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

Objective To compare the efficacy and safety of two different sodium hyaluronate drugs in treating degenerative osteoarthritis (OA) of the knee. Method This randomized, multi‐center, double‐blind, positive‐drug, parallel‐controlled study included 229 patients aged ≥ 45 years who were clinically diag...

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Veröffentlicht in:International journal of rheumatic diseases 2016-03, Vol.19 (3), p.271-278
Hauptverfasser: Xin, Yang, Jianhao, Lin, Tiansheng, Sun, Yongqiang, Hao, Weimin, Fan, Ming, Chen, Tiezheng, Sun, Jianhua, Yao, Liang, Xuan, Xiaoyuan, Gu, Yongping, Cao
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container_issue 3
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container_title International journal of rheumatic diseases
container_volume 19
creator Xin, Yang
Jianhao, Lin
Tiansheng, Sun
Yongqiang, Hao
Weimin, Fan
Ming, Chen
Tiezheng, Sun
Jianhua, Yao
Liang, Xuan
Xiaoyuan, Gu
Yongping, Cao
description Objective To compare the efficacy and safety of two different sodium hyaluronate drugs in treating degenerative osteoarthritis (OA) of the knee. Method 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. Conclusion 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.
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Method 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. Conclusion 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.</description><identifier>ISSN: 1756-1841</identifier><identifier>EISSN: 1756-185X</identifier><identifier>DOI: 10.1111/1756-185X.12782</identifier><identifier>PMID: 26555862</identifier><language>eng</language><publisher>England: Blackwell Publishing Ltd</publisher><subject>Aged ; Disability Evaluation ; Double-Blind Method ; Drug Compounding ; Female ; Humans ; Hyaluronic Acid - administration &amp; dosage ; Hyaluronic Acid - adverse effects ; Injections, Intra-Arterial ; Knee Joint - drug effects ; Knee Joint - physiopathology ; Male ; Middle Aged ; multi-center randomized controlled clinical study ; osteoarthritis ; Osteoarthritis, Knee - diagnosis ; Osteoarthritis, Knee - drug therapy ; Osteoarthritis, Knee - physiopathology ; Pain ; Pain Measurement ; Recovery of Function ; sodium hyaluronate ; Therapeutic Equivalency ; Time Factors ; Treatment Outcome ; Viscosupplements - administration &amp; dosage ; Viscosupplements - adverse effects</subject><ispartof>International journal of rheumatic diseases, 2016-03, Vol.19 (3), p.271-278</ispartof><rights>2015 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd</rights><rights>2015 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.</rights><rights>International Journal of Rheumatic Diseases © 2016 Asia Pacific League of Associations for Rheumatology and John Wiley &amp; Sons Australia, Ltd</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5092-91da0f3e7cb08302a93c49e43f4825af28d0177678b5518db1493bb2c9922e843</citedby><cites>FETCH-LOGICAL-c5092-91da0f3e7cb08302a93c49e43f4825af28d0177678b5518db1493bb2c9922e843</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2F1756-185X.12782$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2F1756-185X.12782$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26555862$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Xin, Yang</creatorcontrib><creatorcontrib>Jianhao, Lin</creatorcontrib><creatorcontrib>Tiansheng, Sun</creatorcontrib><creatorcontrib>Yongqiang, Hao</creatorcontrib><creatorcontrib>Weimin, Fan</creatorcontrib><creatorcontrib>Ming, Chen</creatorcontrib><creatorcontrib>Tiezheng, Sun</creatorcontrib><creatorcontrib>Jianhua, Yao</creatorcontrib><creatorcontrib>Liang, Xuan</creatorcontrib><creatorcontrib>Xiaoyuan, Gu</creatorcontrib><creatorcontrib>Yongping, Cao</creatorcontrib><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</title><title>International journal of rheumatic diseases</title><addtitle>Int J Rheum Dis</addtitle><description>Objective To compare the efficacy and safety of two different sodium hyaluronate drugs in treating degenerative osteoarthritis (OA) of the knee. Method 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. 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dosage</topic><topic>Viscosupplements - adverse effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Xin, Yang</creatorcontrib><creatorcontrib>Jianhao, Lin</creatorcontrib><creatorcontrib>Tiansheng, Sun</creatorcontrib><creatorcontrib>Yongqiang, Hao</creatorcontrib><creatorcontrib>Weimin, Fan</creatorcontrib><creatorcontrib>Ming, Chen</creatorcontrib><creatorcontrib>Tiezheng, Sun</creatorcontrib><creatorcontrib>Jianhua, Yao</creatorcontrib><creatorcontrib>Liang, Xuan</creatorcontrib><creatorcontrib>Xiaoyuan, Gu</creatorcontrib><creatorcontrib>Yongping, Cao</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium &amp; Calcified Tissue Abstracts</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>International journal of rheumatic diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Xin, Yang</au><au>Jianhao, Lin</au><au>Tiansheng, Sun</au><au>Yongqiang, Hao</au><au>Weimin, Fan</au><au>Ming, Chen</au><au>Tiezheng, Sun</au><au>Jianhua, Yao</au><au>Liang, Xuan</au><au>Xiaoyuan, Gu</au><au>Yongping, Cao</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>International journal of rheumatic diseases</jtitle><addtitle>Int J Rheum Dis</addtitle><date>2016-03</date><risdate>2016</risdate><volume>19</volume><issue>3</issue><spage>271</spage><epage>278</epage><pages>271-278</pages><issn>1756-1841</issn><eissn>1756-185X</eissn><abstract>Objective To compare the efficacy and safety of two different sodium hyaluronate drugs in treating degenerative osteoarthritis (OA) of the knee. Method 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. Conclusion 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.</abstract><cop>England</cop><pub>Blackwell Publishing Ltd</pub><pmid>26555862</pmid><doi>10.1111/1756-185X.12782</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record>
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subjects Aged
Disability Evaluation
Double-Blind Method
Drug Compounding
Female
Humans
Hyaluronic Acid - administration & dosage
Hyaluronic Acid - adverse effects
Injections, Intra-Arterial
Knee Joint - drug effects
Knee Joint - physiopathology
Male
Middle Aged
multi-center randomized controlled clinical study
osteoarthritis
Osteoarthritis, Knee - diagnosis
Osteoarthritis, Knee - drug therapy
Osteoarthritis, Knee - physiopathology
Pain
Pain Measurement
Recovery of Function
sodium hyaluronate
Therapeutic Equivalency
Time Factors
Treatment Outcome
Viscosupplements - administration & dosage
Viscosupplements - adverse effects
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
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