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口服酶疗法与双氯芬酸治疗膝关节活动性骨关节炎的疗效和耐受性比较:一项开放性随机对照临床试验

Efficacy and tolerability of oral enzyme therapy as compared to diclofenac in active osteoarthrosis of knee joint: an open randomized controlled clinical trial.

作者信息

Tilwe G H, Beria S, Turakhia N H, Daftary G V, Schiess W

机构信息

Department of Medicine, GS Medical College and KEM Hospital, Mumbai.

出版信息

J Assoc Physicians India. 2001 Jun;49:617-21.

Abstract

OBJECTIVE

To compare the efficacy and tolerability of an oral enzyme preparation (Phlogenzym) with that of an NSAID (diclofenac) in the treatment of active osteoarthrosis.

METHODS

Prospective, randomized, controlled, single-blind study of seven weeks duration at a tertiary care centre wherein 50 patients aged 40-75 years, with activated osteoarthrosis of knee joint were randomized to receive phlogenzym tablets (2-3 tablets, bid) or diclofenac sodium 50 mg bid for three weeks.

RESULTS

At the end of therapy (three weeks) and at follow-up visit at seven weeks there was reduction in pain and joint tenderness and swelling in both groups, and slight improvement in the range of movement in the study group. The reduction in joint tenderness was greater (p < 0.05) in the study group receiving phlogenzym.

CONCLUSION

Phlogenzym is as efficacious and well tolerated as diclofenac sodium in the management of active osteoarthrosis over three weeks of treatment.

摘要

目的

比较口服酶制剂(菠萝蛋白酶肠溶片)与非甾体抗炎药(双氯芬酸)治疗活动性骨关节炎的疗效和耐受性。

方法

在一家三级护理中心进行的为期七周的前瞻性、随机、对照、单盲研究,将50名年龄在40 - 75岁、膝关节活动性骨关节炎患者随机分为两组,一组接受菠萝蛋白酶肠溶片(2 - 3片,每日两次),另一组接受双氯芬酸钠50毫克,每日两次,为期三周。

结果

治疗结束时(三周)以及七周随访时,两组患者的疼痛、关节压痛和肿胀均有所减轻,研究组的活动范围略有改善。接受菠萝蛋白酶肠溶片的研究组关节压痛减轻更明显(p < 0.05)。

结论

在治疗活动性骨关节炎的三周时间里,菠萝蛋白酶肠溶片与双氯芬酸钠疗效相当且耐受性良好。

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