Article(id=1292130231280755099, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130221843571059, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.08.002, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1769011200000, receivedDateStr=2026-01-22, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785997453756, onlineDateStr=2026-08-06, pubDate=1777305600000, pubDateStr=2026-04-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785997453756, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785997453755, creator=13701087609, updateTime=1785997453755, updator=13701087609, issue=Issue{id=1292130221843571059, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='8', pageStart='1051', pageEnd='1200', issueExtLink='null', onlineDate='null', pubDate='1777305600000', pubDateStr='2026-04-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785997451505, creator='13701087609', updateTime=1786014411018, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201355276480844, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130221843571059, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201355276480845, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130221843571059, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1058, endPage=1063, ext={EN=ArticleExt(id=1292130233331769756, articleId=1292130231280755099, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial on the treatment of inclisiran combined with rosuvastatin in patients with extremely high-risk atherosclerotic cardiovascular disease, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective

To explore the clinical therapeutic effect of inclisiran injection combined with rosuvastatin tablets in the treatment of patients with extremely high-risk atherosclerotic cardiovascular disease (ASCVD).

Methods

The patients with extremely high-risk ASCVD were divided into the treatment group and the control group according to the actual clinical medication regimens they received. The control group was given rosuvastatin calcium tablets 10 mg, po, qd, while the treatment group was given inclisiran sodium injection 284 mg, ih, for the first time, and 284 mg, ih, again after 3 months on the basis of control group. The treatment duration for both groups was 6 months. The clinical efficacy, lipid profile, low-density lipoprotein cholesterol (LDL-C) target attainment rate, proprotein convertase subtilisin/kexin type 9 (PCSK9) levels, cardiac function, plaque stability, safety evaluation, and cardiovascular benefits were compared between the two groups.

Results

A total of 98 patients were enrolled, with 51 in the control group and 47 in the treatment group. After treatment, the overall response rates in the control group and the treatment group and were 68.63% (35 cases/51 cases) and 87.23% (41 cases/47 cases), respectively; the LDL-C levels were (1.42±0.27) and (1.26±0.22) mmol·L-1, respectively; the LDL-C goal attainment rates at 3 months were 41.18% (21 cases/51 cases) and 61.70% (29 cases/47 cases), respectively; LDL-C goal attainment rates at 6 months were 52.94% (27 cases/51 cases) and 74.47% (35 cases/47 cases), respectively; PCSK9 levels at 3 months were (313.66±41.35) and (295.63±39.43) ng·mL-1, respectively; PCSK9 levels at 6 months were (203.71±33.39) and (184.29±31.54) ng·mL-1, respectively; carotid intima-media thickness were (1.01±0.27) and (0.91±0.11) mm, respectively; plaque areas were (18.52±3.76) and (16.31±3.63) mm2, respectively; proportions of unstable plaques were 39.22% (20 cases/51cases) and 19.15% (9 cases/47 cases), respectively; high-density lipoprotein cholesterol (HDL-C) levels were (1.46±0.55) and (1.47±0.33) mmol·L-1, respectively; apolipoprotein A (ApoA) levels were (1.11±0.25) and (1.10±0.29) g·L-1, respectively. Except HDL-C level and ApoA level, comparisons of other indexes between the two groups showed statistically significant differences (P<0.05, P<0.01). No significant difference in the incidence of adverse events was observed between the control group (5.88%, 3 cases/51 cases) and treatment group (8.51%, 4 cases/47 cases) (P>0.05).

Conclusion

The combination of inclisiran injection and rosuvastatin tablet is effective in the treatment of extremely high-risk ASCVD, significantly improving the total effective rate and the early and sustained LDL-C target attainment rate, and more effectively reducing LDL-C levels and stabilizing plaques. The mechanism may be related to significantly inhibiting PCSK9 levels and further enhancing lipid-lowering and plaque-stabilizing effects.

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目的

探讨英克司兰注射液联合瑞舒伐他汀钙片治疗极高危动脉粥样硬化性心血管疾病(ASCVD)患者的临床治疗效果。

方法

将极高危ASCVD患者依据其临床用药方案分为试验组和对照组。对照组予以瑞舒伐他汀钙片10 mg,po,qd,试验组在对照组基础上联合英克司兰钠注射液,首次给药284 mg,ih,3个月后再次给药284 mg,ih。2组患者治疗时间均为6个月。比较2组患者临床疗效、血脂谱、低密度脂蛋白胆固醇(LDL-C)达标率与前蛋白转化酶枯草溶菌素9(PCSK9)水平、心功能与斑块稳定性、安全性评价和心血管获益。

结果

共纳入98例患者,对照组和试验组分别为51例和47例。治疗后,对照组和试验组总有效率为68.63%(35例/51例)和87.23%(41例/47例)。治疗后,LDL-C水平分别为(1.42±0.27)和(1.26±0.22)mmol·L-1,治疗3个月LDL-C达标率分别为41.18%(21例/51例)和61.70%(29例/47例),治疗6个月LDL-C达标率分别为52.94%(27例/51例)和74.47%(35例/47例),治疗3个月PCSK9水平分别为(313.66±41.35)和(295.63±39.43)ng·mL-1,治疗6个月PCSK9水平分别为(203.71±33.39)和(184.29±31.54)ng·mL-1,颈动脉内膜中层厚度分别为(1.01±0.27)和0.91±0.11)mm,斑块面积分别为(18.52±3.76)和(16.31±3.63)mm2,不稳定斑块占比分别为39.22%(20例/51例)和19.15%(9例/47例),高密度脂蛋白(HDL-C)水平分别为(1.46±0.55)和(1.47±0.33)mmol·L-1,载脂蛋白A(ApoA)水平分别为(1.11±0.25)和(1.10±0.29)g·L-1。除HDL-C水平和ApoA水平外,其他上述指标2组间比较,在统计学上差异均有统计学意义(P<0.05,P<0.01)。2组患者药物不良反应发生率分别为5.88%(3例/51例)和8.51%(4例/47例)(P>0.05)。

结论

英克司兰联合瑞舒伐他汀治疗极高危ASCVD疗效较好,可显著提高患者总有效率与LDL-C早期和持续达标率,并更有效地降低LDL-C水平、稳定斑块,其机制可能与显著抑制PCSK9水平并进一步强化降脂和稳定斑块效果有关。

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周辉(1980-),女,副主任医师,主要从事心律失常,心脏电生理;高脂血症防治方面的工作和研究

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刘亮,副主任医师 MP: 18553376650 E-mail:
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英克司兰联合瑞舒伐他汀治疗极高危动脉粥样硬化性心血管疾病患者的临床研究
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周辉 1a , 郝方杰 1b , 刘亮 1a
中国临床药理学杂志 | 临床与基础桥接研究 2026,42(8): 1058-1063
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中国临床药理学杂志 |临床与基础桥接研究 2026 , 42 (8) : 1058 -1063
英克司兰联合瑞舒伐他汀治疗极高危动脉粥样硬化性心血管疾病患者的临床研究
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周辉1a, 郝方杰1b, 刘亮1a
作者信息
  • 1a.北大医疗鲁中医院,心血管内二科,山东 淄博 255400
  • 1b.北大医疗鲁中医院,健康查体科,山东 淄博 255400
通讯作者:
刘亮,副主任医师 MP: 18553376650 E-mail:
作者简介:

周辉(1980-),女,副主任医师,主要从事心律失常,心脏电生理;高脂血症防治方面的工作和研究

Clinical trial on the treatment of inclisiran combined with rosuvastatin in patients with extremely high-risk atherosclerotic cardiovascular disease
Hui ZHOU1a, Fang-jie HAO1b, Liang LIU1a
Affiliations
  • 1a.Second Department of Cardiovascular Medicine, Peking University Health Science Center - Luzhong Hospital, Zibo 255400, Shandong Province, China
  • 1b.Department of Physical Examination, Peking University Health Science Center - Luzhong Hospital, Zibo 255400, Shandong Province, China
出版时间: 2026-04-28 doi: 10.13699/j.cnki.1001-6821.2026.08.002
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目的

探讨英克司兰注射液联合瑞舒伐他汀钙片治疗极高危动脉粥样硬化性心血管疾病(ASCVD)患者的临床治疗效果。

方法

将极高危ASCVD患者依据其临床用药方案分为试验组和对照组。对照组予以瑞舒伐他汀钙片10 mg,po,qd,试验组在对照组基础上联合英克司兰钠注射液,首次给药284 mg,ih,3个月后再次给药284 mg,ih。2组患者治疗时间均为6个月。比较2组患者临床疗效、血脂谱、低密度脂蛋白胆固醇(LDL-C)达标率与前蛋白转化酶枯草溶菌素9(PCSK9)水平、心功能与斑块稳定性、安全性评价和心血管获益。

结果

共纳入98例患者,对照组和试验组分别为51例和47例。治疗后,对照组和试验组总有效率为68.63%(35例/51例)和87.23%(41例/47例)。治疗后,LDL-C水平分别为(1.42±0.27)和(1.26±0.22)mmol·L-1,治疗3个月LDL-C达标率分别为41.18%(21例/51例)和61.70%(29例/47例),治疗6个月LDL-C达标率分别为52.94%(27例/51例)和74.47%(35例/47例),治疗3个月PCSK9水平分别为(313.66±41.35)和(295.63±39.43)ng·mL-1,治疗6个月PCSK9水平分别为(203.71±33.39)和(184.29±31.54)ng·mL-1,颈动脉内膜中层厚度分别为(1.01±0.27)和0.91±0.11)mm,斑块面积分别为(18.52±3.76)和(16.31±3.63)mm2,不稳定斑块占比分别为39.22%(20例/51例)和19.15%(9例/47例),高密度脂蛋白(HDL-C)水平分别为(1.46±0.55)和(1.47±0.33)mmol·L-1,载脂蛋白A(ApoA)水平分别为(1.11±0.25)和(1.10±0.29)g·L-1。除HDL-C水平和ApoA水平外,其他上述指标2组间比较,在统计学上差异均有统计学意义(P<0.05,P<0.01)。2组患者药物不良反应发生率分别为5.88%(3例/51例)和8.51%(4例/47例)(P>0.05)。

结论

英克司兰联合瑞舒伐他汀治疗极高危ASCVD疗效较好,可显著提高患者总有效率与LDL-C早期和持续达标率,并更有效地降低LDL-C水平、稳定斑块,其机制可能与显著抑制PCSK9水平并进一步强化降脂和稳定斑块效果有关。

英克司兰注射液  /  瑞舒伐他汀钙片  /  动脉粥样硬化性心血管疾病  /  前蛋白转化酶枯草溶菌素9  /  斑块稳定性
Objective

To explore the clinical therapeutic effect of inclisiran injection combined with rosuvastatin tablets in the treatment of patients with extremely high-risk atherosclerotic cardiovascular disease (ASCVD).

Methods

The patients with extremely high-risk ASCVD were divided into the treatment group and the control group according to the actual clinical medication regimens they received. The control group was given rosuvastatin calcium tablets 10 mg, po, qd, while the treatment group was given inclisiran sodium injection 284 mg, ih, for the first time, and 284 mg, ih, again after 3 months on the basis of control group. The treatment duration for both groups was 6 months. The clinical efficacy, lipid profile, low-density lipoprotein cholesterol (LDL-C) target attainment rate, proprotein convertase subtilisin/kexin type 9 (PCSK9) levels, cardiac function, plaque stability, safety evaluation, and cardiovascular benefits were compared between the two groups.

Results

A total of 98 patients were enrolled, with 51 in the control group and 47 in the treatment group. After treatment, the overall response rates in the control group and the treatment group and were 68.63% (35 cases/51 cases) and 87.23% (41 cases/47 cases), respectively; the LDL-C levels were (1.42±0.27) and (1.26±0.22) mmol·L-1, respectively; the LDL-C goal attainment rates at 3 months were 41.18% (21 cases/51 cases) and 61.70% (29 cases/47 cases), respectively; LDL-C goal attainment rates at 6 months were 52.94% (27 cases/51 cases) and 74.47% (35 cases/47 cases), respectively; PCSK9 levels at 3 months were (313.66±41.35) and (295.63±39.43) ng·mL-1, respectively; PCSK9 levels at 6 months were (203.71±33.39) and (184.29±31.54) ng·mL-1, respectively; carotid intima-media thickness were (1.01±0.27) and (0.91±0.11) mm, respectively; plaque areas were (18.52±3.76) and (16.31±3.63) mm2, respectively; proportions of unstable plaques were 39.22% (20 cases/51cases) and 19.15% (9 cases/47 cases), respectively; high-density lipoprotein cholesterol (HDL-C) levels were (1.46±0.55) and (1.47±0.33) mmol·L-1, respectively; apolipoprotein A (ApoA) levels were (1.11±0.25) and (1.10±0.29) g·L-1, respectively. Except HDL-C level and ApoA level, comparisons of other indexes between the two groups showed statistically significant differences (P<0.05, P<0.01). No significant difference in the incidence of adverse events was observed between the control group (5.88%, 3 cases/51 cases) and treatment group (8.51%, 4 cases/47 cases) (P>0.05).

Conclusion

The combination of inclisiran injection and rosuvastatin tablet is effective in the treatment of extremely high-risk ASCVD, significantly improving the total effective rate and the early and sustained LDL-C target attainment rate, and more effectively reducing LDL-C levels and stabilizing plaques. The mechanism may be related to significantly inhibiting PCSK9 levels and further enhancing lipid-lowering and plaque-stabilizing effects.

inclisiran injection  /  rosuvastatin tablets  /  atherosclerotic cardiovascular disease  /  proprotein convertase subtilisin/kexin type 9  /  plaque stability
周辉, 郝方杰, 刘亮. 英克司兰联合瑞舒伐他汀治疗极高危动脉粥样硬化性心血管疾病患者的临床研究. 中国临床药理学杂志, 2026 , 42 (8) : 1058 -1063 . DOI: 10.13699/j.cnki.1001-6821.2026.08.002
Hui ZHOU, Fang-jie HAO, Liang LIU. Clinical trial on the treatment of inclisiran combined with rosuvastatin in patients with extremely high-risk atherosclerotic cardiovascular disease[J]. Chinese Journal of Clinical Pharmacology, 2026 , 42 (8) : 1058 -1063 . DOI: 10.13699/j.cnki.1001-6821.2026.08.002

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doi: 10.13699/j.cnki.1001-6821.2026.08.002
  • 接收时间:2026-01-22
  • 首发时间:2026-08-06
  • 出版时间:2026-04-28
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  • 收稿日期:2026-01-22
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    1a.北大医疗鲁中医院,心血管内二科,山东 淄博 255400
    1b.北大医疗鲁中医院,健康查体科,山东 淄博 255400

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刘亮,副主任医师 MP: 18553376650 E-mail:
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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
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