细菌溶解产物在预防儿童肾病综合征频繁复发中的应用

Clinical observation of OM- 85 BV in preventing frequently relapsing nephrotic syndrome in children

目的观察细菌溶解产物(泛福舒)对预防儿童原发性肾病综合征(PNS)频繁复发的疗效,探讨其临床应用价值。方法选择诊断为PNS频繁复发型患儿50例,将其分为两组,对照组(22例)给予常规的泼尼松和(或)免疫抑制剂等综合治疗,观察组(28例)在常规的泼尼松和(或)免疫抑制剂治疗的同时加用泛福舒口服治疗6个月,观察6个月内两组患儿呼吸道感染次数、因呼吸道感染引起肾病复发次数以及尿蛋白由阳性转为阴性的时间。两组患儿在治疗前及治疗6个月后分别抽血查T细胞亚群CD3+、CD4+、CD8+、CD4+/CD8+及免疫球蛋白Ig A、Ig G、Ig E和Ig M的变化及服药期间的不良反应。结果观察组呼吸道感染次数、因呼吸道感染引起肾病复发次数以及尿蛋白由阳性转为阴性的时间较对照组均明显减少,差异有统计学意义(P<0.05)。观察组与对照组比较,治疗前各项指标差异无统计学意义(P>0.05),治疗后CD3+、Ig M无明显变化(P>0.05),而观察组CD4+、CD4+/CD8+、Ig A、Ig G高于对照组,CD8+、Ig E低于对照组,差异有统计学意义(P<0.05)。观察组PNS完全缓解15例,部分缓解10例,无效3例;对照组完全缓解11例,部分缓解6例,无效5例,两组比较差异有统计学意义(P<0.05)。结论对于PNS频繁复发的患儿,使用糖皮质激素和(或)免疫抑制剂治疗的同时,加用泛福舒可提高其机体免疫力,减少患儿呼吸道感染的次数,延长PNS缓解的时间,能有效预防呼吸道感染诱发的原发性肾病频繁复发及减少尿蛋白,较安全且不良反应少。

Objective The present trial was to investigate the effect of OM- 85 BV on preventing primary nephrotic syndrome in children and explore its value of clinical application. Methods 50 children with frequently relapsing primary nephrotic syndrome were randomly divided into two groups. The control group（ 22 cases） routinely received prednisone and / or immunosuppressive therapy,while the treatment group（ 28 cases） received additional OM- 85 BV for 6consecutive months on top of the conventional prednisone and / or immunosuppressive therapy. Frequency of respiratory infection and resulting nephrotic relapse and duration before urine albumin turns negative were assessed. In addition,the levels of CD3^＋,CD4^＋,CD8^＋and CD4^＋/ CD8^＋ratio,as well as changes in immunoglobulins were tested before and after the intervention. Other adverse reactions were also documented. Results Compared with the control group,OM- 85BV- treated patients suffered fewer times of infection and the resulting nephrotic relapse,as well as a shorter duration before urine albumin turns negative（ P〈0. 05）. No significant difference between the treatment group and the control group was found in any parameter before the treatment（ P〈0. 05）. CD3^＋and Ig M were similar after the treatment（ P〈0. 05）.The levels of CD4^＋,CD4^＋/ CD8^＋,Ig A and Ig G increased,but CD8^＋and Ig E decreased in the treatment group than those in the control group after the treatment. In the treatment group,complete remission was achieved in 15 cases,partial remission in 10 cases,no remission in 3 cases. While in the control group,11 cases had complete remission,with partial remission in 6 cases and no remission in 5 cases. There was a significant difference in the recurrence rate between the two groups（ P〈0. 05）. Conclusion OM- 85 BV could improve the immune function of children with relapsing primary nephrotic syndrome on corticosteroid and / or immunosuppressant therapy. It reduces frequency of infection and prolongs the duration of remission. It can also prevent the respiratory infection,reduce the relapse rate of primary nephrotic syndrome and levels of urine protein. This combined treatment is safe with fewer adverse reactions.