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酮洛芬透皮传递体凝胶治疗膝骨关节炎的安全性和有效性:一项系统评价

Safety and efficacy of topical ketoprofen in transfersome gel in knee osteoarthritis: A systematic review.

作者信息

Sardana Vandit, Burzynski Joanna, Zalzal Paul

机构信息

Division of Orthopedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.

School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada.

出版信息

Musculoskeletal Care. 2017 Jun;15(2):114-121. doi: 10.1002/msc.1163. Epub 2016 Oct 24.

Abstract

PURPOSE

Topical ketoprofen in Transfersome gel has been used for the alleviation of symptoms in osteoarthritis. Non-steroidal anti-inflammatory drugs (NSAIDs) are associated with various side effects. Topical NSAIDs are known to have a lower side-effect profile when compared with systemic administration. The present systematic review aimed to determine the safety and efficacy of topical ketoprofen in Transfersome gel in knee osteoarthritis (OA).

METHODS

A systematic literature review was performed. The electronic databases EMBASE, MEDLINE, HealthStar and PubMed were searched from 1946 to June 2016. A screen of the reference sections of the included studies was also performed. Two blinded reviewers searched, screened, abstracted and evaluated the data quality using the Jadad scale. Studies were included if they contained: at least 50% of participants with knee OA, topical ketoprofen, human subjects and participants from North America or Europe. Study outcomes had to include patient-reported functional outcome scores.

RESULTS

Five studies were included, with a total of 3619 participants, and a mean Jadad score of 3.4/5. Western Ontario McMaster Universities (WOMAC) Osteoarthritis Index was the only outcome measure consistent across all of the randomized controlled trials included in the present review (four of the five included studies). All topical ketoprofen in Transfersome gel groups (25 mg, 50 mg and 100 mg) had improvements in pain that were superior to all other treatment arms, and the 50 mg topical ketoprofen in Transfersome gel group had functional gains that were superior to all other treatment arms. The majority of the adverse events were non-serious and related to skin and subcutaneous tissue disorders, with erythema being the most common. The average of all adverse events and gastrointestinal (GI) adverse events was highest in the oral celecoxib group (47.1% and 15.1%, respectively). The average frequency of GI adverse events in the topical ketoprofen groups was comparable with that in the topical placebo treatment arm. A meta-analysis was not feasible due to the heterogeneity among the studies.

CONCLUSIONS

Topical ketoprofen in Transfersome gel is an effective means of treating symptoms of knee OA, and is superior to oral celecoxib, oral placebo and topical placebo. The most commonly reported adverse events associated with the use of topical ketoprofen in Transfersome gel were non-severe skin and subcutaneous tissue disorders. Furthermore, as topical ketoprofen in Transfersome gel was associated with fewer adverse events when compared with oral celecoxib, and had rates of GI adverse events comparable with those of topical placebo, it may be ideal for those who are unable to take oral NSAIDs.

摘要

目的

传递体凝胶中的外用酮洛芬已被用于缓解骨关节炎症状。非甾体抗炎药(NSAIDs)会引发多种副作用。与全身给药相比,外用NSAIDs的副作用相对较少。本系统评价旨在确定传递体凝胶中的外用酮洛芬治疗膝关节骨关节炎(OA)的安全性和有效性。

方法

进行了一项系统的文献综述。检索了1946年至2016年6月期间的电子数据库EMBASE、MEDLINE、HealthStar和PubMed。还对纳入研究的参考文献部分进行了筛选。两名盲法评审员检索、筛选、提取数据并使用Jadad量表评估数据质量。纳入的研究需包含:至少50%的膝关节OA参与者、外用酮洛芬、人类受试者以及来自北美或欧洲的参与者。研究结果必须包括患者报告的功能结局评分。

结果

纳入了五项研究,共有3619名参与者,Jadad平均评分为3.4/5。西安大略和麦克马斯特大学骨关节炎指数(WOMAC)是本综述纳入的所有随机对照试验(五项纳入研究中的四项)中唯一一致的结局指标。传递体凝胶中所有外用酮洛芬组(25毫克、50毫克和100毫克)的疼痛改善情况均优于所有其他治疗组,传递体凝胶中50毫克外用酮洛芬组的功能改善优于所有其他治疗组。大多数不良事件不严重,与皮肤和皮下组织疾病有关,其中红斑最为常见。口服塞来昔布组的所有不良事件和胃肠道(GI)不良事件的发生率最高(分别为47.1%和15.1%)。外用酮洛芬组的GI不良事件平均发生率与外用安慰剂治疗组相当。由于研究之间存在异质性,因此无法进行荟萃分析。

结论

传递体凝胶中的外用酮洛芬是治疗膝关节OA症状的有效手段,优于口服塞来昔布、口服安慰剂和外用安慰剂。与使用传递体凝胶中的外用酮洛芬相关的最常见不良事件是不严重的皮肤和皮下组织疾病。此外,由于传递体凝胶中的外用酮洛芬与口服塞来昔布相比不良事件较少,且GI不良事件发生率与外用安慰剂相当,因此对于无法服用口服NSAIDs的患者可能是理想选择。

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