Search JIM Advanced Search

Journal of Chinese Integrative Medicine ›› 2012, Vol. 10 ›› Issue (6): 641-646.doi: 10.3736/jcim20120607

• Original Clinical Research • Previous Articles     Next Articles

Effects of salvianolate combined with alprostadil and reduced glutathione on progression of chronic renal failure in patients with chronic kidney diseases: a long-term randomized controlled trial

Peng Fu1(), Xue-qiang Huang2, Ai-hong Yuan1, Guang Yu3, Xiao-bin Mei3, Ruo-lan Cui3   

  1. 1. Department of Nephrology, Tongji Hospital, Tongji University, Shanghai 200065, China
    2. Department of Traditional Chinese Medicine, Changhai Hospital, Second Military Medical University, Shanghai 200433, China
    3. Department of Nephrology, Changhai Hospital, Second Military Medical University, Shanghai 200433, China
  • Received:2011-12-20 Accepted:2012-02-28 Online:2012-06-20 Published:2018-06-15
  • Contact: Peng Fu

Background: Effects of traditional Chinese medicine salvianolate combined with alprostadil and reduced glutathione on delay of progression in patients with acute kidney injury has been confirmed, but the role of this combination therapy on the progression of chronic renal failure is uncertain.
Objective: To investigate the long-term effects of regular administration of salvianolate combined with Western medicine on the progression of chronic renal failure in patients with chronic kidney diseases (CKDs).DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: The study was performed at the ward of the Nephrology Department, Changhai Hospital, Second Military Medical University from August 2004 to October 2010. Thirty patients with CKDs at stage 2 to 4 and impaired renal function were recruited and randomly assigned to a treatment group or a control group, which consisted of 15 patients in each. Based on conventional therapy with the same oral medicines in the control group, patients in the treatment group were treated with salvianolate combined with alprostadil and reduced glutathione liquid intravenously for 7 to 10 d. Patients in the control group did not receive this combination therapy. The therapy was repeated monthly in patients in the treatment group. The follow-up time was an average of four years.MAIN OUTCOME MEASURES: Assessment of renal function, count of white blood cells, and test of serum hemoglobin, electrolytes and albumin were performed before and every year after treatment. Study endpoints were the serum creatinine level doubled from baseline or receiving replacement therapy. Number of remaining patients in each group was calculated at the end of every year.
Results: White blood cell count, serum albumin and electrocyte levels changed little in two groups after four years (P>0.05). Average serum hemoglobin levels in patients in the treatment group was elevated markedly compared with that in the control group after being treated for two years (P<0.01). The percentage of patients reaching the study termination in the treatment group (40%) decreased significantly compared with that (93%) in the control group (P<0.01).
Conclusion: The regular integrated traditional Chinese and Western medicine can effectively delay the deterioration of renal function in patients with CKDs over a period of four years.

Key words: chronic kidney disease, salvianolate, alprostadil, reduced glutathione, randomized controlled trial

Figure 1

Flow diagram of this randomized trial "

Table 1

Baseline characteristics of patients with chronic kidney diseases in two groups"

Item Control group (n=15) Treatment group (n=15)
Age (x±s, years) 51.9±21.7 52.5±18.6
Gender (Male/famale) 10/5 8/7
Body weight (x±s, kg) 67.8±19.4 68.0±20.3
Serum albumin (x±s, g/L) 40.5±10.8 41.3±14.3
Serum creatitine (x±s, mmol/L) 246.4±82.3 252.8±81.6
Estimated glomerular filtration rate (x±s, mL/min) 30.5±14.6 30.3±15.5
Serum hemoglobin (x±s, g/L) 95.3±20.4 96.1±16.7
White blood cells (x±s, ×109/L) 5.26±1.78 5.32±1.69
Serum sodium (x±s, mmol/L) 139.2±14.1 140.0±15.6
Serum potassium (x±s, mmol/L) 4.63±0.68 4.65±0.57
Serum chloride (x±s, mmol/L) 102.0±16.5 101.8±18.4

Figure 2

Number of patients remaining in two groups during course of the study"

Figure 2

Changes in serum hemoglobin content of patients during course of the study"

Group Serum hemoglobin (g/L)
0 year (x±s) 1 year (x±s) 2 years (x±s) 3 years (x±s) 4 years (Mean)
Control 95.2±18.4 (n=15) 112.3±28.6 (n=13) 108.7±39.9 (n=8) 110.4±29.6 (n=5) 109.0 (n=1)
Treatment 97.8±15.6 (n=15) 113.4±34.1 (n=15) 125.2±47.0* (n=14) 130.9±46.5* (n=12) 135.4 (n=9)
[1] Peng WP, Huang YZ, Huang DP . Clinical effects of Kaishi Injection combined with salvianolate injection in treating patients with chronic renal failure: a report of 29 cases[J]. Hainan Yi Xue, 2010,21(5):33-34
doi: 10.3969/j.issn.1003-6350.2010.05.014
彭卫平, 黄颖臻, 黄登鹏 . 凯时注射液联合丹参多酚酸盐注射液治疗慢性肾功能衰竭29例疗效观察[J]. 海南医学, 2010,21(5):33-34
doi: 10.3969/j.issn.1003-6350.2010.05.014
[2] Fu P, Yu G, Huang XQ, Xu J, Mei XB, Wu H, Yuan WJ . Effect of integrated traditional Chinese and Western medicine therapy on progression of acute renal failure in patients with chronic renal insufficiency: a short-term clinical study[J]. J Chin Integr Med, 2004,2(6):429-431
傅鹏, 于光, 黄雪强, 许静, 梅小斌, 吴灏, 袁伟杰 . 中西医结合疗法延缓慢性肾功能不全患者急性肾功能减退的临床研究[J]. 中西医结合学报, 2004,2(6):429-431
[3] Levey AS, Atkins R, Coresh J, Cohen EP, Collins AJ, Eckardt KU, Nahas ME, Jaber BL, Jadoul M, Levin A, Powe NR, Rossert J, Wheeler DC, Lameire N, Eknoyan G . Chronic kidney disease as a global public health problem: approaches and initiatives — a position statement from Kidney Disease Improving Global Outcomes[J]. Kidney Int, 2007,72(3):247-259
doi: 10.1038/
[4] Nakayama Y, Inoue T, Kohda Y, Inoue H, Izumi Y, Tomita K, Nonoguchi H . Long-term observation of renal function on combination therapy with prostaglandin and angiotensin-converting enzyme inhibitor for chronic kidney disease[J]. Clin Nephrol, 2008,69(6):402-407
doi: 10.5414/CNP69402
[5] Germain MJ, Cohen LM, Davison SN . Withholding and withdrawal from dialysis: what we know about how our patients die[J]. Semin Dial, 2007,20(3):195-199
doi: 10.1111/j.1525-139X.2007.00273.x
[6] Shen QF. Clinical nephrology of traditional Chinese medicine[M]. Shanghai: Shanghai Scientific and Technical Publishers, 1998: 305-329
沈庆法 . 中医临床肾脏病学[M]. 上海: 上海科学技术出版社, 1998: 305-329
[7] Xu M, Wang YP, Sun WK, Xuan LJ, Xu YM . Effect of salvianolate on renal function and endogenous endothelin release in chronic renal failure rats[J]. Zhongguo Yao Li Xue Yu Du Li Xue Za Zhi, 2001,15(1):32-35
doi: 10.1007/s11670-001-0053-5
徐曼, 王逸平, 孙伟康, 宣利江, 徐亚明 . 丹参多酚酸盐对大鼠慢性肾衰时肾功能及内源性内皮素释放的影响[J]. 中国药理学与毒理学杂志, 2001,15(1):32-35
doi: 10.1007/s11670-001-0053-5
[8] Hu Y, Zha Y, Yan XY . Effect of salvianolate injection on plasma endothelin-1 and calcitonin gene related peptide levels in treating chronic renal failure[J]. Guizhou Yi Yao, 2011,35(6):502-504
doi: 10.3969/j.ISSN.1000-744X.2011.06.006
胡英, 查艳, 颜晓勇 . 丹参多酚酸盐治疗早期慢性肾衰竭及对血浆ET-1和CGRP水平的影响[J]. 贵州医药, 2011,35(6):502-504
doi: 10.3969/j.ISSN.1000-744X.2011.06.006
[9] Wu ZL. Function of reactive oxygen metabolites. In: Wang HY. Nephrology. 3rd ed[M]. Beijing: People’s Medical Publishing House, 2008: 761-769
吴兆龙 . 反应性氧代谢产物的作用. 见: 王海燕. 肾脏病学. 第3版[M]. 北京: 人民卫生出版社, 2008: 761-769
[10] Keegan RF, Webb CB . Oxidative stress and neutrophil function in cats with chronic renal failure[J]. J Vet Intern Med, 2010,24(3):514-519
doi: 10.1111/j.1939-1676.2010.0498.x pmid: 20384951
[11] Wu CG, Wang L, Fang CQ, Gao J . Protective effect of reduced glutathione on mitochondria in the kidney of diabetic rats[J]. Zhonghua Tang Niao Bing Za Zhi, 2009,1(5):355-358
doi: 10.3760/cma.j.issn.1674-5809.2009.05.010
吴晨光, 王丽, 方春钱, 高静 . 还原型谷胱甘肽对糖尿病大鼠肾脏保护作用的机制研究[J]. 中华糖尿病杂志, 2009,1(5):355-358
doi: 10.3760/cma.j.issn.1674-5809.2009.05.010
[12] Ling Y, Hu SX . Effects of alprostadil on apoptosis induced by renal ischemia-reperfusion injury in rabbits[J]. Zhonghua Shi Yan Wai Ke Za Zhi, 2011,28(8):1356-1358
doi: 10.3760/cma.j.issn.1001-9030.2011.08.056
凌燕, 胡世雄 . 前列地尔对兔肾缺血再灌注时细胞凋亡的保护作用[J]. 中华实验外科杂志, 2011,28(8):1356-1358
doi: 10.3760/cma.j.issn.1001-9030.2011.08.056
[13] PGE1 Study Group; Koch JA, Plum J, Grabensee B, Mödder U . Prostaglandin E1: a new agent for the prevention of renal dysfunction in high risk patients caused by radiocontrast media? Nephrol Dial Transplant. 2000; 15(1):43-49.
[1] Sherman Gu, Arthur Yin Fan. Controversial conclusions from two randomized controlled trials for acupuncture's effects on polycystic ovary syndrome or in vitro fertilization support. Journal of Integrative Medicine, 2020, 18(2): 89-91.
[2] Gerli E.G. Herr, Fábio Goulart da Silva, Francisco José Cidral-Filho, Fabricia Petronilho, Lucinéia Gainski Danielski, Mariana Pereira de Souza Goldim, Afonso Shiguemi Inoue Salgado, Franciane Bobinski, Daniel Fernandes Martins, Eliane R. Winkelmann. Effects of the use of bioceramic wraps in patients with lower limb venous ulcers: A randomized double-blind placebo-controlled trial. Journal of Integrative Medicine, 2020, 18(1): 27-.
[3] Xin-yu Yue, Zhuo-qi Feng, Xi-yi Yu, Jia-min Hu, Xiao-Jing He, Shi Shu. Fire-needle acupuncture for upper limb spastic paralysis after stroke: Study protocol for a randomized controlled trial. Journal of Integrative Medicine, 2019, 17(3): 167-172.
[4] Ya-ru Huangfu, Wei Peng, Bao-jun Guo, Zhi-fu Shen, Li Li, Shi-wei, Liu, Hui Zheng, You-ping Hu. Effects of acupuncture in treating insomnia due to spleen-stomach disharmony syndrome and its influence on intestinal microbiome: Study protocol for a randomized controlled trial. Journal of Integrative Medicine, 2019, 17(3): 161-167.
[5] Pádraic J.Dunne, Julie Lynch, Lucia Prihodova, Caoimhe O'Leary, Atiyeh Ghoreyshi, Sharee A. Basdeo, Donal J.Cox, Rachel Breen, Ali Sheikhi, Áine Carroll, Cathal Walsh, Geraldine McMahon, Barry White. Burnout in the emergency department: Randomized controlled trial of an attention-based training program. Journal of Integrative Medicine, 2019, 17(3): 173-180.
[6] J.M. Oliver-Baxter, H.S. Whitford, D.A. Turnbull, M.J. Bond. Effects of vitamin supplementation on inflammatory markers and psychological wellbeing among distressed women: A randomized controlled trial. Journal of Integrative Medicine, 2018, 16(5): 322-328.
[7] Parunkul Tungsukruthai, Preecha Nootim, Wiwan Worakunphanich, Nareerat Tabtong. Efficacy and safety of herbal steam bath in allergic rhinitis: A randomized controlled trial. Journal of Integrative Medicine, 2018, 16(1): 39-44.
[8] Zahra Hajmohammadi, Mojtaba Heydari, Majid Nimrouzi, Pouya Faridi, Mohammad Javad Zibaeenezhad, Gholamhossein Ranjbar Omrani, Mesbah Shams . Rhus coriaria L. increases serum apolipoprotein-A1 and high-density lipoprotein cholesterol levels: A double-blind placebo-controlled randomized clinical trial. Journal of Integrative Medicine, 2018, 16(1): 45-50.
[9] Laura Belland, Laura Rivera-Reyes, Ula Hwang. Using music to reduce anxiety among older adults in the emergency department: A randomized pilot study. Journal of Integrative Medicine, 2017, 15(6): 450-455.
[10] Hilal Yuksel, Yasemin Cayir, Zahide Kosan, Kenan Tastan. Effectiveness of breathing exercises during the second stage of labor on labor pain and duration: A randomized controlled trial. Journal of Integrative Medicine, 2017, 15(6): 456-461.
[11] Yoshiharu Motoo, Takashi Hakamatsuka, Nobuo Kawahara, Ichiro Arai, Kiichiro Tsutani. Standards of Reporting Kampo Products (STORK) in research articles. Journal of Integrative Medicine, 2017, 15(3): 182-185.
[12] Maria T.Chao, AlexandraChang, SanjayReddy, James D.Harrison, JosephAcquah, MiriaToveg, TrilceSantana, Frederick M.Hecht. Adjunctive acupuncture for pain and symptom management in the inpatient setting: Protocol for a pilot hybrid effectiveness-implementation study. Journal of Integrative Medicine, 2016, 14(3): 228-238.
[13] Nouran A. Aleyeidi, Khaled S. Aseri, Shadia M. Matbouli, Albaraa A. Sulaiamani, Sumayyah A. Kobeisy. Effects of wet-cupping on blood pressure in hypertensive patients: A randomized controlled trial. Journal of Integrative Medicine, 2015, 13(6): 391-399.
[14] Maria Sousa Cláudia, Coimbra Daniela, Machado Jorge, J. Greten Henry. Effects of self-administered exercises based on Tuina techniques on musculoskeletal disorders of professional orchestra musicians: A randomized controlled trial. Journal of Integrative Medicine, 2015, 13(5): 314-318.
[15] Marco Gemma, Elisa Nicelli, Luigi Gioia, Elena Moizo, Luigi Beretta, Maria Rosa Calvi. Acupuncture accelerates recovery after general anesthesia: A prospective randomized controlled trial. Journal of Integrative Medicine, 2015, 13(2): 99-104.
Full text



[1] Jun Hu, Jian-ping Liu. Non-invasive physical treatments for chronic/recurrent headache. Journal of Chinese Integrative Medicine, 2008, 6(1): 31
[2] Yi-ting He, Qing-lin Zha, Jian-ping Yu, Yong Tan, Cheng Lu, Ai-ping Lv. Principal factor analysis of symptoms of rheumatoid arthritis and their correlations with efficacy of traditional Chinese medicine and Western medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 32-36
[3] Jun Cai, Hua Wang, Sheng Zhou, Bin Wu, Hua-rong Song, Zheng-rong Xuan. Effect of Sijunzi Decoction and enteral nutrition on T-cell subsets and nutritional status in patients with gastric cancer after operation: A randomized controlled trial. Journal of Chinese Integrative Medicine, 2008, 6(1): 37-40
[4] Dong Yang, Yong-ping Du, Qing Shen, Wei Chen, Yan Yu, Guang-lei Chen. Expression of alpha-smooth muscle actin in renal tubulointerstitium in patients with kidney collateral stasis. Journal of Chinese Integrative Medicine, 2008, 6(1): 41-44
[5] Zhi-chun Jin. Problems in establishing clinical guideline for integrated traditional Chinese and Western medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 5-8
[6] Xi Lin, Jian-ping Liu. Tai chi for treating rheumatoid arthritis. Journal of Chinese Integrative Medicine, 2008, 6(1): 82
[7] Guo-hong Yuan, Xiao-jing Pang, He-chao Ma. Synergic effects of Danggui Buxue Decoction in reducing toxicity of cytoxan in tumor-bearing mice. Journal of Chinese Integrative Medicine, 2008, 6(1): 83-88
[8] Ning-qun Wang, Liang-duo Jiang, Zong-xing Li. Research progress in asthma-related quality of life. Journal of Chinese Integrative Medicine, 2008, 6(1): 93-97
[9] Daniel Weber, Janelle M Wheat, Geoffrey M Currie. Inflammation and cancer: Tumor initiation, progression and metastasis,and Chinese botanical medicines. Journal of Chinese Integrative Medicine, 2010, 8(11): 1006-1013
[10] Bo Wang , Wei Yan , Li-hui Hou, Xiao-ke Wu. Disorder of Tiangui (kidney essence) and reproductive dysfunction in patients with polycystic ovary syndrome. Journal of Chinese Integrative Medicine, 2010, 8(11): 1018-1022