三七化痔丸联合马应龙麝香痔疮膏治疗痔疮的随机双盲前瞻性临床研究  

A randomized double-blind prospective clinical study on effect of Sanqi Huazhi Wan plus the Mayinglong musk hemorrhoids ointment in the treatment of hemorrhoids

作　　者：周家铭[1] 吴亚萍 宁娜 谭淑云[1] 陈晓琼[1] 李拓阳 肖源律 耿春贤 黄秋凌 黄美近[1] ZHOU Jiaming;WU Yaping;NING Na;TAN Shuyun;CHEN Xiaoqiong;LI Tuoyang;XIAO Yuanlu;GENG Chunxian;HUANG Qiuling;HUANG Meijin

机构地区：[1]中山大学附属第六医院,广东广州510655 [2]广州白云山中一药业有限公司,广东广州510530

出　　处：《中医临床研究》2022年第30期92-95,共4页Clinical Journal Of Chinese Medicine

摘　　要：目的:评估三七化痔丸联合马应龙麝香痔疮膏治疗痔疮的临床效果及安全性。方法:采用随机、双盲、安慰剂平行对照的研究设计。选取在中山大学附属第六医院接受诊治的痔疮患者150例,随机将患者平均分为试验组75例、对照组75例。试验组给予三七化痔丸治疗,对照组给予安慰剂治疗,两组均加用马应龙麝香痔疮膏治疗。记录治疗前、治疗7 d、14 d两组患者的痔核表面黏膜、痔核大小、外痔肿胀、外痔大小等观察指标评分,同时观察不良反应,并比较两组的疗效和安全性。结果:试验组和对照组分别有58例和67例完成治疗。试验组治疗7 d外痔肿胀、外痔大小评分,以及治疗14 d痔核表面黏膜、痔核大小评分均显著低于对照组(P<0.05);SF-36量表评分及不良反应发生率组间差异无统计学意义(P>0.05)。结论:三七化痔丸联合马应龙麝香痔疮膏治疗痔疮可显著改善外痔红肿、缩小外痔体积。另外,在停用马应龙麝香痔疮膏后继续口服三七化痔丸可显著缓解痔核表面黏膜充血、隆起,缩小痔核体积。本治疗方案疗效确切,有利于改善病情,且安全性良好,值得临床推广。Objective:To evaluate the efficacy and safety of Sanqi Huazhi Wan(三七化痔丸)plus the Mayinglong(马应龙)musk hemorrhoids ointment on hemorrhoids.Methods:In this randomized,double-blind,placebo-controlled study,the target enrolment was 150 hemorrhoids patients,and the eligible patients were assigned randomly to the treatment group and the control group,75 patients for each group.Patients in the treatment group received Sanqi Huazhi Wan,and the control group received placebo.Meanwhile,all the patients in the two groups received the Mayinglong musk hemorrhoids ointment.The scores of the mucosa and size of haemorrhoids nuclear,the scores of the swelling degree and size of external hemorrhoids before treatment,at 7 days and 14 days after treatment were recorded.Adverse effects throughout the clinical trial were observed,and the efficacy and safety in the two groups were evaluated.Results:A total of 125 patients completed the trial(58 cases in the treatment group and 67 cases in the control group).The scores of the swelling degree and size of external hemorrhoids at 7 days after treatment,and the scores of the mucosa and size of hemorrhoids nuclear at 14 days after treatment in the treatment group were significantly lower than those in the control group(P<0.05).With regard to SF-36 score and the incidence rate of adverse effects,the difference between the groups was not significant(P>0.05).Conclusion:Sanqi Huazhi Wan plus the Mayinglong musk hemorrhoids ointment for 7 days can improve the swelling degree and size of external hemorrhoids significantly.In addition,oral administration of Sanqi Huazhi Wan after disusing the Mayinglong musk hemorrhoid ointment can significantly relieve mucous congestion and bulge on the surface of hemorrhoids,and reduce hemorrhoids size.This treatment scheme is effective,conducive to improving and stabilizing the condition,with good safety,and is worthy of clinical promotion.

关 键 词：三七化痔丸 痔疮 外痔 痔核 不良反应 

分 类 号：R657.18[医药卫生—外科学]