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氯那唑酸钙与萘普生治疗脊柱骨关节炎、髋关节炎和膝关节炎的双盲对照试验(作者译)

[Double-blind comparative trial of lonazolac-Ca versus naproxen in spinal osteoarthrosis, coxarthrosis and gonarthrosis (author's transl)].

作者信息

Siegmeth W, Placheta P

出版信息

Wien Klin Wochenschr. 1982 Mar 19;94(6):145-7.

PMID:7048748
Abstract

Two groups of patients, each consisting of 20 patients suffering from spinal osteoarthrosis, coxarthrosis or gonarthrosis participated in a double-blind comparative trial. They received either Lonazolac-Ca (200 mg three times daily) or Naproxen (250 mg twice daily plus 1 placebo capsule in between doses) for three weeks. The therapeutic response was assessed by monitoring pain intensity at rest and on exercise, joint tenderness and joint movement, muscular tension, morning stiffness and walking ability. In spinal osteoarthrosis vertebral flexibility was also measured. Nine out of 11 parameters showed significant improvement with Lonazolac-Ca, whereas only 6 out of 11 improved with Naproxen. However, no clinically relevant differences were recorded between both medications. Laboratory tests in both treatment groups revealed no changes in haematological or biochemical parameters nor in urinanalysis results. Drug-related gastro-intestinal side effects were observed in 2 patients of each treatment group. The patients on Lonazolac-Ca tolerated their medication with the aid of concomitant antacids whereas Naproxen had to be discontinued. One case of dermatitis, which was probably not drug-related was observed in each group. One patient suffering from migraine experienced vertigo and headache on taking Lonazolac-Ca; although this was probably not drug-related medication was discontinued.

摘要

两组患者参与了一项双盲对比试验,每组各有20名患有脊柱骨关节炎、髋关节炎或膝关节炎的患者。他们分别接受氯那唑酸钙(每日三次,每次200毫克)或萘普生(每日两次,每次250毫克,两次服药之间加服1粒安慰剂胶囊)治疗,为期三周。通过监测静息和运动时的疼痛强度、关节压痛和关节活动、肌肉紧张度、晨僵及行走能力来评估治疗反应。对于脊柱骨关节炎患者,还测量了椎体灵活性。11项参数中有9项在使用氯那唑酸钙治疗后有显著改善,而使用萘普生治疗后只有6项得到改善。然而,两种药物之间未记录到临床相关差异。两个治疗组的实验室检查均显示血液学或生化参数以及尿液分析结果无变化。每个治疗组均有2名患者出现与药物相关的胃肠道副作用。服用氯那唑酸钙的患者借助同时服用的抗酸剂耐受了药物,而服用萘普生的患者则不得不停药。每组均观察到1例可能与药物无关的皮炎病例。1名偏头痛患者在服用氯那唑酸钙时出现眩晕和头痛;尽管这可能与药物无关,但仍停用了药物。

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