通讯作者: <p>马文萍, 664387609@qq.com

DOI：10.12201/bmr.202606.00063

A retrospective cohort study of tanshinone capsules combined with low-dose isotretinoin soft capsules for moderate-to-severe acne with phlegm-dampness and blood-stasis syndrome

• 摘要：目的 探讨丹参酮胶囊联合小剂量异维A酸软胶囊治疗痰湿瘀结型中重度痤疮的效果及安全性。方法 回顾性收集2024年1月1日至2025年6月30日福建医科大学附属福州市第一总医院皮肤科门诊痰湿瘀结型中重度痤疮患者91例，按实际治疗方案分为对照组40例和观察组51例。对照组予小剂量异维A酸软胶囊联合2%夫西地酸乳膏治疗，观察组在此基础上加用丹参酮胶囊，疗程均为12周。比较两组皮损评分、中医证候总积分、痤疮特异性生活质量量表总分及不良反应。结果 治疗12周后，观察组结节囊肿评分下降幅度大于对照组-2（-2，-1）分比-1（-2，-1）分，组间差异估计值=-0.609，95%CI：-0.913～-0.308，P<0.001；中医证候总积分下降幅度更大-12（-13，-11）分比-10（-11，-9）分，P<0.001；生活质量总分提升幅度更高（30.5±10.4）分比（19.9±7.6）分，P<0.001。两组不良反应总发生率比较差异无统计学意义（29.4%比32.5%，P=0.751），可追溯记录中未见严重不良事件。结论 小剂量异维A酸软胶囊联合丹参酮胶囊治疗痰湿瘀结型中重度痤疮，在12周观察期内与皮损、证候及生活质量改善幅度较大相关，且未观察到明显额外安全性信号。受回顾性非随机分组设计限制，仍需前瞻性研究进一步验证。

  关键词： 痤疮；异维A酸软胶囊；丹参酮胶囊；痰湿瘀结证；回顾性队列研究; ; ; ; 

   

  Abstract: Objective To investigate the effectiveness and safety of tanshinone capsules combined with low-dose isotretinoin soft capsules in the treatment of moderate-to-severe acne with phlegm-dampness and blood-stasis syndrome.Methods Clinical data of 91 patients with moderate-to-severe acne with phlegm-dampness and blood-stasis syndrome who attended the dermatology outpatient clinic of Fuzhou First General Hospital Affiliated with Fujian Medical University from January 1, 2024 to June 30, 2025 were retrospectively collected. According to the actual treatment regimen, 40 patients were assigned to the control group and 51 patients to the observation group. The control group received low-dose isotretinoin soft capsules combined with topical 2% fusidic acid cream, while the observation group additionally received tanshinone capsules. Both groups were treated for 12 weeks. Lesion scores, traditional Chinese medicine syndrome score, total Acne-Specific Quality of Life Questionnaire score, and adverse reactions were compared between the two groups.Results After 12 weeks of treatment, the reduction in nodulocystic lesion score was greater in the observation group than in the control group -2 (-2, -1) points vs. -1 (-2, -1) points; between-group difference estimate=-0.609, 95%CI: -0.913 to -0.308, P<0.001. The reduction in total traditional Chinese medicine syndrome score was also greater in the observation group -12 (-13, -11) points vs. -10 (-11, -9) points, P<0.001. The increase in total quality-of-life score was higher in the observation group than in the control group (30.5±10.4) points vs. (19.9±7.6) points, P<0.001. There was no statistically significant difference in the overall incidence of adverse reactions between the two groups (29.4% vs. 32.5%, P=0.751), and no serious adverse events were identified in the traceable records.Conclusion In patients with moderate-to-severe acne with phlegm-dampness and blood-stasis syndrome, low-dose isotretinoin soft capsules combined with tanshinone capsules was associated with greater improvements in lesion severity, traditional Chinese medicine syndrome score, and acne-related quality of life during the 12-week observation period, without an obvious additional safety signal. Owing to the retrospective non-randomized design, further prospective studies are needed for verification.

  Key words: Acne; Isotretinoin soft capsules; Tanshinone capsules; Phlegm-dampness and blood-stasis syndrome; Retrospective cohort study

  提交时间：2026-06-20

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• 序号	提交日期	编号	操作
  1	2026-06-04	10.12201/bmr.202606.00063V1	下载

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