丹参酮胶囊治疗寻常痤疮的疗效与安全性：一项系统评价和Meta分析
Efficacy and safety of Tanshinone capsule in Acne vulgaris: a systematic review and meta-analysis.
作者信息
Deng Yutong, Feng Ruli, Hu Bo, Ren Xuewen, Zhang Fengchuan, Feng Huishang, Wang Xuewan, Li Yatong, Liu Tangyunni, Cai Lingling, Li Yuanwen
机构信息
Beijing University of Chinese Medicine, Beijing, China.
Department of Dermatology, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.
出版信息
Front Pharmacol. 2025 Mar 31;16:1520039. doi: 10.3389/fphar.2025.1520039. eCollection 2025.
OBJECTIVES
To evaluate the efficacy and safety of Tanshinone capsule as a complementary therapy in managing of Acne Vulgaris.
METHODS
A systematic search of six databases was conducted to identify relevant randomized controlled trials (RCTs) from each database for nearly 20 years (from 1 Jan 2004, to 1 June 2024). The Cochrane Handbook was used to evaluate the risk of bias. Meta-analysis was performed using Review Manager 5.4.1, and publication bias was assessed the Stata SE 12.0 software. GRADEpro was used to assess the quality of the evidence.
RESULTS
A total of 2,969 participants from 28 studies were included. We found that Tanshinone capsules can reduce acne recurrence rates [risk ratio () 0.44, 95% confidence interval (CI): 0.34 to 0.57, < 0.00001]; downregulate levels of necrosis factor-alpha (TNF-α) [ mean difference () 0.44, -10.18, 95% CI: -13.57 to -8.04, < 0.00001], interleukin (IL) 4 ( -6.46, 95%CI: -7.14 to -5.77, < 0.00001), IL-6 ( -16.14, 95%CI: -30.10 to -2.18, = 0.02), IL-8 ( -4.48, 95%CI: -8.30 to -0.65, = 0.02) and testosterone ( -14.50, 95%CI: -17.59 to -11.40, < 0.00001); lower Global Acne Grading System (GAGS) score ( -4.71, 95%CI: -7.62 to -1.80, = 0.002); decrease sebum secretion rates ( -0.29, 95%CI: -0.49 to -0.10, = 0.003), but the regulation of Luteinizing hormone (LH), Follicle-stimulating hormone (FSH), Estradiol (E) is not obvious. In terms of safety, the incidence of adverse events in the experimental group was less than that in the control group ( 0.70, 95%CI: 0.56 to 0.87, = 0.001). The Begg test and Egger test results indicated no publication bias. Furthermore, the levels of evidence ranged from very low to moderate due to risk of bias and heterogeneity.
CONCLUSION
Tanshinone capsules can relieve the symptoms of acne vulgaris, regulate inflammatory cytokines and hormone levels in patients, and reduce recurrence. However, due to the limitations of this study, more multi-center and large-sample studies are needed to confirm these conclusions.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024562320, identifier CRD42024562320.
目的
评估丹参酮胶囊作为辅助疗法治疗寻常痤疮的疗效和安全性。
方法
对六个数据库进行系统检索，以识别每个数据库中近20年（从2004年1月1日至2024年6月1日）的相关随机对照试验（RCT）。使用Cochrane手册评估偏倚风险。使用Review Manager 5.4.1进行荟萃分析，并使用Stata SE 12.0软件评估发表偏倚。使用GRADEpro评估证据质量。
结果
共纳入28项研究的2969名参与者。我们发现丹参酮胶囊可降低痤疮复发率[风险比（RR）0.44，95%置信区间（CI）：0.34至0.57，P<0.00001]；下调肿瘤坏死因子-α（TNF-α）水平[平均差（MD）0.44，-10.18，95%CI：-13.57至-8.04，P<0.00001]、白细胞介素（IL）4（MD -6.46，95%CI：-7.14至-5.77，P<0.00001）、IL-6（MD -16.14，95%CI：-30.10至-2.18，P = 0.02）、IL-8（MD -4.48，95%CI：-8.30至-0.65，P = 0.02）和睾酮（MD -14.50，95%CI：-17.59至-11.40，P<0.00001）；降低全球痤疮分级系统（GAGS）评分（MD -4.71，95%CI：-7.62至-1.80，P = 0.002）；降低皮脂分泌率（MD -0.29，95%CI：-0.49至-0.10，P = 0.003），但对促黄体生成素（LH）、促卵泡生成素（FSH）、雌二醇（E）的调节不明显。在安全性方面，试验组不良事件发生率低于对照组（RR 0.70，95%CI：0.56至0.87，P = 0.001）。Begg检验和Egger检验结果表明无发表偏倚。此外，由于存在偏倚风险和异质性，证据水平从极低到中等不等。
结论
丹参酮胶囊可缓解寻常痤疮症状，调节患者体内炎症细胞因子和激素水平，降低复发率。然而，由于本研究存在局限性，需要更多的多中心、大样本研究来证实这些结论。
系统评价注册
https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024562320，标识符CRD42024562320。
Zotero 插件