续骨酒的临床安全性考察

Study on the clinical safety of Xugu liquor

目的:考察续骨酒的临床安全性。方法:患者用药2个疗程,于用药前及用药后分别收集血样、尿样等,检测血常规、肝功能(谷丙转氨酶、碱性磷酸酶、总蛋白、白蛋白、球蛋白、白/球蛋白比值、总胆红素、直接胆红素)、肾功能(糖、尿酸、尿素氮、肌酐)、尿常规及心电图,观察并记录用药后是否有发热、红疹、瘙痒、皮肤发红等过敏样反应及观察患者在用药过程中是否有心慌、心悸、胸闷、胸痛等中毒样的临床反应。结果:与用药前比较,用药后红细胞数、红细胞压积、单核细胞绝对值显著降低(P<0.05);血小板数、血小板体积分布宽度、淋巴细胞绝对值、淋巴细胞百分比、直接胆红素显著升高(P<0.05),但各检测指标均在正常范围内;未见发热、皮肤红疹、瘙痒、皮肤发红等过敏样反应,亦未见心电图异常及用药期间未见出现心慌、心悸、胸闷、胸痛等中毒样的临床症状。结论:续骨酒处方安全可靠,可供患者安心使用。

Objective:To investigate the clinical safety of Xugu liquor(续骨酒).Method:Blood samples and urine samples were collected before and after two courses of medication.Blood routine,liver function(Alanine Aminotransferase,phosphatase,total protein,albumin,Globulin,white/globulin ratio,Total bilirubin,direct bilirubin),renal function(sugar,uric acid,uric acid,creatinine),urine routine and electrocardiogram were detected.Whether there were allergic reactions such as fever,rash,pruritus,skin redness and whether the patient had palpitation,chest tightness,chest pain and other toxic clinical reactions during the use of the drug was observed and recorded.Results:Compared with that before treatment,the absolute value of erythrocyte count,hematocrit and mononuclear cells decreased significantly after treatment(P<0.05).Platelet count,platelet volume distribution width,absolute lymphocyte value,lymphocyte percentage,and direct bilirubin were significantly increased(P<0.05),but all indexes were within the normal range.There were no allergic reactions such as fever,skin rash,pruritus and redness,and no abnormal electrocardiogram and toxic clinical symptoms such as palpitations,chest tightness and chest pain.Conclusion:The prescription of Xugu liquor is safe and reliable and it can be used by patients at ease.