title: The efficacy and safety of sodium hyaluronate injection (Adant®) in treating degenerative osteoarthritis: a multi-center, randomized, double-blind, positive-drug parallel-controlled and non-inferiority clinical study.
abstract: OBJECTIVE
  To compare the efficacy and safety of two different sodium hyaluronate drugs in treating degenerative osteoarthritis (OA) of the knee.
  
  
  METHODS
  This randomized, multi-center, double-blind, positive-drug, parallel-controlled study included 229 patients aged ≥ 45 years who were clinically diagnosed with degenerative OA of the knee. The patients were randomly assigned to receive for 5 consecutive weeks a once-weekly intra-articular injection of the investigational drug Adant®, which is manufactured by fermentation, or the control drug Artz®, which is manufactured by extraction of cockscomb. The follow-up examinations were conducted 1, 2, 3, 4 and 6 weeks after the first injection. The primary efficacy parameter was the decrease in the visual analog scale (VAS) scores of pain on movement caused by load-bearing, and the secondary efficacy parameter was the decrease in the Lequesne index.
  
  
  RESULTS
  The intra-articular injections of Adant® and Artz® produced a significant reduction in the VAS scores for pain on movement (50.4 and 50.3 mm, respectively) and in the Lequesne index. There were no significant differences in efficacy and safety between the two drugs and non-inferiority in VAS score decreases was confirmed.
  
  
  CONCLUSIONS
  The results of this study show that both Adant® and Artz® are effective for the treatment of OA and that there were no statistical differences between them in the VAS scores of pain on movement, Lequesne index or safety during the observation period with short-time follow up.
authors.affiliation: Department of Orthopedic Surgery, Peking University First Hospital, Beijing, China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Xin
authors.affiliation: Center of Bone and Joint Disease, Peking University People's Hospital, Beijing, China.
authors.forename: Lin
authors.initials: L
authors.lastname: Jianhao
authors.affiliation: Department of Orthopedic Surgery, General Hospital of the Chinese PLA Beijing Region, Beijing, China.
authors.forename: Sun
authors.initials: S
authors.lastname: Tiansheng
authors.affiliation: Department of Orthopedic Surgery, Shanghai Ninth People's Hospital, Affiliated to Shanghai Jiaotong University, Shanghai, China.
authors.forename: Hao
authors.initials: H
authors.lastname: Yongqiang
authors.affiliation: Department of Orthopedic Surgery, Jiangsu Provincial People's Hospital, Nanjing, China.
authors.forename: Fan
authors.initials: F
authors.lastname: Weimin
authors.affiliation: Department of Orthopedic Surgery, Peking University First Hospital, Beijing, China.
authors.forename: Chen
authors.initials: C
authors.lastname: Ming
authors.affiliation: Center of Bone and Joint Disease, Peking University People's Hospital, Beijing, China.
authors.forename: Sun
authors.initials: S
authors.lastname: Tiezheng
authors.affiliation: Department of Orthopedic Surgery, General Hospital of the Chinese PLA Beijing Region, Beijing, China.
authors.forename: Yao
authors.initials: Y
authors.lastname: Jianhua
authors.affiliation: Department of Orthopedic Surgery, Shanghai Ninth People's Hospital, Affiliated to Shanghai Jiaotong University, Shanghai, China.
authors.forename: Xuan
authors.initials: X
authors.lastname: Liang
authors.affiliation: Department of Orthopedic Surgery, Jiangsu Provincial People's Hospital, Nanjing, China.
authors.forename: Gu
authors.initials: G
authors.lastname: Xiaoyuan
authors.affiliation: Department of Orthopedic Surgery, Peking University First Hospital, Beijing, China.
authors.forename: Cao
authors.initials: C
authors.lastname: Yongping
mesh_terms: D000368:Aged; D004185:Disability Evaluation; D004311:Double-Blind Method; D004339:Drug Compounding; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D007269:Injections, Intra-Arterial; D007719:Knee Joint / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D010147:Pain Measurement; D020127:Recovery of Function; D013810:Therapeutic Equivalency; D013997:Time Factors; D016896:Treatment Outcome; D055675:Viscosupplements / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D055675:Viscosupplements; D006820:Hyaluronic Acid
keywords: multi-center randomized controlled clinical study; osteoarthritis; sodium hyaluronate