Article(id=1291704923788431633, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704771212234905, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.17.005, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1746633600000, receivedDateStr=2025-05-08, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896052547, onlineDateStr=2026-08-05, pubDate=1758038400000, pubDateStr=2025-09-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896052547, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896052547, creator=13701087609, updateTime=1785896052547, updator=13701087609, issue=Issue{id=1291704771212234905, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='17', pageStart='2401', pageEnd='2550', issueExtLink='null', onlineDate='null', pubDate='1758038400000', pubDateStr='2025-09-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896016147, creator='13701087609', updateTime=1785896900366, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291708479866164175, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704771212234905, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291708479866164176, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704771212234905, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2423, endPage=2428, ext={EN=ArticleExt(id=1291704924274970898, articleId=1291704923788431633, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial of beraprost sodium combined with alprostadil in patients with stage Ⅲ diabetic nephropathy, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective

To explore the clinical efficacy and safety of beraprost sodium tablets combined with alprostadil injection in patients with stage Ⅲ diabetic nephropathy.

Methods

According to queuing method, inpatients with stage Ⅲ diabetic nephropathy treated in the hospital were divided into treatment group and control group. Treatment group was treated with beraprost sodium tablets + alprostadil injection (the first 2 weeks: intravenous drip of alprostadil injection 10 μg qd. the last 2 weeks: oral beraprost sodium tables 40 μg tid), while control group was treated with alprostadil injection (the same administration method as treatment group for 4 weeks). The clinical efficacy, β2 microglobulin (β2-MG), cystatin C (Cys-C), blood urea nitrogen (BUN), serum creatinine (SCr), urinary albumin to creatinine ratio (UACR), transforming growth factor β1 (TGF-β1), tissue inhibitor of metalloproteinase-1 (TIMP-1), matrix metalloproteinase-9 (MMP-9), hemoglobin Alc (HbAlc), fasting blood glucose (FBG), 2 h postprandial blood glucose (2 h PBG), homeostasis model assessment for insulin resistance (HOMA-IR), hypersensitive C-reactive protein (hs-CRP), tumor necrosis factor α (TNF-α) and interleukin-6 (IL-6) were compared between the two groups, and the safety was evaluated.

Results

Among the 103 patients, there were 52 cases in treatment group and 51 cases in control group. The efficiency rate in treatment group was higher than that in control group [92.31% (48 cases/52 cases) vs. 78.43% (40 cases/51 cases), P<0.05]. After treatment, levels of serum β2-MG in treatment group and control group were (0.25±0.06) and (0.31±0.07) mg·L-1, BUN levels were (5.70±0.91) and (6.89±1.01) mmol·L-1, SCr levels were (85.46±8.89) and (93.88±9.77) μmol·L-1, Cys-C levels were (1.38±0.26) and (1.64±0.30) mg·L-1, UACR levels were (140.24±31.04) and (176.40±36.19) mg·g-1, respectively; levels of serum TIMP-1 were (88.34±12.36) and (97.62±15.44) ng·mL-1, TGF-β1 levels were (112.49±17.24) and (138.50±19.84) ng·mL-1, MMP-9 levels were (130.69±21.30) and (114.79±19.77) μg·L-1, respectively; levels of serum IL-6 were (141.49±28.85) and (173.49±32.36) pg·mL-1, hs-CRP levels were (7.64±1.16) and (9.29±1.54) mg·L-1, TNF-α levels were (23.65±4.34) and (29.12±3.86) pg·mL-1, and differences in the above indexes between treatment group and control group were all statistically significant (all P<0.05). During treatment, there was 1 case with diarrhea, 1 case with rash and 1 case with nausea and vomiting in treatment group, while there was 1 case with rash and 1 case with diarrhea in control group. There was no statistically significant difference in incidence of adverse drug reactions between treatment group and control group (5.77% vs. 3.92%, P>0.05).

Conclusion

Alprostadil injection combined with beraprost sodium tablets can effectively improve renal function, regulate metabolism of extracellular matrixes in renal tissues, relieve inflammatory response and improve clinical curative effect in patients with stage Ⅲ diabetic nephropathy.

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目的

探讨贝前列素钠片与前列地尔注射液联合治疗对糖尿病肾病Ⅲ期患者的临床疗效和安全性。

方法

将本院就诊的糖尿病肾病Ⅲ期住院患者按队列法分为试验组和对照组,试验组患者给予贝前列素钠片+前列地尔注射液联合治疗(前2周静脉滴注前列地尔注射液,10 μg qd;后2周口服贝前列素钠片,40 μg tid),对照组患者给予前列地尔注射液(给药方式同试验组,连续治疗4周)。比较2组患者的临床疗效、β2微球蛋白(β2-MG)、胱抑素C(Cys-C)、血尿素氮(BUN)、血肌酸酐(SCr)、尿白蛋白与肌酸酐比值(UACR)、转化生长因子β1(TGF-β1)、金属蛋白酶组织抑制因子-1(TIMP-1)、基质金属蛋白酶-9(MMP-9)、糖化血红蛋白(HbAlc)、空腹血糖(FBG)、餐后2 h血糖(2 h PBG)、胰岛素抵抗指数(HOMA-IR)、超敏C反应蛋白(hs-CRP)、肿瘤坏死因子α(TNF-α)和白介素6(IL-6)水平,并进行安全性评价。

结果

共纳入103例患者,试验组52例、对照组51例。试验组患者的有效率为92.31%(48例/52例),显著高于对照组的78.43%(40例/51例)(P<0.05)。治疗后,试验组与对照组患者的血清β2-MG水平分别为(0.25±0.06)和(0.31±0.07)mg·L-1;BUN水平分别为(5.70±0.91)和(6.89±1.01)mmol·L-1;SCr水平分别为(85.46±8.89)和(93.88±9.77)μmol·L-1;Cys-C水平分别为(1.38±0.26)和(1.64±0.30)mg·L-1;UACR水平分别为(140.24±31.04)和(176.40±36.19)mg·g-1;血清细胞外基质调控指标TIMP-1水平分别为(88.34±12.36)和(97.62±15.44)ng·mL-1;TGF-β1水平分别为(112.49±17.24)和(138.50±19.84)ng·mL-1,MMP-9水平分别为(130.69±21.30)和(114.79±19.77)μg·L-1;血清炎性指标IL-6水平分别为(141.49±28.85)和(173.49±32.36)pg·mL-1;hs-CRP水平分别为(7.64±1.16)和(9.29±1.54)mg·L-1;TNF-α水平分别为(23.65±4.34)和(29.12±3.86)pg·mL-1,试验组的上述指标和对照组比较,在统计学上差异均有统计学意义(均P<0.05)。治疗过程中,试验组患者发生皮疹、腹泻、恶心呕吐各1例,对照组患者发生皮疹、腹泻各1例,试验组和对照组的总药物不良反应发生率比较,在统计学上差异无统计学意义(5.77% vs. 3.92%,P>0.05)。

结论

前列地尔注射液与贝前列素钠片联合治疗可有效改善糖尿病肾病Ⅲ期患者肾功能,调节肾组织细胞外基质代谢,减轻机体炎性反应,提高临床疗效。

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王崇欣(1988-),女,主治医师,主要从事糖尿病肾病方面的临床工作和研究

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郑月月,副主任医师 MP: 15203770780 E-mail:
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贝前列素钠联合前列地尔治疗糖尿病肾病Ⅲ期患者的临床研究
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王崇欣 , 郑月月 , 石小霞
中国临床药理学杂志 | 临床与基础桥接研究 2025,41(17): 2423-2428
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中国临床药理学杂志 |临床与基础桥接研究 2025 , 41 (17) : 2423 -2428
贝前列素钠联合前列地尔治疗糖尿病肾病Ⅲ期患者的临床研究
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王崇欣, 郑月月 , 石小霞
作者信息
  • 南阳医学高等专科学校 第一附属医院 内分泌科,河南 南阳 473000
通讯作者:
郑月月,副主任医师 MP: 15203770780 E-mail:
作者简介:

王崇欣(1988-),女,主治医师,主要从事糖尿病肾病方面的临床工作和研究

Clinical trial of beraprost sodium combined with alprostadil in patients with stage Ⅲ diabetic nephropathy
Chong-xin WANG, Yue-yue ZHENG , Xiao-xia SHI
Affiliations
  • Department of Endocrinology, the First Affiliated Hospital of Nanyang Medical College, Nanyang 473000, Henan Province, China
出版时间: 2025-09-17 doi: 10.13699/j.cnki.1001-6821.2025.17.005
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目的

探讨贝前列素钠片与前列地尔注射液联合治疗对糖尿病肾病Ⅲ期患者的临床疗效和安全性。

方法

将本院就诊的糖尿病肾病Ⅲ期住院患者按队列法分为试验组和对照组,试验组患者给予贝前列素钠片+前列地尔注射液联合治疗(前2周静脉滴注前列地尔注射液,10 μg qd;后2周口服贝前列素钠片,40 μg tid),对照组患者给予前列地尔注射液(给药方式同试验组,连续治疗4周)。比较2组患者的临床疗效、β2微球蛋白(β2-MG)、胱抑素C(Cys-C)、血尿素氮(BUN)、血肌酸酐(SCr)、尿白蛋白与肌酸酐比值(UACR)、转化生长因子β1(TGF-β1)、金属蛋白酶组织抑制因子-1(TIMP-1)、基质金属蛋白酶-9(MMP-9)、糖化血红蛋白(HbAlc)、空腹血糖(FBG)、餐后2 h血糖(2 h PBG)、胰岛素抵抗指数(HOMA-IR)、超敏C反应蛋白(hs-CRP)、肿瘤坏死因子α(TNF-α)和白介素6(IL-6)水平,并进行安全性评价。

结果

共纳入103例患者,试验组52例、对照组51例。试验组患者的有效率为92.31%(48例/52例),显著高于对照组的78.43%(40例/51例)(P<0.05)。治疗后,试验组与对照组患者的血清β2-MG水平分别为(0.25±0.06)和(0.31±0.07)mg·L-1;BUN水平分别为(5.70±0.91)和(6.89±1.01)mmol·L-1;SCr水平分别为(85.46±8.89)和(93.88±9.77)μmol·L-1;Cys-C水平分别为(1.38±0.26)和(1.64±0.30)mg·L-1;UACR水平分别为(140.24±31.04)和(176.40±36.19)mg·g-1;血清细胞外基质调控指标TIMP-1水平分别为(88.34±12.36)和(97.62±15.44)ng·mL-1;TGF-β1水平分别为(112.49±17.24)和(138.50±19.84)ng·mL-1,MMP-9水平分别为(130.69±21.30)和(114.79±19.77)μg·L-1;血清炎性指标IL-6水平分别为(141.49±28.85)和(173.49±32.36)pg·mL-1;hs-CRP水平分别为(7.64±1.16)和(9.29±1.54)mg·L-1;TNF-α水平分别为(23.65±4.34)和(29.12±3.86)pg·mL-1,试验组的上述指标和对照组比较,在统计学上差异均有统计学意义(均P<0.05)。治疗过程中,试验组患者发生皮疹、腹泻、恶心呕吐各1例,对照组患者发生皮疹、腹泻各1例,试验组和对照组的总药物不良反应发生率比较,在统计学上差异无统计学意义(5.77% vs. 3.92%,P>0.05)。

结论

前列地尔注射液与贝前列素钠片联合治疗可有效改善糖尿病肾病Ⅲ期患者肾功能,调节肾组织细胞外基质代谢,减轻机体炎性反应,提高临床疗效。

贝前列素钠片  /  前列地尔注射液  /  糖尿病肾病  /  肾功能  /  胰岛素抵抗指数
Objective

To explore the clinical efficacy and safety of beraprost sodium tablets combined with alprostadil injection in patients with stage Ⅲ diabetic nephropathy.

Methods

According to queuing method, inpatients with stage Ⅲ diabetic nephropathy treated in the hospital were divided into treatment group and control group. Treatment group was treated with beraprost sodium tablets + alprostadil injection (the first 2 weeks: intravenous drip of alprostadil injection 10 μg qd. the last 2 weeks: oral beraprost sodium tables 40 μg tid), while control group was treated with alprostadil injection (the same administration method as treatment group for 4 weeks). The clinical efficacy, β2 microglobulin (β2-MG), cystatin C (Cys-C), blood urea nitrogen (BUN), serum creatinine (SCr), urinary albumin to creatinine ratio (UACR), transforming growth factor β1 (TGF-β1), tissue inhibitor of metalloproteinase-1 (TIMP-1), matrix metalloproteinase-9 (MMP-9), hemoglobin Alc (HbAlc), fasting blood glucose (FBG), 2 h postprandial blood glucose (2 h PBG), homeostasis model assessment for insulin resistance (HOMA-IR), hypersensitive C-reactive protein (hs-CRP), tumor necrosis factor α (TNF-α) and interleukin-6 (IL-6) were compared between the two groups, and the safety was evaluated.

Results

Among the 103 patients, there were 52 cases in treatment group and 51 cases in control group. The efficiency rate in treatment group was higher than that in control group [92.31% (48 cases/52 cases) vs. 78.43% (40 cases/51 cases), P<0.05]. After treatment, levels of serum β2-MG in treatment group and control group were (0.25±0.06) and (0.31±0.07) mg·L-1, BUN levels were (5.70±0.91) and (6.89±1.01) mmol·L-1, SCr levels were (85.46±8.89) and (93.88±9.77) μmol·L-1, Cys-C levels were (1.38±0.26) and (1.64±0.30) mg·L-1, UACR levels were (140.24±31.04) and (176.40±36.19) mg·g-1, respectively; levels of serum TIMP-1 were (88.34±12.36) and (97.62±15.44) ng·mL-1, TGF-β1 levels were (112.49±17.24) and (138.50±19.84) ng·mL-1, MMP-9 levels were (130.69±21.30) and (114.79±19.77) μg·L-1, respectively; levels of serum IL-6 were (141.49±28.85) and (173.49±32.36) pg·mL-1, hs-CRP levels were (7.64±1.16) and (9.29±1.54) mg·L-1, TNF-α levels were (23.65±4.34) and (29.12±3.86) pg·mL-1, and differences in the above indexes between treatment group and control group were all statistically significant (all P<0.05). During treatment, there was 1 case with diarrhea, 1 case with rash and 1 case with nausea and vomiting in treatment group, while there was 1 case with rash and 1 case with diarrhea in control group. There was no statistically significant difference in incidence of adverse drug reactions between treatment group and control group (5.77% vs. 3.92%, P>0.05).

Conclusion

Alprostadil injection combined with beraprost sodium tablets can effectively improve renal function, regulate metabolism of extracellular matrixes in renal tissues, relieve inflammatory response and improve clinical curative effect in patients with stage Ⅲ diabetic nephropathy.

beraprost sodium tablet  /  alprostadil injection  /  diabetic nephropathy  /  renal function  /  homeostasis model assessment for insulin resistance
王崇欣, 郑月月, 石小霞. 贝前列素钠联合前列地尔治疗糖尿病肾病Ⅲ期患者的临床研究. 中国临床药理学杂志, 2025 , 41 (17) : 2423 -2428 . DOI: 10.13699/j.cnki.1001-6821.2025.17.005
Chong-xin WANG, Yue-yue ZHENG, Xiao-xia SHI. Clinical trial of beraprost sodium combined with alprostadil in patients with stage Ⅲ diabetic nephropathy[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (17) : 2423 -2428 . DOI: 10.13699/j.cnki.1001-6821.2025.17.005

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doi: 10.13699/j.cnki.1001-6821.2025.17.005
  • 接收时间:2025-05-08
  • 首发时间:2026-08-05
  • 出版时间:2025-09-17
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  • 收稿日期:2025-05-08
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    南阳医学高等专科学校 第一附属医院 内分泌科,河南 南阳 473000

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郑月月,副主任医师 MP: 15203770780 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
小菇属 Mycena 11 5.26
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红菇属 Russula 17 8.13
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