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Article(id=1292130485854036826, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130360968630762, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.06.001, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1766937600000, receivedDateStr=2025-12-29, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785997514450, onlineDateStr=2026-08-06, pubDate=1774627200000, pubDateStr=2026-03-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785997514450, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785997514450, creator=13701087609, updateTime=1785997514450, updator=13701087609, issue=Issue{id=1292130360968630762, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='6', pageStart='751', pageEnd='900', issueExtLink='null', onlineDate='null', pubDate='1774627200000', pubDateStr='2026-03-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785997484675, creator='13701087609', updateTime=1786014452071, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201527440068743, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130360968630762, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201527440068744, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130360968630762, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=751, endPage=758, ext={EN=ArticleExt(id=1292130486080529243, articleId=1292130485854036826, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Dose-finding study of amlodipine besilate/bisoprolol fumarate fixed-dose combination in the treatment of mild to moderate essential hypertension: A multicenter, randomized, double-blind, phase Ⅱ clinical trial, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective

To evaluate the efficacy and safety of different dose combinations of levamlodipine besilate tablets and bisoprolol fumarate tablets compared with placebo and control.

Methods

A multicenter, randomized, double-blind, double-dummy, placebo-positive drug-controlled dose-finding study in which patients with grade 1-2 essential hypertension were randomly divided into 5 groups after 14 days of placebo, namely: group A (placebo group), group B (levamlodipine besilate 2.5 mg/placebo), group C (bisoprolol 5 mg/placebo), group D (levamlodipine besilate 2.5 mg/bisoprolol fumarate 2.5 mg group) and E group (levamlodipine besilate 2.5 mg/bisoprolol fumarate 5 mg group), treated for 56 days. 14 days, 28 days, and 56 days after treatment, the main indicators-diastolic blood pressure, and the secondary indicators-systolic blood pressure, were analyzed, and the efficacy and safety were analyzed.

Results

After 56 days of treatment, the decrease in diastolic blood pressure was 3.26±8.09 mmHg in group A, 8.89±6.97 mmHg in group B, 7.89±6.48 mmHg in group C, 12.64±6.49 mmHg in group D, and 13.46±7.80 mmHg in group E. Compared with group A, groups B, C, D, and E, P<0.001; the reduction of blood pressure between groups D and E (combination treatment group) and group B and C (monotherapy group) was significantly lower than that of group A P<0.01, and P>0.05 between combination treatment groups (D and E) and monotherapy groups (B and C groups). In terms of reducing systolic blood pressure, group B (decrease of 13.39±11.48 mmHg), group D (decrease of 17.55±10.31 mmHg) and group E (decrease of 20.60±13.06 mmHg) and group A (decrease of 5.55±13.19 mmHg) were P<0.001; group E compared with group B and C, P<0.001; compared between group D and C, P<0.01; and P>0.05 between groups D and E of the two combination treatment groups.

Conclusion

The 2.5 mg levamlodipine besilatee tablets combined with 2.5 mg bisoprolol fumarate tablets and 2.5 mg levamlodipine besilate tablets combined with 5 mg bisoprolol fumarate tablets have good efficacy and are better than the single agent levamlodipine besilate or bisoprolol fumarate in reducing diastolic blood pressure, and are well tolerated.

, authors=Yuan-yuan CHEN1, Ning-ling SUN1, Feng-jiang LIU2, Yan-ling QU3, Li TIAN4, Ying LIU5, Bei-jian CHEN6, Zhi-xing YANG7, Xin-chun YANG8, authorsList=Yuan-yuan CHEN, Ning-ling SUN, Feng-jiang LIU, Yan-ling QU, Li TIAN, Ying LIU, Bei-jian CHEN, Zhi-xing YANG, Xin-chun YANG, authorCompany=null, correspAuthors=Ning-ling SUN, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1292130486365741916, articleId=1292130485854036826, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=苯磺酸左氨氯地平/富马酸比索洛尔固定复方治疗轻中度原发性高血压的剂量探索：一项多中心、随机、双盲、Ⅱ期临床试验, columnId=1246531407485489349, journalTitle=中国临床药理学杂志, columnName=临床与基础桥接研究, runingTitle=null, highlight=null, articleAbstract=
目的

评价苯磺酸左氨氯地平片和富马酸比索洛尔片的不同剂量组合与安慰剂和对照药相比的有效性和安全性。

方法

多中心、随机、双盲、双模拟、安慰剂与阳性药对照的剂量探索研究，入组患者为1~2级原发性高血压患者，在安慰剂14 d后随机分为5组，即：A组（安慰剂组）、B组（苯磺酸左氨氯地平2.5 mg/安慰剂组）、C组（富马酸比索洛尔5 mg/安慰剂组）、D组（苯磺酸左氨氯地平2.5 mg/富马酸比索洛尔2.5 mg组）和E组（苯磺酸左氨氯地平2.5 mg/富马酸比索洛尔5 mg组），治疗56 d。治疗后14、28、56 d分别测定诊室血压，分析每组主要指标即舒张压的降压幅度和次要指标即收缩压的降压幅度、有效性，并进行安全性评估。

结果

治疗56 d后，舒张压下降幅度各组分别为A组（3.26±8.09）mmHg、B组（8.89±6.97）mmHg、C组（7.89±6.48）mmHg、D组（12.64±6.49）mmHg、E组（13.46±7.80）mmHg。B、C、D及E组与A组比较，差异有统计学意义（P<0.001）； D组及E组（联合治疗组）与B组及C组（单药治疗组）间比较降压幅度均有显著性P<0.01；联合治疗组之间（D组与E组）及单药治疗组之间（B组与C组）比较，差异无统计学意义（P>0.05）。在降低收缩压方面，B组（下降13.39±11.48 mmHg）、D组（下降17.55±10.31 mmHg）及E组（下降20.60±13.06 mmHg）与A组（下降5.55±13.19 mmHg）比较，差异有统计学意义（P<0.001）；E组与B组及C组比较，P<0.001；D组与C组比较，差异有统计学意义（P<0.01）；两个联合治疗组D与E组比较，差异无统计学意义（P>0.05）。

结论

2.5 mg苯磺酸左氨氯地平片联合2.5 mg富马酸比索洛尔片和2.5 mg苯磺酸左氨氯地平片联合5 mg富马酸比索洛尔片组均有很好的降压幅度和疗效，在降低舒张压方面优于单药苯磺酸左氨氯地平和富马酸比索洛尔，且安全耐受性好。

, authors=陈源源1, 孙宁玲1, 刘凤江2, 屈艳玲3, 田立4, 刘莹5, 陈贝健6, 杨志星7, 杨新春8, authorsList=陈源源, 孙宁玲, 刘凤江, 屈艳玲, 田立, 刘莹, 陈贝健, 杨志星, 杨新春, authorCompany=null, correspAuthors=孙宁玲, authorNote=

陈源源（1961-），女，主任医师，主要从事高血压疾病相关研究

, correspAuthorsNote=
孙宁玲，教授，主任医师，博士生导师 MP: 13701333202 E-mail:
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陈源源（1961-），女，主任医师，主要从事高血压疾病相关研究

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陈源源（1961-），女，主任医师，主要从事高血压疾病相关研究

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苯磺酸左氨氯地平/富马酸比索洛尔固定复方治疗轻中度原发性高血压的剂量探索：一项多中心、随机、双盲、Ⅱ期临床试验
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陈源源 1 , 孙宁玲 1 , 刘凤江 2 , 屈艳玲 3 , 田立 4 , 刘莹 5 , 陈贝健 6 , 杨志星 7 , 杨新春 8
中国临床药理学杂志 | 临床与基础桥接研究 2026,42(6): 751-758
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中国临床药理学杂志 |临床与基础桥接研究 2026 , 42 (6) : 751 -758
苯磺酸左氨氯地平/富马酸比索洛尔固定复方治疗轻中度原发性高血压的剂量探索：一项多中心、随机、双盲、Ⅱ期临床试验
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陈源源1, 孙宁玲1 , 刘凤江2, 屈艳玲3, 田立4, 刘莹5, 陈贝健6, 杨志星7, 杨新春8
作者信息
  • 1.北京大学人民医院，北京 100044
  • 2.施慧达药业集团有限公司，吉林 吉林市 134300
  • 3.运城市中心医院，山西 运城 044099
  • 4.河北医科大学第一医院，河北 石家庄 050000
  • 5.辽宁省人民医院，辽宁 沈阳 110016
  • 6.菏泽市立医院，山东 菏泽 274006
  • 7.山西省心血管病医院，太原 030024
  • 8.首都医科大学附属北京朝阳医院，北京 100161
通讯作者:
孙宁玲，教授，主任医师，博士生导师 MP: 13701333202 E-mail:
作者简介:

陈源源（1961-），女，主任医师，主要从事高血压疾病相关研究

Dose-finding study of amlodipine besilate/bisoprolol fumarate fixed-dose combination in the treatment of mild to moderate essential hypertension: A multicenter, randomized, double-blind, phase Ⅱ clinical trial
Yuan-yuan CHEN1, Ning-ling SUN1 , Feng-jiang LIU2, Yan-ling QU3, Li TIAN4, Ying LIU5, Bei-jian CHEN6, Zhi-xing YANG7, Xin-chun YANG8
Affiliations
  • 1.People’s Hospital of Peking University, Beijing 100044, China
  • 2.Shihuida Pharmaceutical Group, Jilin 134300, Jilin Province, China
  • 3.Yuncheng Central Hospital of Shanxi Province, Yuncheng 044099, Shanxi Province, China
  • 4.The First Hospital of Hebei Medical University, Shijiazhuang 050000, Hebei Province, China
  • 5.The People’s Hospital of Liaoning Provincial, Shenyang 110016, Liaoning Province, China
  • 6.Heze Municipal Hospital, Heze 274006, Shandong Province, China
  • 7.Shanxi Cardiovascular Hospital, Taiyuan 030024, Shanxi Province, China
  • 8.Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China
出版时间: 2026-03-28 doi: 10.13699/j.cnki.1001-6821.2026.06.001
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摘要
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目的

评价苯磺酸左氨氯地平片和富马酸比索洛尔片的不同剂量组合与安慰剂和对照药相比的有效性和安全性。

方法

多中心、随机、双盲、双模拟、安慰剂与阳性药对照的剂量探索研究，入组患者为1~2级原发性高血压患者，在安慰剂14 d后随机分为5组，即：A组（安慰剂组）、B组（苯磺酸左氨氯地平2.5 mg/安慰剂组）、C组（富马酸比索洛尔5 mg/安慰剂组）、D组（苯磺酸左氨氯地平2.5 mg/富马酸比索洛尔2.5 mg组）和E组（苯磺酸左氨氯地平2.5 mg/富马酸比索洛尔5 mg组），治疗56 d。治疗后14、28、56 d分别测定诊室血压，分析每组主要指标即舒张压的降压幅度和次要指标即收缩压的降压幅度、有效性，并进行安全性评估。

结果

治疗56 d后，舒张压下降幅度各组分别为A组（3.26±8.09）mmHg、B组（8.89±6.97）mmHg、C组（7.89±6.48）mmHg、D组（12.64±6.49）mmHg、E组（13.46±7.80）mmHg。B、C、D及E组与A组比较，差异有统计学意义（P<0.001）； D组及E组（联合治疗组）与B组及C组（单药治疗组）间比较降压幅度均有显著性P<0.01；联合治疗组之间（D组与E组）及单药治疗组之间（B组与C组）比较，差异无统计学意义（P>0.05）。在降低收缩压方面，B组（下降13.39±11.48 mmHg）、D组（下降17.55±10.31 mmHg）及E组（下降20.60±13.06 mmHg）与A组（下降5.55±13.19 mmHg）比较，差异有统计学意义（P<0.001）；E组与B组及C组比较，P<0.001；D组与C组比较，差异有统计学意义（P<0.01）；两个联合治疗组D与E组比较，差异无统计学意义（P>0.05）。

结论

2.5 mg苯磺酸左氨氯地平片联合2.5 mg富马酸比索洛尔片和2.5 mg苯磺酸左氨氯地平片联合5 mg富马酸比索洛尔片组均有很好的降压幅度和疗效，在降低舒张压方面优于单药苯磺酸左氨氯地平和富马酸比索洛尔，且安全耐受性好。

原发性高血压  /  随机、双盲、安慰剂对照  /  血压降低幅度  /  安全性
Objective

To evaluate the efficacy and safety of different dose combinations of levamlodipine besilate tablets and bisoprolol fumarate tablets compared with placebo and control.

Methods

A multicenter, randomized, double-blind, double-dummy, placebo-positive drug-controlled dose-finding study in which patients with grade 1-2 essential hypertension were randomly divided into 5 groups after 14 days of placebo, namely: group A (placebo group), group B (levamlodipine besilate 2.5 mg/placebo), group C (bisoprolol 5 mg/placebo), group D (levamlodipine besilate 2.5 mg/bisoprolol fumarate 2.5 mg group) and E group (levamlodipine besilate 2.5 mg/bisoprolol fumarate 5 mg group), treated for 56 days. 14 days, 28 days, and 56 days after treatment, the main indicators-diastolic blood pressure, and the secondary indicators-systolic blood pressure, were analyzed, and the efficacy and safety were analyzed.

Results

After 56 days of treatment, the decrease in diastolic blood pressure was 3.26±8.09 mmHg in group A, 8.89±6.97 mmHg in group B, 7.89±6.48 mmHg in group C, 12.64±6.49 mmHg in group D, and 13.46±7.80 mmHg in group E. Compared with group A, groups B, C, D, and E, P<0.001; the reduction of blood pressure between groups D and E (combination treatment group) and group B and C (monotherapy group) was significantly lower than that of group A P<0.01, and P>0.05 between combination treatment groups (D and E) and monotherapy groups (B and C groups). In terms of reducing systolic blood pressure, group B (decrease of 13.39±11.48 mmHg), group D (decrease of 17.55±10.31 mmHg) and group E (decrease of 20.60±13.06 mmHg) and group A (decrease of 5.55±13.19 mmHg) were P<0.001; group E compared with group B and C, P<0.001; compared between group D and C, P<0.01; and P>0.05 between groups D and E of the two combination treatment groups.

Conclusion

The 2.5 mg levamlodipine besilatee tablets combined with 2.5 mg bisoprolol fumarate tablets and 2.5 mg levamlodipine besilate tablets combined with 5 mg bisoprolol fumarate tablets have good efficacy and are better than the single agent levamlodipine besilate or bisoprolol fumarate in reducing diastolic blood pressure, and are well tolerated.

essential hypertension  /  randomized; double-blind; placebo-controlled  /  blood pressure reduction  /  safety
陈源源, 孙宁玲, 刘凤江, 屈艳玲, 田立, 刘莹, 陈贝健, 杨志星, 杨新春. 苯磺酸左氨氯地平/富马酸比索洛尔固定复方治疗轻中度原发性高血压的剂量探索：一项多中心、随机、双盲、Ⅱ期临床试验. 中国临床药理学杂志, 2026 , 42 (6) : 751 -758 . DOI: 10.13699/j.cnki.1001-6821.2026.06.001
Yuan-yuan CHEN, Ning-ling SUN, Feng-jiang LIU, Yan-ling QU, Li TIAN, Ying LIU, Bei-jian CHEN, Zhi-xing YANG, Xin-chun YANG. Dose-finding study of amlodipine besilate/bisoprolol fumarate fixed-dose combination in the treatment of mild to moderate essential hypertension: A multicenter, randomized, double-blind, phase Ⅱ clinical trial[J]. Chinese Journal of Clinical Pharmacology, 2026 , 42 (6) : 751 -758 . DOI: 10.13699/j.cnki.1001-6821.2026.06.001

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doi: 10.13699/j.cnki.1001-6821.2026.06.001
  • 接收时间：2025-12-29
  • 首发时间：2026-08-06
  • 出版时间：2026-03-28
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  • 收稿日期：2025-12-29
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作者信息
    1.北京大学人民医院，北京 100044
    2.施慧达药业集团有限公司，吉林 吉林市 134300
    3.运城市中心医院，山西 运城 044099
    4.河北医科大学第一医院，河北 石家庄 050000
    5.辽宁省人民医院，辽宁 沈阳 110016
    6.菏泽市立医院，山东 菏泽 274006
    7.山西省心血管病医院，太原 030024
    8.首都医科大学附属北京朝阳医院，北京 100161

通讯作者:

孙宁玲，教授，主任医师，博士生导师 MP: 13701333202 E-mail:
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https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/10.13699/j.cnki.1001-6821.2026.06.001
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2种不同金属材料的力学参数
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Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
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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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