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Journal of Chinese Integrative Medicine ›› 2008, Vol. 6 ›› Issue (3): 253-257.doi: 10.3736/jcim20080306

• Original Clinical Research • Previous Articles     Next Articles

Efficacy of hirudin in treating immunoglobulin A nephropathy with hematuria: a randomized controlled trial

Kai-long Li(),Ya-ni He, Hong-yi Zuo, Hui-min Wang, Han-lu Ding, Ju-rong Yang   

  1. Department of Nephrology, Daping Hospital, Third Military Medical University, Chongqing 400042, China
  • Received:2007-08-15 Online:2008-03-20 Published:2008-03-15
  • Contact: KL Li E-mail:likailong1966@163.com

Objective: To investigate the curative effects and side effects of hirudin in treating immunoglobulin A nephropathy (IgAN) with hematuria and minimal proteinuria in a short-term.Methods: Two hundred and sixty-two histologically confirmed cases of IgAN with hematuria and minimal proteinuria from 1998 to 2007 were randomly divided into hirudin-treated group (peroral administration of Maixuekang capsules) and dipyridamole-treated group (peroral administration of dipyridamole). In the two groups, contrast analysis of conformation and counts of erythrocytes in urine, urine protein quantitation in 24 hours, levels of serum creatinine (Scr) and creatinine clearance rate (Ccr), blood lipid, five items of blood clotting and side effects was performed.Results: After six-month treatment, the anisotrophy rate and the counts of erythrocytes in urine, and the urine protein quantitation in 24 hours in hirudin-treated group were decreased distinctly as compared with pre-treatment (P<0.01) and dipyridamole-treated group (P<0.05). On the other hand, Ccr was increased obviously in hirudin-treated group as compared with pre-treatment and dipyridamole-treated group (P<0.01). The blood lipid was also ameliorated in hirudin-treated group, but there was no significant difference. The anticoagulation effect of hirudin was better than dipyridamole (P<0.01). Efficacy assessment showed that the total response rate, complete remission rate and predominance remission rate in hirudin-treated group were higher than those in dipyridamole-treated group. Few side effects were found in both groups, and the rate of adverse reaction in gastrointestinal tract was lower in hirudin-treated group as compared with that in dipyridamole-treated group (P<0.05).Conclusion: Compared with dipyridamole, hirudin has superiority in kidney protection and decreasing the anisotrophy rate, counts of erythrocytes in urine and the urine protein

Key words: immunoglobulin A nephropathy, hematuria, hirudins, clinical research, randomized controlled trial

CLC Number: 

  • R692.31

Table 1

Renal histopathological staging of IgAN patients in two groups [Cases (%)]"

Group n Ⅳ~Ⅴ
Hirudin-treated 166 55 (33.1%) 17 (10.2%) 81 (48.8%) 13 (7.8%)
Dipyridamole-treated 96 34 (35.4%) 9 (9.4%) 46 (47.9%) 7 (7.3%)

Table 2

Changes of conformation and counts of erythrocytes in urine and levels of Scr and Ccr in two groups before treatment and after six-month treatment ($\bar{x}$±s )"

Group n Anisotrophy rate
of uric erythrocytes (%)
Uric erythrocyte
count (cells/μl)
Scr
(μmol/L)
Ccr
(ml/min)
Hirudin-treated
Pre-treatment 166 82.4±22.7 37.5±26.2 122.6±5.7 85.0±16.7
Post-treatment 166 29.6±13.5*△△ 4.3±9.7*△△ 105.2±7.9 108.4±10.2*△△
Dipyridamole-treated
Pre-treatment 96 78.6±25.1 38.8±25.6 116.8±6.3 87.7±14.9
Post-treatment 96 66.8±28.6 30.7±27.7 114.7±19.4 92.5±18.9

Table 3

Changes of blood lipid in two groups before treatment and after six-month treatment ($\bar{x}$±s, mmol/L )"

Group n TC TG HDL LDL
Hirudin-treated
Pre-treatment 166 5.42±2.32 1.33±0.79 1.55±0.36 2.39±0.63
Post-treatment 166 4.77±1.83 1.12±0.38 1.62±0.44 2.17±0.73
Dipyridamole-treated
Pre-treatment 96 5.75±2.66 1.27±0.80 1.61±0.24 2.38±0.70
Post-treatment 96 5.03±2.48 1.25±0.77 1.60±0.25 2.22±0.79

Table 4

Changes of five items of blood clotting in two groups before treatment and after six-month treatment ($\bar{x}$±s )"

Group n PT (s) INR FIB (g/L) TT (s) APTT (s)
Hirudin-treated
Pre-treatment 166 7.88±5.47 0.62±0.14 5.78±1.03 10.57±5.77 20.88±9.66
Post-treatment 166 12.69±3.12*△△ 0.97±0.22*△△ 3.57±1.16*△△ 15.33±2.65*△△ 31.25±6.90*
Dipyridamole-treated
Pre-treatment 96 7.72±6.15 0.60±0.27 5.81±0.92 10.38±6.44 22.36±10.62
Post-treatment 96 8.68±3.25 0.66±0.18 4.99±1.03 11.12±3.47 27.70±13.41

Table 5

Curative effects in two groups after six-month treatment [Cases (%)]"

Group n CR PR Effective Failure Total response rate
Hirudin-treated 166 83 (50.0)** 57 (34.3)** 22 (13.3)** 4 (2.4)** 162 (97.6)**
Dipyridamole-treated 96 13 (13.5) 16 (16.7) 34 (35.4) 33 (34.4) 63 (65.6)

Table 6

Side effects in two groups after six-month treatment [Cases (%)]"

Group n Side effect
Spontaneous petechia
on skin and mucosa
Gingiva bleeding Alimentary tract
hemorrhage
Nausea
Hirudin-treated 166 11 (6.6%) 8 (4.8%) 5 (3.0%)* 6 (3.6%)*
Dipyridamole-treated 96 5 (5.2%) 4 (4.2%) 7 (7.3%) 8 (8.3%)
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