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目的 :观察口服猪血清免疫球蛋白治疗轮状病毒肠炎的疗效和安全性。方法 :研究对象为 1 998年 1 0月～ 1 999年 1月和 1 999年 1 1月～ 2 0 0 0年 1月在广州市四家大医院住院或门诊的 3岁以下轮状病毒肠炎患儿 ,病程在 2天以内。共观察 3 2 2例 ,其中双盲对照试验 2 43例住院患儿 (治疗组 1 2 8例和对照组 1 1 5例 ) ,采用分层分段随机双盲设计 ,分别予猪血清免疫球蛋白口服液或安慰剂 ;开放试验(开放组 ) 79例门诊患儿给予猪血清免疫球蛋白口服液。3组的剂量均为 0 .5ml·kg-1次 ,每日 3次口服 ,疗程 3天。所有患儿均予同样支持治疗 ,有脱水者给予静脉补液或口服补液纠正水电解质平衡紊乱。结果 :双盲对照试验治疗组的总有效率 (痊愈+显效 )和痊愈率分别为 73 .5 %和 3 8.3 % ,均分别显著高于对照组的 5 1 .3 %和 1 4.8% (P <0 .0 1 )。开放组的疗效与双盲对照试验治疗组相近 ,总有效率和痊愈率分别为 81 %和 3 9.2 % ,(P >0 .0 5 )。结论 :猪血清免疫球蛋白口服液治疗婴幼儿轮状病毒肠炎安全、有效、服用方便 ,值得临床推广应用
Objective: To observe the efficacy and safety of oral swine serum immunoglobulin in the treatment of rotavirus enteritis. Methods: The subjects of our study were rotavirus enteritis under 3 years of age from January 1998 to January 1999 and January to January 1999 to January 2000 in Guangzhou Grand Four Hospital. Children, duration of less than 2 days. A total of 232 cases were observed, of which 243 were hospitalized in double-blind controlled trial (128 cases in treatment group and 115 cases in control group). The patients were randomly divided into two groups: Protein oral solution or placebo. In the open trial (open group), 79 cases of outpatients received porcine serum immunoglobulin oral solution. The dosage of 3 groups were 0. 5ml · kg-1 times, 3 times a day orally, course of treatment for 3 days. All children were given the same supportive treatment, dehydration were given intravenous rehydration or oral rehydration to correct water and electrolyte balance disorders. Results: The total effective rate (recovery + effective) and cure rate in the double-blind control group were 73.5% and 8.3% respectively, which were significantly higher than those in the control group 51.3% and 4.8% (P <0 .0 1). The efficacy of the open group was similar to that of the double-blind control trial, with a total effective rate and cure rate of 81% and 39.2%, respectively (P> 0.05). Conclusion: Porcine serum immunoglobulin oral solution for the treatment of infantile rotavirus enteritis is safe, effective and easy to take, which is worthy of clinical application