摘要
目的探讨蛇制剂联用青霉胺治疗类风湿关节炎(RA)的疗效、安全性和免疫调节作用。方法采用双盲随机安慰剂对照试验,患者随机分成两组,分别给予蛇制剂和青霉胺,安慰剂和青霉胺治疗,疗程为12周。应用酶联免疫吸附试验(ELISA)方法测定患者治疗前后外周血中白细胞介素(IL)-1!、IL-2、IL-6和肿瘤坏死因子(TNF)-"水平。结果共有60例RA患者完成试验,治疗组和对照组各30例。治疗组ACR20有效为80%,对照组ACR20有效为60%(P<0.05),ACR50和ACR70疗效两组差异无统计学意义;不良反应发生率治疗组13%,对照组37%,差异有统计学意义(P<0.05)。两组均明显降低RA患者TNF-"水平,但治疗组降低的程度要强于对照组,差异有统计学意义(P<0.05)。结论蛇制剂合用青霉胺治疗类风湿关节炎疗效要优于单用青霉胺,并且不良反应发生率低。
Objective To evaluate the efficacy and safety of Shezhiji combined with peneiUamine treatment of patients with rheumatoid arthritis （RA） and its effect on cytokines. Methods This is a randotnized, placebo-controlled trial. Patients with RA were randomized into 2 groups to receive 12 weeks treatment either with Shezhiji combined with pencillamine, or with placebo and pencillamine. The levels of IL-1β, IL-2, IL-6 and TNF-α in serum were assayed by ELISA before and after treatment. Results A total of 60 patients with RA finished the trial, 30 cases in the treatment group and 30 cases in the control group, There was significant difference between ACR20 80% of patients in the treatment group and 60% in the control group （P〈 0.05）. There was no difference in ACR50 and ACR70. The incidence of related adverse events were 13% and 37% in the treatment group and the control group respectively （P〈0.05）. The level of TNF-α was decreased in two groups, but the lower level of TNF-α in the treatment group （P〈0.05）, Conclusion The efficacy and safety of Shezhiji combined with pencillamine is better than pencillamine alone.
出处
《中华风湿病学杂志》
CAS
CSCD
2006年第5期269-272,共4页
Chinese Journal of Rheumatology
