【摘要】：背景與目的近些年來,全球腫瘤的發(fā)病率逐漸升高,成為造成人類死亡的主要原因,對于中晚期腫瘤患者,化療仍為其治療的主要方法[1]。人們“談癌色變”,不僅因為其大多數(shù)并不能完全治愈,危及生命,同時也因為在化療期間不能耐受的不良反應(yīng),如惡心、嘔吐、脫發(fā)、乏力等,而惡心、嘔吐往往表現(xiàn)的更為突出,被認(rèn)為是患者最能感知的反應(yīng),化療相關(guān)性惡心嘔吐(Chemotherapy-induced nausea and vomiting CINV)由化療所引起的惡心及嘔吐,根據(jù)調(diào)查CINV已為患者恐懼治療及耐受的主要原因[2,3]。CINV為腫瘤患者化療期間最常見的毒副反應(yīng),很大程度影響著患者的生活質(zhì)量,導(dǎo)致患者在長期治療中易出現(xiàn)較差的依從性,造成治療的延誤甚至中斷;此外CINV也可以導(dǎo)致患者代謝的失衡、自身意識及功能狀態(tài)的削減、營養(yǎng)物質(zhì)的耗竭,極大的阻礙了有效的抗腫瘤治療,成為臨床中的一個重要挑戰(zhàn)[4,5]。盡管CINV的發(fā)生率比較高,但人們對CINV發(fā)生機(jī)制的研究,并不是完全透徹,其中多認(rèn)為神經(jīng)遞質(zhì)5-羥色胺(5-HT)參與了急性CINV的發(fā)生、P物質(zhì)(SP P substance)或者5-HT的再釋放參與了延遲性CINV的發(fā)生。隨著5-HT3受體拮抗劑如托烷司瓊等在臨床預(yù)防及治療CINV的大量應(yīng)用,CINV的控制率得到了很大的提升,主要表現(xiàn)在對急性CINV的控制,這使得患者在治療中的營養(yǎng)供給及精神心理安慰,有了必要的保障,雖然一代5-HT3受體拮抗劑被多次、大劑量的應(yīng)用于臨床中,顯示出了不錯的療效,唯獨在延遲性CINV的防治上沒有太大的進(jìn)展[6]。帕洛諾司瓊(PALO)注射液或膠囊為其二代的5-HT3受體拮抗劑,在設(shè)計之初,就被賦予了特殊的分子剛性結(jié)構(gòu),這樣一來,它和5-HT3受體的結(jié)合更加的緊密,也導(dǎo)致了能夠發(fā)揮更加持久的作用,更加特異性阻斷5-HT3受體,使得對多發(fā)生于院外的延遲性CINV被更好的控制;此外最新研究提示,帕洛諾司瓊不僅阻滯了5-HT和5-HT3受體的結(jié)合,同時隨著時間和劑量的變化,可通過串?dāng)_5-HT3R和NK-1R通路從而更好的控制延遲性CINV,這可能成為PALO被多種指南推薦用于預(yù)防延遲性CINV的藥物的理論依據(jù)[7,8]。因此,為了使患者可以使用最小的經(jīng)濟(jì)成本,從而獲得最佳的致吐效果,本研究通過選用三種不同的止吐方案,來預(yù)防中、高度化療致吐性藥物所致的CINV,觀察三種方案如鹽酸PALO膠囊、鹽酸PALO注射液、托烷司瓊注射液等的療效,探究其不良反應(yīng)的發(fā)生,運(yùn)用藥物經(jīng)濟(jì)學(xué)原理對三種藥物進(jìn)行成本-效果分析,從而尋找出一種療效近且較經(jīng)濟(jì)的治療方法[9]。資料與方法選取我院2015年06月-2016年06月經(jīng)病理學(xué)或細(xì)胞學(xué)確診為惡性腫瘤的患者90例,年齡在18-70歲,主要采取以順鉑及阿霉素為主的方案化療,隨機(jī)分為A、B、C三組,A組采用鹽酸PALO膠囊、B組采用鹽酸PALO注射液、C組采用托烷司瓊注射液,預(yù)防CINV,觀察各組對急性CINV、延遲性CINV、化療全期CINV的控制情況,不良反應(yīng)的發(fā)生情況,統(tǒng)計其并運(yùn)用藥物經(jīng)濟(jì)學(xué)原理對三種不同的止吐方案進(jìn)行成本效果分析。統(tǒng)計學(xué)方法采用SPSS21.0統(tǒng)計學(xué)軟件應(yīng)用于所統(tǒng)計資料數(shù)據(jù)的處理,X2檢驗用于檢驗計數(shù)資料;X±s用來表示計量資料,運(yùn)用方差分析數(shù)據(jù);均以p值小于0.05為具有統(tǒng)計學(xué)意義。結(jié)果1.一般資料的比較:共入選90例患者,隨機(jī)分為A組(鹽酸PALO膠囊組)30例,B組(鹽酸PALO注射液組)30例,C組(托烷司瓊注射液組)30例,三組患者的臨床資料如年齡、性別、KPS評分、腫瘤類型等無統(tǒng)計學(xué)差異,具有可比性。2.三組患者各期嘔吐控制情況的比較:PALO膠囊、PALO注射液及托烷司瓊注射液注射液對預(yù)防急性CINV的CRR分別為86.7%、83.3%、73.3%,不具有可比性,但對延遲性CINV的預(yù)防治療上,PALO膠囊及注射液組的CRR明顯高于托烷司瓊注射液組,為73.3%vs 43.3%和70.0%vs 43.3%(P0.05),具有統(tǒng)計學(xué)差異,PALO的兩種不同制劑,在預(yù)防延遲性CINV方面CRR未取得統(tǒng)計學(xué)差異。化療全期CINV的CRR,三組分別為76.7%、66.7%、36.7%,同樣PALO組優(yōu)于托烷司瓊組(P0.05),PALO的兩種不同制劑CRR也未取得統(tǒng)計學(xué)差異。3.三組患者的不良反應(yīng):A組出現(xiàn)的不適癥狀主要為乏力2例,其發(fā)生率為6.7%;B組出現(xiàn)腹脹2例,頭暈1例,發(fā)生率為10.0%,C組出現(xiàn)便秘者1例,頭暈1例、乏力2例,發(fā)生率為13.3%,三組造成不適的臨床癥狀,發(fā)生率之間對比,無統(tǒng)計學(xué)意義(P0.05),并且程度輕微,對臨床治療未形成太大的干擾。4.三組患者的CEA比較:鹽酸PALO膠囊組C/E最低為(3.29±0,31),其次是鹽酸PALO注射液組(6.87±0.17),托烷司瓊組最高為(9.60±0.68),三組患者相比具有統(tǒng)計學(xué)差異(P0.05)。結(jié)論1.鹽酸PALO膠囊及其注射液可以很好地控制中、高度化療藥物所致的惡心嘔吐,對延遲性CINV的CRR高于托烷司瓊注射液,且不良反應(yīng)輕微。2.成本效果分析提示:鹽酸PALO膠囊最佳,其注射液次之,均優(yōu)于托烷司瓊注射液。
[Abstract]:Background and purpose in recent years, the incidence of global tumor is increasing, which has become the main cause of human death. For patients with middle and advanced cancer, chemotherapy is still the main method of treatment, [1]. people "talk about cancer color change", not only because most of them are not completely cured, endanger life, but also because they are not tolerated during chemotherapy. Adverse reactions, such as nausea, vomiting, alopecia, and fatigue, and nausea and vomiting tend to be more prominent, and are considered the most perceptive response of the patient, chemotherapy associated nausea and vomiting (Chemotherapy-induced nausea and vomiting CINV) caused by chemotherapy and nausea and vomiting, according to the investigation of CINV for the patient's fear treatment and tolerance The main cause of [2,3].CINV is the most common toxic and side effects during the chemotherapy of cancer patients, which greatly affects the quality of life of the patients, which leads to the patient's poor compliance in the long-term treatment and the delay of treatment. In addition, CINV can also lead to the imbalance of the patient's metabolism, the reduction of the consciousness and function state of the patient, and the nutrition of the patient. The exhaustion of material has greatly hindered effective antitumor therapy and became an important challenge in the clinic, [4,5]., although the incidence of CINV is high, but the study of the mechanism of CINV is not completely thorough. Most of them think that the neurotransmitter 5- hydroxytryptamine (5-HT) is involved in the occurrence of acute CINV, the P substance (SP P substance) or 5-HT. Rerelease is involved in the occurrence of delayed CINV. As 5-HT3 receptor antagonists, such as tuxeetron, have been used in clinical prevention and treatment of CINV, the control rate of CINV has been greatly improved, mainly in the control of acute CINV, which makes the patient in the treatment of nutritional supply and psychological comfort, the necessary protection, Although a generation of 5-HT3 receptor antagonists have been used in a large dose of clinical application for many times, it has shown a good effect. Only in the prevention and control of delayed CINV, the [6]. paronisetron (PALO) injection or capsule is a 5-HT3 receptor antagonist of the second generation, which has been given a special molecular rigid structure at the beginning of the plan. As a result, it is more closely associated with the 5-HT3 receptor, which leads to a more persistent effect and a more specific blocking of the 5-HT3 receptor, making it better to control the delayed CINV that is multiple in the hospital; furthermore, the latest research suggests that the delonisetron not only hinder the binding of 5-HT and 5-HT3 receptors, but also with time and time. Dose changes can be used to better control delayed CINV by crosstalk 5-HT3R and NK-1R pathways, which may be the theoretical basis for PALO to be recommended by multiple guidelines for the prevention of delayed CINV. Therefore, in order to enable the patient to use the minimum cost of the economy, the best emetic effect can be obtained. This study uses three kinds of methods. Different Antiemetic Schemes to prevent the CINV caused by high chemotherapy emetic drugs, observe the efficacy of three schemes, such as hydrochloric acid PALO capsule, PALO injection of hydrochloric acid, and the injection of antanisetron, to explore the occurrence of its adverse reactions, and use the principle of pharmacoeconomics to analyze the cost effect of the three drugs, so as to find out a kind of therapeutic effect. And the more economical treatment method [9]. data and methods selected 90 cases of malignant tumor diagnosed by pathology or cytology in 06 period of 2015 in our hospital, 90 cases of malignant tumor, aged 18-70 years old, mainly adopt cisplatin and adriamycin based regimen chemotherapy, randomly divided into A, B, C three groups, A group PALO capsule, B group PALO injection, C, C. The group used tuxeetron injection to prevent CINV and observe the control of acute CINV, delayed CINV, full phase CINV of chemotherapy and the occurrence of adverse reactions. Statistics it and use the principle of pharmacoeconomics to analyze the cost effect of three different Antiemetic Schemes. Statistical method is applied to the statistics of SPSS21.0 statistics. Data processing, X2 test was used to test the count data; X + s was used to express measurement data and use variance analysis data. All P values were less than 0.05. Results 1. general data were compared: 90 cases were selected, 30 cases were randomly divided into A group (PALO capsule group), 30 cases of B group (hydrochloric acid PALO injection group), and group C (toreisetron There were 30 cases in the injection group. The clinical data of the three groups, such as age, sex, KPS score and tumor type, were not statistically different, and the comparison of the vomiting control in different groups of patients with comparable.2. three groups was compared: PALO capsules, PALO injection and the injection of antaneisetron injection for the prevention of acute CINV CRR were 86.7%, 83.3%, 73.3%, not comparable, But for the prophylactic treatment of delayed CINV, the CRR of the PALO capsule and the injection group was significantly higher than that of the tuxetron group, which was 73.3%vs 43.3% and 70.0%vs 43.3% (P0.05), with statistical differences. The two different formulations of PALO were not statistically different in the prevention of delayed CINV. The CRR of the whole stage CINV was 76.7%, 66.7%, 66.7%, respectively. 36.7%, 36.7%, the same group in the same group was superior to the antaneisetron group (P0.05), and the two different preparations of PALO had no statistically significant difference in the adverse reaction of the.3. three group: the discomfort symptoms in the A group were mainly asthenia in 2, and the incidence was 6.7%; the B group had 2 abdominal distension, 1 dizziness, 10%, 1 cases of constipation in C, 1 dizziness and 2 asthenia in B. The rate of birth was 13.3%, and the three groups caused the discomfort clinical symptoms, the incidence was not statistically significant (P0.05), and the degree was slight. The CEA comparison of the patients in the group of.4. three was not too large for clinical treatment. The lowest C/E in the group of PALO hydrochloride capsules was (3.29 + 0,31), followed by the PALO injection group (6.87 + 0.17), and the highest (9.6) in the group of antinisetron. 0 + 0.68), the three groups were statistically different (P0.05). Conclusion 1. hydrochloric hydrochloric acid capsule and its injection can well control the nausea and vomiting caused by high chemotherapeutic drugs. The CRR of delayed CINV is higher than that of the antinisetron injection, and the mild.2. cost effect of the adverse reaction is indicated: the best of hydrochloric acid PALO capsule is the injection times. All of them were superior to the antaneisetron injection.
【學(xué)位授予單位】：鄭州大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R730.53

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