水蛭素治疗以血尿为主要表现的免疫球蛋白A型肾病的随机对照临床研究

目的：视察以血尿为主要表现的免疫球蛋白A型肾病（immunoglobulin A nephropalhy，IgAN）患者使用水蛭素治疗的近期疗效和副作用。方法：选择1998～2007年我科经肾组织活检病理证实的以血尿为主要表现的IgAN患者262例，按口服水蛭素（肠溶脉血康胶囊）和潘生丁不同，随机分成水蛭素组和潘生丁组。以尿红细胞形态及计数、24h尿蛋白定量、血肌酐（serum creatinine，Scr）、内生肌酐清除率（creatinine clearance rate，Ccr）、血脂1项、凝血5项和副作用等为疗效评价指标。结果：两组患者治疗半年后，水蛭素组尿红细胞畸形率与计数和24h尿蛋白定量均较治疗前显著下降（P〈0．01），且显著低于潘生丁组（P〈0．05）；水蛭素组Ccr较治疗前明显升高。并显著高于潘生丁组（P＜0．01）；水蛭素组患者的血脂也有改善，但差异无统计学意义；水蛭素抗凝作用明显强于潘生丁（P〈0．01）。综合判定，水蛭素组的总有效率、完全缓解率和显著缓解率均显著高于潘生丁组（P＜0．01）。两组发生副作用的病例数均较少，水蛭素组胃肠道不良反应的发生率也显著低于潘生丁组（P〈0．05）。结论：水蛭素在降低IgAN血尿、蛋白尿和肾脏保护方面比潘生丁更具有优势。

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

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.