复方角菜酸酯乳膏和复方角菜酸酯栓治疗混合痔的疗效及安全性对比研究

Comparison of the efficacy and safety of compound carraghenates cream and compound carraghenates suppository in the treatment of mixed hemorrhoids

目的研究复方角菜酸酯乳膏治疗痔病的疗效及安全性,并与复方角菜酸酯栓剂比较。方法采用多中心、开放、对比的研究方法,将252例混合痔患者随机分为治疗组和对照组,分别应用复方角菜酸酯乳膏和复方角菜酸酯栓剂,在用药后30min至6d量化评价两组疼痛、出血、水肿、脱出等情况。结果用药后在疼痛以外的其他症状改善方面,两组疗效均显著,有效率分别为87.3%和94.8%,组间差异无统计学意义(P>0.05)。但在各时间点,治疗组患者疼痛平均得分均低于对照组(P<0.05)。在用药后30min和3h,止痛起效的患者比例明显高于对照组(P<0.01)。治疗组在30min和3h总起效患者的比例也高于对照组(P<0.01)。用药期间,两组均无不良反应。结论复方角菜酸酯乳膏用于混合痔的治疗,在缓解疼痛和起效时间上有优势;在改善疼痛以外的症状方面,与复方角菜酸酯栓相似。

Objective To evaluate and compare the efficacy and safety of tit an oreine cream with compound carraghenates suppository in the treatment of mixed h emorrhoids. Methods Two hundred and fifty two patients with mixed hemorrhoids w ere enrolled in this randomized,open,multicentral trial. Patients applied titano reine cream (study group,n=133) or compound carraghenates suppository (control g roup,n=119). The symptomatic relief including pain,bleeding and edema was evalua ted by scoring system at 30 minutes,3 hours,6 hours,1day,2 days,3 days,4 days,6 days after adminstration. Results Symptoms were significantly improved in both g roups(87.3%,94.8%,respectively) excepting syptom of pain relief,but there was no significant difference between two groups(P >0.05). The pain scores were lowe r at every observing point in the study group than those in the control group (P < 0.05). The propertions of the patients with pain relief and all symptoms relie f were both higher in the study group than that in the control group at 30 mim,3 h after drug used(both P< 0.01). No side effect was found during the triad. Con clusion Titanoreine cream has predominance of relieving pain and response time c ompared with compound carraghenates suppository,but other effects on mixed hemor rhoid are similar between the two groups.