[1]蔡滨,宋婷,金保方,等.四妙鳖甲颗粒联合他达拉非治疗阴虚毒瘀型糖尿病性勃起功能障碍临床观察[J].陕西中医,2025,46(12):1632-1636.[doi:DOI:10.3969/j.issn.1000-7369.2025.12.009]
　CAI Bin,SONG Ting,JIN Baofang,et al.A clinical observation of Simiaobiejia granules combined with Tadalafil in the treatment of diabetes mellitus-induced erectile dysfunction patients of Yin deficiency and toxic stasis type[J].,2025,46(12):1632-1636.[doi:DOI:10.3969/j.issn.1000-7369.2025.12.009]
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四妙鳖甲颗粒联合他达拉非治疗阴虚毒瘀型糖尿病性勃起功能障碍临床观察

《陕西中医》[ISSN:1000-7369/CN:61-1281/TN]

卷:
46
期数:
2025年12期
页码:
1632-1636
栏目:
临床研究
出版日期:
2025-12-05

文章信息/Info

Title:
A clinical observation of Simiaobiejia granules combined with Tadalafil in the treatment of diabetes mellitus-induced erectile dysfunction patients of Yin deficiency and toxic stasis type
作者:
蔡滨1; 宋婷1; 金保方2; 孙大林2; 邓伟民2; 刘媛媛3; 张霞4; 张文秀4; 彭宇翔5
（1.南京中医药大学附属医院 江苏省中医院，江苏 南京 210029；2.东南大学附属中大医院，江苏 南京 210009；3.东南大学医学院，江苏 南京 210009；4.青海大学医学院，青海 西宁 810016；5.南京医科大学天元书院，江苏 南京 211166）
Author(s):
CAI Bin1; SONG Ting1; JIN Baofang2; SUN Dalin2; DENG Weimin2; LIU Yuanyuan3; ZHANG Xia4; ZHANG Wenxiu4; PENG Yuxiang5
（1.The Affiliated Hospital of Nanjing University of Chinese Medicine,Jiangsu Provincial Hospital of Chinese Medicine,Nanjing 210029,China；2.Zhongda Hospital,Southeast University,Nanjing 210009,China；3.Medical College of Southeast University,Nanjing 210009,China；4.Medical College of Qinghai University,Xining 810086,China；5.Nanjing Medical University Tianyuan Honors School,Nanjing 211166,China）
关键词:
糖尿病; 勃起功能障碍; 阴虚毒瘀证; 四妙鳖甲颗粒; 随机对照试验; 中医药循证
Keywords:
Diabetes mellitus; Erectile dysfunction; Yin deficiency and toxic stasis syndrome; Simiaobiejia granules; Randomized controlled trial; Evidence-based traditional Chinese medicine
分类号:
R 587.2
DOI:
DOI:10.3969/j.issn.1000-7369.2025.12.009
文献标志码:
A
摘要:
目的：观察四妙鳖甲颗粒联合他达拉非治疗阴虚毒瘀型糖尿病性勃起功能障碍的临床疗效。方法：纳入阴虚毒瘀型糖尿病性勃起功能障碍患者120例，随机分为试验组和对照组，试验组给予四妙鳖甲颗粒联合他达拉非治疗，四妙鳖甲颗粒每日一剂，分早晚两次口服，他达拉非每日一次，每次5 mg口服，对照组给予他达拉非治疗，每日一次，每次5 mg口服，连续服用8周，记录两组治疗前后IIEF-5评分和TCMS评分，并比较IIEF-5评分和TCMS评分有效率。结果：IIEF-5评分变化方面，组内比较，治疗后两组均有显著提高（P＜0.01），组间比较，试验组优于对照组（P＜0.05），IIEF-5评分有效率方面，试验组总有效率为75.86%，对照组总有效率为61.40%，两组比较有统计学差异（P＜0.01）。TCMS评分变化方面，组内比较，治疗后试验组有显著提高（P＜0.01），对照组无统计学差异（P＞0.05），组间比较，试验组明显优于对照组（P＜0.01），在TCMS评分有效率上，试验组的总有效率为77.59%，而对照组为1.75%，两组比较差异具有统计学意义（P＜0.01）。结论：四妙鳖甲颗粒联合他达拉非可以有效改善阴虚毒瘀型糖尿病性勃起功能障碍患者的勃起功能，并且在改善中医症候方面具有明显优势。
Abstract:
Objective:To observe the clinical curative effect of Simiaobiejia granules combined with Tadalafil in the treatment of diabetes mellitus-induced erectile dysfunction patients of Yin deficiency and toxic stasis type.Methods:120 patients with diabetes mellitus-induced erectile dysfunction of Yin deficiency and toxic stasis type were enrolled in the study.Random allocation was used to divide them into two groups,which included the experimental and control groups.The patients in the experimental group were given with Simiaobiejia granules,bid,orally,combined with Tadalafil,5 mg,qd,orally.The patients in the control group were given with tadalafil,5 mg,qd,orally.After 8 weeks treatment,the international erectile function index-5 (IIEF-5) score and traditional Chinese medicine syndrome (TCMS) score of the two groups were recorded before and after treatment,and the effective rate of IIEF-5 score and TCMS score were compared.Results:As for the IIEF-5 score,significant progress was made by both groups after treatment (P<0.01),and the experimental group performed better than the control group (P<0.05).In terms of IIEF-5 score efficiency,the experimental group total effective rate was 75.86%,and the control group total effective rate was 61.40%,with statistically significant (P<0.01).In terms of TCMS score,the experimental group had a significant increase after treatment (P<0.01),but there was no significant difference in the control group (P＞0.05).In terms of TCMS score efficiency,the experimental group total effective rate was 77.59%,and the control group total effective rate was 1.75%,with statistically significant (P<0.01).Conclusion:Simiaobiejia granules can effectively improve erectile function in patients with diabetes mellitus-induced erectile dysfunction of Yin deficiency and toxic stasis type,and has obvious advantages in improving TCM symptoms.

参考文献/References:

[1]杨文英.中国糖尿病的流行特点及变化趋势[J].中国科学:生命科学,2018,48(8):812-819.
[2]KOUIDRAT Y,PIZZOL D,COSCO T,et al.High prevalence of erectile dysfunction in diabetes:A systematic review and meta-analysis of 145 studies[J].Diabet Med,2017,34(9):1185-1192.
[3]林家坤,张运萍,姚晓文,等.2型糖尿病勃起功能障碍中医诊治进展[J].光明中医,2021,36(1):152-155.
[4]马紫阳,任飞强,杨雪梅,等.中医辨证治疗阳痿研究进展[J].陕西中医,2021,42(3):402-404.
[5]中西医结合诊疗勃起功能障碍专家共识[J].中国中西医结合外科杂志,2022,28(6):763-768.
[6]中华医学会糖尿病学分会.中国2型糖尿病防治指南(2020年版)(上)[J].中国实用内科杂志,2021,41(8):668-695.
[7]中华医学会糖尿病学分会.中国2型糖尿病防治指南(2020年版)(下)[J].中国实用内科杂志,2021,41(9):757-784.
[8]中华医学会男科学分会.勃起功能障碍诊断与治疗指南[J].中华男科学杂志,2022,28(8):722-755.
[9]国家药品监督管理局.中药新药临床研究指导原则(试行)[M].北京:中国医药科技出版社,2002:231-234.
[10]刘黎明,张爱平,冀小卫,等.糖尿病性勃起功能障碍发病机制的研究进展[J].泌尿外科杂志(电子版),2022,14(1):57-61.
[11]经加吻,李瑜璠,孟庆波,等.中医药在糖尿病合并勃起功能障碍治疗中的应用及思考[J].中医药临床杂志,2024,36(7):1235-1239.
[12]赵凡,李海松,张春和,等.难治性勃起功能障碍中西医结合防治策略述评[J].中华中医药杂志,2023,38(9):4013-4021.
[13]周华,孙志兴,项子良.二地鳖甲煎联合他达拉非治疗糖尿病性勃起功能障碍35例[J].南京中医药大学学报,2015,31(5):491-493.
[14]黄健,徐福松.二地鳖甲煎治疗勃起功能障碍肾阴虚证临床观察[J].中华男科学杂志,2012,18(12):1143-1146.
[15]邓伟民,孙大林,蔡滨,等.二地鳖甲煎治疗男科疾病验案举隅[J].环球中医药,2017,10(11):1377-1379.
[16]金保方.阳痿论评注[M].北京:中国中医药出版社,2019:124.
[17]XU Z,CAI K,SU S L,et al.Salvianolic acid B and tanshinone ⅡA synergistically improve early diabetic nephropathy through regulating PI3K/Akt/NF-κB signaling pathway[J].J Ethnopharmacol，2024，319(Pt 3):117356.
[18]ZHANG Y,JIN D,AN X,et al.Lychee seed as a potential hypoglycemic agent,and exploration of its underlying mechanisms[J].Front Pharmacol，2021，12:737803.
[19]WAN Q,LUO S,LU Q,et al.Protective effects of puerarin on metabolic diseases:Emphasis on the therapeutical effects and the underlying molecular mechanisms[J].Biomed Pharmacother，2024，179:117319.
[20]LIU S,WANG L,ZHANG Z,et al.The potential of astragalus polysaccharide for treating diabetes and its action mechanism[J].Front Pharmacol，2024,15:1339406.
[21]WANG J,BI C,XI H,et al.Effects of administering berberine alone or in combination on type 2 diabetes mellitus:A systematic review and meta-analysis[J].Front Pharmacol， 2024，15:1455534.
[22]符宇,余海滨,李真,等.鳖甲煎丸对糖尿病合并动脉粥样硬化大鼠血脂、血管内皮功能以及基质金属蛋白酶9的影响[J].世界科学技术-中医药现代化,2014,16(5):1010-1013.
[23]LIU H,ZHANG Z,LI J,et al.Oligosaccharides derived from Lycium barbarum ameliorate glycolipid metabolism and modulate the gut microbiota community and the faecal metabolites in a type 2 diabetes mouse model:Metabolomic bioinformatic analysis[J].Food Funct，2022，13(9):5416-5429.
[24]丁维,钟立仁,张海波,等.丹参酮ⅡA磺酸钠对高脂血症勃起功能障碍大鼠Nrf2/HO-1通路及勃起功能的影响[J].陕西中医,2020,41(11):1520-1523，1538.
[25]任婧,卜竹林,李晓芬,等.基于生物信息学和实验联合探讨熟地黄治疗2型糖尿病的潜在机制[J].中草药,2025,56(2):566-584.
[26]韩明丽,田丹,车欣宇,等.基于网络药理学研究金银花对糖尿病的作用机制[J].山东第一医科大学(山东省医学科学院)学报,2022,43(3):172-177.
[27]张佳莹,尚津锋,刘欣,等.基于网络药理学研究玄参治疗糖尿病的作用机制[J].安徽医药,2024,28(12):2349-2353，2546.
[28]王喜鸟,姚文慧,潘珍珍,等.淫羊藿苷改善糖尿病小鼠血管功能的作用及其机制[J].中国药科大学学报,2022,53(2):215-221.
[29]邓志军,李阿荣,罗永佳,等.荔枝核改善胰岛素抵抗治疗2型糖尿病的网络调控作用研究[J].广东药科大学学报,2020,36(6):834-839.
[30]王璐,陈秋燕,梁韬,等.葛根素通过NLRP3-Caspase-1-GSDMD通路抑制高糖诱导的MIN6细胞焦亡[J].中国医院药学杂志,2025,45(11):1221-1227.
[31]孟祥云,汪永锋,郭树明,等.当归多糖对STZ诱导的糖尿病大鼠糖化血清蛋白、免疫反应及氧化应激的影响[J].西部中医药,2022,35(2):27-31.
[32]武洁,刘旭光,冯晓辞,等.黄芪多糖调控Wnt1信号对糖尿病大鼠糖脂代谢紊乱影响机制研究[J].辽宁中医药大学学报,2024,26(11):43-51.
[33]刘亚慧,郑香梅,李阳,等.黄连素对糖尿病大鼠血脂代谢及胰岛素抵抗的作用[J].西北药学杂志,2024,39(3):65-69.

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备注/Memo

备注/Memo:
国家自然科学基金资助项目（82374257,82074440）；东南大学附属中大医院中西医协同医学科研项目（2023ZXYXT14）
更新日期/Last Update: 2025-12-08