Hangzhou Traditional Chinese Medicine Hospital Affiliated to Zhejiang Chinese Medical University, Hangzhou, China.
Zhuji Maternal and Child Health Hospital, Shaoxing, China.
Immun Inflamm Dis. 2023 Oct;11(10):e1044. doi: 10.1002/iid3.1044.
To assess the effectiveness and safety of the total glucosides of paeony (TGP) combined with hydroxychloroquine (HCQ) on the treatment of primary Sjögren's syndrome (pSS) by conducting a meta-analysis.
Eight databases were searched for randomized controlled trials (RCTs) reporting the use of TGP combined with HCQ for pSS, which are before May 10, 2022. Meta-analyses were performed on disappeared clinical symptoms (dry mouth and dry eyes), Schirmer's test, saliva flow test, erythrocyte sedimentation rate (ESR), index of immunoglobulin G (IgG), immunoglobulin M (IgM), immunoglobulin A (IgA), and adverse events (AEs). The Revman 5.4 software was used for this meta-analysis.
Seven RCTs which included 632 participants were identified. The pooled results showed significant differences in clinical symptoms disappear (dry mouth and dry eyes) (p = .0004), IgM (p < .00001), IgA (p < .00001), salivary flow rate (p < .00001) and Schirmer's test (p = .02) in the comparison of TGP combined with HCQ and HCQ alone. For the IgG and ESR, both pooled and subgroup analyses showed that TGP + HCQ was superior to HCQ alone. For the safety analysis, no significant differences in AEs (p = .39) was revealed. The more frequently seen adverse reactions were diarrhea, vomit and there was no severe adverse events were reported in TGP + HCQ group.
Therefore, TGP + HCQ can be considered to be a potentially valid and safe combination for the treatment of pSS in the clinic.
通过荟萃分析评估白芍总苷(TGP)联合羟氯喹(HCQ)治疗原发性干燥综合征(pSS)的疗效和安全性。
检索了截至 2022 年 5 月 10 日的八个数据库,以获取报告 TGP 联合 HCQ 治疗 pSS 的随机对照试验(RCT)。对消失的临床症状(口干和眼干)、泪液分泌试验、唾液流率、红细胞沉降率(ESR)、免疫球蛋白 G(IgG)、免疫球蛋白 M(IgM)、免疫球蛋白 A(IgA)和不良事件(AE)进行荟萃分析。本荟萃分析采用 Revman 5.4 软件。
共纳入 7 项 RCT,包括 632 名参与者。汇总结果显示,在口干和眼干临床症状消失(p = .0004)、IgM(p < .00001)、IgA(p < .00001)、唾液流率(p < .00001)和泪液分泌试验(p = .02)方面,TGP 联合 HCQ 与 HCQ 单独治疗相比差异有统计学意义。对于 IgG 和 ESR,汇总分析和亚组分析均显示 TGP + HCQ 优于 HCQ 单独治疗。对于安全性分析,AE 无显著差异(p = .39)。TGP + HCQ 组更常见的不良反应是腹泻、呕吐,未报告严重不良事件。
因此,TGP + HCQ 可被认为是一种有效的、安全的联合用药方案,可用于临床治疗 pSS。