CAJ | 학술논문

目的：评价欣生静片治疗广泛性焦虑症（心肝火旺证）的有效性和安全性。方法：采用随机、双盲双模拟、多中心平行对照试验设计，试验组和对照组分别给予欣生静片和丁螺环酮治疗4周。结果：试验组的总有效率和疗效指数均优于对照组（P＜0.05）。两组均能显著改善HAMA评分，组间差异具有统计学意义（P＜0.01）。两组患者的中医症状均能改善，但试验组的总有效率及中医证候的愈显率和评分均优于对照组（P＜0.01）。两组的HAMD17项评分均有显著改善（P＜0.01），试验组优于对照组（P＜0.01）。试验组的不良反应发生率、严重程度显著低于对照组（P＜0.01）。结论：欣生静片治疗广泛性焦虑症安全、有效，显著优于丁螺环酮，临床应用价值高。
목적：평개흔생정편치료엄범성초필증（심간화왕증）적유효성화안전성。방법：채용수궤、쌍맹쌍모의、다중심평행대조시험설계，시험조화대조조분별급여흔생정편화정라배동치료4주。결과：시험조적총유효솔화료효지수균우우대조조（P＜0.05）。량조균능현저개선HAMA평분，조간차이구유통계학의의（P＜0.01）。량조환자적중의증상균능개선，단시험조적총유효솔급중의증후적유현솔화평분균우우대조조（P＜0.01）。량조적HAMD17항평분균유현저개선（P＜0.01），시험조우우대조조（P＜0.01）。시험조적불량반응발생솔、엄중정도현저저우대조조（P＜0.01）。결론：흔생정편치료엄범성초필증안전、유효，현저우우정라배동，림상응용개치고。
Objective:To evaluate the efficacy and safety of Xinshengjing tablet in the treatment of patients with generalized anxiety disorder (GAD) (the syndrome of hyperactivity of heart-liver fire). Methods:A randomized, double-blind, double-dummy, parallel and multicenter control clinical trial was performed. Patients were divided into an experimental group and a control group and treated with Xinshengjing tablet or buspirone for four weeks, respectively. Results: The total effective rate and the therapy index were significantly higher in the experimental group than in the control group (P<0.05). HAMA scores in two groups were obviously improved and the differences were statistically significant (P<0.01). TCM syndromes in two groups were improved, however, the total effective rate and the cure rate and score of TCM syndromes were signiifcantly higher in the experimental group than in the control group (P<0.01). HAMD-17 scores in two groups were signiifcantly improved, which were much better in the experimental group than in the control group (P<0.01). The incidence and severity of adverse reaction event were lower in the experimental group than in the control group (P<0.01) Conclusion:Xinshengjing tablet is safe and effective for the treatment of patients with GAD and worthy of clinical application.