口服猪血清免疫球蛋白治疗轮状病毒肠炎的多中心临床研究

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1998年10 月～ 1999 年1 月和1999 年11 月～ 2000 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322 例, 其中双盲对照试验243 例住院患儿(治疗组128 例和对照组115 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. 5 ml·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38. 3 %, 均分别显著高于对照组的51. 3 %和14. 8 %(P <0. 01)。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39. 2 %,(P >0. 05)。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。

Muticentral study of oral swine serum immunoglobulins in treatment of infantile rotavirus enteritis

AIM: To evaluate efficacy and safety of oral swine serum immunoglobulins in treatment of infantile rotavirus enteritis. METHODS: 322 infants with rotavirus enteritis were randomly divided into three groups: Double-blinded control trial was carried out in 243 inpatients randomly divided into two groups (128 infants received oral swine serum immunoglobulins in the treatment group, 115 infants received placebo in the control group), and 79 outpatients as the open group received oral swine serum immunoglobulins. Every group was received 0. 5 ml·kg^-1 of oral swine serum immunoglobulins or placebo thrice daily for 3 days. RESTULTS: The total therapeutic effective rate (cure and apparent effect)and curative rate were 73. 5 % and 38. 3 % respectively in the treatment group, significantly higher than 51. 3 % and 14. 8 % in the control group (P <0. 01).The therapeutic effect of the open group was similar to the treatment group. The total therapeutic effective rate and curative rate were 81 % and 39. 2 % respectively (P >0. 05). CONCLUSION: The oral administration of swine serum immunoglobulins is effective, safe and convenient in treating rotavirus enteritis of infants.