The efficacy and safety of total glucosides of peony in the treatment of primary Sjogren's syndrome: a multi-center, randomized, double-blinded, placebo-controlled clinical trial
单位：[1]Department of Rheumatology, China-Japan Friendship Hospital, No.2, East Yinghua Road, Chaoyang District, Beijing 100029, China[2]Department of Rheumatology and Immunology, Anhui Provincial Hospital, Hefei, Anhui, China[3]Department of Rheumatology and Immunology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China[4]Department of Rheumatology and Immunology, Changhai Hospital, Shanghai, China[5]Department of Rheumatology and Immunology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China[6]Department of Rheumatology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China江苏省人民医院[7]Department of Rheumatology, Hebei General Hospital, Shijiazhuang, Hebei, China[8]Department of Clinical Immunology, Xi-Jing Hospital, Xi’an, Shaanxi, China[9]Division of Rheumatoid Immunology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China[10]Department of Rheumatology and Immunology, Tianjin Medical University General Hospital, Tianjin, China[11]Boon Pharmaceutical Research Ltd., 45 Topanga, Irvine, CA 92602, USA
To evaluate the efficacy and safety of total glucosides of peony (TGP) in adults with primary Sjogren's syndrome (pSS). A multi-center, randomized, double-blinded, placebo-controlled study was conducted between March 2012 and July 2014 at ten Chinese hospitals. In total, 320 pSS patientsclassified according to the 2002 American-European Consensus Group Criteriawere randomized (2:1 ratio) to receive TGP(600mg, tid) in the TGP group or placebo for 24weeks in the placebo group. Study personnel, investigators, and patients were blinded to the treatment grouping. The primary endpoint was the improvement of EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at week 24. The secondary endpoints were dry eyes/mouth/skin/nose/throat/vagina visual analogue scale (VAS), pain and discomfort VAS, fatigue VAS, mental discomfort VAS, patient global assessment (PGA), EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI), Schirmer's test, basal/stimulated salivary flow-rate values, and erythrocyte sedimentation rate (ESR). All adverse events were recorded during the trial period. ESSPRI improved more in the TGP than the placebo group (p<0.001). Dry eyes/throat/vagina VAS, fatigue VAS, mental discomfort VAS, PGA, Schirmer's test, and ESR also improved more in the TGP group than in the placebo group (all p<0.05). Stimulated salivary flow-rate values increased in the TGP group at week 12 but not at week 24. Adverse events in TGP group were 10.9%. TGP can alleviate some dryness symptoms as well as disease activity in pSS patients over 24weeks. TGP was well tolerated by study subjects. TGP seems to be an effective and safe treatment for pSS.
第一作者单位：[1]Department of Rheumatology, China-Japan Friendship Hospital, No.2, East Yinghua Road, Chaoyang District, Beijing 100029, China
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推荐引用方式(GB/T 7714)：
Liu Xia,Li Xiaomei,Li Xiangpei,et al.The efficacy and safety of total glucosides of peony in the treatment of primary Sjogren's syndrome: a multi-center, randomized, double-blinded, placebo-controlled clinical trial[J].CLINICAL RHEUMATOLOGY.2019,38(3):657-664.doi:10.1007/s10067-018-4315-8.
APA：
Liu, Xia,Li, Xiaomei,Li, Xiangpei,Li, Zhijun,Zhao, Dongbao...&Wang, Guochun.(2019).The efficacy and safety of total glucosides of peony in the treatment of primary Sjogren's syndrome: a multi-center, randomized, double-blinded, placebo-controlled clinical trial.CLINICAL RHEUMATOLOGY,38,(3)
MLA：
Liu, Xia,et al."The efficacy and safety of total glucosides of peony in the treatment of primary Sjogren's syndrome: a multi-center, randomized, double-blinded, placebo-controlled clinical trial".CLINICAL RHEUMATOLOGY 38..3(2019):657-664
