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Meta-analysis of efficacy and safety of primary Sjögren's syndrome treated by total glucosides of paeony
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DOI   10.11656/j.issn.1672-1519.2024.04.12
Key Words   systematic review;total glucosides of paeony;primary Sjögren's syndrome;randomized controlled trial
Author NameAffiliationE-mail
WEI Bowen Rheumatology and Immunology Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China
National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300193, China 
 
LIU Wei Rheumatology and Immunology Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China
National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300193, China 
fengshiliuwei@163.com 
ZHANG Shumin Rheumatology and Immunology Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China
National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300193, China 
 
WANG Aihua Rheumatology and Immunology Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China
National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300193, China 
 
LIN Fangfang Rheumatology and Immunology Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China
National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300193, China 
 
DING Jiuli Rheumatology and Immunology Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China
National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300193, China 
 
QI Hao Rheumatology and Immunology Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China
National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300193, China 
 
Abstract
    [Objective] To systematically evaluate the efficacy and safety of primary Sjögren's syndrome(pSS) treated by total glucosides of paeony(TGP). [Methods] Databases of CNKI,VIP,CBM,Wanfang,PubMed,EMBASE,and Cochrane were searched(from inception to October 29,2022) to screen the randomized controlled trials(RCTs) of TGP for pSS. Two authors independently screened the literature,extracted data,and performed literature quality evaluation,and Meta-analysis was performed using RevMan 5.4 software.[Results] A total of 368 literatures were retrieved,and 10 RCTs were included after the screening,including 874 subjects. The Meta-analysis showed that the treatment of pSS with TGP alone was more effective in the Schirmer's test[MD=1.31,95%CI(0.74,1.88),P<0.000 01],salivary flow rate[MD=0.12,95%CI(0.02,0.21),P=0.02],and erythrocyte sedimentation rate(ESR)[MD=-7.30,95%CI(-16.64, 1.24),P=0.000 4]. When TGP in combination with Western medicine,and efficacy in the Schirmer's test[MD=1.10,95%CI(0.36, 3.17),P=0.01],salivary flow rate[MD=-6.96,95%CI(-8.34,-5.57),P<0.000 01],ESR[MD=-9.87,95%CI(-12.64,-7.10),P<0.000 01],rheumatoid factor(RF)[MD=-9.95,95%CI(-13.45,-6.45),P<0.000 01],C-reactive protein(CRP)[MD=-1.76,95%CI(-2.92,-0.60),P=0.003],immunoglobulin G(IgG)[MD=-3.19,95%CI(-4.22,-2.17),P<0.000 01],IgA[MD=-0.97,95%CI(-1.36,-0.58),P<0.000 01] and IgM[MD=-0.44,95%CI(-0.72,-0.16),P=0.002] were significantly more efficacious,with significantly higher efficiency and fewer adverse effects,all with statistically significant differences(P<0.05). [Conclusion] The current research evidence suggests that TGP is effective in improving exocrine function(Schirmer's test and salivary flow rate),reducing inflammatory indices(ESR,RF and CRP) and immunoglobulins(IgG,IgA and IgM) in pSS patients,improving serum gamma globulin,ESSPRI and other indices,while having fewer and less symptomatic adverse effects and the safety is better. However,due to the limitations of the sample size,methodological quality,and outcome indicators of the included studies,this conclusion needs to be validated by more high-quality studies.

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