药物评价研究  2016, Vol. 39 Issue (2): 278-281
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毒毛花苷K注射液与去乙酰毛花苷注射液治疗老年心衰患者的药效及经济学对比
薛彦宁, 李继霞, 贺苗, 米晶晶, 赵丹    
榆林市第二人民医院药剂科, 陕西 榆林 719000
摘要: 目的 探讨不同心衰药物对老年心衰患者的效果,并评价其经济学情况,以期选择合适方法,降低医疗费用支出。方法 选取2012年1月-2015年1月56例老年心衰患者为研究对象,随机分成2组,每组28例。对照组予去乙酰毛花苷注射液治疗,观察组予毒毛花苷K注射液治疗,观察治疗后在药效和经济学指标变化情况。结果 疗效上,对照组与观察组心血管不良事件发生率均为21.42%,两组比较差异无统计学意义;对照组血小板减少、味觉障碍、肝肾功能损害、消化道反应、皮疹发生率分别为17.86%、10.71%、14.29%、17.86%、7.14%;观察组血小板减少、味觉障碍、肝肾功能损害、消化道反应、皮疹发生率分别为14.29%、10.71%、17.86%、14.29%、10.71%,两组差异无统计学意义;两组治疗后血小板、中性粒细胞、凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)较治疗前无变化,治疗前后比较差异无统计学意义;对照组每盒单价为52.31元,观察组每盒为12.61元,加上各自的其他治疗费用,对照组平均为(6 415.45±535.56)元/人,观察组为(4 884.25±243.45)元/人,两组比较差异有统计学意义(P<0.05)。结论 毒毛花苷K治疗老年心衰效果与去乙酰毛花苷注射液相当,医疗费用支出较低,更加经济实惠。
关键词: 心衰     药效     经济学     去乙酰毛花苷注射液     毒毛花苷K    
Efficacy and economics comparison on Strophanthin K Injection and Deslanoside Injection in elderly patients with heart failure
XUE Yan-ning, LI Ji-xia, HE Miao, MI Jing-jing, ZHAO Dan     
Pharmacy Department, The Second People's Hospital of Yulin City, Yulin 719000, China
Abstract: Objective To investigate the regimen efficacy of different prescriptions in elderly patients with heart failure, and evaluate the economic situation, in order to choose the right method and decrease the medicine fee. Methods The elderly patients (56 cases) with heart failure from January 2010 to January 2013 were chosen and divided into two groups, the control group had 28 cases, given Deslanoside Injection, the observation group had 28 cases, given Strophanthin K Injection, the effectiveness and economic indicators after treatment were observed. Results The incidence of cardiovascular adverse events in control group was 21.42%, the observation group was 21.42%, without significant difference (P > 0.05). The incidence of thrombocytopenia, taste disorders, liver and kidney function damage, gastrointestinal tract reaction in control group were 17.86%, 10.71%, 14.29%, 17.86%, and 7.14%, while those in the observation group were 14.29%, 10.71%, 17.86%, 14.29%, and 10.71%, without significant difference (P > 0.05). The platelets, neutrophils, PT, and APTT of two groups after treatment had no significant differences (P > 0.05), and the each unit price of control group was 52.31 yuan, the observation group was 12.61%, with their other treatment, the control group average was (6 415.45 ± 535.56) yuan/person, while that in the observation group was (4 884.25 ± 243.45) yuan/person,with statistical significance (P < 0.05). Conclusion Strophanthin K Injection in treatment of heart failure in elder patients had obviously efficacy, the medical expense was low and more economical and practical.
Key words: heart failure     drug efficacy     economic     Deslanoside Injection     Strophanthin K Injection    

心衰是临床上常见的一种病症,在临床上根据衰竭速度可分为急性心力衰竭和慢性心力衰竭,其中慢性心力衰竭占多数,急性心力衰竭以左心衰为主,表现为肺水肿[1, 2, 3]。目前随着医疗技术发展和心衰研究深入,心衰治疗药物种类越来越多,药物效果也相应得到提高。但其药物费用支出在临床上仍有较大差异。本次研究通过观察老年心衰患者不同用药方案在药效和经济学情况比较,以期选择最佳的治疗方法,提高临床治疗水平。

1 资料与方法 1.1 临床资料

选取2012年1月-2015年1月榆林市第二人民医院56例老年心衰患者为研究对象,随机分成2组,每组各28例。对照组男15例,女13例;年龄最小61岁,最大78岁,平均年龄为(70.6±3.2)岁;病程最短5个月,最长4年,平均为(2.1±0.6)年;NYHA心衰程度为Ⅰ级10例,Ⅱ级9例,Ⅲ级9例;疾病类型:冠心病4例,高血压性心脏病9例,扩张型心肌病5例,先天性心脏病10例。观察组男14例,女14例;年龄最小60岁,最大80岁,平均年龄为(70.2±3.1)岁;病程最短6个月,最长5年,平均为(2.3±0.7)年;NYHA心衰程度为Ⅰ级9例,Ⅱ级10例,Ⅲ级9例;疾病类型:冠心病5例,高血压性心脏病10例,扩张型心肌病4例,先天性心脏病9例。两组患者在性别、年龄、病程等方面比较无明显差异性,具有可比性。

入选标准[4]为年龄在80岁以下病情稳定的急性心衰患者,左室收缩功能减低,纽约心功能分级在Ⅲ级以下,有较好的依从性,能按规律服药,定期来医院监测血压、心率和体质量者。排除严重肝肾功能损害者,排除β受体阻滞剂禁忌者,排除ACEI/ARB禁忌者,排除恶性肿瘤者。

1.2 方法

所有患者加强供氧,用吸氧面罩间断正压呼吸给氧,改善呼吸困难症状;使用血管扩张药,减轻前负荷和后负荷,改善心功能。并使用镇静剂消除患者紧张情绪,用利尿剂加强疗效。对照组予去乙酰毛花苷注射液(上海旭东海普药业有限公司,批号101201,规格为0.2 mg׃2 mL),首剂量为0.4 mg,用5%葡萄糖注射液稀释后缓慢注射,后每4小时注射1次,剂量为0.2 mg。观察组予毒毛花苷K注射液(青岛正大海尔制药有限公司,批号20100407,规格为1 mL׃0.25 mg),首次剂量为0.25 mg加入等渗葡萄糖液20 mL中缓慢注射,每2小时重复1次。

1.3 疗效评定标准

结合相关文献[5, 6, 7, 8]进行疗效评定,观察两组治疗后在心血管不良事件上发生率,如纤颤、心源性休克、冠脉血运重建等。观察在血小板减少、味觉障碍、肝肾功能损害、消化道反应、皮疹等不良反应发生率情况。观察两组用药前和用药6周后在血小板计数、中性粒细胞计数、凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)变化情况。并进行市场调查,了解两者价格,计算开始服药至出院后1年使用剂量费用,加上住院期间费用总和。

1.4 统计学处理

采用SPSS16.0软件进行分析,将调查统计的内容作为变量,计量资料采用t检验,计数资料采用χ2检验。

2 结果 2.1 两组心血管不良事件发生率比较

对两组心血管不良事件发生率进行比较,对照组心血管不良事件发生率合计为21.42%,观察组心血管不良事件发生率为21.42%,两组比较差异无统计学意义,见表 1

表 1 两组心血管不良事件发生率比较 Table 1 Comparison of adverse cardiac events rate in both groups
2.2 两组不良反应情况比较

对两组不良反应进行比较,对照组血小板减少、味觉障碍、肝肾功能损害、消化道反应、皮疹发生率分别为17.86%、10.71%、14.29%、17.86%、7.14%;观察组血小板减少、味觉障碍、肝肾功能损害、消化道反应、皮疹发生率分别为14.29%、10.71%、17.86%、14.29%、10.71%,两组差异无统计学意义,见表 2

表 2 两组不良反应情况比较 Table 2 Comparison of adverse reactions in both groups
2.3 两组治疗前后相关指标比较

两组治疗后血小板、中性粒细胞、PT、APTT较治疗前无变化,治疗前后比较差异无统计学意义(P>0.05),治疗后两组血小板、中性粒细胞、PT、APTT比较差异无统计学意义(P>0.05),见表 3

表 3 两组治疗前后相关指标比较 Table 3 Comparison of relevant date before and after treatment in both groups
2.4 两组治疗后经济学指标分析

对两组经济学指标比较,对照组每盒单价为52.31元,观察组每盒为12.61元,加上各自的其他治疗费用,对照组平均年治疗费用为(6 415.45±535.56)元/人,观察组为(4 884.25±243.45)元/人,两组比较差异有统计学意义(P<0.05)。

3 讨论

去乙酰毛花苷注射液是一种抗心律失常药物,其能快速加强心肌收缩,减慢心律,促使心脏输血量增加,改善血液循环[9]。研究称,该药物还能促使肺血管含氧饱和度增加,能阻滞右心室血液动力,促使肿大的肝脏回缩,促使心衰症状缓解。能导致心房率的加速和心房扑动转为心房纤颤;缩短浦肯野纤维有效不应期[10, 11]。另外由于其负性频率作用促使舒张期相对延长,能促进心肌血供。另外该药物能选择性地与心肌细胞膜Na+-K+-ATP酶结合而抑制该酶活性,使心肌细胞膜内外Na+-K+主动偶联转运受损,心肌细胞内Na+浓度升高,从而使肌膜上Na+-Ca2+交换趋于活跃,使细胞浆内Ca2+增多[12]。毒毛花苷K是从毒毛旋花种子中提取的强心苷,具有脂溶性低,化学活性高的特定。其具有正性肌力作用,能选择性的和细胞膜Na+-K+-ATP酶结合而抑制该酶活性,促使心肌细胞钠离子升高,兴奋心肌,激动心肌收缩蛋白,增加心肌收缩力。另外也能改善血液动力学,能增强迷走神经张力,减慢心率,延缓房室传导[13]。研究称,中毒量强心苷对中枢交感神经的兴奋致使交感神经张力过高,是强心苷诱发心律失常的神经性因素,且强心苷对人的动脉和静脉有直接收缩作用[14, 15, 16, 17, 18]。故两者在临床作用上类似。

结果显示,两组在心血管不良事件发生率和不良反应发生率上比较无差异性,且治疗前后在血小板、中性粒细胞、PT、APTT上比较差异也无统计学意义,这说明两种药物对患者的影响均较低,运用于治疗心衰患者均适宜。

从经济学指标上,去乙酰毛花苷注射液平均年治疗费用为(6415.45±535.56)元/人,毒毛花苷为(4884.25±243.45)元/人,这说明在经济学指标上是有差异性的。分析原因可能是毒毛花苷本身价格较低,再者在疗效上类似,患者的心衰病情是基本相同,故其在经济学指标上有变化,但就临床实际上来说,每个治疗心衰药物的使用价值均有一定差异,不能代替其独立的使用价值[19, 20],本次研究的仅仅是综合治疗后显示的价值。另外,每一个药物在性别、不同病情等方面均有差异性,在运用药物时要结合患者临床症状体征进行适当调整,才能更有效的治疗。但本次研究的目的是对使用心衰药物进行一个量化的标准,以期指导临床更安全有效经济的使用药物。

综上所述,毒毛花苷K治疗老年心衰效果显著,医疗费用支出较低,更加经济实惠,值得临床推广应用。

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