Article(id=1292126460966359481, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126460546929080, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.03.001, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1747929600000, receivedDateStr=2025-05-23, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785996554842, onlineDateStr=2026-08-06, pubDate=1771257600000, pubDateStr=2026-02-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785996554842, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785996554842, creator=13701087609, updateTime=1785996554842, updator=13701087609, issue=Issue{id=1292126460546929080, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='3', pageStart='301', pageEnd='450', issueExtLink='null', onlineDate='null', pubDate='1771257600000', pubDateStr='2026-02-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785996554742, creator='13701087609', updateTime=1786014541627, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201903060963536, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126460546929080, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201903060963537, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126460546929080, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=301, endPage=305, ext={EN=ArticleExt(id=1292126461155103162, articleId=1292126460966359481, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial of ezetimibe and alirocumab in combination with rosuvastatin in the treatment of coronary artery disease, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective

To observe the clinical efficacy and safety of ezetimibe tablets or alirocumab injection in conjunction with rosuvastatin calcium tablets for the treatment of coronary heart disease (CHD).

Methods

Patients with CHD were randomly divided into two groups. Both groups took rosuvastatin calcium tablets, 10 mg once daily. The control group additionally received ezetimibe tablets,10 mg once daily, while the treatment group received alirocumab injection (subcutaneous injection, 75 mg per dose, once every two weeks). After 6 months of treatment, the two groups were compared in terms of clinical efficacy, lipid metabolism, cardiac function and myocardial injury markers. Adverse drug reactions during treatment were recorded.

Results

This study enrolled a total of 118 patients, with 59 assigned to treatment group and 59 to the control group. During the 6-month treatment period, 4 patients in the control group dropped out due to changes in their condition. In treatment group, 6 patients dropped out, comprising 3 due to changes in the treatment plan and 3 who voluntarily withdrew from the study midway. Ultimately, 55 patients in the control group and 53 in the treatment group were included in the final analysis. After treatment, the total clinical effective rates were 90.57% (48 cases/53 cases) in treatment group and 72.73% (40 cases /55 cases) in control group, with statistically significant difference (P<0.05). After treatment, the cholesterol levels in the treatment and control groups were (2.58±0.40) and (3.60±0.52) mmol·L-1, respectively; low-density lipoprotein cholesterol levels were (2.16±0.36) and (2.51±0.44) mmol·L-1, respectively; N-terminal pro-brain natriuretic peptide (NT-proBNP) levels were (301.12±20.11) and (326.54±25.84) pg·mL-1, respectively; cardiac troponin Ⅰ (cTnⅠ) levels were (0.53±0.19) and (0.90±0.26) μg·L-1, respectively; matrix metalloproteinase-9 (MMP-9) levels were (31.04±4.05) and (37.25±4.72) ng·mL-1, respectively; left ventricular ejection fraction (LVEF) were (49.79±5.33)% and (45.09±5.21)%, respectively; left ventricular end-diastolic diameter (LVEDD) were (50.36±3.23) and (55.11±3.48) mm, respectively; and left ventricular end-systolic diameter (LVESD) were (35.04±3.72) and (40.64±3.97) mm, respectively. The aforementioned indicators in treatment group showed statistically significant differences compared to control group (all P<0.05). Adverse drug reactions in control group included 2 cases of nausea and vomiting, 2 cases of diarrhea, 3 cases of fatigue and 2 cases of arthralgia. Treatment group reported 2 cases of nausea and vomiting, 3 cases of diarrhea, 2 cases of fatigue, 1 case of arthralgia and 2 cases of injection site redness and swelling. The overall incidence rates of adverse drug reactions in treatment and control groups were 18.87% (10 cases/53 cases) and 16.36% (9 cases/55 cases), respectively, with no statistically significant difference (P>0.05).

Conclusion

Both ezetimibe tablets and alirocumab injection demonstrate good therapeutic efficacy in the treatment of coronary heart disease. However, the combination of alirocumab injection with rosuvastatin calcium tablets can further improve lipid metabolism and cardiac function.

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目的

观察依折麦布片与阿利西尤单抗注射液联合瑞舒伐他汀钙片治疗冠心病的临床疗效与安全性。

方法

将冠心病患者随机分为试验组和对照组,2组均服用瑞舒伐他汀钙片,每次10 mg,每天1次,对照组在此基础上联合应用依折麦布片,每次10 mg,每天1次,试验组则联合应用阿利西尤单抗注射液,每次皮下注射75 mg,每2周1次,2组均治疗6个月。比较2组患者的临床疗效、血脂代谢情况、心功能指标和心肌损伤指标,并进行安全性评价。

结果

本研究共纳入118例患者,试验组和对照组各59例,其中对照组因病情变化脱落4例,试验组因治疗方案改变脱落3例,中途退出研究脱落3例,最终对照组纳入55例、试验组纳入53例。治疗后,试验组和对照组的临床总有效率分别为90.57%(48例/53例)和72.73%(40例/55例),试验组显著高于对照组(P<0.05)。治疗后,试验组和对照组的胆固醇水平分别为(2.58±0.40)和(3.60±0.52)mmol·L-1,低密度脂蛋白胆固醇分别为(2.16±0.36)和(2.51±0.44)mmol·L-1,脑利钠肽前体(NT-proBNP)水平分别为(301.12±20.11)和(326.54±25.84)pg·mL-1,心肌肌钙蛋白(cTnI)水平分别为(0.53±0.19)和(0.90±0.26)μg·L-1,基质金属蛋白酶-9(MMP-9)水平分别为(31.04±4.05)和(37.25±4.72)ng·mL-1,左室射血分数(LVEF)分别为(49.79±5.33)%和(45.09±5.21)%,左室舒张末期内径(LVEDD)分别为(50.36±3.23)和(55.11±3.48)mm,左室收缩末期内径(LVESD)分别为(35.04±3.72)和(40.64±3.97)mm,试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05)。对照组出现2例恶心呕吐,2例腹泻,3例乏力,2例关节痛;试验组出现2例恶心呕吐,3例腹泻,2例乏力,1例关节痛,2例注射部位红肿。试验组和对照组的药物不良反应总发生率分别为18.87%(10例/53例)和16.36%(9例/55例),在统计学上差异无统计学意义(P>0.05)。

结论

依折麦布片与阿利西尤单抗注射液均对冠心病有较好的治疗效果,但阿利西尤单抗注射液联合瑞舒伐他汀钙片可以进一步改善血脂代谢和心功能。

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伊新芝(1974-),女,副主任医师,主要从事高血压及心力衰竭方面的工作和研究

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伊新芝 MP: 15981752360 E-mail:
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依折麦布与阿利西尤单抗联合瑞舒伐他汀治疗冠心病的临床研究
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伊新芝 , 刘洁茹 , 依力努尔·赛买提
中国临床药理学杂志 | 临床与基础桥接研究 2026,42(3): 301-305
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中国临床药理学杂志 |临床与基础桥接研究 2026 , 42 (3) : 301 -305
依折麦布与阿利西尤单抗联合瑞舒伐他汀治疗冠心病的临床研究
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伊新芝 , 刘洁茹, 依力努尔·赛买提
作者信息
  • 新疆维吾尔自治区第三人民医院 心血管内科,新疆维吾尔自治区 乌鲁木齐 830000
通讯作者:
伊新芝 MP: 15981752360 E-mail:
作者简介:

伊新芝(1974-),女,副主任医师,主要从事高血压及心力衰竭方面的工作和研究

Clinical trial of ezetimibe and alirocumab in combination with rosuvastatin in the treatment of coronary artery disease
Xin-zhi YI , Jie-ru LIU, YILINUER · Saimaiti
Affiliations
  • Department of Cardiology, The Third People’s Hospital of Xinjiang Uygur Autonomous Region, Urumqi 830000, Xinjiang Uygur Autonomous Region, China
出版时间: 2026-02-17 doi: 10.13699/j.cnki.1001-6821.2026.03.001
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目的

观察依折麦布片与阿利西尤单抗注射液联合瑞舒伐他汀钙片治疗冠心病的临床疗效与安全性。

方法

将冠心病患者随机分为试验组和对照组,2组均服用瑞舒伐他汀钙片,每次10 mg,每天1次,对照组在此基础上联合应用依折麦布片,每次10 mg,每天1次,试验组则联合应用阿利西尤单抗注射液,每次皮下注射75 mg,每2周1次,2组均治疗6个月。比较2组患者的临床疗效、血脂代谢情况、心功能指标和心肌损伤指标,并进行安全性评价。

结果

本研究共纳入118例患者,试验组和对照组各59例,其中对照组因病情变化脱落4例,试验组因治疗方案改变脱落3例,中途退出研究脱落3例,最终对照组纳入55例、试验组纳入53例。治疗后,试验组和对照组的临床总有效率分别为90.57%(48例/53例)和72.73%(40例/55例),试验组显著高于对照组(P<0.05)。治疗后,试验组和对照组的胆固醇水平分别为(2.58±0.40)和(3.60±0.52)mmol·L-1,低密度脂蛋白胆固醇分别为(2.16±0.36)和(2.51±0.44)mmol·L-1,脑利钠肽前体(NT-proBNP)水平分别为(301.12±20.11)和(326.54±25.84)pg·mL-1,心肌肌钙蛋白(cTnI)水平分别为(0.53±0.19)和(0.90±0.26)μg·L-1,基质金属蛋白酶-9(MMP-9)水平分别为(31.04±4.05)和(37.25±4.72)ng·mL-1,左室射血分数(LVEF)分别为(49.79±5.33)%和(45.09±5.21)%,左室舒张末期内径(LVEDD)分别为(50.36±3.23)和(55.11±3.48)mm,左室收缩末期内径(LVESD)分别为(35.04±3.72)和(40.64±3.97)mm,试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05)。对照组出现2例恶心呕吐,2例腹泻,3例乏力,2例关节痛;试验组出现2例恶心呕吐,3例腹泻,2例乏力,1例关节痛,2例注射部位红肿。试验组和对照组的药物不良反应总发生率分别为18.87%(10例/53例)和16.36%(9例/55例),在统计学上差异无统计学意义(P>0.05)。

结论

依折麦布片与阿利西尤单抗注射液均对冠心病有较好的治疗效果,但阿利西尤单抗注射液联合瑞舒伐他汀钙片可以进一步改善血脂代谢和心功能。

阿利西尤单抗注射液  /  依折麦布片  /  瑞舒伐他汀钙片  /  冠心病
Objective

To observe the clinical efficacy and safety of ezetimibe tablets or alirocumab injection in conjunction with rosuvastatin calcium tablets for the treatment of coronary heart disease (CHD).

Methods

Patients with CHD were randomly divided into two groups. Both groups took rosuvastatin calcium tablets, 10 mg once daily. The control group additionally received ezetimibe tablets,10 mg once daily, while the treatment group received alirocumab injection (subcutaneous injection, 75 mg per dose, once every two weeks). After 6 months of treatment, the two groups were compared in terms of clinical efficacy, lipid metabolism, cardiac function and myocardial injury markers. Adverse drug reactions during treatment were recorded.

Results

This study enrolled a total of 118 patients, with 59 assigned to treatment group and 59 to the control group. During the 6-month treatment period, 4 patients in the control group dropped out due to changes in their condition. In treatment group, 6 patients dropped out, comprising 3 due to changes in the treatment plan and 3 who voluntarily withdrew from the study midway. Ultimately, 55 patients in the control group and 53 in the treatment group were included in the final analysis. After treatment, the total clinical effective rates were 90.57% (48 cases/53 cases) in treatment group and 72.73% (40 cases /55 cases) in control group, with statistically significant difference (P<0.05). After treatment, the cholesterol levels in the treatment and control groups were (2.58±0.40) and (3.60±0.52) mmol·L-1, respectively; low-density lipoprotein cholesterol levels were (2.16±0.36) and (2.51±0.44) mmol·L-1, respectively; N-terminal pro-brain natriuretic peptide (NT-proBNP) levels were (301.12±20.11) and (326.54±25.84) pg·mL-1, respectively; cardiac troponin Ⅰ (cTnⅠ) levels were (0.53±0.19) and (0.90±0.26) μg·L-1, respectively; matrix metalloproteinase-9 (MMP-9) levels were (31.04±4.05) and (37.25±4.72) ng·mL-1, respectively; left ventricular ejection fraction (LVEF) were (49.79±5.33)% and (45.09±5.21)%, respectively; left ventricular end-diastolic diameter (LVEDD) were (50.36±3.23) and (55.11±3.48) mm, respectively; and left ventricular end-systolic diameter (LVESD) were (35.04±3.72) and (40.64±3.97) mm, respectively. The aforementioned indicators in treatment group showed statistically significant differences compared to control group (all P<0.05). Adverse drug reactions in control group included 2 cases of nausea and vomiting, 2 cases of diarrhea, 3 cases of fatigue and 2 cases of arthralgia. Treatment group reported 2 cases of nausea and vomiting, 3 cases of diarrhea, 2 cases of fatigue, 1 case of arthralgia and 2 cases of injection site redness and swelling. The overall incidence rates of adverse drug reactions in treatment and control groups were 18.87% (10 cases/53 cases) and 16.36% (9 cases/55 cases), respectively, with no statistically significant difference (P>0.05).

Conclusion

Both ezetimibe tablets and alirocumab injection demonstrate good therapeutic efficacy in the treatment of coronary heart disease. However, the combination of alirocumab injection with rosuvastatin calcium tablets can further improve lipid metabolism and cardiac function.

alirocumab injection  /  ezetimibe tablet  /  rosuvastatin calcium tablet  /  coronary artery disease
伊新芝, 刘洁茹, 依力努尔·赛买提. 依折麦布与阿利西尤单抗联合瑞舒伐他汀治疗冠心病的临床研究. 中国临床药理学杂志, 2026 , 42 (3) : 301 -305 . DOI: 10.13699/j.cnki.1001-6821.2026.03.001
Xin-zhi YI, Jie-ru LIU, YILINUER · Saimaiti. Clinical trial of ezetimibe and alirocumab in combination with rosuvastatin in the treatment of coronary artery disease[J]. Chinese Journal of Clinical Pharmacology, 2026 , 42 (3) : 301 -305 . DOI: 10.13699/j.cnki.1001-6821.2026.03.001
  • 新疆维吾尔自治区自然科学基金资助项目(2022D01C269)
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doi: 10.13699/j.cnki.1001-6821.2026.03.001
  • 接收时间:2025-05-23
  • 首发时间:2026-08-06
  • 出版时间:2026-02-17
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  • 收稿日期:2025-05-23
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新疆维吾尔自治区自然科学基金资助项目(2022D01C269)
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    新疆维吾尔自治区第三人民医院 心血管内科,新疆维吾尔自治区 乌鲁木齐 830000

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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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