Hawel R, Klein G, Singer F, Mayrhofer F, Kähler S T
Rehabilitationszentrum für Erkrankungen des rheumatischen Formenkreises, Bad Hofgastein, Austria.
Int J Clin Pharmacol Ther. 2003 Apr;41(4):153-64. doi: 10.5414/cpp41153.
Osteoarthritis (OA) is often treated with nonsteroidal anti-inflammatory drugs (NSAIDs) or selective inhibitors of cyclooxygenase-2 (COX-2).
This clinical trial aimed to assess directly the relative therapeutic efficacy of the isolated active enantiomer of ibuprofen, named dexibuprofen (S(+)-ibuprofen) in a special crystal form, and the selective COX-2 inhibitor celecoxib in adults with OA of the hip. Moreover, the hypothesis that the tolerability/safety profile of dexibuprofen is comparable to celecoxib is to be tested.
The investigation was a randomized, parallel-group, double-blind, active controlled clinical trial, conducted from January 2001 to February 2002 in 4 rehabilitation centers in Austria. 148 inpatients were randomly assigned to dexibuprofen 800 mg or celecoxib 200 mg daily. The primary criterion was the improvement in the Western Ontario and' McMasters osteoarthritis index (WOMAC OA index) after 15 days of therapy.
Evaluation of the WOMAC OA index proved that dexibuprofen 400 mg b.i.d. is not inferior to celecoxib 100 mg b.i.d. with the Mann-Whitney estimator equal to 0.5129 and the corresponding lower boundary of the 95% confidence interval equal to 0.4409. The overall incidence of adverse drug reactions was 12.16% in the dexibuprofen group and 13.51% in the celecoxib group. 8.1% of patients on dexibuprofen and 9.5% on celecoxib suffered from gastrointestinal disorders.
In the presented clinical trial dexibuprofen has at least equal efficacy and a comparable safety/tolerability profile as celecoxib in adult patients suffering from osteoarthritis of the hip.
骨关节炎（OA）通常用非甾体抗炎药（NSAIDs）或环氧化酶-2（COX-2）选择性抑制剂进行治疗。
本临床试验旨在直接评估布洛芬的单一活性对映体右布洛芬（S(+)-布洛芬）的一种特殊晶体形式，与选择性COX-2抑制剂塞来昔布在成年髋骨关节炎患者中的相对治疗效果。此外，还要检验右布洛芬的耐受性/安全性与塞来昔布相当这一假设。
该研究是一项随机、平行组、双盲、活性对照临床试验，于2001年1月至2002年2月在奥地利的4个康复中心进行。148名住院患者被随机分配，分别每日服用800毫克右布洛芬或200毫克塞来昔布。主要标准是治疗15天后西加拿大和麦克马斯特大学骨关节炎指数（WOMAC OA指数）的改善情况。
对WOMAC OA指数的评估证明，每日两次服用400毫克右布洛芬并不劣于每日两次服用100毫克塞来昔布，曼-惠特尼估计值为0.5129，95%置信区间的相应下限为0.4409。右布洛芬组药物不良反应的总发生率为12.16%，塞来昔布组为13.51%。服用右布洛芬的患者中有8.1%、服用塞来昔布的患者中有9.5%出现胃肠道疾病。
在本临床试验中，右布洛芬在成年髋骨关节炎患者中至少具有与塞来昔布同等的疗效以及相当的安全性/耐受性。
