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替鲁膦酸盐作为舟状骨疾病治疗的新型治疗药物:一项双盲安慰剂对照临床试验。

Tiludronate as a new therapeutic agent in the treatment of navicular disease: a double-blind placebo-controlled clinical trial.

作者信息

Denoix J M, Thibaud D, Riccio B

机构信息

CIRALE/ENVA IPC, Goustranville, 14430 Dozulé, France.

出版信息

Equine Vet J. 2003 Jun;35(4):407-13. doi: 10.2746/042516403776014226.

Abstract

REASONS FOR PERFORMING STUDY

Bisphosphonates, such as tiludronate, are used to normalise bone metabolism via inhibition of bone resorption. Areas of increased bone resorption and formation are typical lesions in a diseased navicular bone.

OBJECTIVES

To determine if bone remodelling changes occurring in navicular disease may be corrected with therapies regulating bone metabolism.

METHODS

We designed a double-blind, placebo-controlled clinical trial to compare 2 doses of tiludronate, 0.5 mg/kg and 1 mg/kg bwt administered via daily i.v. injections over 10 days for the treatment of navicular disease. Seventy-three horses, split into 2 subpopulations of recent and chronic cases, were enrolled to be followed-up over 6 months. Of these, 33 recent and 17 chronic cases meeting the selection criteria were maintained in the final efficacy analyses. Clinical examinations were videorecorded and reviewed blindly by an independent expert.

RESULTS

Horses treated with the higher dose showed optimal improvement of lameness and return to normal level of activity 2-6 months post treatment. The more recent the onset of clinical signs at the time of treatment, the greater the efficacy. The treatment did not modify the response to extension and flexion tests. The lower dose failed to significantly improve the condition.

CONCLUSIONS

Tiludronate efficacy is demonstrated in the treatment of navicular disease at the dose of 1 mg/kg bwt.

POTENTIAL RELEVANCE

Our results support the clinical relevance of bone remodelling changes in the outcome of navicular disease.

摘要

开展本研究的原因

双膦酸盐类药物,如替鲁膦酸盐,可通过抑制骨吸收来使骨代谢正常化。骨吸收和形成增加的区域是舟状骨疾病的典型病变。

目的

确定舟状骨疾病中发生的骨重塑变化是否可以通过调节骨代谢的疗法得到纠正。

方法

我们设计了一项双盲、安慰剂对照的临床试验,比较2种剂量的替鲁膦酸盐,即0.5毫克/千克和1毫克/千克体重,通过每日静脉注射给药,持续10天,用于治疗舟状骨疾病。73匹马被分为近期病例和慢性病例两个亚组,进行为期6个月的随访。其中,33例近期病例和17例慢性病例符合入选标准,纳入最终疗效分析。临床检查进行录像,并由一名独立专家进行盲法评估。

结果

接受高剂量治疗的马匹在治疗后2至6个月跛行得到最佳改善,活动水平恢复正常。治疗时临床症状出现的时间越近,疗效越好。该治疗未改变对伸展和屈曲试验的反应。低剂量未能显著改善病情。

结论

替鲁膦酸盐以1毫克/千克体重的剂量治疗舟状骨疾病有效。

潜在意义

我们的结果支持了骨重塑变化在舟状骨疾病预后中的临床相关性。

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