西红花总苷片对肿瘤患者心脏保护作用的临床效果分析  

A clinical study on the cardioprotective effect of total saffron glycosides tablets on tumor patients

作　　者：范世明 刘权 汪明群 张春梅 罗缨 刘世兵 李龙刚 杨太林 任燕 FAN Shiming;LIU Quan;WANG Mingqun;ZHANG Chunmei;LUO Ying;LIU Shibing;LI Longgang;YANG Tailin;REN Yan(Department of Internal Medicine,Changning County Hospital of Traditional Chinese Medicine,Yibin,Sichuan 644300,China;Department of Internal Medicine,Gongxian People's Hospital,Yibin,Sichuan 644400,China;Department of Pharmacy,Changning County Hospital of Traditional Chinese Medicine,Yibin,Sichuan 644300,China;Department of Respiratory and Critical Care Medicine,Jiang'an County People's Hospital,Yibin,Sichuan 644200,China;Shandong Ruiyang Pharmaceutical Co.,Ltd,Zibo,Shandong 256100,China;Department of Internal Medicine,Xingwen County Hospital of Traditional Chinese Medicine,Yibin,Sichuan 644500,China;Department of Outpatient,Changning County Hospital of Traditional Chinese Medicine,Yibin,Sichuan 644300,China)

机构地区：[1]四川省宜宾市长宁县中医医院内一科,四川宜宾644300 [2]四川省宜宾市珙县人民医院内科,四川宜宾644400 [3]四川省宜宾市长宁县中医医院药剂科,四川宜宾644300 [4]四川省宜宾市江安县人民医院呼吸与危重症医学科,四川宜宾644200 [5]山东省瑞阳制药股份有限公司,山东淄博256100 [6]四川省宜宾市兴文县中医医院内科,四川宜宾644500 [7]四川省宜宾市长宁县中医医院门诊部,四川宜宾644300

出　　处：《医药前沿》2024年第16期38-43,共6页Journal of Frontiers of Medicine

基　　金：宜宾市卫生健康委员会项目(2021YW0047)。

摘　　要：目的:评估西红花总苷片对肿瘤患者心脏保护的作用和安全性。方法:选取宜宾市长宁县中医医院、宜宾市珙县人民医院、宜宾市兴文县中医医院、宜宾市江安县人民医院、宜宾市江安县中医医院2021年10月—2023年6月收治的283例肿瘤患者为研究对象,按照治疗方法的不同分为西红花总苷片组(96例,接受西红花总苷片治疗)、普通治疗组(88例,普通护心药物治疗)、对照组(99例,模仿西红花总苷片的外观和味道的安慰剂治疗)。比较三组患者的纽约心脏协会(NYHA)心功能分级、6min步行距离、左室射血分数(LVEF)、谷草转氨酶(AST)、乳酸脱氢酶(LDH)、肌酸激酶(CK)、肌酸激酶同工酶(CK-MB)、α-羟丁酸脱氢酶(α-HNDH)、肌钙蛋白(TnI)、N端钠尿肽前体(NT-proBNP)变化,并进行安全性评价。结果:西红花总苷片治疗组心功能改善情况优于普通治疗组和对照组,差异有统计学意义(P<0.05)。随着时间延长,三组6min步行距离逐渐增加,LVEF水平逐渐升高,且治疗1周、2个月、4个月后,西红花总苷片组的6min步行距离长于对照组及普通治疗组,治疗2个月、4个月后,LVEF高于对照组及普通治疗组,差异有统计学意义(P<0.05)。随着时间增加,三组AST、LDH、CK、CK-MB、α-HNDH、cTnl水平逐渐降低,且治疗1周、2个月、4个月后西红花总苷片组的AST、LDH、CK、CK-MB、α-HNDH、cTnl水平低于普通治疗组、对照组,差异有统计学意义(P<0.05)。随着时间增加,三组BNP水平逐渐降低,且治疗1周、2个月、4个月后西红花总苷片组BNP水平低于普通治疗组、对照组,差异有统计学意义(P<0.05)。三组均无较严重的肝肾功能损害及血、尿和凝血功能方面的异常。结论:西红花总苷片在改善肿瘤患者心功能受损方面效果显著。此外,西红花总苷片可能对肿瘤患者的心肌酶学指标有益,有助于改善心肌功能,还可改善心力衰竭患者的NT-proBNP水平,且安�Objective The aim of this study was to evaluate the cardioprotective effect and safety of total saffron glycoside tablets relative to a placebo group in tumor patients.Methods A total of 283 tumor patients admitted to Changning County Hospital of Traditional Chinese Medicine,Gongxian People's Hospital,Xingwen County Hospital of Traditional Chinese Medicine,Jiang'an County People's Hospital,Jiang'an County Hospital of Traditional Chinese Medicine in Yibin City from October 2021 to June 2023 were selected as the research subjects.According to different treatment methods,they were divided into a saffron treatment group(96 cases,receiving treatment with saffron total glycoside tablets),a regular treatment group(88 cases,receiving treatment with common heart care drugs),and a placebo group(99 cases,receiving placebo treatment that mimics the appearance and taste of saffron total glycoside tablets).Compare the New York Heart Association(NYHA)cardiac function classification,6-minute walking distance,left ventricular ejection fraction(LVEF),aspartate aminotransferase(AST),lactate dehydrogenase(LDH),creatine kinase(CK)and creatine kinase isoenzyme(CK-MB)among three groups of patientsα-Hydroxybutyrate dehydrogenase(α-Changes in HNDH,TnI,and N-terminal natriuretic peptide precursor(NT proBNP)were evaluated for safety).Results The improvement of heart function in the treatment group with saffron total glycoside tablets was better than that in the ordinary treatment group and the control group,and the difference was statistically significant(P<0.05).As time went on,the 6-minute walking distance of the three groups gradually increased,and the LVEF level gradually increased.After 1 week,2 months and 4 months of treatment,the 6-minute walking distance of the saffron total glycoside tablet treatment group was longer than that of the control group and the ordinary heart care drug group,and the LVEF was higher than that of the control group and the ordinary heart care drug group,with statistical significance(P<0.05).As time goes

关 键 词：肿瘤所致心脏毒性 西红花总苷片 多中心随机对照试验 心脏保护作用 

分 类 号：R730[医药卫生—肿瘤]