Clinical trial of tacrolimus capsules combined with prednisolone acetate tablets in the treatment of systemic lupus erythematosus
10.13699/j.cnki.1001-6821.2017.05.004
- VernacularTitle:他克莫司胶囊联合醋酸泼尼松龙片治疗系统性红斑狼疮的临床研究
- Author:
Shang-Ying HE
1
;
Jie LIN
;
Peng HUANG
;
Ai-Mei FENG
Author Information
1. 瑞安市人民医院药学部
- Keywords:
tacrolimus capsule;
prednisolone acetate tablet;
systemic lupus erythematosus;
safety
- From:
The Chinese Journal of Clinical Pharmacology
2017;33(5):398-400
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the clinical efficacy and safety of tacrolimus capsules combined with prednisolone acetate tablets in the treatment of systemic lupus erythematosus.Methods A total of 54 patients with systemic lupus erythematosus were randomly divided into control group and treatment group with 27 cases per group.Control group was treated with prednisolone acetate tablets 40 mg qd,oral.Treatment group was given tacrolimus capsules 1 mg per time bid,oral,on the basis of control group.The clinical efficacy,interleukin-4 (IL-4),monocyte chemoattractant protein-4 (MCP-4),white blood cell (WBC),platelet (PLT),erythrocyte sedimentation rate (ESR) and adVerse drug reactions were compared between two groups.Results After treatment,the total effective rates in treatment and control groups were 92.59％ (25/27 cases) and 70.37％ (19/27 cases) with significant difference (P ＜ 0.05).After treatment,the main indexes in treatment and control groups were compared:IL-4 were (135.67 ± 16.88),(165.47 ±23.22)ng · L-1;MCP-4 were (3.17 ± 0.46),(4.98 ±0.71)ng· L-1;WBC were (4.83 ±0.58) ×109,(3.67 ±0.46) × 109/L;PLT were (153.22±18.85) ×109,(113.22 ± 16.26) × 109/L;ESR were (15.26 ± 3.14),(23.65 ± 3.58)mm · h-1,the differences were statistically significant (P ＜ 0.05).The adverse drug reactions in two groups were based on leukopenia,gastrointestinal discomfort and infection,and the incidences of adverse drug reactions in treatment and control groups were 18.52％ and 14.81％,without significant difference (P ＞ 0.05).Conclusion Tacrolimus capsules combined with prednisolone acetate tablets have a definitive clinical efficacy in the treatment of systemic lupus erythematosus,which can significantly reduce the serum levels of IL-4 and MCP-4,improve clinical efficacy,without increasing the incidence of adverse drug reactions.
