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

Clinical trial of tacrolimus capsules combined with prednisolone acetate tablets in the treatment of systemic lupus erythematosus

目的观察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疗效及安全性。方法将54例系统性红斑狼疮患者随机分为对照组27例和试验组27例。对照组予以醋酸泼尼松龙每次40 mg,qd,口服;试验组在对照组治疗的基础上,予以他克莫司胶囊每次1 mg,bid,口服。2组患者均治疗1个月。比较2组患者的临床疗效、血清白细胞介素-4(IL-4)、单核细胞趋化蛋白-4(MCP-4)水平、白细胞、血小板、红细胞沉降率,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为92.59%(25/27例)和70.37%(19/27例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的IL-4分别为(135.67±16.88),(165.47±23.22)ng·L^(-1);MCP-4分别为(3.17±0.46),(4.98±0.71)ng·L^(-1);白细胞分别为(4.83±0.58)×10~9,(3.67±0.46)×10~9/L;血小板分别为(1 5 3.2 2±1 8.8 5)×1 0~9,(113.22±16.26)×10~9/L;红细胞沉降率分别为(15.26±3.14),(23.65±3.58)mm·h^(-1),差异均有统计学意义(P<0.05)。2组患者的药物不良反应以白细胞下降、消化道不适、感染为主,试验组和对照组的药物不良反应发生率分别为18.52%和14.81%,差异无统计学意义(P>0.05)。结论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疗效显著,其能明显地降低患者的IL-4及MCP-4水平,且不增加药物不良反应的发生率。

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 controlgroups 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） × 10^9,（ 3. 67 ± 0. 46） × 10^9/L; PLT were（ 153. 22 ± 18. 85） × 10^9,（ 113. 22 ± 16. 26） × 10^9/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.