Li Ming, Li Yan, Xiang Lujing, Li Linfeng
Department of Dermatology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Front Pharmacol. 2022 Sep 23;13:961371. doi: 10.3389/fphar.2022.961371. eCollection 2022.
Total glycosides of paeony (TGP), an active compound extracted from the dried roots of Pall., has been widely used to treat chronic urticaria (CU) in China. This study aims to systematically evaluate the efficacy and safety of TGP as an add-on treatment for the treatment of CU in adolescents and adults. Eight literature databases and two clinical trial registries were searched from their inception to 31 May 2022. Randomized controlled trials on TGP as an add-on treatment for CU in adolescents and adults were included. The Cochrane Collaboration's risk of bias tool was used for the methodological quality assessment, and RevMan 5.3 software and Stata 12.0 software were used for data analyses. A total of 30 studies with 2,973 participants were included in this meta-analysis. The methodological qualities of all included studies were suboptimal. The pooled results showed that TGP combined with H1-antihistamine was superior to H1-antihistamine alone in the cure rate (risk ratio (RR) = 1.54, 95% confidence interval (CI) = 1.39 to 1.71, < 0.00001), total efficacy rate (RR = 1.33, 95%CI = 1.26 to 1.40, < 0.00001), urticaria activity score 7 (mean difference (MD) = -4.03, 95%CI = -6.62 to -1.44, = 0.002), recurrence rate (RR = 0.31, 95%CI = 0.20 to 0.46, < 0.00001), and the level of IgE in serum (standardized mean difference (SMD) = -1.96, 95%CI = -3.02 to -0.90, = 0.0003). In terms of safety, the incidence of diarrhea (RR = 6.19, 95%CI = 3.39 to 11.29, < 0.00001) was significantly increased in the TGP plus H1-antihistamine groups, and no abnormal results of laboratory tests and electrocardiogram were reported in two groups. The qualities of evidences were evaluated as moderate to low. TGP as an add-on treatment could provide a good effect for CU in adolescents and adults with mild and tolerable adverse events. However, in view of poor methodological quality, high-quality and long-term clinical trials are needed in the future to confirm and update the evidence.
芍药总苷（TGP）是从芍药干燥根中提取的一种活性化合物，在中国已被广泛用于治疗慢性荨麻疹（CU）。本研究旨在系统评价TGP作为附加治疗药物用于青少年和成人CU治疗的疗效和安全性。检索了8个文献数据库和2个临床试验注册库，检索时间从建库至2022年5月31日。纳入了关于TGP作为附加治疗药物用于青少年和成人CU治疗的随机对照试验。采用Cochrane协作网偏倚风险工具进行方法学质量评估，使用RevMan 5.3软件和Stata 12.0软件进行数据分析。本荟萃分析共纳入30项研究，涉及2973名参与者。所有纳入研究的方法学质量均欠佳。汇总结果显示，TGP联合H1抗组胺药在治愈率（风险比（RR）=1.54，95%置信区间（CI）=1.39至1.71，P<0.00001）、总有效率（RR = 1.33，95%CI = 1.26至1.40，P<0.00001）、荨麻疹活动评分7（平均差（MD）=-4.03，95%CI = -6.62至-1.44，P = 0.002）、复发率（RR = 0.31，95%CI = 0.20至0.46，P<0.00001）以及血清IgE水平（标准化均差（SMD）=-1.96，95%CI = -3.02至-0.90，P = 0.0003）方面均优于单用H1抗组胺药。在安全性方面，TGP加H1抗组胺药组腹泻发生率（RR = 6.19，95%CI = 3.39至11.29，P<0.00001）显著升高，两组均未报告实验室检查和心电图异常结果。证据质量评估为中等至低等。TGP作为附加治疗药物可为青少年和成人CU提供良好疗效，且不良事件轻微可耐受。然而，鉴于方法学质量较差，未来需要高质量的长期临床试验来证实和更新证据。
