Rutner M, Fitzek J, Jahnel-Kracht H, Otto J, Krause W
Krankenhaus Essen-Werden.
Fortschr Med. 1995 Mar 20;113(8):111-3.
Two clinical studies were carried out to investigate the efficacy and safety as well as the local and systemic availability of a hydroxyethylsalicyclate gel. A double blind, multicenter trial, involving 113 patients with nonarticular rheumatic back pain, revealed statistically significant relief of pain as compared with placebo. Local and systemic tolerance was excellent. An open study of bioavailability after local application in 16 patients showed a mean salicylate concentration of 0.93 +/- 0.5 microgram/ml in the synovial fluid and 0.40 +/- 0.23 microgram/ml in the synovial membrane, compared with 0.14 +/- 0.04 microgram/ml in the serum. Genetisinic acid was not detected, while OH-hippuric acid was detected only in the serum and synovial fluid.
开展了两项临床研究,以调查羟乙基水杨酸酯凝胶的疗效、安全性以及局部和全身的药物利用度。一项双盲、多中心试验纳入了113例非关节性风湿性背痛患者,结果显示与安慰剂相比,疼痛缓解具有统计学意义。局部和全身耐受性良好。一项针对16例患者局部用药后生物利用度的开放性研究表明,滑液中水杨酸盐的平均浓度为0.93±0.5微克/毫升,滑膜中为0.40±0.23微克/毫升,而血清中为0.14±0.04微克/毫升。未检测到龙胆酸,而仅在血清和滑液中检测到羟基马尿酸。