TABLE 1.
The characteristics of included studies.
| Author | Year | Study design | Gender (M/F) | Age (year) | Sample size | Intervention and dose | Treatment duration | Main outcomes | Reference | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Experimental | Control | Experimental | Control | ||||||||
| Jiang W | 2014 | Prospective | 0/50 | 29.3 ± 9.7 32.5 ± 11.5 | 25 | 25 | IGU 25 mg bid + HCQ 200 mg bid + P 5–10 mg qd | HCQ 200 mg bid + P 5–10 mg qd | 12w | PLT, IgG, Schirmer’s test, ESSPRI, ESSDAI, effective rate, AEs | Jiang et al. (2014) |
| Jiang DX | 2016 | Prospective | 0/60 | 28–76 | 30 | 30 | IGU 25 mg bid + HCQ 200 mg bid + MP 8 mg qd | HCQ 200 mg bid + MP 8 mg qd | 12w | ESR, RF, IgG, AEs | Jiang et al. (2016) |
| Xia ZB | 2017 | Prospective | 0/100 | 24–76 | 50 | 50 | IGU 25 mg bid + MP 8 mg qd | HCQ 200 mg bid + MP 8 mg qd | 12w | ESR, RF, IgG | Xia et al. (2017) |
| Xu D | 2017 | Prospective | 12/82 | 28–77 | 47 | 47 | IGU 25 mg bid + HCQ 200 mg bid + MP 8 mg qd | HCQ 200 mg bid + MP 8 mg qd | 3 m | ESR, RF, PLT, IgG, Schirmer's test, Salivary flow rate, ESSPRI, ESSDAI, effective rate, AEs | Xu et al. (2017) |
| Li CJ | 2018 | Prospective | 29/39 | NF | 34 | 34 | IGU 25 mg bid + HCQ 200 mg bid + MP 8 mg qd | HCQ 200 mg bid + MP 8 mg qd | 12w | ESR, RF, IgG, Salivary flow rate, ESSPRI, effective rate, AEs | Li et al. (2018) |
| Luo QW | 2018 | Prospective | 9/71 | 30–76 | 40 | 40 | IGU 25 mg bid + MP 8 mg qd | HCQ 200 mg bid + MP 8 mg qd | 3 m | Effective rate, AEs | Luo et al. (2018) |
| Liao Y | 2018 | Prospective | 0/40 | 25–69 | 20 | 20 | IGU 25 mg qd-bid + HCQ 0.2 g bid + TGP 0.6 g tid | HCQ 0.2 g bid + TGP 0.6 g tid | 12w | ESR, IgG | Liao (2018) |
| Wang Y | 2018 | Retrospective | 13/63 | 27–78 | 38 | 38 | IGU 25 mg bid + HCQ 0.2 g bid + MP 8 mg qd | HCQ 0.2 g bid + MP 8 mg qd | 12w | ESR, RF, IgG, effective rate | Wang (2018) |
| Bai J | 2019 | Prospective | NF | 25–76 | 30 | 30 | IGU 25 mg bid + HCQ 0.2 g bid + MP 8 mg qd | LEF 10–50 mg qd + HCQ 0.2 g bid + MP 8 mg qd | 12w | RF, IgG, ESR, AEs, ESSDAI, ESSPRI | Bai and Jiao (2019) |
| Ji JH | 2019 | Prospective | 10/72 | 30–65 | 41 | 41 | IGU 25 mg bid + HCQ 0.2 g bid + MP 8 mg qd | HCQ 0.2 g bid + MP 8 mg qd | 12w | ESR, RF, PLT, IgG, Schirmer's test, Salivary flow rate, ESSPRI, ESSDAI, effective rate | Ji and Cheng (2019) |
| Wang YL | 2019 | Prospective | 5/59 | 60–83 | 32 | 32 | IGU 25 mg bid + HCQ 0.1 g bid + TGP 0.6 g bid | HCQ 0.1 g bid + TGP 0.6 g bid | 12w | ESR, RF, IgG, Schirmer's test, Salivary flow rate, ESSPRI, ESSDAI, effective rate, AEs | Wang et al. (2019) |
| Zhang J | 2019 | Prospective | 25/61 | 24–63 | 43 | 43 | IGU 25 mg bid + HCQ 200 mg bid + MP 8 mg qd | HCQ 200 mg bid + MP 8 mg qd | 12w | ESR, RF, PLT, IgG, Schirmer's test, Salivary flow rate, ESSPRI, ESSDAI, effective rate, AEs | Wang et al. (2019) |
| Zhang XY | 2019 | Prospective | 36/84 | 28–71 | 60 | 60 | IGU 25 mg bid + MP 8 mg qd | HCQ 0.2 g bid + MP 8 mg qd | 3 m | Schirmer's test, ESSDAI, effective rate | Zhang (2019) |
| Zhao L | 2019 | Prospective | 47/35 | 35–75 | 41 | 41 | IGU 25 mg bid + MP 8 mg qd | HCQ 0.2 g bid + MP 8 mg qd | 12w | ESR, RF, IgG, effective rate, AEs | Zhao (2019) |
| Li RR | 2020 | Prospective | 0/46 | 23–77 | 23 | 23 | IGU 25 mg bid + HCQ 0.2 g bid + MP 8 mg qd | HCQ 0.2 g bid + MP 8 mg qd | 12w | ESR, IgG, Salivary flow rate, ESSPRI, effective rate, AEs | Li and Long (2020) |
| Lin T | 2020 | Prospective | 15/75 | 32–75 | 45 | 45 | IGU 25 mg bid + MP 8 mg qd | HCQ 0.2 g bid + MP 8 mg qd | 12w | Effective rate, AEs | Lin and Zhang (2020) |
| Jiang W | 2020 | Prospective | NF | 29.3 ± 9.7 | 25 | 25 | IGU 25 mg bid + HCQ 0.2 g bid + P 10 mg qd | HCQ 0.2 g bid + P 10 mg qd | 12w | PLT, IgG, Schirmer's test, ESSPRI, ESSDAI, AEs | Jiang W. et al. (2020) |
| Wang ZH | 2020 | Prospective | 15/45 | 32–78 | 30 | 30 | IGU 25 mg bid + HCQ 0.2–0.4 g bid + MP 8 mg qd | HCQ 0.2–0.4 g bid + MP 8 mg qd | NF | Effective rate | Wang and Wang. (2020) |
| Yu WJ | 2020 | Prospective | 33/43 | 20–50 | 38 | 38 | IGU 25 mg bid + MP 8 mg qd | HCQ 0.2 g bid + MP 8 mg qd | 12w | ESR, RF, IgG | Yu (2020) |
M, male; F, female; IGU, iguratimod; HCQ, hydroxychloroquine; P, prednisone; MP, methyl prednisolone; TGP, the total glucosides of paeony; NF, not found; ESSPRI, EULAR Sjogren's Syndrome patient reported index; ESSDAI, EULAR Sjögren's Syndrome disease activity index; AEs, adverse event rates; ESR, erythrocyte sedimentation rate; RF, rheumatoid factor; IgG, immunoglobulin G; LEF, leflunomide.