肠外曲克芦丁和卡唑铬联合治疗痔疮切除术后状态:一项随机、双盲、安慰剂对照、IV期研究
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Basile M, Gidaro S, Pacella M, Biffignandi PM, Gidaro GS
肠外曲克芦丁和卡唑铬联合治疗痔疮切除术后状态:一项随机、双盲、安慰剂对照、IV期研究
中华医学杂志2001;17(4):256-61。
- PubMed ID
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11922398 (PubMed视图］
- 摘要
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黄酮类化合物，如曲克芦丁，已被证明是治疗慢性静脉功能不全的安全有效的药物。先前研究表明，曲克芦丁150 mg和卡唑铬1.5 mg (Fleboside安瓿)的固定组合在急性非复杂性痔疮非手术患者中具有良好的疗效和安全性。这项随机、双盲、安慰剂对照研究的目的是调查积极联合治疗痔疮切除术后患者的疗效和耐受性。30例患者随机接受两种治疗之一:曲克芦丁150 mg和卡唑铬1.5 mg，或安慰剂，即3 ml安瓿，每天两次，手术后连续五天，从手术当天开始。疗效参数评估如下:在基线(T1)，第一次给药后(T2;手术后第2天(T3)、手术后第5天(T4);基于视觉模拟量表(VAS)的痔疮症状:疼痛、分泌物、出血、炎症和瘙痒;如有止痛药摄入;时间恢复生理排便;水肿评估(基于四点量表:0 =无水肿; 1 = mild; 2 = moderate; 3 = severe); camera pictures taken at T1 and T4 (in selected patients); and blood coagulation tests. Analysis between treatment groups revealed a highly significant difference at T3 and T4 for the total VAS score (p = 0.007 and p = 0.001, respectively) in favor of the active combination treatment. A statistically significant difference was also observed for bleeding and pruritus at T3 and for these two parameters and both inflammation and edema at T4 (p < 0.001) in favor of the active combination group. No adverse events were reported. Neither the active combination nor placebo affected blood coagulation tests. We conclude that intramuscular administration of the fixed combination of troxerutin 150 mg and carbazochrome 1.5 mg is effective, well tolerated and superior to placebo in improving hemorrhoidal and post-surgical symptoms during the five days following surgery.
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