羟苯磺酸钙在肾移植术后移植肾功能不全患者中应用的临床观察

Clinical observation on the application of calcium dobesilate in renal transplant recipients with renal allograft dysfunction

目的探讨羟苯磺酸钙治疗肾移植术后移植肾功能不全的有效性和安全性。方法回顾性分析2009年9月至2012年2月期间,在解放军总医院泌尿外科进行随访的移植肾功能不全患者,共150例。患者均排除急性排斥反应。所有患者被告知其治疗目的,均取得患者同意。患者均给予羟苯磺酸钙1000mg/d,分两次于每日早晚餐间口服,服用1～24个月(中位时间18个月)。观察患者羟苯磺酸钙治疗前、治疗后各时间点移植肾功能的变化情况,主要指标包括血清肌酐(Scr)、估算肾小球滤过率(estimated glomerular filtration rate,eGFR)、血尿素氮(BUN)及血清尿酸等。记录不良反应的发生情况,主要指标包括丙氨酸转氨酶(ALT)、天冬氨酸转氨酶(AST)、空腹血糖、总胆固醇及甘油三酯等。结果服药期间,4例因出现明显的胃肠道反应停药退出研究;2例死亡,死亡原因分别为肺癌转移和猝死。使用羟苯磺酸钙治疗后,移植肾功能基本保持原有水平或比治疗前好转,与治疗前比较,治疗后各时间点的Scr明显降低,eGFR明显升高(P<0.05或P<0.01)。羟苯磺酸钙的主要不良反应为胃肠道反应,大部分患者对治疗能耐受。与治疗前比较,治疗后各时间点的肝功能、血糖、血脂无明显变化。结论羟苯磺酸钙治疗肾移植术后移植肾功能不全是有效和安全的。

Objective To investigate the efficacy and safety of calcium dobesilate in treating renal transplant recipients with renal allograft dysfunction. Methods Clinical data of 150 renal transplant recipients with renal allograft dysfunction were retrospectively analyzed. They were followed up in Department of Urology in General Hospital of PLA from September 2009 to February 2012. Acute rejection was exeluded in all of the recipients. This study was approved by loeal ethical eommittee and the informed consent of all participating subjects was obtained. All of the patients took ealcium dobesilate （ 1 000 rag/d） orally for twiee a day during breakfast and dinner for 1-24 months （ median time 18 months）. The change of renal allograft function was observed before and after calcium dobesilate treatment. The main indicators ineluded serum creatinine （Ser）, estimated glomerular filtration rate （ eGFR）, blood urea nitrogen （ BUN）, serum uric acid and so on. The occurrence of adverse reaction was recorded including the change of alanine aminotransferase （ALT）, aspartate aminotransferase （AST）, fasting blood glucose, total eholesterol, triglyceride and so on. Results During the period of taking medieine, 4 cases exited the study for severe gastrointestinal reaction and 2 cases died of lung cancer metastasis and sudden death. After treatment of calcium dobesilate, the renal function of transplant kidney kept in original level or got better than before. Compared with those before the treatment, Scr was significantly decreased and eGFR was significantly inereased in every time point after treatment （ P 〈 0. 05 or P 〈 0. 01 ）. The main adverse reaetion of calcium dobesilate was gastrointestinal reaction, whieh most patients could tolerate. There was no significant change in liver function, blood glucose and blood lipid level in every time point after treatment. Conclusions Calcium dobesilate is effective and safe in treatment of renal transplant recipients with renal allograft dysfunction.