口服微循环调节剂治疗急性痔发作的随机双盲临床研究

Clinical trial of oral microcirculation regulator on the treatment of acute onset of hemorrhoid: result of a randomized double blind study

目的 研究应用微粒化的高纯度香叶木甙 (爱脉朗 )治疗急性痔发作。方法 92例患者参加本研究。随机、双盲的研究计划经伦理委员会批准 ,有书面知情同意。研究组用香叶木甙 ,对照组用安慰剂 ,疗程为 7d。结果 90例患者完成了全过程 ,数据输入电脑后开盲。开盲后研究组为 47例 ,对照组为 43例。在安全性方面两组均未出现全身不良反应 ,也未出现血液系统、肝、肾等脏器功能损害。在第 7天时复查发现 :(1)疼痛症状消失的患者在研究组为 6 8 1% ,对照组为 39 5 % ,2组之间有显著差别 (P =0 0 0 7)。 (2 )水肿体征消失和明显改善的患者在研究组为 95 7% ,对照组为79 1% ,2组之间有显著差别 (P =0 0 16 )。 (3)出血消失的患者在研究组为 89 4% ,对照组为 6 9 8% ,2组之间有显著差别 (P =0 0 2 0 )。结论 香叶木甙与安慰剂相比 ,对于疼痛 ,水肿 ,出血等的疗效有显著差别 。

Objective To evaluate the clinical efficacy and safety of Alvenor in the treatment of acute hemorrhoids. [WT5”HZ]Methods[WT5”BZ] This was a prospective, randomized, double blind, placebo controlled study for the effect of Alvenor. The patients presenting acute hemorrhoidal episode (within 48 hours) were enrolled. The duration of study was seven days.[WT5”HZ] Results[WT5”BZ] There were 90 patients (47 men, 43 women) with a mean age of 43 years (range 18～75 years). Study group receiving Alvenor ( n =47) and control group receiving Placebo ( n =43). After 7 days treatment, no major adverse event was observed. Blood cell count, hepatic and renal function were not affected. Efficacy parameters were shown as follows: The reduction of pain score had significant difference between the two groups. Improvement rate in study group was 68 1% and in control group was 39 5% ( P =0 007). The edema improvement rate in the study group was 95 7% and in control group was 79 1%% ( P =0 016). The bleeding improvement rate in study group was also higher than in control group, 89 4% vs 69 8% ( P =0 020).Conclusions Our data showed that Alvenor was safe in the treatment of acute hemorrhoids. Study group had significantly better results than control group in pain release, edema and bleeding improvements.