长期使用GCSB-5对骨关节炎患者胃肠道的安全性及疗效：一项为期24周的多中心研究。
Gastrointestinal safety and efficacy of long-term GCSB-5 use in patients with osteoarthritis: A 24-week, multicenter study.
作者信息
Ha Chul-Won, Park Yong-Beom, Kyung Hee-Soo, Han Chung-Soo, Bae Ki-Cheor, Lim Hong-Chul, Park Sang-Eun, Lee Myung Chul, Won Ye-Yeon, Lee Dong-Chul, Cho Sung-Do, Kim Chang-Wan, Kim Jin-Goo, Kang Joon-Soon, Lee Ju-Hong, Choi Eui-Sung, Seon Jong-Keun, Lee Woo-Suk, Bin Seong-Il
机构信息
Department of Orthopedic Surgery, Stem Cell & Regenerative Medicine Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Department of Orthopedic Surgery, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, South Korea.
出版信息
J Ethnopharmacol. 2016 Aug 2;189:310-8. doi: 10.1016/j.jep.2016.05.031. Epub 2016 May 16.
ETHNOPHARMACOLOGY RELEVANCE
A previous study indicated non-inferiority of GCSB-5 to celecoxib regarding efficacy and safety in treating OA; however, the gastrointestinal (GI) safety data was limited to 12 weeks. Accordingly, a longer term study with a larger number of patients was necessary to establish the GI safety of GCSB-5.
AIM OF STUDY
The primary goal was to determine the safety and efficacy of 24-week use of GCSB-5. The secondary goal was to compare the GI safety data of GCSB-5 with that of the previously reported Celecoxib Long-term Arthritis Safety Study (CLASS).
METHOD
This was a 24-week, multicenter, single-arm phase IV Study for the safety and efficacy of GCSB-5. A total of 761 patients were enrolled and 756 patients received at least one dose of GCSB-5. Among them, 629 patients (82.7%) completed the 24 week follow up. The primary goal was to determine the safety and efficacy of GCSB-5 for 24 weeks. The secondary goal was to compare the GI safety data of GCSB-5 with that of the previously reported Celecoxib Long-term Arthritis Safety Study (CLASS).
RESULTS
The incidence of GI disorders of GCSB-5 was 23.7%. The annual rate of perforation, ulcer obstruction, or bleeding (PUB) incidence was 0.0%. The drop-out rate due to GI disorders following GCSB-5 use was 4.8%. Compared to celecoxib data from CLASS, the incidence of GI disorders (23.7% vs. 31.4%, p<0.001), annual rate of PUB and gastroduodenal ulcers (0.0% vs 2.2%, p=0.004), and drop-out rate due to GI disorders following GCSB-5 use were significantly low (4.8% vs 8.7%, p<0.001). Efficacy was proven by significant improvements in Western Ontario McMaster Questionnaire (WOMAC) scale, Korean Knee Score (KKS), 100-mm pain visual analogue scale (VAS), and physician's global assessments of patient's response to therapy (PGART).
CONCLUSIONS
The safety and efficacy profile of GCSB-5 are comparable to celecoxib. These results indicate GCSB-5 is safe for a long-term treatment of knee OA patients.
TRIAL REGISTRATION
ClinicalTrials.gov (NCT01604239).
民族药理学相关性
先前一项研究表明，在治疗骨关节炎的疗效和安全性方面，GCSB-5不劣于塞来昔布；然而，胃肠道（GI）安全性数据仅限于12周。因此，有必要进行一项纳入更多患者的长期研究，以确定GCSB-5的胃肠道安全性。
研究目的
主要目标是确定使用GCSB-5 24周的安全性和有效性。次要目标是将GCSB-5的胃肠道安全性数据与先前报道的塞来昔布长期关节炎安全性研究（CLASS）的数据进行比较。
方法
这是一项为期24周的多中心、单臂IV期研究，旨在评估GCSB-5的安全性和有效性。共招募了761名患者，756名患者接受了至少一剂GCSB-5。其中，629名患者（82.7%）完成了24周的随访。主要目标是确定GCSB-5使用24周的安全性和有效性。次要目标是将GCSB-5的胃肠道安全性数据与先前报道的塞来昔布长期关节炎安全性研究（CLASS）的数据进行比较。
结果
GCSB-5引起的胃肠道疾病发生率为23.7%。穿孔、溃疡梗阻或出血（PUB）年发生率为0.0%。使用GCSB-5后因胃肠道疾病导致的退出率为4.8%。与CLASS研究中的塞来昔布数据相比，胃肠道疾病发生率（23.7%对31.4%，p<0.001）、PUB和胃十二指肠溃疡年发生率（0.0%对2.2%，p=0.004）以及使用GCSB-5后因胃肠道疾病导致的退出率均显著较低（4.8%对8.7%，p<0.001）。西安大略和麦克马斯特大学骨关节炎指数（WOMAC）量表、韩国膝关节评分（KKS）、100毫米疼痛视觉模拟量表（VAS）以及医生对患者治疗反应的整体评估（PGART）的显著改善证明了其疗效。
结论
GCSB-5的安全性和有效性与塞来昔布相当。这些结果表明，GCSB-5对膝关节骨关节炎患者进行长期治疗是安全的。
试验注册
ClinicalTrials.gov（NCT01604239）。
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