利胆颗粒的急性毒性研究和临床疗效观察

Study on the acute toxicity and the clinical curative effect observation of lidan granules

目的 研究利胆颗粒的急性毒性和临床疗效。方法 对利胆颗粒进行小鼠急性毒性试验 ;以利胆颗粒为实验组 ( 1 87例 ) ,利胆排石颗粒为对照组 ( 1 0 9例 )对急 ,慢性胆囊炎、胆石症患者进行疗效对比。结果 小鼠急性毒性试验表明利胆颗粒毒性太低 ,无法测得LD50 。利胆颗粒给小鼠一日ig的最大耐受最大于 2 8g/kg ,为人临床用量 ( 31 5 g/日 )的 5 3 3倍 ,试验组临床治愈率、有效率分别为 40 64%与83 42 % ;对照组分别为 2 4 77%与 70 64%。采用 χ2 检验 ,试验组与对照组临床治愈率、有效率进行比较 ,两组增多具有显著性差异 (P <0 0 5 )。结论 利胆颗粒小鼠急性毒性甚低。试验组与对照组治疗胆囊炎、胆石症的临床疗效有显著性差异。临床综合评价试验组明显优于对照组。

Objective To study the acute toxicity and observe the curative effects of lidan granules Methods The acute toxic test of lidan granules was done with mice Patients of acute and chronic cholecystitis and bilestone diseases using lidan granules as test group(187 cases) and using lidan paishi granules as contrast group(109 cases), both clinical therapeutic results were compared Results Theacute toxic test showed that the acute toxicity of lidan granules was too low to measure LD 50 The maximum tolerant quantites for mice ig / day was more than 28 g/kg, which was 53 3 times to the clinical dosage of human(31 5 g/day) The curable rate and the effective rate of the test group (40 64%, 83 42%)were significantly differences from those of the contrast group (24 77%, 70 64% )( P <0 05) Conclusion The acute toxic test showed that the acute toxicity of lidan granules was very low The clinical curable effect of the gallbladder inflammation and the gallstone disease in the test group were significantly difference from the contrast group The general evaluations of the clinical study demonstrated that the test group were obviously better than the contrast group