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篇名 探討糖尿病藥品Pioglitazone原廠藥與學名藥療效相等性評估
卷期 10:2
並列篇名 An Evaluation of the Therapeutic Equivalence of Brand-Name and Generic Anti-Diabetic Pioglitazone
作者 林志綱張倪芳陳世爵
頁次 016-019
關鍵字 pioglitazone療效相等性糖化血色素pioglitazonetherapeutic equivalenceglycated hemoglobin
出刊日期 201404

中文摘要

目的
為比較原廠藥與學名藥在藥品療效上是否具相同效果, 本研究選用在控制糖尿病常用的T h i a z o l i d i n e d i o n e s類抗糖尿病藥物pioglitazone。研究方法為「比較相同病患使用原廠藥及改用學名藥後,在糖化血色素(Hb A1c)值的表現來比較兩者療效上是否有相等性」。
方法
此研究為回溯性研究,於台中某區域教學醫院收集資料,研究對象為2010年9月17日換廠當天前後一個月(8月17日~10月17日)之病患。研究對象資料收集期間為2010年3月1日~9月17日有服用原廠藥,並於2010年9月17日~2011年9月1日持續服用學名藥。取換廠前2010年3月1日~2010年9月1日及換廠後2011年3月1日~2011年9月1日期間兩次H b A1c紀錄。統計方法採取雙尾配對T-檢定(paired-t test)方式來比較兩者換廠前後之HbA1c是否有無顯著的差異。
結果
納入本研究之病患共1 5 8 人。排除研究期間不符合條件之病患後共37人。結果發現換廠前後的H b A1c平均值並不具有統計學上的差異(p=0.863)。
結論
本研究顯示服用此兩者不同廠牌的p i o g l i t a z o n e藥品,似乎對於糖尿病病患控制H bA1c値上,並無統計學上的差異。因此對病患血糖控制上的差異,原廠藥與學名藥之間的疑慮是無法被證實的。

英文摘要

Purposes
Pioglitazone, an anti-diabetic thiazolidinedione that is commonly used to control diabetes, was studied to determine whether brand-name and generic preparations were therapeutic equivalents by comparing the glycated hemoglobin (HbA1c) levels of the same patients.
Methods
In this retrospective study, data were collected from a regional teaching hospital in Taichung from August 17 to October 17, 2010 (one month before and after September 17, 2010, the day of the switch from the brand-name to the generic drug). Study subjects must have taken the brand-name drug from March 1 to September 17, 2010, and continually taken the generic drug from September 17, 2010 and September 1, 2011. Two HbA1c levels were taken from March 1, 2010 ~ September 1, 2010 and March 1, 2011 ~ September 1, 2011 as representative values for before and after the switch. A two-tailed paired t-test was used to determine whether there was a significant difference between HbA1c levels before and after switching from the brand-name to the generic drug.
Results
Initially, 158 patients were included in this study; however, after patients who did not meet the study criteria were excluded, 37 remained. There was no statistical difference (p=0.863) between the mean levels of HbA1c before and after the switch from the brandname to the generic drug.
Conclusions
The two pioglitazone products did not a show statistical difference in HbA1c levels of diabetic patients. Therefore, concern about a difference in blood sugar control between these drugs is unwarranted.

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