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目的:分析余仁生发宝对大鼠肾脏功能的影响,评价其长期毒性试验的安全性。方法:健康SD大鼠随机分成低、中、高3组,设立纯水空白对照组。每天灌胃给药1次,给药后3个月、6个月及停药4周后,观察大鼠体重及一般情况、检测肾功进行统计分析。结果:连续给药6个月后,UREA高、中剂量组、Crea高剂量组与对照组比较差异有显著性(P<0.01),连续给药3个月及停药恢复4周后,各组UREA、Crea检测结果与对照组比较无统计学差异(P>0.05)。结论:余仁生发宝在高剂量、长期运用时对肾功UREA/Crea有一定的影响,但在拟定的人体临床用量较为安全,但针对长期使用的患者,应该定期监测肾功较为恰当。
OBJECTIVE: To analyze the effect of Yu-Ren-Sheng-Bao on renal function in rats and to evaluate the safety of its long-term toxicity test. Methods: Healthy SD rats were randomly divided into three groups: low, medium and high, and a control group of pure water was established. Administration of gavage once a day, 3 months after administration, 6 months and withdrawal of 4 weeks after the observation of body weight and general conditions, the detection of renal function were statistically analyzed. Results: After 6 months of continuous administration, the UREA high dose group, middle dose group and Crea high dose group had significant difference compared with the control group (P <0.01). After continuous administration for 3 months and recovery for 4 weeks There was no significant difference between UREA and Crea test group and control group (P> 0.05). CONCLUSION: Yu Ren Sheng Fat Bao has a certain influence on renal function UREA / Crea at high dose and long-term use, but it is safer to use in the proposed human clinical dosage. However, it is appropriate to monitor renal function regularly for long-term use.