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一项针对老年患者的钙和维生素D3补充剂Calcichew D3 Forte与Ad Cal D3可接受性的随机、单盲、交叉比较。

A randomised, single-blind, crossover comparison of the acceptability of the calcium and vitamin D3 supplements Calcichew D3 Forte and Ad Cal D3 in elderly patients.

作者信息

Rees T P, Howe I

机构信息

Shire Pharmaceuticals Ltd, East Anton, Andover, Hants SP10 5RG, UK.

出版信息

Curr Med Res Opin. 2001;16(4):245-51. doi: 10.1185/030079901750120178.

DOI:10.1185/030079901750120178
PMID:11268708
Abstract

BACKGROUND

Supplements of calcium and vitamin D are given to elderly patients in order to reduce the likelihood of osteoporotic fractures. The acceptability of the preparation is an important component of the compliance of such patients with their treatment.

AIM

To compare the acceptability of Calcichew D3 Forte (CDF) and Ad Cal D3 (ACD).

METHOD

This was a randomised, crossover, comparative study of two formulations of calcium and vitamin D. Patients took CDF for seven days followed by ACD for seven days, or vice versa, according to the randomisation schedule. At the end of each treatment period, patients used visual analogue scales (VAS) to indicate the grittiness, chalkiness, taste, ease of chewing, ease of swallowing and stickiness of each preparation.

RESULTS

One hundred and two elderly patients taking calcium supplements were recruited. Of these, 94 were suitable for inclusion in the efficacy analysis. The VAS scores were significantly lower for CDF than for ACD for grittiness (p = 0.0051), chalkiness (p = 0.0005), ease of chewing (p = 0.0001), ease of swallowing (p = 0.0001) and stickiness (p = 0.0001). These findings indicate that patients found CDF more acceptable than ACD. There was no difference between the groups for the taste score (p = 0.64). Overall, 79.8% of patients stated a preference for CDF, 10.6% preferred ACD and 9.6% had no preference.

CONCLUSION

Patients preferred CDF and found it more acceptable than ACD.

摘要

背景

为老年患者补充钙和维生素D以降低骨质疏松性骨折的可能性。制剂的可接受性是此类患者治疗依从性的重要组成部分。

目的

比较钙尔奇D3咀嚼片(CDF)和阿法骨化醇软胶囊(ACD)的可接受性。

方法

这是一项对两种钙和维生素D制剂进行的随机、交叉、对照研究。患者根据随机安排服用CDF 7天,然后服用ACD 7天,或反之。在每个治疗期结束时,患者使用视觉模拟量表(VAS)来表明每种制剂的砂质感、白垩感、味道、咀嚼难易程度、吞咽难易程度和黏性。

结果

招募了102名正在服用补钙制剂的老年患者。其中,94名适合纳入疗效分析。CDF在砂质感(p = 0.0051)、白垩感(p = 0.0005)、咀嚼难易程度(p = 0.0001)、吞咽难易程度(p = 0.0001)和黏性(p = 0.0001)方面的VAS评分显著低于ACD。这些结果表明患者发现CDF比ACD更可接受。两组在味道评分上无差异(p = 0.64)。总体而言,79.8%的患者表示更喜欢CDF,10.6%更喜欢ACD,9.6%无偏好。

结论

患者更喜欢CDF,且发现它比ACD更可接受。

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