万古霉素联合丙种球蛋白治疗新生儿败血症的效果及安全性分析

Effect and safety of Vancomycin combined with gamma globulin in the treatment of neonatal sepsis

目的观察万古霉素联合丙种球蛋白治疗新生儿败血症的效果及安全性。方法选取河南省南阳市第一人民医院2020年1月至2023年1月收治的91例新生儿败血症患儿,按治疗方法对入组患儿进行分组,分为常规组(45例)和联合组(46例),常规组予以常规抗菌治疗,联合组采用万古霉素配合治疗,比较2组患儿治疗前后的免疫功能、炎症因子改善情况,用药后的细菌清除情况、症状缓解时间及用药安全性。结果治疗前,2组患儿的免疫功能差异无统计学意义(P>0.05);治疗后,联合组的免疫球蛋白A(IgA)为(2.15±0.46)g/L、免疫球蛋白M(IgM)为(1.88±0.52)g/L、免疫球蛋白G(IgG)为(15.8±4.5)g/L,均高于常规组[(1.72±0.33)g/L、(1.25±0.45)g/L、(12.8±5.1)g/L],差异具有统计学意义(P<0.05)。治疗前,2组患者的炎症因子差异无统计学意义;治疗后,联合组的C-反应蛋白(CRP)为(9.4±2.3)mg/L,降钙素原(PCT)为(1.6±0.4)ng/L,白细胞介素-6(IL-6)为(103±20)ng/L,均低于常规组[(10.8±2.0)mg/L、(2.08±0.25)ng/L、(115±21)ng/L],差异具有统计学意义(P<0.05)。在不同治疗方案下,联合组治疗1 d后的细菌清除率为43%(20/46),治疗3 d后的细菌清除率为70%(32/46),治疗7 d后的细菌清除率为89%(41/46),均高于常规组[29%(13/45)、56%(25/45)、67%(30/45)],差异具有统计学意义(P<0.05)。联合组的退热时间为(2.26±0.18)d,水肿消散时间为(4.3±1.3)d,拒奶恢复时间为(5.2±1.3)d,住院时间为(8.2±2.2)d,均低于常规组[(3.15±1.06)d、(5.8±1.1)d、(6.6±2.0)d、(10.2±3.1)d],差异具有统计学意义(P<0.05)。在不同治疗方案下,联合组的药物相关不良反应发生率为15%(7/46),常规组11%(5/45),差异无统计学意义(P>0.05)。结论万古霉素联合丙种球蛋白治疗新生儿败血症能有效增强患儿免疫功能并减轻炎症反应,对提升患儿细菌清除率、促进症状恢复均有积极意义,且此联合用药方案安全性较高,未明显增加药物相关不良反应发生风险。

Objective To observe the efficacy and safety of Vancomycin combined with gamma globulin in the treatment of neonatal sepsis.Methods A total of 91 cases of neonatal sepsis admitted to the First People′s Hospital of Nanyang City,Henan Province,from January 2020 to January 2023 were included,and the enrolled children were grouped by the randomized numerical table method and classified as the conventional group(45 cases)and the combined group(46 cases)respectively.The conventional group was given conventional antibacterial treatment,while the combined group was given Vancomycin treatment.The immune function,improvement of inflammation factor,bacterial clearance,symptomatic relief time,and safety of medication were compared before and after the treatment of the 2 groups of children.Results Before treatment,the immune function of the two groups of children was no statistically significant difference(P>0.05);After treatment,the IgA,IgM,and IgG of the combination group were(2.15±0.46)g/L,(1.88±0.52)g/L,and(15.8±4.5)g/L,which were higher than those of the conventional group[(1.72±0.33)g/L,(1.25±0.45)g/L,and(12.8±5.1)g/L],and the difference was statistically significant(P<0.05).Before treatment,there was no statistically significant difference in inflammatory factors between the 2 groups.After treatment,the CRP of the combination group was(9.41±2.26)mg/L,PCT was(1.65±0.36)ng/L,and IL-6 was(103±20)ng/L,which were lower than those of the conventional group[(10.8±2.0)mg/L,(2.08±0.25)ng/L,and(115±21)ng/L],and the difference was statistically significant(P<0.05).Under different treatment regimens,the bacterial clearance rate of the combination group was 43%(20/46)after 1 day of treatment,the bacterial clearance rate was 70%(32/46)after 3 days of treatment,and the bacterial clearance rate was 89%(41/46)after 7 days of treatment,which were higher than those in the conventional group[29%(13/45)56%(25/45),67%(30/45),]and the difference was statistically significant(P<0.05).In the combined group,the time for fever reduction was(2.26±0.18)days,the time for edema dissipation was(4.3±1.3)days,the time for recovery from milk refusal was(5.2±1.3)days,and the time for hospitalization was(8.2±2.2)days,which were lower than those in the conventional group[(3.15±1.06)d,(5.8±1.1)d,(6.6±2.0)d,(10.2±3.1)d],the difference was statistically significant.Under different treatment regimens,the incidence of drug-related side effects in the combination group was 15%(7/46),which was slightly higher than that in the conventional group,which was 11%(5/45),and the difference was not statistically significant(P>0.05).Conclusion The treatment of neonatal sepsis with vancomycin and gammaglobulin can effectively enhances the immune function of children and reduces inflammatory reaction,which is of positive significance in improving the bacterial clearance rate of children and promoting the recovery of symptoms.Moreover,the safety of this combination of drug regimen is relatively high,and the risk of the occurrence of drug-related side effects has not been significantly increased.