替羅非班相關血小板減少的臨床研究
發(fā)布時間：2018-11-07 16:21
【摘要】：背景和目的： 抗栓治療是當今治療急性冠脈綜合征（ACS）的主要手段。鹽酸替羅非班（tirofibanhydrochloride)是一種可逆性非肽類血小板膜糖蛋白GP IIb/IIIa受體拮抗劑，能夠作用于血小板聚集的最后通路，有明顯的抗栓作用，但應用替羅非班等血小板膜糖蛋白GPIIb/IIIa受體拮抗劑有時會發(fā)現(xiàn)血小板減少的情況，甚至發(fā)生血小板減少癥（Tirofibaninduced thrombocytopenia)，大大增加了出血風險。本實驗旨在研究應用替羅非班后發(fā)生血小板減少及出血事件發(fā)生的情況，并初步探討其影響因素，為臨床合理用藥及用藥安全提供參考。 方法： 該研究為前瞻性研究。選擇自2014年5月-2015年1月期間因冠心病于吉林大學中日聯(lián)誼醫(yī)院心內科住院治療的患者，經過入選標準及排除標準篩選后，按2:1的比例隨機分為實驗組與對照組，并將實驗組中應用替羅非班超過24小時患者劃為實驗亞組。共140名患者被納入該研究，其中男性85名，女性55名。入組患者常規(guī)給予阿司匹林、氯吡格雷（或替格瑞洛）、肝素治療，實驗組按照替羅非班說明書，根據(jù)患者體重進行計算，給予替羅非班治療；對照組不給予替羅非班治療。記錄所有入選患者的個人基本信息，包括：病歷號、姓名、性別、年齡、身高、體重等；并記錄患者是否應用低分子肝素（種類及劑量）、氯吡格雷/替格瑞洛。實驗組及對照組分別于應用替羅非班后/造影術后2h、6h、9h、12h、24h分別靜脈采血行血常規(guī)檢測，并記錄患者是否發(fā)生出血事件。血小板減少癥的定義：血小板基線正常（100-300×109/L)或高于300×109/L，應用替羅非班后24h內出現(xiàn)下述情況：血小板計數(shù)＜100×109/L判定為血小板減少癥。并分度如下：血小板計數(shù)在50-100×109/L范圍內判定為輕度血小板減少癥；血小板計數(shù)在20-50×109/L判定為重度血小板減少癥；若血小板計數(shù)＜20×109/L應判定為極重度血小板減少癥。出血事件：實驗組應用替羅非班治療后出現(xiàn)牙齦出血、術肢滲血或血腫、結膜充血、血尿等。對照組術后出血牙齦出血、術肢滲血或血腫、結膜充血、血尿等。最終實驗數(shù)據(jù)借助SPSS13.0軟件進行數(shù)據(jù)分析。計量資料經正態(tài)性檢驗后，若符合正態(tài)分布，則表示為均數(shù)±標準差（x±s)，并行方差齊性檢驗。方差齊，則進一步采取t檢驗；方差不齊則進一步采用非參數(shù)檢驗。若計量資料不符合正態(tài)分布，則表示為中位數(shù)，組間非參數(shù)檢驗。計數(shù)資料的統(tǒng)計學分析：定性數(shù)據(jù)以例數(shù)（百分比）表示，組間計數(shù)資料比較采用方差分析與卡方檢驗。如P＜0.05，，則判定為統(tǒng)計學有顯著差異。 結果： 在應用替羅非班治療的實驗組中（N=84),發(fā)生血小板減少癥的病例數(shù)為2例（2.35%），均為男性，血小板減少癥的程度均為輕度，未發(fā)生重度及極重度的血小板減少。血小板減少癥發(fā)生的時間為應用替羅非班后的2-9小時和6-12小時，檢測到的血小板計數(shù)最低的時間點均為應用替羅非班后6小時(分別為95×109/L和87×109/L）。這兩例血小板減少癥患者中有一位表現(xiàn)為輕度的牙齦出血，另一位無明確出血表現(xiàn)。 在實驗組與對照組之間，與2小時血小板計數(shù)基線相比，6小時、9小時、12小時與24小時的血小板計數(shù)均無顯著差異。2-6小時、6-9小時、9-12小時的血小板變化情況均無顯著差異（P＞0.05），而12-24小時P＜0.05（t=-2.833，P=0.005），說明應用替羅非班后12-24小時，替羅非班對血小板計數(shù)的變化產生了影響�？紤]到替羅非班對血小板計數(shù)的影響可能存在藥物濃度依賴性，將實驗組中超過24小時亞組的數(shù)據(jù)與對照組重新進行分析。結果仍顯示與2小時血小板計數(shù)基線相比，6小時、9小時、12小時與24小時的血小板計數(shù)均無顯著差異，而在2-9小時內實驗亞組與對照組的血小板計數(shù)變化情況均有降低趨勢，9-24小時實驗亞組血小板計數(shù)變化情況有所回升，對照組無明顯變化和有所升高。實驗亞組與對照組在6-9小時的血小板計數(shù)變化情況P＜0.1，在9-12小時和12-24小時的血小板計數(shù)變化情況P＜0.05，有統(tǒng)計學差異。 結論: 1.替羅非班可致血小板減少癥，但概率較低。 2.替羅非班可導致用藥早期（6-9小時）血小板計數(shù)降低幅度增大、用藥后期（12-24小時）血小板計數(shù)回升幅度減小。 3.血小板數(shù)量改變多發(fā)生于應用替羅非班早期（2-9小時）。 4.應用替羅非班時酌情減慢給藥速度可以降低出血風險。 5.應用替羅非班后會影響血小板計數(shù)的變化幅度，血小板計數(shù)降低幅度增大可能與出血風險相關，血小板計數(shù)是預測應用替羅非班出血風險的有效指標之一。
[Abstract]:Background and purpose: Antithrombotic therapy is the main factor in the treatment of acute coronary syndrome (ACS) The tirofiban hydrochloride is a reversible non-peptide platelet membrane glycoprotein GP IIb/ IIIa receptor antagonist, which can act on the last path of platelet aggregation, and has obvious anti-thrombus effect. The role of platelet membrane glycoprotein GPIIb/ IIIa receptor antagonists, such as tirofiban and the like, is sometimes found to be in the case of thrombocytopenia, and even thrombocytopenia, which greatly increases the bleeding The purpose of this study is to study the occurrence of thrombocytopenia and bleeding events after the non-shift of tiltropine, and to explore the influencing factors. Reference. The method comprises the following steps of: The study was a prospective study. From May 2014 to January 2015, patients who were hospitalized for coronary heart disease in the Department of Cardiology of the Sino-Japanese Liyi Hospital of Jilin University were selected to be randomly divided according to the ratio of 2: 1 after the inclusion criteria and the exclusion criteria were selected. The experimental group and the control group were used, and the treatment group was used in the treatment group for more than 24 hours. The patient was classified as an experimental subgroup. A total of 140 patients were included in the study, of which male 8 5, 55 women. The patients enrolled in the group were routinely given aspirin, chlorhexidine (or tegregrow), and heparin. The experimental group was given a non-shift treatment according to the weight of the patient according to the instructions for the non-shift of the patient; the control group did not Non-class treatment was given for tilo. Individual basic information for all enrolled patients was recorded, including medical record number, name, sex, age, height, body weight, etc., and whether the patient was using low molecular weight heparin (type and dose), chlorine, The experimental group and the control group were respectively subjected to routine blood collection and blood collection for 24h, 6h, 9h, 12h, and 24h, respectively, and recorded the patients in the experimental group and the control group. Whether the bleeding event occurred. The definition of thrombocytopenia: the platelet baseline was normal (100-300/ 109/ L) or higher than 300-109/ L, and the following conditions occurred in 24h after the application of tetropine: platelet count <100-109/ L It is defined as thrombocytopenia. The index is as follows: the platelet count is determined to be mild thrombocytopenia in the range of 50-100-109/ L; the platelet count is determined to be severe thrombocytopenia at 20-50-109/ L; if the platelet count is less than 20-109/ L, it is determined that the platelet count is extremely low Severe thrombocytopenia. Bleeding event: The experimental group was treated with terotherapy for gingival bleeding, bleeding or hematomas, Conjunctival congestion, hematuria, etc. In the control group, bleeding, bleeding, or hematomas, Conjunctival congestion, hematuria, etc. The final experimental data was by means of SPSS13. 0 Data analysis is performed on the software. After the measurement data is tested in positive state, if the normal distribution is met, it is expressed as the average standard deviation (x/ s). If the variance is equal, the t-test is further adopted; if the variance is not the same, the variance is equal to one. Step is non-normal test. If the measurement data does not meet the normal distribution, it is expressed as the median Statistical analysis of counting data: the qualitative data is expressed in number (percentage), and the inter-group counting data is used by the party The difference analysis and the card-side test. If P <0.05, it is determined that statistics Results: In the experimental group (N = 84), the number of cases of thrombocytopenia was 2 (2.35%). There was a severe and very severe thrombocytopenia. The time for thrombocytopenia was 2-9 hours and 6-12 hours after the application of tetropine, and the lowest time point for the detected platelet count was 6 hours after the non-shift in the application (95% 1, respectively). 09/ L and 87 (109/ L), one of the two thrombocytopenia patients showed mild teeth There was no significant difference in the platelet count between the experimental group and the control group, 6 hours, 9 hours, 12 hours and 24 hours compared with the 2-hour platelet count baseline (P> 0.05), while 12-24 h p <0.05 (t =-2.833, p = 0. 005), for 12-24 hours after the application of tiropin, for example, The effect of non-shift on platelet count has been affected. In consideration of the potential for drug concentration dependence on the effects of tetroban on platelet count, more than 24 in the experimental group The data of the hour sub-group was re-analyzed with the control group. The results still showed no significant difference in platelet counts for 6 hours, 9 hours, 12 hours, and 24 hours compared to the 2-hour platelet count baseline, whereas in the 2-9-hour test sub-group and the control There was a tendency to decrease the platelet count in the group, and the changes of platelet count in the subgroup at 9-24 h were observed. The platelet count in the experimental subgroup and the control group at 6-9 hours was significantly higher than that in the control group (P <0.01), and the platelet count in 9-12 hours and 12-24 hours change There was a statistical difference between P <0.05 and P <0.05. Conclusion: 1. The titilin non-class can cause thrombocytopenia, but the probability is low. 2. tetroban may lead to an early (6-9 hour) decrease in platelet count by an increase in platelet count The platelet count recovered in the later period (12-24 hours) was decreased. 3. The change in the number of platelets occurs more than in the early (2-9) phase of the application (h). 4. The administration speed can be slowed down as appropriate when applied to the roo non-class, and the risk of bleeding can be reduced. 5. The change in the platelet count will be affected after the application of the tetroban, and the decrease in platelet count is increased.
【學位授予單位】：吉林大學
【學位級別】：碩士
【學位授予年份】：2015
【分類號】：R541.4
本文編號：2316896
[Abstract]:Background and purpose: Antithrombotic therapy is the main factor in the treatment of acute coronary syndrome (ACS) The tirofiban hydrochloride is a reversible non-peptide platelet membrane glycoprotein GP IIb/ IIIa receptor antagonist, which can act on the last path of platelet aggregation, and has obvious anti-thrombus effect. The role of platelet membrane glycoprotein GPIIb/ IIIa receptor antagonists, such as tirofiban and the like, is sometimes found to be in the case of thrombocytopenia, and even thrombocytopenia, which greatly increases the bleeding The purpose of this study is to study the occurrence of thrombocytopenia and bleeding events after the non-shift of tiltropine, and to explore the influencing factors. Reference. The method comprises the following steps of: The study was a prospective study. From May 2014 to January 2015, patients who were hospitalized for coronary heart disease in the Department of Cardiology of the Sino-Japanese Liyi Hospital of Jilin University were selected to be randomly divided according to the ratio of 2: 1 after the inclusion criteria and the exclusion criteria were selected. The experimental group and the control group were used, and the treatment group was used in the treatment group for more than 24 hours. The patient was classified as an experimental subgroup. A total of 140 patients were included in the study, of which male 8 5, 55 women. The patients enrolled in the group were routinely given aspirin, chlorhexidine (or tegregrow), and heparin. The experimental group was given a non-shift treatment according to the weight of the patient according to the instructions for the non-shift of the patient; the control group did not Non-class treatment was given for tilo. Individual basic information for all enrolled patients was recorded, including medical record number, name, sex, age, height, body weight, etc., and whether the patient was using low molecular weight heparin (type and dose), chlorine, The experimental group and the control group were respectively subjected to routine blood collection and blood collection for 24h, 6h, 9h, 12h, and 24h, respectively, and recorded the patients in the experimental group and the control group. Whether the bleeding event occurred. The definition of thrombocytopenia: the platelet baseline was normal (100-300/ 109/ L) or higher than 300-109/ L, and the following conditions occurred in 24h after the application of tetropine: platelet count <100-109/ L It is defined as thrombocytopenia. The index is as follows: the platelet count is determined to be mild thrombocytopenia in the range of 50-100-109/ L; the platelet count is determined to be severe thrombocytopenia at 20-50-109/ L; if the platelet count is less than 20-109/ L, it is determined that the platelet count is extremely low Severe thrombocytopenia. Bleeding event: The experimental group was treated with terotherapy for gingival bleeding, bleeding or hematomas, Conjunctival congestion, hematuria, etc. In the control group, bleeding, bleeding, or hematomas, Conjunctival congestion, hematuria, etc. The final experimental data was by means of SPSS13. 0 Data analysis is performed on the software. After the measurement data is tested in positive state, if the normal distribution is met, it is expressed as the average standard deviation (x/ s). If the variance is equal, the t-test is further adopted; if the variance is not the same, the variance is equal to one. Step is non-normal test. If the measurement data does not meet the normal distribution, it is expressed as the median Statistical analysis of counting data: the qualitative data is expressed in number (percentage), and the inter-group counting data is used by the party The difference analysis and the card-side test. If P <0.05, it is determined that statistics Results: In the experimental group (N = 84), the number of cases of thrombocytopenia was 2 (2.35%). There was a severe and very severe thrombocytopenia. The time for thrombocytopenia was 2-9 hours and 6-12 hours after the application of tetropine, and the lowest time point for the detected platelet count was 6 hours after the non-shift in the application (95% 1, respectively). 09/ L and 87 (109/ L), one of the two thrombocytopenia patients showed mild teeth There was no significant difference in the platelet count between the experimental group and the control group, 6 hours, 9 hours, 12 hours and 24 hours compared with the 2-hour platelet count baseline (P> 0.05), while 12-24 h p <0.05 (t =-2.833, p = 0. 005), for 12-24 hours after the application of tiropin, for example, The effect of non-shift on platelet count has been affected. In consideration of the potential for drug concentration dependence on the effects of tetroban on platelet count, more than 24 in the experimental group The data of the hour sub-group was re-analyzed with the control group. The results still showed no significant difference in platelet counts for 6 hours, 9 hours, 12 hours, and 24 hours compared to the 2-hour platelet count baseline, whereas in the 2-9-hour test sub-group and the control There was a tendency to decrease the platelet count in the group, and the changes of platelet count in the subgroup at 9-24 h were observed. The platelet count in the experimental subgroup and the control group at 6-9 hours was significantly higher than that in the control group (P <0.01), and the platelet count in 9-12 hours and 12-24 hours change There was a statistical difference between P <0.05 and P <0.05. Conclusion: 1. The titilin non-class can cause thrombocytopenia, but the probability is low. 2. tetroban may lead to an early (6-9 hour) decrease in platelet count by an increase in platelet count The platelet count recovered in the later period (12-24 hours) was decreased. 3. The change in the number of platelets occurs more than in the early (2-9) phase of the application (h). 4. The administration speed can be slowed down as appropriate when applied to the roo non-class, and the risk of bleeding can be reduced. 5. The change in the platelet count will be affected after the application of the tetroban, and the decrease in platelet count is increased.
【學位授予單位】：吉林大學
【學位級別】：碩士
【學位授予年份】：2015
【分類號】：R541.4
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本文編號：2316896
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