[1]孙红艳,吕安坤,史雨晴,等.白芍总苷胶囊联合硫酸羟氯喹治疗干燥综合征疗效的Meta分析[J].西部中医药,2026,39(09):64-70.[doi:10.12174/j.issn.2096-9600.2026.09.14]
　SUN Hongyan,LYU Ankun,SHI Yuqing,et al.Efficacy of Total Glucosides of Paeony Capsules Combined with Hydroxychloroquine ulfate for Sj?gren?s Syndrome: A Meta-Analysis[J].Western Journal of Traditional Chinese Medicine,2026,39(09):64-70.[doi:10.12174/j.issn.2096-9600.2026.09.14]
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白芍总苷胶囊联合硫酸羟氯喹治疗干燥综合征疗效的Meta分析()

《西部中医药》[ISSN:2096-9600/CN:62-1204/R]

卷:
39
期数:
2026年09期
页码:
64-70
栏目:
二次研究
出版日期:
2026-09-07

文章信息/Info

Title:
Efficacy of Total Glucosides of Paeony Capsules Combined with Hydroxychloroquine ulfate for Sj?gren?s Syndrome: A Meta-Analysis
作者:
孙红艳1, 吕安坤2, 史雨晴1, 布艾加尔·坡拉提1
1.新疆医科大学，新疆 乌鲁木齐 830017
2.新疆医科大学附属中医医院，新疆 乌鲁木齐 830000
Author(s):
SUN Hongyan1, LYU Ankun2, SHI Yuqing1, Bu?aijiaer POLAT1
1.Xinjiang Medical University, Urumqi 830017, China
2.TCM Hospital Affiliated to Xinjiang Medical University, Urumqi 830000, China
关键词:
干燥综合征; 白芍总苷胶囊; 硫酸羟氯喹; Meta分析
Keywords:
Sj?gren’s syndrome; total glucosides of paeony capsules; hydroxychloroquine sulfate; Meta analysis
分类号:
R257
DOI:
10.12174/j.issn.2096-9600.2026.09.14
文献标志码:
A
摘要:
目的采用Meta分析方法评价白芍总苷胶囊联合硫酸羟氯喹治疗干燥综合征的临床效果，为临床治疗提供循证依据。 方法检索Pubmed、Cochrane、维普数据库、万方数据库、中国知网数据库，查找白芍总苷胶囊联合硫酸羟氯喹治疗干燥综合征的随机对照试验文献。对采集的数据进行Meta分析。 结果共纳入9篇研究文献，包含758例患者，纳入文献质量均为低质量文献。与单用硫酸羟氯喹相比，白芍总苷胶囊联合硫酸羟氯喹在提高临床疗效方面存在明显优势（OR=2.55，95%CI：1.27～5.11，P=0.008）；血沉（MD=-7.38，95%CI：-11.91～-2.86，P=0.001）、免疫球蛋白A（immunoglobulin A，IgA）（MD=-0.67，95%CI：-1.11～-0.22，P=0.003）、IgM（MD=-0.47，95%CI：-0.63～-0.31，P＜0.000 01）、IgG（MD=-3.27，95%CI：-4.12～-2.43，P＜0.000 01）、唾液流量（MD=-8.54，95%CI：-11.56～-5.52，P＜0.000 01）的降低效果优于对照组；唾液流率（MD=0.04，95%CI：0.02～0.05，P＜0.000 01）升高效果优于对照组；口干症状（MD=-1.33，95%CI：-2.19～-0.48，P=0.002）、关节痛（MD=-1.64，95%CI：-2.58～-0.70，P=0.0006）改善优于对照组。但γ球蛋白（MD=-2.32，95%CI：-7.69～3.05，P=0.40）降低情况、Schimer试验（MD=3.10，95%CI：-0.17～6.37，P=0.06）、眼干症状（MD=-0.80，95%CI：-1.71～0.11，P=0.09）与对照组比较无差异。白芍总苷胶囊联合硫酸羟氯喹组不良反应发生率（OR=1.39，95%CI：0.77～2.51，P=0.28）与对照组比较无差异。 结论白芍总苷胶囊联合硫酸羟氯喹治疗干燥综合征的效果优于单用硫酸羟氯喹，且不会增加安全性风险。但上述结论仍需高质量临床随机对照试验进一步验证。
Abstract:
ObjectiveTo evaluate the clinical efficacy of total glucosides of paeony (TGP) capsules combined with hydroxychloroquine sulfate in the treatment of Sj?gren’s syndrome (SS) using a Meta-analysis, and to provide evidence-based support for clinical practice. MethodsA comprehensive literature search was performed in PubMed, the Cochrane Library, VIP Database, Wanfang Database, and CNKI (China National Knowledge Infrastructure) to identify randomized controlled trials (RCTs) on the combination of TGP capsules and hydroxychloroquine sulfate for the treatment of SS. Meta-analysis was then conducted on the extracted data from the included studies. ResultsA total of nine studies involving 758 patients were included, all of which were assessed as low quality. Compared with hydroxychloroquine sulfate alone, the combination of TGP capsules and hydroxychloroquine sulfate demonstrated significant advantages in improving clinical efficacy (OR = 2.55, 95% CI: 1.27–5.11, P = 0.008). The combination therapy was also superior to the control group in reducing erythro-cyte sedimentation rate (ESR) (MD=-7.38, 95% CI:-11.91 to -2.86, P = 0.001), immunoglobulin A (IgA) (MD =-0.67, 95% CI:-1.11 to -0.22, P = 0.003), IgM (MD =-0.47, 95% CI:-0.63 to -0.31, P < 0.000 01), IgG (MD = -3.27, 95% CI: -4.12 to -2.43, P < 0.000 01), and in reducing salivary output (MD =-8.54, 95% CI: -11.56 to -5.52, P <0.000 01), while showing a superior increase in salivary flow rate (MD = 0.04, 95% CI: 0.02–0.05, P < 0.000 01). Furthermore, the combination group showed greater improvement in xerostomia (MD =-1.33, 95% CI: -2.19 to -0.48, P = 0.002) and arthralgia (MD = -1.64, 95% CI: -2.58 to -0.70, P = 0.0006) compared with the control group. However, no significant differences were observed between the two groups in terms of reduction of gamma globulin (MD = -2.32, 95% CI: -7.69 to 3.05, P = 0.40), Schirmer’s test (MD = 3.10, 95% CI: -0.17 to 6.37, P = 0.06), or xerophthalmia (MD = -0.80, 95% CI: -1.71 to 0.11, P = 0.09). There was also no significant difference in the incidence of adverse reactions between the combination group and the control group (OR = 1.39, 95% CI: 0.77–2.51, P = 0.28). ConclusionThe combination of TGP capsules and hydroxychloro-quine sulfate demonstrates superior efficacy over hydroxychloroquine sulfate monotherapy in the treatment of SS, without increasing safety risks. However, the above conclusions still require further validation by high-quality randomized controlled trials.

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备注/Memo

备注/Memo:
国家自然科学基金地区基金（81860835）；新疆维吾尔自治区自然科学基金面上项目（2018D01C173）。孙红艳（1980—），女，博士学位，硕士研究生导师，教授。研究方向：中西医结合治疗内科疾病。Email：sunhongyan2009@163.com。
更新日期/Last Update: 2026-09-15