来氟米特与雷公藤多苷治疗强直性脊柱炎的疗效以及安全性对比研究

The Contrastive Research about the Effect and Safety of Leflunomide and Tripterysium Glycosides on Treating Ankylosing Spondylitis

目的对来氟米特与雷公藤多苷治疗强直性脊柱炎(AS)的疗效以及安全性进行对比。方法选取2010年3月至2012年3月惠民县人民医院收治的AS患者58例为研究对象,采用随机字数表法将所有患者分为来氟米特组和雷公藤多苷组,每组29例。来氟米特组给予来氟米特片,第1周每日30 mg,分3次饭后口服;第2周后每日20 mg,分2次饭后口服。雷公藤多苷组给予雷公藤多苷片,每日60 mg,分3次饭后口服。比较两组患者治疗后3个月、6个月的VAS、BASDAI评分以及红细胞沉降率变化,并对治疗过程中患者出现的不良反应进行记录。结果来氟米特组治疗3个月后的VAS评分为(5.21±0.84)分、BASDAI(5.34±0.68)分,以及红细胞沉降率值(32.29±9.61)mm/h,6个月后的VAS评分为(2.45±0.13)分、BASDAI(3.19±0.27)分,以及红细胞沉降率值(17.56±4.31)mm/1h;雷公藤多苷组治疗3个月后的VAS评分(4.11±0.79)分、BASDAI(5.41±0.67)分,以及红细胞沉降率值(31.77±8.96)mm/h,6个月后的VAS评分(2.51±0.22)分、BASDAI(3.35±0.31)分,以及红细胞沉降率值(18.91±4.29)mm/h。两组患者治疗后3个月及治疗后6个月的各项观察指标均较治疗前有明显下降,且差异有统计学意义(P<0.05),但组间比较差异并无统计学意义(P>0.05)。来氟米特治疗组不良反应发生率为13.79%,明显低于雷公藤多苷治疗组的41.38%,且差异有统计学意义(P<0.05)。结论来氟米特与雷公藤多苷治疗AS的临床疗效相似,但雷公藤多苷的不良反应较多。

Objective To compare the effect and safety of leflunomide and tripterysium glycosides on treating ankylosing spondylitis（AS）.Methods A total of 58 patients with ankylosing spondylitis who were admitted to Huimin People＇s Hospital during Mar.2010 and Mar.2012 were included as the research object.According to random number table,they were divided equally and randomly into two groups：29 cases in each group.The first group were treated with leflunomide and the other group were treated with tripterysium glycosides.In the first week,the first group had leflunomide 30 mg per day,three times after meals.In the second week,the first group had leflunomide 20 mg,twice after meals.The other group was treated with tripterysium glycosides had tripterysium glycosides 60 mg per day,three times after meals.The score of VAS,BASDAI and ESR of the two groups after three months＇ and six months＇ treatment were compared.The adverse reactions in the therapeutic process were recorded.Results After 3 months,VAS of the first group treated with leflunomide was（5.21 ± 0.84）,BASDAI（5.34 ± 0.68）and ESR（32.29 ± 9.61） mm/h ; after 6 months,VAS（2.45 ±0.13）,BASDAI（3.19 ±0.27）and ESR（17.56 ±4.31） mm/h; after 3 months,VAS of the other group treated with tripterysium glycosides was（4.11 ± 0.79）,BASDAI（5.41 ± 0.67）and ESR（31.77 ± 8.96） mm/h,after 6 months,V AS（2.51 ± 0.22）,BASDAI（3.35 ± 0.31）and ESR（18.91 ±4.29） mm/h.Comparing with pre-treatment,after three months＇ and six months＇ treatment,the score of VAS,BASDAI and ESR of patients in two groups decreased significantly（P ＜ 0.05）.The difference between the two groups had no statistical significance（P ＞ 0.05）.The incidence of adverse reactions in the group treated with leflunomide treatment was 13.79％,which was obviously lower than the group treated with tripterysium glycosides（41.38％）,and the difference had statistical significance（P ＜ 0.05）.Conclusion The clinical effect of leflunomide and tripterysium on treating ankylosing spondylitis is similar,but the adverse reactions of tripterysium glycosides are more often observed.