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The efficacy and safety of Jitongning Capsule (脊痛宁胶囊) in patients with ankylosing spondylitis

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Abstract

Objective

To confirm the efficacy and safety of Jitongning Capsule 脊痛宁胶囊 in the treatment of ankylosing spondylitis (AS).

Methods

A total of 120 AS patients with early-intermediate were randomly and equally assigned to Jitongning Capsule group and sulfasalazine group. Jitongning Capsule was orally taken 4.5 g per day and sulfasalazine was orally taken 2 g daily for 12 months. The primary endpoint was the proportion of patients achieving the Assessment in Ankylosing Spondylitis 20 (ASAS 20), secondary end points included Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), patient’s global assessment by VAS rating, spinal pain, general pain and night pain, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Tumor necrosis factor-α (TNF-α), interferon-γ (IFN-γ) and interleukin-4 (IL-4) in the peripheral blood mononuclear cells (PBMC) of AS patients were measured.

Results

A total of 111 patients completed the study. There were 58 patients in Jitongning group and 53 patients in sulfasalazine group. Both drugs showed mild and occasional side effects. After treated by Jitongning Capsule and sulfasalazine, the proportion of ASAS20 responders at 12 month was 72.41% (42/58) and 67.92% (36/53) respectively. Both Jitongning Capsule and sulfasalazine treatment induced significant decrease in the proportion of CD4+T cell and CD8+T cell expressing TNF-α and IFN-γ at 12-month of treatment compared with baseline values (P<0.05).

Conclusion

Jitongning Capsule are effective in a setting close to real-life medical care with a sustained improvement in signs and symptoms of AS, and reduce cytokine levels in PBMC. It showed comparable effects to sulfasalazine.

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Authors and Affiliations

  1. Department of Rheumatology, Chinese PLA General Hospital, Beijing, 100853, China

    Yan-yan Wang  (王炎焱), Zheng Zhao  (赵 征) & Feng Huang  (黄 烽)

  2. Department of Nephrology, First Hospital Affiliated to General Hospital of PLA, Beijing, 100048, China

    Hui Lu  (路 辉)

Authors
  1. Yan-yan Wang  (王炎焱)
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  2. Hui Lu  (路 辉)
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  3. Zheng Zhao  (赵 征)
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  4. Feng Huang  (黄 烽)
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Corresponding author

Correspondence to Feng Huang  (黄 烽).

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Wang, Yy., Lu, H., Zhao, Z. et al. The efficacy and safety of Jitongning Capsule (脊痛宁胶囊) in patients with ankylosing spondylitis. Chin. J. Integr. Med. 19, 98–103 (2013). https://doi.org/10.1007/s11655-012-1212-x

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  • DOI: https://doi.org/10.1007/s11655-012-1212-x

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