CAJ | 학술논문

目的：探讨健康志愿者单次口服不同剂量广金钱草总黄酮胶囊的安全性和耐受性。方法：采用随机双盲安慰剂对照（试验组∶安慰剂组＝4∶1）、单剂量递增设计，将54例符合入选标准的受试者分为试验组46例、安慰剂组8例。试验组受试者分别单剂量口服广金钱草总黄酮胶囊133、399、798、1197、1596、1995、2394 mg，给药后定时进行血常规、尿常规、血生化、心电图、凝血功能监测，并记录生命体征和不良反应发生情况。结果：54例受试者均完成研究，试验组46例受试者中有9例出现了不良反应（占试验组受试者的19?6％）；安慰剂组8例受试者中，2例发生了不良反应（占安慰剂组受试者的25?0％），不能除外与试验药物的可能关系，其他受试者无不良反应发生。结论：健康人体单次服用133～2394 mg广金钱草总黄酮胶囊较为安全，耐受性良好。
목적：탐토건강지원자단차구복불동제량엄금전초총황동효낭적안전성화내수성。방법：채용수궤쌍맹안위제대조（시험조∶안위제조＝4∶1）、단제량체증설계，장54례부합입선표준적수시자분위시험조46례、안위제조8례。시험조수시자분별단제량구복엄금전초총황동효낭133、399、798、1197、1596、1995、2394 mg，급약후정시진행혈상규、뇨상규、혈생화、심전도、응혈공능감측，병기록생명체정화불량반응발생정황。결과：54례수시자균완성연구，시험조46례수시자중유9례출현료불량반응（점시험조수시자적19?6％）；안위제조8례수시자중，2례발생료불량반응（점안위제조수시자적25?0％），불능제외여시험약물적가능관계，기타수시자무불량반응발생。결론：건강인체단차복용133～2394 mg엄금전초총황동효낭교위안전，내수성량호。
OBJECTIVE:To evaluate the safety and tolerance of single dose total flavonoids of herba desmodii styracifolii capsules in healthy volunteers. METHODS:A randomized, double?blind placebo?controlled, dose?escalation study was conducted in 54 eligible subjects, with the ratio of experiment group to placebo group at 4∶1. The subjects were randomly assigned to experiment group ( 46 cases ) receiving single oral dose of total flavonoids of herba total flavonoids(133,399,798,1 197,1 596,1 995 or 2394 mg, respectively). The placebo group was 8 cases. After drug administration, patients? blood routine, urine routine, blood biochemistry, ECG examination, blood clotting function were monitored and their vital signs and adverse events were recorded. RESULTS:Of the 54 cases with study completion, adverse events were noted in 9 cases in experiment group ( 19?6%,9/46 ) and 2 cases in placebo group (25?0%,2/8), which might be related to the use of experimental drugs. No adverse events occurred in the other cases. CONCLUSIONS:Single dose(133?2 394 mg) of total flavonoids of herba desmodii styracifolii capsule was safe and well tolerated in healthy volunteers.