一项关于5-Loxin治疗膝骨关节炎有效性和安全性的双盲、随机、安慰剂对照研究。

A double blind, randomized, placebo controlled study of the efficacy and safety of 5-Loxin for treatment of osteoarthritis of the knee.

作者信息

Sengupta Krishanu, Alluri Krishnaraju V, Satish Andey Rama, Mishra Simanchala, Golakoti Trimurtulu, Sarma Kadainti Vs, Dey Dipak, Raychaudhuri Siba P

机构信息

Cellular and Molecular Biology Division, Laila Impex R&D Center, Jawahar Autonagar, Vijayawada, India.

出版信息

Arthritis Res Ther. 2008;10(4):R85. doi: 10.1186/ar2461. Epub 2008 Jul 30.

DOI:10.1186/ar2461

PMID:18667054

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2575633/

Abstract

INTRODUCTION

5-Loxin is a novel Boswellia serrata extract enriched with 30% 3-O-acetyl-11-keto-beta-boswellic acid (AKBA), which exhibits potential anti-inflammatory properties by inhibiting the 5-lipoxygenase enzyme. A 90-day, double-blind, randomized, placebo-controlled study was conducted to evaluate the efficacy and safety of 5-Loxin in the treatment of osteoarthritis (OA) of the knee.

METHODS

Seventy-five OA patients were included in the study. The patients received either 100 mg (n = 25) or 250 mg (n = 25) of 5-Loxin daily or a placebo (n = 25) for 90 days. Each patient was evaluated for pain and physical functions by using the standard tools (visual analog scale, Lequesne's Functional Index, and Western Ontario and McMaster Universities Osteoarthritis Index) at the baseline (day 0), and at days 7, 30, 60 and 90. Additionally, the cartilage degrading enzyme matrix metalloproteinase-3 was also evaluated in synovial fluid from OA patients. Measurement of a battery of biochemical parameters in serum and haematological parameters, and urine analysis were performed to evaluate the safety of 5-Loxin in OA patients.

RESULTS

Seventy patients completed the study. At the end of the study, both doses of 5-Loxin conferred clinically and statistically significant improvements in pain scores and physical function scores in OA patients. Interestingly, significant improvements in pain score and functional ability were recorded in the treatment group supplemented with 250 mg 5-Loxin as early as 7 days after the start of treatment. Corroborating the improvements in pain scores in treatment groups, we also noted significant reduction in synovial fluid matrix metalloproteinase-3. In comparison with placebo, the safety parameters were almost unchanged in the treatment groups.

CONCLUSION

5-Loxin reduces pain and improves physical functioning significantly in OA patients; and it is safe for human consumption. 5-Loxin may exert its beneficial effects by controlling inflammatory responses through reducing proinflammatory modulators, and it may improve joint health by reducing the enzymatic degradation of cartilage in OA patients.

TRIAL REGISTRATION

(

CLINICAL TRIAL REGISTRATION NUMBER

ISRCTN05212803.).

摘要

引言

5-Loxin是一种新型的锯叶棕提取物，富含30%的3-O-乙酰基-11-酮基-β-乳香酸（AKBA），它通过抑制5-脂氧合酶展现出潜在的抗炎特性。开展了一项为期90天的双盲、随机、安慰剂对照研究，以评估5-Loxin治疗膝骨关节炎（OA）的疗效和安全性。

方法

75例OA患者纳入研究。患者每日服用100毫克（n = 25）或250毫克（n = 25）的5-Loxin或安慰剂（n = 25），为期90天。在基线（第0天）以及第7、30、60和90天，使用标准工具（视觉模拟量表、Lequesne功能指数以及西安大略和麦克马斯特大学骨关节炎指数）对每位患者的疼痛和身体功能进行评估。此外，还对OA患者滑液中的软骨降解酶基质金属蛋白酶-3进行了评估。对血清中的一系列生化参数、血液学参数进行测量，并进行尿液分析，以评估5-Loxin对OA患者的安全性。

结果

70例患者完成了研究。在研究结束时，两种剂量的5-Loxin均使OA患者的疼痛评分和身体功能评分在临床和统计学上有显著改善。有趣的是，早在治疗开始7天后，补充250毫克5-Loxin的治疗组在疼痛评分和功能能力方面就有显著改善。与治疗组疼痛评分的改善情况相一致，我们还注意到滑液基质金属蛋白酶-3显著降低。与安慰剂相比，治疗组的安全性参数几乎没有变化。