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FDA批准结肠镜检查前肠道准备新产品

来源:爱唯医学网    时间:2012年07月20日    点击数:    5星

随着一种粉末状产品获得美国食品药品管理局(FDA)批准,结肠镜检查前结肠清洁有了新的选择,其用法是在水中溶解后分2次使用。Ferring制药公司将以Prepopik这一商品名进行销售,从2012年10月起可购买到该产品。

Prepopik是匹克硫酸钠(一种兴奋性泻药)与氧化镁、无水柠檬酸的复方制剂。氧化镁和无水柠檬酸可生成柠檬酸镁,后者是一种渗透性泻药。根据7月17日FDA宣布批准令的声明,该药的用法为将2包药粉溶于冷水中,在2个不同时间点吞服。

根据药品处方信息,确定吞服药液时间的方法有2种。“分日法”是首选方法:在结肠镜检查的前一个晚上服用第1剂,在检查前的早晨服用第2剂。另一种选择是“前日法”:在结肠镜检查前一天的下午和晚上各服用1剂,之间间隔6 h。2次服用药液后都需要额外吞服清洗液。

该产品获得批准是基于2项随机临床研究,涉及约1,200名接受结肠镜检查的成人。这些受试者被随机分组,采用“分日法”或“前日法”使用Prepopik,或接受对照方案[在结肠镜检查前一天服用聚乙二醇加电解质(PEG+E)及2片5 mg比沙可啶片]。

在这2项研究中,Prepopik在清洁结肠方面均与对照方案同样有效,但在评估“分日法”方案的研究中,这一方案优于对照方案。

与Prepopik相关的最常见不良事件为恶心、呕吐和头痛。在采用“分日法”服用Prepopik的患者中,恶心、呕吐和头痛的发生率分别为2.6%、1%和1.6%,而对照方案组分别为3.7%、3.4%和1.7%。在评估“前日法”方案的研究中,采用“前日法”服用Prepopik的患者分别有3%、1.4%和2.7%发生恶心、呕吐和头痛,而对照方案组分别为4.3%、2%和1.7%。

在结肠镜检查当天,异常电解质变化在使用Prepopik的患者中更多见,但处方信息称这一变化是“一过性的”。

FDA药物评价与研究中心的Victoria Kusiak博士在声明中指出:“结肠镜检查前肠道清洁方案的选择应以患者的健康和个人意向为基础。”

作为批准条件之一,Ferring需要开展研究以确定该产品用于儿童是否安全、有效。

爱思唯尔 版权所有

By: ELIZABETH MECHCATIE, Internal Medicine News Digital Network

Another option for colon cleansing before colonoscopy is available, with the approval of a powder-based product that is dissolved in water and administered in two doses.

The product will be marketed as Prepopik by Ferring Pharmaceuticals, and will be available in October 2012, the company statement said.

The product is a combination of sodium picosulfate (a stimulant laxative) and magnesium oxide with anhydrous citric acid, which form magnesium citrate, an osmotic laxative. The patient receives two packets of powder to be dissolved in cold water and consumed at two different times, according to the Food and Drug Administration statement announcing the approval on July 17.

There are two options for when the product can be consumed in relation to the procedure time, according to the prescribing information. The "split-dose" method is preferred, and this involves taking the first dose the night before the colonoscopy and the second in the morning before the colonoscopy. Another option is to take the two doses in the afternoon and evening of the day before the procedure, with 6 hours between doses, known as the "day-before" method, the statement said. Additional clear fluids should be consumed after both dosing regimens.

Approval was based on two randomized clinical studies of about 1,200 adults undergoing a colonoscopy, who were assigned to the split-dose Prepopik regimen, the day-before Prepopik regimen, or a control regimen of polyethylene glycol plus electrolytes (PEG+E) with two 5-mg bisacodyl tablets taken the day before the colonoscopy.

In both studies, the use of Prepopik was as effective as the control preparation in cleansing the colon, but in the study that evaluated the split-dose regimen, this regimen was superior to the control preparation, the statement said.

The most common adverse events associated with Prepopik were nausea, vomiting, and headache. With split-dose Prepopik, the rates of nausea, vomiting, and headache were 2.6%, 1%, and 1.6%, respectively, compared with 3.7%, 3.4%, and 1.7% for the control regimen. With day-before Prepopik, rates of nausea, vomiting, and headache were 3%, 1.4%, and 2.7%, compared with 4.3%, 2%, and 1.7% for the control regimen.

On the day of colonoscopy, the rates of abnormal electrolyte shifts were numerically higher among those who used Prepopik, but the shifts were "transient in nature," according to the prescribing information.

In the statement, Dr. Victoria Kusiak, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said, "The choice of a bowel cleansing regimen for colonoscopy should be based on a patient’s health and personal preferences."

As a condition of approval, Ferring is required to conduct studies to determine if the product is safe and effective in children.


 

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