CAJ | 학술논문

目的：评价胆石片治疗不伴有胆囊结石的慢性胆囊炎（肝胆气郁证）的有效性和安全性。方法采用随机、双盲、安慰剂平行对照、多中心临床试验设计。120例不伴有结石的慢性胆囊炎患者符合本试验纳入标准，试验组和对照组各60例。分别采用胆石片（6粒/次，3次/ d）及胆石片安慰剂（6粒/次，3次/ d）进行为期4周的治疗。以中医证候积分（包括右胁胀痛、口苦、咽干、嗳气、恶心、厌食油腻、纳食减少、胃脘痞满、上腹饱胀、右上腹部压痛和大便秘结）和腹部超声检查进行疗效评价。以血、尿、大便常规，肝功能（ALT、AST、TBIL、DBIL）、肾功能（Bun、Cr）和心电图检查结果作为安全性评价的依据。结果治疗4周后，经 CMH 卡方检验，两组主要疗效、次要疗效及影像学疗效中痊愈率、显效率、有效率、无效率及总有效率比较差异有统计学意义（P <0.01）。安全性：两组均无严重不良事件发生。结论胆石片能有效治疗不伴有胆囊结石的慢性胆囊炎，并有良好的安全性。
목적：평개담석편치료불반유담낭결석적만성담낭염（간담기욱증）적유효성화안전성。방법채용수궤、쌍맹、안위제평행대조、다중심림상시험설계。120례불반유결석적만성담낭염환자부합본시험납입표준，시험조화대조조각60례。분별채용담석편（6립/차，3차/ d）급담석편안위제（6립/차，3차/ d）진행위기4주적치료。이중의증후적분（포괄우협창통、구고、인간、애기、악심、염식유니、납식감소、위완비만、상복포창、우상복부압통화대편비결）화복부초성검사진행료효평개。이혈、뇨、대편상규，간공능（ALT、AST、TBIL、DBIL）、신공능（Bun、Cr）화심전도검사결과작위안전성평개적의거。결과치료4주후，경 CMH 잡방검험，량조주요료효、차요료효급영상학료효중전유솔、현효솔、유효솔、무효솔급총유효솔비교차이유통계학의의（P <0.01）。안전성：량조균무엄중불량사건발생。결론담석편능유효치료불반유담낭결석적만성담낭염，병유량호적안전성。
Objective To evaluate the efficacy and safety of Danshi tablet,a Chinese herbal medi-cine for smoothing liver,in treating chronic cholecystitis without gallbladder stones patients with hepatobiliary- qi stagnation syndrome. Methods A randomized,double - blind,and placebo control method was adopt-ed. One hundred and twenty cases of chronic cholecystitis conforming to the inclusive criteria were randomly divided into treatment group(n = 60)and control group(n = 60). Patients in the treatment group were treated with Danshi tablet,six tablets each time and three times a day. Patients in the control group received Simula-tion agent,six tablets each time and three times a day. After 4 weeks of treatment,the efficacy of Danshi tab-let was evaluated by the score of the syndromes of traditional Chinese Medicine and the examination of ab-dominal ultrasound. The safety of Danshi tablet was assessed by laboratory data and adverse events. Results After 4 weeks of treatment,the curative and markedly effective rate was 3. 45% in control group and 27. 12%in treatment group,and there was statistically significant difference between the two groups(P < 0. 01). The total effective rate was 27. 59% in control group and 66. 10% in treatment group,and there was statistically significant difference(P < 0. 01). Efficacy of TCM syndrome:the cure and markedly effective rate was 5. 17% in control group and 40. 68% in treatment group,and the difference between the two groups was statisti-cally significant(P < 0. 01). The total effective rate was 34. 48% in control group and 81. 36% in treatment group,and the difference between the two groups was statistically significant(P < 0. 01). Imaging Efficacy:the Cure and markedly effective rate was 16. 36% in control group and 45. 28% in treatment group,and the difference between the two groups was statistically significant(P <0. 01). The total effective rate was 61. 82%in control group and 81. 13% in treatment group,and the difference between the two groups was statistically significant(P < 0. 05). Safety:no serious adverse events occurred in either groups. Conclusion Danshi tab-let is effective and safe for treatment of chronic cholecystitis patients with chronic cholecystitis without gall-bladder stones patients with hepatobiliary - qi stagnation syndrome.