迈之灵片对混合痔切除术后并发症疗效的多中心临床研究  

Multi-center clinical study of the efficacy of Aescuven forte tablets on complications during postoperative period after mixed hemorrhoidectomy

作　　者：陆宏[1] 郑德[1] 周昊[2] 金炜[3] 金文琪 胡婕[4] 应光耀[5] 唐晓军 杨巍[1] LU Hong;ZHENG De;ZHOU Hao;JIN Wei;JIN Wenqi;HU Jie;YING Guangyao;TANG Xiaojun;YANG Wei(Department of Anorectal Surgery,Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200021,China;Department of Anorectal Surgery,Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200030,China;Department of Anorectal Surgery,Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200437,China;Department of Anorectal Surgery,Shanghai Traditional Chinese Medical Hospital,Shanghai 200071,China;Department of Anorectal Surgery,Shanghai Jiading Hospital of Traditional Chinese Medicine,Shanghai 201800,China;Department of Anorectal Surgery,Fangta Hospital of Traditional Chinese Medicine of Shanghai Songjiang District,Shanghai 201600,China)

机构地区：[1]上海中医药大学附属曙光医院肛肠科,上海200021 [2]上海中医药大学附属龙华医院肛肠科,上海200030 [3]上海中医药大学附属岳阳中西医结合医院肛肠科,上海200437 [4]上海市中医医院肛肠科,上海200071 [5]上海市嘉定区中医医院肛肠科,上海201800 [6]上海市松江区方塔中医医院肛肠科,上海201600

出　　处：《药学服务与研究》2019年第2期111-113,142,共4页Pharmaceutical Care and Research

基　　金：上海市科学技术委员会科研计划项目(16401971600);上海市中医药事业发展三年行动计划(重大研究)项目(ZY3-CCCX-2-1003);上海市名老中医学术经验研究工作室建设项目(SHGZS-2017028)

摘　　要：目的:观察混合痔切除术后应用迈之灵片的临床疗效。方法:将来自6个分中心的240例病人采用随机数字表法分为试验组(n=120)和对照组(n=120),所有病人均接受混合痔切除术。术后第1天(d 1)开始服药,试验组病人口服迈之灵片(2片/次,bid),对照组病人口服痔宁片(3片/次,tid),疗程1周。观察两组病人的主要术后临床症状,包括肛缘水肿、创面出血和创面疼痛情况,比较两种药物的临床症状改善有效率。结果:术后d 1(用药前),两组病人的临床症状比较,差异无统计学意义(P>0.05)。术后d 3,两组病人的肛缘水肿(P<0.01)和创面疼痛(P<0.05)比较,试验组显著优于对照组。术后d 7,两组病人的肛缘水肿、创面疼痛、创面出血症状比较,试验组显著优于对照组(P<0.01),并且试验组的症状改善有效率显著优于对照组(87.50%vs 69.17%,P<0.05)。结论:迈之灵片对混合痔切除术后的疼痛、肛缘水肿、创面出血症状有良好疗效,显著优于痔宁片。Objective : To observe the clinical efficacy of Aescuven forte tablets on complications during postoperative period after mixed hemorrhoidectomy. Methods : Two hundred and forty patients from 6 sub-centers were randomly divided into the trial group ( n =120) and the control group ( n =120), and all the patients underwent mixed hemorrhoidectomy. The patients began to take drugs on the first day after surgery (ie.d 1). The patients in the trial group were given oral administration of Aescuven forte tablets (2 tablets a time, bid ), and the patients in the control group were given Zhining tablets (3 tablets a time, tid ), all with a treatment course of 1 week. The main postoperative clinical symptoms of the 2 groups were closely observed, including the symptoms of anal edema, wound surface hemorrhage or pain. Then, the rate of symptom improvement was compared between the 2 groups. Results : On the d 1 (before drug administration), no significant differences regarding anal edema, wound surface hemorrhage or pain could be observed between the 2 groups ( P >0.05). On day 3, anal edema ( P < 0.01) and wound surface pain ( P <0.05) of the trial group were significantly superior to those of the control group. On day 7, anal edema, wound surface hemorrhage or pain in the trial group were also significantly superior to those of the control group, and statistical significance could be seen, when comparisons were made between them ( P <0.01). The rate of treatment efficacy of the trial group was also significantly superior to that of the control group (87.50% vs 69.17%, P <0.05). Conclusion : Aescuven forte tablets could produce good therapeutic effects on anal edema, wound surface hemorrhage or pain after mixed hemorrhoidectomy, and they are significantly superior to those of Zhining tablets.

关 键 词：迈之灵 混合痔切除术 疗效评价 临床试验 Ⅱ期 痔宁片 

分 类 号：R969.4[医药卫生—药理学]