复方银杏叶萃取物胶囊用于痔术后的临床研究

Clinical Trial of Compound Ginkgo Biloba Extract Capsule on Cases with Operation of Hemorrhoids

目的 :观察复方银杏叶萃取物胶囊 (静可福 )用于痔手术后减轻水肿、疼痛、渗血的疗效。方法 :采用多中心、开放、随机对照的方法 ,研究组 6 4例患者在术前术后常规治疗的基础上 ,自术前 1 d开始服用复方银杏叶萃取物胶囊 (静可福 ) ,连服 7d,对照组 72例患者仅给予术前术后常规治疗 ,观察指标包括患者术后出血、水肿和疼痛等症状的变化 ,使用止痛药的情况。结果 :研究组患者术后第六天症状总积分和各症状积分经 t检验和秩和检验均有显著差异 :研究组患者各症状改善时间显著短于对照组 ;研究组患者使用止痛药的比例为 4 5 .3% ,显著低于对照组的 6 3.9% ,P =0 .0 30。止痛药的使用天数经秩和检验亦有显著差异 ,研究组患者使用止痛药的天数显著短于对照组。研究组发现不良反应 2例 ,发生率 3.1 % ,表现为消化道不适和乏力。结论 :复方银杏叶萃取物胶囊 (静可福 )用于痔术后可有效缓解疼痛、出血、水肿等症状 ,减低止痛药的使用率 ,缩短使用时间 ,用药安全 。

Objective:To observe the effect of Compound Ginkgo Biloba Extract Capsule(Ginkor fort)on reduction of bleeding,pain and edema after operation of hemorrhoids.Methods:It is a multi centered,open,randomized control study with 64 patients in study group and 72 patients in control group.The study group started the treatment with Ginkor Fort one day before operation and the treatment period was 7 days.At the same time,a routine treatment was provided before and after the operation.For the control group,only routine treatment was provided.Evaluation criteria include score of symptoms and dosage of antalgica.Results:After treatment,all of the score of each symptom and total score of all symptoms are significantly lower than control group.In study group,the progress time of each symptom is significantly shorter than the control group.45 3% patients in the study group have ever used antalgics,and this proportion is significantly lower than 63.9%,which was that of control group,P=0 030.The dosage of antalgica in study group also significantly lower than the control group.There were 2 AE in the study group.The incidence rate was 3 1%,and clinical manifestation was gastro intestine tract malaise and inertia Compound Ginkgo Biloba Extract Capsule (Ginkor fort)can alleviate significantly postoperative pain and edema,and relieved wound blood exudation,fecal blood at day 6 after operation.Slight side effect was observed in 1 6% of patients.Conclusion:Compound Ginkgo Biloba Extraction Capsule (Ginkor fort) can effectively alleviate the symptoms such as bleeding,pain and edema.It can decrease the administrative rate and dosage of antalgic.The treatment is safe with good compliance.