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已发表论文
他克莫司联合泼尼松作为慢性炎症性脱髓鞘性多发性神经
Authors Di L , Wen X, Zhu W , Wang M, Lu Y , Xu M, Chen H, Da Y
Received 6 June 2025
Accepted for publication 30 September 2025
Published 7 October 2025 Volume 2025:14 Pages 1133—1143
DOI https://doi.org/10.2147/ITT.S536989
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Professor Michael Shurin
Li Di, Xinmei Wen, Wenjia Zhu, Min Wang, Yan Lu, Min Xu, Hai Chen, Yuwei Da
Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, People’s Republic of China
Correspondence: Yuwei Da, Department of Neurology, Xuanwu Hospital, Capital Medical University, 45 Changchun Street, Xicheng, Beijing, 100053, People’s Republic of China, Email dayuwei100@hotmail.com
Purpose: This study aimed to evaluate the efficacy and safety of tacrolimus as an add-on therapy in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
Patients and Methods: This retrospective cohort analysis was conducted using data from CIDP patients in the database of Xuanwu Hospital, Capital Medical University between April 2019 and June 2023. This study compared the efficacy of tacrolimus plus prednisone (T&P) versus prednisone monotherapy (PM) as maintenance immunosuppressive therapy. The primary endpoint was the response rate, defined as ≥ 1-point improvement in INCAT score, assessed at 3, 6, and 12 months. Secondary endpoints included: (1) I-RODS score changes from baseline to 3, 6, and 12 months; (2) the monthly median daily prednisone dose; (3) relapse rate (INCAT score worsening ≥ 1 point) in the 12-month follow-up; and (4) adverse event profiles over the 12-month follow-up period.
Results: Among 74 screened CIDP patients, 34 (45.9%) were included, with 16 receiving T&P and 18 receiving PM. All patients completed follow-up (median: 1.4 years; range: 1.0– 6.5 years). The T&P group demonstrated significantly higher response rates at 3 and 6 months compared to PM, though this difference attenuated by 12 months. I-RODS improvements were significantly greater in the T&P group at all time points. The relapse rate was lower in the T&P group (12.5% vs 33.3%). The T&P group maintained significantly lower prednisone doses from month 2 onward, with higher prednisone discontinuation rates at 12 months (43.8% vs 11.1%; p=0.01). Both groups showed comparable safety profiles, with no serious adverse reactions reported.
Conclusion: Tacrolimus plus prednisone therapy demonstrated superior clinical outcomes compared to prednisone monotherapy in CIDP maintenance treatment, including accelerated symptomatic improvement, reduced relapse risk, and facilitated corticosteroid tapering. The combination regimen maintained an acceptable safety profile without serious adverse events, supporting its corticosteroid-sparing role in CIDP management.
Keywords: chronic inflammatory demyelinating polyneuropathy, CIDP, tacrolimus, prednisone, immunosuppressive therapy
Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, People’s Republic of China
Correspondence: Yuwei Da, Department of Neurology, Xuanwu Hospital, Capital Medical University, 45 Changchun Street, Xicheng, Beijing, 100053, People’s Republic of China, Email dayuwei100@hotmail.com
Purpose: This study aimed to evaluate the efficacy and safety of tacrolimus as an add-on therapy in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
Patients and Methods: This retrospective cohort analysis was conducted using data from CIDP patients in the database of Xuanwu Hospital, Capital Medical University between April 2019 and June 2023. This study compared the efficacy of tacrolimus plus prednisone (T&P) versus prednisone monotherapy (PM) as maintenance immunosuppressive therapy. The primary endpoint was the response rate, defined as ≥ 1-point improvement in INCAT score, assessed at 3, 6, and 12 months. Secondary endpoints included: (1) I-RODS score changes from baseline to 3, 6, and 12 months; (2) the monthly median daily prednisone dose; (3) relapse rate (INCAT score worsening ≥ 1 point) in the 12-month follow-up; and (4) adverse event profiles over the 12-month follow-up period.
Results: Among 74 screened CIDP patients, 34 (45.9%) were included, with 16 receiving T&P and 18 receiving PM. All patients completed follow-up (median: 1.4 years; range: 1.0– 6.5 years). The T&P group demonstrated significantly higher response rates at 3 and 6 months compared to PM, though this difference attenuated by 12 months. I-RODS improvements were significantly greater in the T&P group at all time points. The relapse rate was lower in the T&P group (12.5% vs 33.3%). The T&P group maintained significantly lower prednisone doses from month 2 onward, with higher prednisone discontinuation rates at 12 months (43.8% vs 11.1%; p=0.01). Both groups showed comparable safety profiles, with no serious adverse reactions reported.
Conclusion: Tacrolimus plus prednisone therapy demonstrated superior clinical outcomes compared to prednisone monotherapy in CIDP maintenance treatment, including accelerated symptomatic improvement, reduced relapse risk, and facilitated corticosteroid tapering. The combination regimen maintained an acceptable safety profile without serious adverse events, supporting its corticosteroid-sparing role in CIDP management.
Keywords: chronic inflammatory demyelinating polyneuropathy, CIDP, tacrolimus, prednisone, immunosuppressive therapy