CAJ | 학술논문

采用随机、双盲、安慰剂平行对照、多中心临床试验，考察了复方中药颗粒治疗非酒精性脂肪肝临床疗效，初步评价其有效性及安全性。受试者依从性好；主要疗效指标肝/脾 CT 比值升高，试验组临床有效率为67.57%，安慰剂组有效率为39.09%，差异有统计学意义（P =0.0000）。次要疗效指标中医症候积分值降低，试验组下降了5.64±3.79，安慰剂组下降了3.32±2.87，差异有统计学意义（P ﹤0.0001）。试验组不良反应发生率为1.8%，与安慰剂组比较差异无统计学意义（P =0.4977）。在接受试验药或对照药过程中，所有受试者均未发生严重不良事件。
채용수궤、쌍맹、안위제평행대조、다중심림상시험，고찰료복방중약과립치료비주정성지방간림상료효，초보평개기유효성급안전성。수시자의종성호；주요료효지표간/비 CT 비치승고，시험조림상유효솔위67.57%，안위제조유효솔위39.09%，차이유통계학의의（P =0.0000）。차요료효지표중의증후적분치강저，시험조하강료5.64±3.79，안위제조하강료3.32±2.87，차이유통계학의의（P ﹤0.0001）。시험조불량반응발생솔위1.8%，여안위제조비교차이무통계학의의（P =0.4977）。재접수시험약혹대조약과정중，소유수시자균미발생엄중불량사건。
The paper examined the clinical efficacy of chinese medicine compound granules in treatment of non - alco-holic fatty liver disease using randomized,double - blind,placebo - control and multi - center clinical trials,and evaluated its effectiveness and safety. The subjects compliance was good. The main outcome indicators of liver/ spleen CT ratio in-creased. The treatment group effective rate was 67. 57% ,and the placebo group effective rate was 39. 09% . The difference was statistically significant(P = 0. 000 0). Secondary efficacy index TCM symptoms integral value was reduced. The experi-mental group decreased by 5. 64 ± 3. 79,and the placebo group decreased by 3. 32 ± 2. 87. The difference was statistically significant(P ﹤ 0. 000 1). The incidence of adverse reactions of experimental group was 1. 8% ,no statistically significant difference(P = 0. 497 7)compared with the placebo group. In the process of tested drug or placebo,no serious adverse e-vents in subjects.