摘要
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.
出处
《中华普通外科杂志》
CSCD
2000年第7期431-433,共3页
Chinese Journal of General Surgery