 155 and 154 in the STDP and placebo groups, respectively. STDP significantly prolonged exercise duration with an increase of 51.0 s, compared to a decrease of 12.0 s with placebo (change rate: -11.1% vs. 3.2%, P<0.01). The increase in METs was significantly greater in the STDP group than in the placebo group (change: -0.4 vs. 0.0, change rate: -5.0% vs. 0.0%, P<0.01). The improvement of total angina symptom scores (25.0% vs. 0.0%), CM symptom scores (38.7% vs. 11.8%), reduction of nitroglycerin consumption (100.0% vs. 11.3%), and all domains of SAQ, were significantly greater with STDP than placebo (all P<0.01). The changes in Q-T intervals at 28 and 56 days from baseline were similar between the two groups (both P>0.05). Twenty-five participants (16.3%) with STDP and 16 (10.5%) with placebo experienced AEs (P=0.131), with no serious AEs observed.
CONCLUSION
STDP could improve exercise tolerance in patients with stable angina and phlegm-heat and blood stasis syndrome, with a favorable safety profile. (Registration No. ChiCTR-IPR-15006020).
目的
通过运动持续时间和代谢当量评估麝香通心滴丸（STDP）治疗痰热瘀血证稳定型心绞痛患者的有效性和安全性。
方法
这项多中心、随机、双盲、安慰剂对照的临床试验纳入了来自22家医院的痰热瘀血证稳定型心绞痛患者。他们以1:1的比例随机分为STDP组（35毫克/丸，每日6丸）或安慰剂组，治疗56天。主要结局是治疗56天后通过标准Bruce运动平板试验评估的运动持续时间和代谢当量（METs）。次要结局包括总心绞痛症状评分、中医症状评分、西雅图心绞痛问卷（SAQ）评分、心电图ST-T段变化以及不良事件（AE）。
结果
本试验共纳入309例患者，STDP组和安慰剂组分别为155例和154例。与安慰剂组运动持续时间减少12.0秒相比，STDP组显著延长运动持续时间达51.0秒（变化率：-11.1%对3.2%，P<0.01）。STDP组METs的增加显著大于安慰剂组（变化：-0.4对0.0，变化率：-5.0%对0.0%，P<0.01）。与安慰剂组相比，STDP组总心绞痛症状评分的改善（25.0%对0.0%）、中医症状评分的改善（38.7%对11.8%）、硝酸甘油消耗量的减少（100.0%对11.3%）以及SAQ的所有领域均显著更优（均P<0.01）。两组从基线起28天和56天的Q-T间期变化相似（均P>0.05）。STDP组25名参与者（16.3%）和安慰剂组16名参与者（10.5%）发生不良事件（P=0.131），未观察到严重不良事件。
结论
STDP可改善痰热瘀血证稳定型心绞痛患者的运动耐量，安全性良好。（注册号：ChiCTR-IPR-15006020）
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