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

DOI: 10.12201/bmr.202606.00063

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  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

  Submit time: 20 June 2026

  Copyright: The copyright holder for this preprint is the author/funder, who has granted biomedRxiv a license to display the preprint in perpetuity.
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