Objective To investigate the efficacy and safety of isotretinoin combined with Qingre Sanjie tablets in the treatment of moderate to severe acne.

Methods A retrospective analysis was conducted on the clinical data of patients with moderate to severe acne who treated in the Department of Dermatology of Zhejiang Dermatology Hospital from January 2022 to December 2024. According to the treatment regimen, patients were divided into the observation group (isotretinoin + Qingre Sanjie Tablets) and the control group (isotretinoin). The lesion severity, erythema, porphyrins, and dermal hemoglobin index were compared between the two groups before and after treatment.

Results A total of 100 patients with moderate to severe acne were included, with 50 cases in each group. After treatment, the observation group showed significantly higher improvements in the Global Acne Grading System score (12.38±4.21 vs. 8.15±3.76), the effective rate of inflammatory lesion remission (84.00% vs. 60.00%), and patient satisfaction (86.00% vs. 64.00%) than the control group, with all differences being statistically significant (P<0.05). Additionally, the observation group achieved superior improvements in dermal hemoglobin index, porphyrin level and erythema area compared with the control group, and the differences were statistically significant (P<0.05). There was no significant difference in the incidence of adverse reactions between the two groups (12.00% vs. 26.00%, P=0.074).

Conclusion Isotretinoin combined with Qingre Sanjie tablets is superior to isotretinoin alone in promoting lesion resolution and improving objective skin indicatros in moderate to severe acne within an 8-week treatment course, with a favorable safety profile.

1. 茶渝斯, 吴文娟, 何黎. 痤疮不同皮损内微生物组学分析[J]. 中国皮肤性病学杂志, 2025, 39(4): 386-393.ChaYS, WuWJ, HeL. Microbial community analysis of different acne lesions[J]. Chinese Journal of Dermatology and Venereology, 2025, 39(4): 386-393. DOI: 10.13735/j.cjdv.1001-7089.202411045.

2. 马琳, 王楚婷, 张勇. 治疗寻常痤疮新药:trifarotene[J].中国新药与临床杂志, 2024, 43(11): 820-824.MaL, WangCT, ZhangY. New drug for the treatment of acne vulgaris: trifarotene[J]. Chinese Journal of New Drugs and Clinical Remedies, 2024, 43(11): 820-824. DOI: 10.14109/j.cnki.xyylc.2024.11.04.

3. 陈默, 赵亚. 油性皮肤和皮脂分泌的调节[J]. 日用化学品科学, 2013, 36(11): 32-34. DOI: 10.13222/j.cnki.dc.2013.11.015.

4. 张长宋, 陈树民. 毛囊角化过度在痤疮发病机制中的作用[J]. 中国麻风皮肤病杂志, 2002, 18(1): 46-48. DOI: 10.3969/j.issn.1009-1157.2002.01.030.

5. 姜晓可, 梁丽丽. 寻常痤疮中的微生态机制研究[J].中国微生态学杂志, 2024, 36(2): 245-248.JiangXK, LiangLL. Microecological mechanism in acne vulgaris[J]. Chinese Journal of Microecology, 2024, 36(2): 245-248. DOI: 10.13381/j.cnki.cjm.202402020.

6. 李东影, 孙娅楠, 杨伟峰, 等. 痤疮丙酸杆菌系统发育型及其在痤疮发病中作用研究进展[J]. 临床皮肤科杂志, 2022, 51(12): 757-761.LiDY, SunYN, YangWF, et al. Advances in phylotype and pathogenicity of Cutibacterium acnes and its correlation with acne[J]. Journal of Clinical Dermatology, 2022, 51(12): 757-761. DOI: 10.16761/j.cnki.1000-4963.2022.12.019.

7. 李军友, 刘白, 吴瑾. 痤疮治疗研究进展[J]. 中国麻风皮肤病杂志, 2025, 41(7): 533-537.LiJY, LiuB, WuJ. Research progress on acne treatment[J]. Chinese Journal of Leprosy and Dermatology, 2025, 41(7): 533-537. DOI: 10.12144/zgmfskin202507533.

8. 潘廷猛, 王鑫, 陈雪路, 等. 小剂量异维A酸与多西环素治疗中重度丘疹脓疱性玫瑰痤疮的临床对照研究[J]. 临床皮肤科杂志, 2023, 52(1): 53-57.PanTM, WangX, ChenXL, et al. Clinical comparative study of low-dose isotretinoin and doxycycline in the treatment of moderate to severe papulopustular rosacea[J]. Journal of Clinical Dermatology, 2023, 52(1): 53-57. DOI: 10.16761/j.cnki.1000-4963.2023.01.017.

9. MelnikBC. Acne transcriptomics: fundamentals of acne pathogenesis and isotretinoin treatment[J]. Cells, 2023, 12(22): 2600. DOI: 10.3390/cells12222600.

10. BagatinE, CostaCS. The use of isotretinoin for acne-an update on optimal dosing, surveillance, and adverse effects[J]. Expert Rev Clin Pharmacol, 2020, 13(8): 885-897. DOI: 10.1080/17512433.2020.1796637.

11. 殷桃, 徐永梓, 谢艳秋. 口服异维A酸联合中医药治疗痤疮的研究进展[J]. 中国中西医结合皮肤性病学杂志, 2024, 23(1): 92-95.YinT, XuYZ, XieYQ. Research progress on oral isotretinoin combined with traditional chinese medicine in the treatment of acne[J]. Chinese Journal of Integrative Dermatology and Venereology, 2024, 23(1): 92-95. DOI: 10.3969/j.issn.1672-0709.2024.01.027.

12. 丁娟, 张建青, 陈宏. 清热散结片联合异维A酸软胶囊、克拉霉素缓释片治疗寻常型痤疮的临床效果及对血清IL-17的影响[J]. 中华中医药学刊, 2021, 39(5): 67-69.DingJ, ZhangJQ, ChenH. Clinical efficacy of Qingre Sanjie tablets combined with isotretinoin soft capsules and clarithromycin sustained-release tablets in the treatment of acne vulgaris and their effect on serum IL-17[J]. Chinese Journal of Traditional Chinese Medicine, 2021, 39(5): 67-69. DOI: 10.13193/j.issn.1673-7717.2021.05.018.

13. 杨静, 陈仁康. 清热散结胶囊联合异维A酸软胶囊治疗中、重度痤疮的疗效观察[J]. 现代药物与临床, 2016, 31(1): 75-78.YangJ, ChenRK. Clinical observation on the therapeutic effect of qingre sanjiecapsules combined with isotretinoin soft capsules in the treatment of moderate to severe acne[J]. Modern Drugs and Clinical, 2016, 31(1): 75-78. DOI: 10.7501/j.issn.1674-5515.2016.01.018.

14. 朱颖, 曹玉, 蒋健, 等. 清热散结片/胶囊的研究现状及探讨[J]. 中国医药科学, 2023, 13(8): 39-42.ZhuY, CaoY, JiangJ, et al. Current research status and discussion on Qingre Sanjie Tablets/Capsules[J]. China Medicine and Pharmacy, 2023, 13(8): 39-42. DOI: 10.27282/d.cnki.gsdzu.2020.000314.

15. 胡冰洁. 清热散结方治疗寻常痤疮瘀热互结证临床疗效观察及其对血清SOD水平的影响[D]. 济南: 山东中医药大学, 2020.HuBJ. Clinical observation on the efficacy of Qingre Sanjie Decoction in treating acne with the syndrome of blood-heat stagnation and its effect on serum SOD levels[D]. Jinan: Shandong University of Traditional Chinese Medicine, 2020. DOI: 10.3969/j.issn.2095-0616.2023.08.012.

16. SungkhasunyaP, AsawanondaP, KumtornrutC. Efficacy and safety of fish oil supplementation combined with low-dose isotretinoin for moderate-to-severe acne vulgaris: A randomized controlled non-inferiority trial[J]. J Am Acad Dermatol, 2026, 95(2): 416-422. DOI: 10.1016/j.jaad.2026.03.001.