102例冠心苏合丸相关性肾损害不良反应分析

Analysis on 102 cases of renal damage induced by Guanxinsuhe pills

目的：分析冠心苏合丸引起肾损害的不良反应临床特点。方法：回顾研究102例因服用冠心苏合丸引起相关性肾损害不良反应患者的临床资料，分析冠心苏合丸致肾损害的临床特点、ADR表现、服药情况、治疗方法等。结果：102例患者中，女性76例，占74．51％；平均年龄为（66．42±10．31）岁；平均服用药物时间为（8．45±7．55）年；服用1～9年出现ADR的患者占61．76％；102例ADR程度分级均为严重，临床表现均不典型，病情呈隐匿性进展，均伴有贫血，贫血程度与肾功能减退程度不平行；67例肾图检查均出现双侧肾功能中重度受损；98例B超双肾体积缩小，严重受损，且大小不对称。结构不清呈弥漫性改变；25例肾脏病理活检以中重度慢性小管间质性肾炎为主。结论：患者肾功能受损情况与服用冠心苏合丸的时间长短、服用剂量不平行，个体差异较大；肾功能呈进行性损害，对出现贫血、肾功能损害及肾脏大小改变的患者应追问其服药史，以求尽快确诊救活。

Objective： To analyze the clinical features of renal damage caused by Guanxinsuhe pills. Methods： Clinical data about 102 cases of renal damage induced by Guanxinsuhe pills were analyzed retrospectively, including clinical features of renal damage, clinical manifestations of ADRs, usage and treatment, etc. Results： Among 102 cases, female patients accounted for 74.51%; mean age was （66.42 ~ 10.31） years, the average medication time was （8.45 ~ 7.55） years, the patients with 1-9 years of medication duration accounted for 61.76%. According to grading criteria, 102 cases were all serious, clinical manifestation was untypical, the progression of ADR was latent. And all the cases had anemia, the degrees of anemia was not parallel with the decline of renal function. Besides, there were 67 cases that renal function was moderately damaged according to renogram; Both kidney of 98 patients shrank and were damaged severely, asymmetry of renal size was also showed by ultrasonic B-scanner; Moderately severe chronic tubulointerstitial nephritis was mainly found in 25 cases renal pathological biopsy. Conclusion： Renal damage was not parallel with medication duration and dosage with large individual differences. Because of progressive decrease of renal function, clinicians should inquire medication history of patients who have anemia, renal damage and change in kidney size, in order to diagnose correctly and give treatment as soon as possible.