双料喉风散灌肠治疗溃疡性直肠炎的随机对照临床研究  

Shuangliao Houfeng San Enema for the Treatment of Ulcerative Proctitis:A Randomized Controlled Clinical Study

作　　者：陈白莉[1] 高翔[1] 张芳宾[1] 杨莉[1] 杨荣萍[1] 胡品津[1] 

机构地区：[1]中山大学附属第一医院消化内科,510080

出　　处：《胃肠病学》2009年第9期532-535,共4页Chinese Journal of Gastroenterology

摘　　要：背景:双料喉风散为常用中成药,通过向口咽部直接喷洒治疗口咽炎症和溃疡疗效肯定且安全。目的:通过与糖皮质激素灌肠比较,观察双料喉风散灌肠治疗轻中度活动性溃疡性直肠炎(UP)的疗效和安全性。方法:采用随机对照研究方案,将入组UP病例随机分为治疗组和对照组,在口服美沙拉秦的基础上分别予双料喉风散和地塞米松灌肠,疗程8周。评估两组治疗前后血便临床评分和内镜、组织学评分,记录治疗过程中出现的不良事件。随访停止灌肠后12周内临床复发情况。结果:共30例UP患者入组,治疗组16例,对照组14例。治疗第8周末,治疗组和对照组临床缓解率分别为81.2%和78.6%,组间差异无统计学意义(P>0.05);两组内镜和组织学评分均较治疗前显著降低(P<0.01),组间内镜缓解率差异无统计学意义(62.5%对64.3%,P>0.05)。治疗组不良事件发生率显著低于对照组(12.5%对50.0%,P<0.05),临床复发率与对照组相比无明显差异(7.7%对18.2%,P>0.05)。结论:双料喉风散灌肠治疗UP的临床缓解率、内镜缓解率和临床复发率与地塞米松相仿,不良事件发生率较低,值得在临床上推广应用。Background： Shuangliao Houfeng San （HES） is a Chinese patent herb medicine accepted as a medicine for treating erosions and ulcerations of tongue, pharynx and oral cavity with good efficacy and safety. Aims： To determine the efficacy and safety of HFS enema treatment in patients with mild to moderate active ulcerative proctitis （UP） by comparing it with glucocorticoid enema. Methods： A randomized controlled trial was performed in patients with histologically proven UP. Patients were allocated randomly into treatment group and control group and received HFS enema or dexamethasone （DXM） enema, respectively, for 8 weeks on the underlying basis of oral administration of mesalazine. Efficacy evaluation included the score of rectal bleeding, which represented the clinical activity of UP, and endoscopic and histological scores at entry of study and after treatment. All adverse events during the treatment course were recorded. Patients with remission were followed up for another 12 weeks to assess the relapse rate. Results： Thirty UP patients were enrolled, 16 in the treatment group and 14 in the control group. After 8-week treatment, 81.2% of patients in treatment group obtained clinical remission compared with 78.6% in control group （P〉0.05）. Endoscopic and histological scores in both the treatment group and control group were significantly improved when compared with those at the baseline （P〈0.01）, while no significant difference in endoscopic remission rate was observed between treatment group and control group （62.5% vs. 64.3%, P〉0.05）. Rate of adverse events in treatment group was significantly lower than that in control group （12.5% vs. 50.0%, P〈O.05）, but the relapse rates between these two groups were not statistically different （7.7% vs. 18.2%, P〉0.05）. Conclusions： HFS enema is as effective as DXM enema for inducing clinical and endoscopic remission and preventing clinical relapse in UP patients, and has lower incidence of adverse events. It is valid for use

关 键 词：直肠炎 溃疡性 双料喉风散 地塞米松 灌肠 随机对照试验 

分 类 号：R259[医药卫生—中西医结合]