TWI814627B - Drug Concentration Detection System - Google Patents
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- 239000003814 drug Substances 0.000 title claims abstract description 51
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- 238000001514 detection method Methods 0.000 title claims abstract description 21
- 239000008280 blood Substances 0.000 claims abstract description 176
- 210000004369 blood Anatomy 0.000 claims abstract description 176
- 238000001802 infusion Methods 0.000 claims description 14
- 238000001647 drug administration Methods 0.000 claims description 6
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- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
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Abstract
一種藥物濃度檢測系統,主要包含一儲存模組、一醫囑模組與一運算模組,儲存模組儲存多筆抽血數據,醫囑模組根據選擇指令與抽血時間將多筆抽血數據的其中之二設定為先選抽血數據與後選抽血數據,且設定第一濃度與第二濃度,當非反序抽血時,醫囑模組根據峰值濃度的抽血時間與給藥時間產生第一間隔時間,根據谷值濃度的抽血時間與給藥時間產生第二間隔時間與一估算數據,運算模組根據估算數據與預設公式產生預測藥物濃度數據,達到自動化預測臨床療效指標即24小時之濃度-時間曲線下面積,且根據是否反序抽血,修正計算公式。A drug concentration detection system mainly includes a storage module, a doctor's order module and a computing module. The storage module stores multiple blood drawing data. The doctor's order module stores the multiple blood drawing data according to the selection instructions and blood drawing time. The second one is set to select the blood drawing data first and the blood drawing data later, and set the first concentration and the second concentration. When the blood is drawn in non-reverse order, the doctor's order module generates the blood drawing time and administration time based on the peak concentration. In the first interval, the second interval and an estimated data are generated based on the blood drawing time and administration time of the trough concentration. The computing module generates predicted drug concentration data based on the estimated data and the preset formula to achieve automated prediction of clinical efficacy indicators. The area under the concentration-time curve for 24 hours, and the calculation formula is modified according to whether blood is drawn in reverse order.
Description
本發明是有關於一種醫藥檢驗技術,特別是指一種藥物濃度檢測系統。The present invention relates to a medical testing technology, in particular to a drug concentration detection system.
部分疾病在利用藥物治療的過程中,需要透過定期抽血檢測血液中的藥物濃度,來決定是否需要調整下一次給藥的劑量,然而,由於實際給藥與抽血檢驗的時間,通常可能因為臨床情境而多有變動,可能進而導致無法如期進行檢驗藥物濃度,或因時間誤差而導致檢測失真。In the process of drug treatment for some diseases, it is necessary to regularly draw blood to test the drug concentration in the blood to determine whether the dose of the next dose needs to be adjusted. However, due to the time between actual administration and blood testing, it may usually be due to Clinical situations often change, which may lead to failure to test drug concentration as scheduled, or detection distortion due to time errors.
因此,本發明的一目的,即在提供一種用以解決上述問題的藥物濃度檢測系統。Therefore, an object of the present invention is to provide a drug concentration detection system to solve the above problems.
於是,該藥物濃度檢測系統包含一儲存模組、一醫囑模組與一運算模組。Therefore, the drug concentration detection system includes a storage module, a medical order module and a computing module.
儲存模組儲存多筆抽血數據,每一抽血數據具有一藥物濃度數據、一抽血時間、一給藥時間、一給藥間隔時間、一輸注時間。The storage module stores multiple blood drawing data. Each blood drawing data has a drug concentration data, a blood drawing time, a drug administration time, a drug administration interval time, and an infusion time.
醫囑模組電連接該儲存模組,根據一選擇指令將該多筆抽血數據的其中之一設定為一先選抽血數據,該醫囑模組根據該先選抽血數據的一抽血時間與其前後|一個給藥間隔時間+1小時|區間內之抽血數據的剩餘之一設定為一後選抽血數據,其中若有多筆數據,該先選抽血數據的抽血時間的前後二筆抽血數據對應該先選抽血數據的二個絕對間隔時間,該二個絕對間隔時間中的最小值所對應的抽血數據設定為該後選抽血數據,該醫囑模組將該先選抽血數據的該藥物濃度數據設定一第一濃度,將該後選抽血數據的該藥物濃度數據設定一第二濃度,當該第一濃度>該第二濃度時,該第一濃度=峰值濃度(Cp)、該第二濃度=谷值濃度(Ct),反之,當該第一濃度<該第二濃度時,該第一濃度=谷值濃度(Ct)、該第二濃度=峰值濃度(Cp),該醫囑模組根據比較該先選抽血數據之該第一濃度及該抽血時間、該後選抽血數據之該第二濃度及該抽血時間,判斷是否反序抽血。當判斷結果是非反序抽血,則該醫囑模組該醫囑模組根據該峰值濃度(Cp)的抽血時間與該給藥時間產生一第一間隔時間,該醫囑模組根據該谷值濃度(Ct)的抽血時間與該給藥時間產生一第二間隔時間,且產生一估算數據,該估算數據包括該第一濃度、該第二濃度、該第一間隔時間、該第二間隔時間、該給藥間隔時間、該輸注時間。The medical order module is electrically connected to the storage module, and sets one of the plurality of blood drawing data as a first-selected blood drawing data according to a selection instruction. The medical order module sets a blood drawing time according to the first-selected blood drawing data. Before and after | a dosing interval + 1 hour | the remaining one of the blood drawing data within the interval is set as a later-selected blood drawing data. If there are multiple pieces of data, the blood drawing data should be selected first before and after the blood drawing time. The two blood drawing data correspond to the two absolute intervals of the blood drawing data that should be selected first. The blood drawing data corresponding to the minimum value of the two absolute interval times is set as the subsequent blood drawing data. The doctor's order module sets the blood drawing data. The drug concentration data of the blood drawing data is first selected to set a first concentration, and the drug concentration data of the subsequently selected blood drawing data is set to a second concentration. When the first concentration > the second concentration, the first concentration =peak concentration (Cp), the second concentration = valley concentration (Ct), conversely, when the first concentration < the second concentration, the first concentration = valley concentration (Ct), the second concentration = Peak concentration (Cp), the medical order module determines whether to reverse the order based on comparing the first concentration and the blood drawing time of the first-selected blood drawing data, and the second concentration and the blood drawing time of the second-selected blood drawing data. Draw blood. When the judgment result is non-reverse blood drawing, the doctor's order module generates a first interval time based on the blood drawing time of the peak concentration (Cp) and the administration time, and the doctor's order module generates a first interval time based on the trough concentration The blood drawing time of (Ct) and the administration time generate a second interval time, and generate an estimated data. The estimated data includes the first concentration, the second concentration, the first interval time, and the second interval time. , the dosing interval, and the infusion time.
運算模組電連接該醫囑模組以接收該估算數據,且根據該估算數據與一預設公式產生一預測藥物濃度數據。The computing module is electrically connected to the medical order module to receive the estimated data, and generates predicted drug concentration data based on the estimated data and a preset formula.
本發明的功效在於:根據抽血數據與輸入設定,自動化估算以得到預測藥物濃度。The effect of the present invention is to automatically estimate and obtain the predicted drug concentration based on blood drawing data and input settings.
在本發明被詳細描述前,應當注意在以下的說明內容中,類似的元件是以相同的編號來表示。Before the present invention is described in detail, it should be noted that in the following description, similar elements are designated with the same numbering.
參閱圖1,本發明藥物濃度檢測系統的一實施例,應用於醫囑開立與檢驗報告的醫囑檢查系統,且包含一儲存模組3、一電連接該儲存模組3的醫囑模組2、一電連接醫囑模組2及儲存模組3的運算模組4、一電連接醫囑模組2的介面模組1。Referring to Figure 1, an embodiment of the drug concentration detection system of the present invention is applied to a medical order inspection system for issuing medical orders and test reports, and includes a storage module 3, a
如圖2所示,該藥物濃度檢測系統執行一種藥物濃度檢測方法,該藥物濃度檢測方法包含步驟S~步驟J。As shown in Figure 2, the drug concentration detection system executes a drug concentration detection method, and the drug concentration detection method includes steps S to J.
步驟(S) ,介面模組1用以接收選擇指令且傳送到醫囑模組2,該選擇指令用以選擇多筆抽血數據的其中之一。介面模組1用以接收一輸入設定且傳送到該醫囑模組2,該輸入設定包括一第一預檢時間與一第二預檢時間,當該醫囑模組2判斷第一預檢時間-預定給藥時間<0時,則產生一第一警示訊息,由該介面模組1顯示該第一警示訊息。當該醫囑模組2判斷第一預檢時間-該預定給藥時間>該給藥間隔時間時,則產生一第二警示訊息,由該介面模組1顯示該第二警示訊息。當該醫囑模組2判斷∣第二預檢時間-預定給藥時間∣>該給藥間隔時間時,則產生一第三警示訊息,由該介面模組1顯示該第三警示訊息。其中,在正常狀況下,第一預檢時間的定義是輸注完後間隔1~2小時的藥物峰值濃度(Cp)的抽血時間,第二預檢時間的定義是下次給藥時間前30分鐘的藥物谷值濃度 (Ct)的抽血時間。In step (S), the interface module 1 is used to receive a selection instruction and transmit it to the doctor's
步驟(A) ,儲存模組3儲存多筆抽血數據,每一抽血數據具有一藥物濃度數據、一抽血時間、一給藥時間、一給藥間隔時間、一輸注時間。In step (A), the storage module 3 stores multiple blood drawing data. Each blood drawing data has a drug concentration data, a blood drawing time, a drug administration time, a drug administration interval time, and an infusion time.
步驟(B) ,醫囑模組2根據一選擇指令將該多筆抽血數據的其中之一設定為一先選抽血數據。步驟(C):該醫囑模組2根據該先選抽血數據的一抽血時間與一絕對間隔時間將該多筆抽血數據的剩餘之一設定為一後選抽血數據,其中,該絕對間隔時間的定義是該抽血時間前後的|一個給藥間隔時間+1小時|區間內,其中若有多筆抽血數據,該先選抽血數據的抽血時間的前後二筆抽血數據對應該先選抽血數據的二個絕對間隔時間,該二個絕對間隔時間中的最小值所對應的抽血數據就是後選抽血數據;當該二個絕對間隔時間是相同,則該醫囑模組2產生一錯誤信號傳送到該介面模組1,由該介面模組1顯示。在此舉例說明,例如儲存模組3中,該日共有四筆抽血數據,抽血時間分別為第一筆00:30、第二筆 08:30、第三筆11:00、第四筆 19:00 ,若選擇指令將第三筆抽血數據設定為先選抽血數據,給藥時間為該日09:00且給藥間隔時間為8小時,則該日02:00至20:00之抽血數據皆可納入篩選,即第二筆抽血數據及第四筆抽血數據,由於第二筆抽血數據的絕對間隔時間是2.5小時<第四筆抽血數據的絕對間隔時間是8小時,因此將第二筆抽血數據設定為後選抽血數據。若將第四筆抽血數據的抽血時間改為13:30,則第二筆和第四筆的絕對間隔時間相同,會顯示資料來源異常,無法自動試算。In step (B), the
步驟(D) ,該醫囑模組2將該先選抽血數據的該藥物濃度數據設定一第一濃度,將該後選抽血數據的該藥物濃度數據設定一第二濃度。In step (D), the
步驟(E) ,該醫囑模組2根據判斷是否第一濃度>第二濃度。當該第一濃度>該第二濃度時,進到步驟(F1),該第一濃度=峰值濃度(Cp)、該第二濃度=谷值濃度(Ct)。當該第一濃度<該第二濃度時,進到步驟(F2),該第一濃度=谷值濃度(Ct)、該第二濃度=峰值濃度(Cp)。In step (E), the
步驟(F1) ,該醫囑模組2分析該先選抽血數據之該抽血時間、該後選抽血數據之該抽血時間,判斷是否反序抽血,也就是判斷是否先選抽血時間–該後選抽血時間<0。當該第一濃度>該第二濃度時,該第一濃度=峰值濃度(Cp)、該第二濃度=谷值濃度(Ct),此時,當該先選抽血時間–該後選抽血時間<0,則表示抽血順序沒有反序抽血,進到步驟(H1),反之,當該先選抽血時間–該後選抽血時間>0,則表示抽血順序為反序抽血,進到步驟(H2)。步驟(F2),該醫囑模組2判斷是否先選抽血時間–該後選抽血時間<0,當該第一濃度<該第二濃度時,該第一濃度=谷值濃度(Ct)、該第二濃度=峰值濃度(Cp),此時,當該先選抽血時間–該後選抽血時間>0,則表示抽血順序沒有反序抽血,進到步驟(H3),反之,當該先選抽血時間–該後選抽血時間<0,則表示抽血順序為反序抽血,進到步驟(H4)。In step (F1), the doctor's
步驟(H1) ,當判斷結果是第一濃度>第二濃度且非反序抽血,則該醫囑模組2根據該先選抽血數據的該抽血時間與該給藥時間產生一第一間隔時間,該醫囑模組2根據該後選抽血數據的該抽血時間與該給藥時間產生一第二間隔時間,且產生一估算數據,該估算數據包括該第一濃度、該第二濃度、該第一間隔時間、該第二間隔時間、該給藥間隔時間、該輸注時間。如圖3所示,輸注時間是1小時、第一間隔時間=11小時-9小時=2小時、第二間隔時間=20.5小時-9小時=11.5小時、給藥間隔時間=12小時、第一濃度=Cp=35 mg/L、第二濃度=Ct=15 mg/L。Step (H1), when the judgment result is that the first concentration > the second concentration and blood drawing is not in reverse order, the doctor's
步驟(H2) ,當該判斷結果是第一濃度>第二濃度且反序抽血,則該醫囑模組2根據該先選抽血數據的該抽血時間與該給藥時間產生該第一間隔時間,該醫囑模組2根據該後選抽血數據的該抽血時間與該給藥時間與一偏移值產生該第二間隔時間。該第一間隔時間=該先選抽血數據的該抽血時間-該給藥時間,該第二間隔時間=該後選抽血數據的該抽血時間+該偏移值-該給藥時間,偏移值定義為給藥間隔時間。如圖4所示,輸注時間是1小時、第一間隔時間=11小時-9小時=2小時、第二間隔時間=8.5小時+12小時-9小時=11.5小時、給藥間隔時間=12小時、第一濃度=Ct=15 mg/L、第二濃度=Cp=35 mg/L。Step (H2), when the judgment result is that the first concentration > the second concentration and blood is drawn in reverse order, the doctor's
步驟(H3) ,當判斷結果是第一濃度<第二濃度且非反序抽血,則該醫囑模組2根據該後選抽血數據的該抽血時間與該給藥時間產生一第一間隔時間,該醫囑模組2根據該先選抽血數據的該抽血時間與該給藥時間產生一第二間隔時間,且產生一估算數據,該估算數據包括該第一濃度、該第二濃度、該第一間隔時間、該第二間隔時間、該給藥間隔時間、該輸注時間。如圖5所示,輸注時間是1小時、第一間隔時間=11小時-9小時=2小時、第二間隔時間=20.5小時-9小時=11.5小時、給藥間隔時間=12小時、第一濃度=Cp=35 mg/L、第二濃度=Ct=15 mg/L。Step (H3), when the judgment result is that the first concentration < the second concentration and the blood is not drawn in reverse order, the doctor's
步驟(H4),當該判斷結果是第一濃度<第二濃度且反序抽血,則該醫囑模組2根據該後選抽血數據的該抽血時間與該給藥時間產生該第一間隔時間,該醫囑模組2根據該先選抽血數據的該抽血時間與該給藥時間與一偏移值產生該第二間隔時間。該第一間隔時間=該後選抽血數據的該抽血時間-該給藥時間,該第二間隔時間=該先選抽血數據的該抽血時間+該偏移值-該給藥時間,偏移值定義為給藥間隔時間。如圖6所示,輸注時間是1小時、第一間隔時間=11小時-9小時=2小時、第二間隔時間=8.5小時+12小時-9小時=11.5小時、給藥間隔時間=12小時、第一濃度=Ct=15 mg/L、第二濃度=Cp=35 mg/L。Step (H4), when the judgment result is that the first concentration < the second concentration and the blood is drawn in reverse order, the doctor's
步驟(I):運算模組4接收該第一模式信號,且根據該第一模式信號與一預設公式產生一預測藥物臨床療效指標數據,也就是臨床療效指標的24小時之濃度-時間曲線下面積 (area under the concentration-versus-time curve,以下簡稱AUC)。Step (I): The computing module 4 receives the first mode signal, and generates a predicted drug clinical efficacy index data according to the first mode signal and a preset formula, that is, a 24-hour concentration-time curve of the clinical efficacy index. Area under the concentration-versus-time curve (hereinafter referred to as AUC).
其中,當該第一濃度>該第二濃度時,該第一濃度=峰值濃度(Cp)、該第二濃度=谷值濃度(Ct),反之,當該第一濃度<該第二濃度時,該第一濃度=谷值濃度(Ct)、該第二濃度=峰值濃度(Cp)。參數T2的定義是該第二間隔時間、參數T1的定義是該第一間隔時間、參數Tinf的定義是該輸注時間、參數Tau的定義是該給藥間隔時間,參數AUC 24的定義是預測藥物臨床療效指標數據。 Wherein, when the first concentration>the second concentration, the first concentration=peak concentration (Cp), the second concentration=trough concentration (Ct), conversely, when the first concentration<the second concentration , the first concentration = valley concentration (Ct), the second concentration = peak concentration (Cp). The parameter T2 is defined as the second interval time, the parameter T1 is defined as the first interval time, the parameter Tinf is defined as the infusion time, the parameter Tau is defined as the dosing interval time, and the parameter AUC 24 is defined as the predicted drug Clinical efficacy indicator data.
在此舉例說明非反序抽血時,如圖3所示,計算如下:Here is an example of non-reverse blood drawing, as shown in Figure 3, the calculation is as follows:
(hr -1) (hr -1 )
mg/L mg/L
mg/L mg/L
mg·hr/L mg·hr/L
mg·hr/L mg·hr/L
mg·hr/L mg·hr/L
若是反序抽血時,如圖4所示,計算如下:If blood is drawn in reverse order, as shown in Figure 4, the calculation is as follows:
(hr -1) (hr -1 )
mg/L mg/L
mg/L mg/L
mg·hr/L mg·hr/L
mg·hr/L mg·hr/L
mg·hr/L mg·hr/L
步驟(J),該醫囑模組2判斷該預測藥物濃度數據是否大於一閾值,若是(例如,預測藥物濃度數據>1500),則該醫囑模組2產生一警示資訊,警示資訊顯示請醫師確定抽血正確性或與藥師聯絡,若無(例如,預測藥物濃度數據<1500),則產生一具有該預測藥物濃度數據的結果表單。In step (J), the
綜上所述,上述實施例具有以下優點:一、根據抽血數據與輸入設定,自動化估算以得到預測藥物濃度。二、根據輸入設定與預定給藥時間與給藥間隔時間,判斷系統參數設定(例如,預定給藥時間)是否合理,且不合理時提供警示訊息。三、根據抽血時間與藥物濃度判斷是否反序抽血,而使用偏移值來修正計算公式,達到正確計算AUC數值的功效。四、根據閥值的設定,來檢核預測AUC數據是否出現異常,提供數據給醫生或藥師作為修改依據。To sum up, the above embodiments have the following advantages: 1. Based on the blood drawing data and input settings, automatic estimation is performed to obtain the predicted drug concentration. 2. Based on the input settings, scheduled dosing time and dosing interval, determine whether the system parameter setting (for example, scheduled dosing time) is reasonable, and provide a warning message if it is unreasonable. 3. Determine whether to draw blood in reverse order based on the blood drawing time and drug concentration, and use the offset value to correct the calculation formula to achieve the correct calculation of the AUC value. 4. According to the setting of the threshold, check whether the predicted AUC data is abnormal, and provide the data to the doctor or pharmacist as a basis for modification.
惟以上所述者,僅為本發明的實施例而已,當不能以此限定本發明實施的範圍,凡是依本發明申請專利範圍及專利說明書內容所作的簡單的等效變化與修飾,皆仍屬本發明專利涵蓋的範圍內。However, the above are only examples of the present invention and should not be used to limit the scope of the present invention. All simple equivalent changes and modifications made based on the patent scope of the present invention and the content of the patent specification are still within the scope of the present invention. within the scope covered by the patent of this invention.
1:介面模組 2:醫囑模組 3:儲存模組 4:運算模組 S~J:s藥物濃度檢測的步驟 1:Interface module 2:Doctor’s order module 3:Storage module 4:Computational module S~J:s steps for drug concentration detection
本發明的其他的特徵及功效,將於參照圖式的實施方式中清楚地呈現,其中: 圖1是本發明藥物濃度檢測系統的一實施例的一系統圖; 圖2是實施例執行藥物濃度檢測方法的一流程圖; 圖3是第一濃度>第二濃度且非反序抽血藥物濃度變化的一示意圖; 圖4是第一濃度>第二濃度且反序抽血藥物濃度變化的一示意圖; 圖5是第一濃度<第二濃度且非反序抽血藥物濃度變化的一示意圖;及 圖6是第一濃度<第二濃度且反序抽血藥物濃度變化的一示意圖。 Other features and effects of the present invention will be clearly presented in the embodiments with reference to the drawings, in which: Figure 1 is a system diagram of an embodiment of the drug concentration detection system of the present invention; Figure 2 is a flow chart of the implementation of the drug concentration detection method according to the embodiment; Figure 3 is a schematic diagram of drug concentration changes in first concentration > second concentration and non-reverse blood drawing; Figure 4 is a schematic diagram of drug concentration changes in first concentration > second concentration and blood drawing in reverse order; Figure 5 is a schematic diagram of drug concentration changes in first concentration < second concentration and non-reverse blood drawing; and Figure 6 is a schematic diagram showing changes in drug concentration in reverse order blood draw with first concentration < second concentration.
1:介面模組 1:Interface module
2:醫囑模組 2:Doctor’s order module
3:儲存模組 3:Storage module
4:運算模組 4:Computational module
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