帕洛诺司琼胶囊、注射液及托烷司琼注射液预防HEC、MEC所致CINV的成本效果分析

发布时间：2018-07-18 09:29

【摘要】：背景与目的近些年来,全球肿瘤的发病率逐渐升高,成为造成人类死亡的主要原因,对于中晚期肿瘤患者,化疗仍为其治疗的主要方法[1]。人们“谈癌色变”,不仅因为其大多数并不能完全治愈,危及生命,同时也因为在化疗期间不能耐受的不良反应,如恶心、呕吐、脱发、乏力等,而恶心、呕吐往往表现的更为突出,被认为是患者最能感知的反应,化疗相关性恶心呕吐(Chemotherapy-induced nausea and vomiting CINV)由化疗所引起的恶心及呕吐,根据调查CINV已为患者恐惧治疗及耐受的主要原因[2,3]。CINV为肿瘤患者化疗期间最常见的毒副反应,很大程度影响着患者的生活质量,导致患者在长期治疗中易出现较差的依从性,造成治疗的延误甚至中断;此外CINV也可以导致患者代谢的失衡、自身意识及功能状态的削减、营养物质的耗竭,极大的阻碍了有效的抗肿瘤治疗,成为临床中的一个重要挑战[4,5]。尽管CINV的发生率比较高,但人们对CINV发生机制的研究,并不是完全透彻,其中多认为神经递质5-羟色胺(5-HT)参与了急性CINV的发生、P物质(SP P substance)或者5-HT的再释放参与了延迟性CINV的发生。随着5-HT3受体拮抗剂如托烷司琼等在临床预防及治疗CINV的大量应用,CINV的控制率得到了很大的提升,主要表现在对急性CINV的控制,这使得患者在治疗中的营养供给及精神心理安慰,有了必要的保障,虽然一代5-HT3受体拮抗剂被多次、大剂量的应用于临床中,显示出了不错的疗效,唯独在延迟性CINV的防治上没有太大的进展[6]。帕洛诺司琼(PALO)注射液或胶囊为其二代的5-HT3受体拮抗剂,在设计之初,就被赋予了特殊的分子刚性结构,这样一来,它和5-HT3受体的结合更加的紧密,也导致了能够发挥更加持久的作用,更加特异性阻断5-HT3受体,使得对多发生于院外的延迟性CINV被更好的控制;此外最新研究提示,帕洛诺司琼不仅阻滞了5-HT和5-HT3受体的结合,同时随着时间和剂量的变化,可通过串扰5-HT3R和NK-1R通路从而更好的控制延迟性CINV,这可能成为PALO被多种指南推荐用于预防延迟性CINV的药物的理论依据[7,8]。因此,为了使患者可以使用最小的经济成本,从而获得最佳的致吐效果,本研究通过选用三种不同的止吐方案,来预防中、高度化疗致吐性药物所致的CINV,观察三种方案如盐酸PALO胶囊、盐酸PALO注射液、托烷司琼注射液等的疗效,探究其不良反应的发生,运用药物经济学原理对三种药物进行成本-效果分析,从而寻找出一种疗效近且较经济的治疗方法[9]。资料与方法选取我院2015年06月-2016年06月经病理学或细胞学确诊为恶性肿瘤的患者90例,年龄在18-70岁,主要采取以顺铂及阿霉素为主的方案化疗,随机分为A、B、C三组,A组采用盐酸PALO胶囊、B组采用盐酸PALO注射液、C组采用托烷司琼注射液,预防CINV,观察各组对急性CINV、延迟性CINV、化疗全期CINV的控制情况,不良反应的发生情况,统计其并运用药物经济学原理对三种不同的止吐方案进行成本效果分析。统计学方法采用SPSS21.0统计学软件应用于所统计资料数据的处理,X2检验用于检验计数资料;X±s用来表示计量资料,运用方差分析数据;均以p值小于0.05为具有统计学意义。结果1.一般资料的比较:共入选90例患者,随机分为A组(盐酸PALO胶囊组)30例,B组(盐酸PALO注射液组)30例,C组(托烷司琼注射液组)30例,三组患者的临床资料如年龄、性别、KPS评分、肿瘤类型等无统计学差异,具有可比性。2.三组患者各期呕吐控制情况的比较:PALO胶囊、PALO注射液及托烷司琼注射液注射液对预防急性CINV的CRR分别为86.7%、83.3%、73.3%,不具有可比性,但对延迟性CINV的预防治疗上,PALO胶囊及注射液组的CRR明显高于托烷司琼注射液组,为73.3%vs 43.3%和70.0%vs 43.3%(P0.05),具有统计学差异,PALO的两种不同制剂,在预防延迟性CINV方面CRR未取得统计学差异。化疗全期CINV的CRR,三组分别为76.7%、66.7%、36.7%,同样PALO组优于托烷司琼组(P0.05),PALO的两种不同制剂CRR也未取得统计学差异。3.三组患者的不良反应:A组出现的不适症状主要为乏力2例,其发生率为6.7%;B组出现腹胀2例,头晕1例,发生率为10.0%,C组出现便秘者1例,头晕1例、乏力2例,发生率为13.3%,三组造成不适的临床症状,发生率之间对比,无统计学意义(P0.05),并且程度轻微,对临床治疗未形成太大的干扰。4.三组患者的CEA比较:盐酸PALO胶囊组C/E最低为(3.29±0,31),其次是盐酸PALO注射液组(6.87±0.17),托烷司琼组最高为(9.60±0.68),三组患者相比具有统计学差异(P0.05)。结论1.盐酸PALO胶囊及其注射液可以很好地控制中、高度化疗药物所致的恶心呕吐,对延迟性CINV的CRR高于托烷司琼注射液,且不良反应轻微。2.成本效果分析提示:盐酸PALO胶囊最佳,其注射液次之,均优于托烷司琼注射液。
[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.
【学位授予单位】：郑州大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R730.53

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