[Clinical testing of intra-articularly injected glycosaminoglycan polysulfate in gonarthrosis ( a controlled multicenter double-blind study)].
In order to evaluate the clinical efficacy of glycosaminoglycan polysulfate (GAGPS) in osteoarthrosis of the knee, a double blind comparative study was carried out at 26 orthopaedic clinics throughout Japan. A total of 120 patients was divided into two groups; one group was treated with 1 mg GAGPS (control group) and the other with 50 mg GAGPS (drug group). Five or more injections (average: 9.3) were given at about weekly intervals (average: 8.2 days). The score derived from the knee scoring scale improved significantly in both groups, either after the 5th and the 10th injections. The score that had improved after the 10th injection in drug group was statistically superior compared to the control (p less than 0.05), however, the difference in the two groups after the 5th injection did not reach a level of any statistical significance. Doctors' assessment of the usefulness of the drug based on the balance of effects and side effects was obtained in 71.2% and 41.1% in drug group and control group, respectively. The difference was statistically significant (p less than 0.01). In conclusion, the authors confirmed that the intraarticular injections of 50 mg GAGPS were useful for osteoarthrosis of the knee although the clinical symptoms were improved only gradually following the injections.
D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D006025:Glycosaminoglycans / Q000008:administration & dosage* / Q000627:therapeutic use; D006801:Humans; D007270:Injections, Intra-Articular; D007719:Knee Joint; D010003:Osteoarthritis / Q000000981:diagnostic imaging / Q000188:drug therapy*; D011859:Radiography
D006025:Glycosaminoglycans; C013786:A73025
Klinische Prüfung von intraartikulär injiziertem Glykosaminoglykanpolysulfat bei Gonarthrosen (kontrollierte, multizentrische Doppelblindstudie).