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根据卫生部卫药发(1992)35号文件,我们进行了开放、对照、多中心Ⅲ期临床研究,以探讨加贝酯对急性出血坏死性胰腺炎的疗效。共观察85例,治疗组49例,对照组36例,我们发现:治疗组有效率为74.2%,而对照组为36.0%(P<0.05);死亡率分别为4.1%与22.2%(P<0.05);两组在缓解症状、消退体征与血淀粉酶恢复正常的有效率分别为75.4%、71.8%与81.6%以及38.8%、36.0%与44.4%(P<0.05,三者均同),两组在缓解症状、消退体征与血淀粉酶恢复正常的时间分别为5.41±2.38、5.76±2.32与4.58±2.39以及7.11±2.47、7.55±2.48与7.58±1.95日(P<0.05三者均同)。治疗后血象、肝、肾功能无明显改变。以上表明:本品对急性出血坏死性胰腺炎的治疗安全可靠,有迅速缓解临床症状、降低死亡率与提高存活率之效。
According to the Ministry of Health Wei Yao (1992) 35, we conducted an open, controlled, multicenter phase III clinical study to explore the efficacy of Gabapentin on acute hemorrhagic necrotizing pancreatitis. A total of 85 cases were observed, 49 cases in the treatment group and 36 cases in the control group. We found that the effective rate was 74.2% in the treatment group and 36.0% in the control group (P <0.05), and the mortality rates were 4. 1% and 22.2%, respectively (P <0.05). The effective rates of symptom relief, signs of regression and blood amylase recovery in the two groups were 75.4%, 71.8% and 81.6% respectively, and 38 .8%, 36.0% and 44.4% (P <0.05, all three were the same). The time to relieve symptom, regression sign and blood amylase were 5.41 ± 2 in both groups. 38, 5.76 ± 2.32 and 4.58 ± 2.39 and 7.11 ± 2.47, 7.55 ± 2.48 and 7.858 ± 1.95 days (P <0.05, respectively All the same). After treatment of blood, liver, kidney function no significant change. The above shows that: This product is safe and reliable for the treatment of acute hemorrhagic necrotizing pancreatitis, which can quickly relieve clinical symptoms, reduce mortality and improve the survival rate.