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[关于药物辅料三种信息来源的可靠性]

[Reliability of 3 sources of information about medication excipients].

作者信息

Buitrago F, Altimiras J, Nieto-Hernández T

机构信息

Centro de Salud Universitario La Paz, Unidad Docente de Medicina Familiar y Comunitaria, Badajoz.

出版信息

Aten Primaria. 1996 Nov 30;18(9):480-3.

PMID:9280442
Abstract

OBJECTIVE

To find how reliably three sources of therapeutic information record the composition of excipients: the Vademecum, the pharmaceutical catalogue and the instructions sheets of pharmaceutical products.

DESIGN

Descriptive study.

SETTING

Primary care.

PATIENTS AND OTHER PARTICIPANTS

Initially, 658 orally-taken products were selected. Whether four excipients (saccharine, saccharose, lactose and ethanol) appeared in these products' composition formulas was compared.

RESULTS

In 70.6% +/- 5.11 there was discordance on the excipients in the composition formulas in one of the three sources of therapeutic information. The instructions sheets contained information on the number of excipients in 98.7% +/- 1.3 of the products, the pharmaceutical catalogue in 87.2% +/- 3.7 and the Vademecum in 65.7% +/- 5.3. So the Vademecum was the source of therapeutic information containing the highest percentage of products with no kind of information about excipients, followed by the catalogue and the instructions sheets. The instructions sheets were the best source of therapeutic information for 289 products. 10.3% of laboratories did not quantify their excipients in any of the three sources under study.

CONCLUSIONS

The Vademecum and pharmaceutical catalogue do not include very reliable information about these four excipients in the composition formulas of pharmaceutical products. It is important to make available to doctors straightforward texts which provide more reliable and up-to-date information.

摘要

目的

探究三种治疗信息来源记录辅料成分的可靠性,这三种来源分别是《医学指南》、药品目录和药品说明书。

设计

描述性研究。

地点

初级保健机构。

患者及其他参与者

最初选取了658种口服产品,比较这四种辅料(糖精、蔗糖、乳糖和乙醇)是否出现在这些产品的成分配方中。

结果

在70.6%±5.11%的情况下,三种治疗信息来源之一在成分配方中的辅料信息存在不一致。药品说明书包含了98.7%±1.3%的产品的辅料数量信息,药品目录包含了87.2%±3.7%的产品的辅料数量信息,《医学指南》包含了65.7%±5.3%的产品的辅料数量信息。因此,《医学指南》是治疗信息来源中不含任何辅料信息的产品比例最高的,其次是药品目录和药品说明书。药品说明书是289种产品的最佳治疗信息来源。10.3%的实验室在研究的三种来源中均未对其辅料进行量化。

结论

《医学指南》和药品目录并未包含关于药品成分配方中这四种辅料的非常可靠的信息。向医生提供更直接、更可靠和最新信息的文本非常重要。

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