摘要
目的：评价国产双氯芬酸钠利多卡因注射液治疗强直性脊柱炎(AS)的有效性和安全性。方法：采用多中心、随机、双盲、阳性药物平行对照研究。入选AS病人139例,完成134例,其中国产双氯芬酸钠利多卡因注射液组(试验组)67例。进口双氯芬酸钠利多卡因注射液组(对照组)67例。2组药物均为2 mL,肌内注射,qd,疗程5 d。观察2组疗效和不良反应。结果：试验组显效率和有效率分别为2%和39%,对照组分别为6%和49%。试验组不良反应发生率为16%,对照组不良反应发生率为18%。2组疗效和不良反应发生率差异均无显著意义(P＞0．05)。结论：国产双氯芬酸钠利多卡因注射液治疗强直性脊柱炎的疗效和安全性与进口同类产品相当。
AIM： To evaluate the efficacy and safety of diclofenac sodium/lidocaine injection （made in China） in treatment of ankylosing spondylitis. METHODS： A randomized, double-blind, and active-control, parallel-group study were conducted in 139 patients. They were randomly divided into two groups, intramuscular injection of diclofenac sodium/lidocaine injection made in China （n = 67） or made in Switzerland （n = 67）. Every patient received 2 mL of the mixture injection qd, intramuscularly for a course of 5 d. RESULTS： The indexes of pain （visual analogue scale） in both groups were reduced, and index of patient or investigator global assessment of disease status were improved. The obvious efficient rates and efficient rates of the trial group and the controlled group were 2 %, 39 % and 6 %, 49 %, respectively, showing no significance difference between the two groups. The difference of the side-effect incidences between the two groups was also of no significance （16 % vs 18 %）. CONCLUSION： Diclofenas sodium/lidocaine injection （made in China） is effective and safe in the treatment of ankylosing spondylitis, as well as the imported one.
出处
《中国新药与临床杂志》
CSCD
北大核心
2006年第7期519-522,共4页
Chinese Journal of New Drugs and Clinical Remedies
关键词
双氯芬酸
利多卡因
脊柱炎
强直性
双盲法
随机对照试验
多中心研究
diclofenace
lidocaine
spondylitis, ankylosing
double-blind method
randomized controlledtrials
muhicenter studies
