人免疫球蛋白联合注射用头孢哌酮钠舒巴坦钠治疗新生儿感染性肺炎的临床研究

Clinical trial of human immunoglobulin combined with cefoperazone sodium and sulbactam sodium for injection in the treatment of neonatal infective pneumonia

目的 观察人免疫球蛋白联合注射用头孢哌酮钠舒巴坦钠治疗新生儿感染性肺炎的临床疗效及安全性。方法 将感染性肺炎新生儿分为对照组和试验组。对照组给予注射用头孢哌酮钠舒巴坦钠2 g,静脉滴注,每天2次;试验组在对照组治疗的基础上给予人免疫球蛋白250 mg·kg^(-1),静脉滴注,每天1次。2组患儿均治疗7 d。记录2组的症状缓解时间及药物不良反应发生情况,分析2组的临床疗效。结果 试验组和对照组各纳入30例。治疗后,试验组和对照组的总有效率分别为96.67%和76.67%,差异有统计学意义(P<0.05)。治疗后,试验组和对照组的体温稳定时间分别为(2.41±0.31)和(3.45±0.42)d;喘息消失时间分别为(2.80±0.29)和(3.53±0.42)d;咳嗽消失时间分别为(5.05±0.81)和(7.10±1.22)d;肺啰音消失时间分别为(5.04±0.48)和(6.46±0.77)d;呼吸困难缓解时间分别为(2.14±0.23)和(3.07±0.37)d;T辅助细胞(CD4^(+))水平分别为(47.76±4.87)%和(38.38±5.54)%;T抑制细胞(CD8^(+))水平分别为(28.91±8.64)%和(32.78±3.78)%;CD4^(+)/CD8^(+)水平分别为1.82±0.65和1.19±0.23,差异均有统计学意义(均P<0.05)。试验组和对照组的药物不良反应总发生率分别为10.00%和13.33%,差异无统计学意义(P>0.05)。结论 人免疫球蛋白联合注射用头孢哌酮钠舒巴坦钠可有效改善感染性肺炎新生儿的临床症状,并明显减轻炎症反应,提高免疫功能,安全性较高。

Objective To observe the clinical efficacy and safety of human immunoglobulin combined with cefoperazone sodium and sulbactam sodium for injection in the treatment of neonatal infectious pneumonia. Methods The neonates suffering from infectious pneumonia were divided into control group and treatment group. Control group was given cefoperazone sodium and sulbactam sodium for injection 2 g ^(+) sodium chloride injection 100 mL, intravenous infusion, twice a day;treatment group was given human immunoglobulin 250 mg·kg^(-1)^(+) 5% glucose injection 50 mL, once a day, on the basis of control group, intravenous infusion. The treatment lasted for 7 days. Symptom relief time and adverse drug reactions of the two groups were recorded;immune function indexes of the two groups were detected, and clinical efficacy of the two groups were analyzed. Results Thirty cases were included in the treatment group and control group. After treatment, the total effective rate of treatment group and control group were96. 67% and 76. 67%, the difference was statistically significant(P< 0. 05). After treatment, the temperaturestabilization time of treatment group and control group were(2. 41 ± 0. 31) and(3. 45 ± 0. 42) d;the disappearancetime of gasp were(2. 80 ± 0. 29) and(3. 53 ± 0. 42) d;the disappearance time of cough were(5. 05 ± 0. 81) and(7. 10 ± 1. 22) d;the disappearance time of lung rales were(5. 04 ± 0. 48) and(6. 46 ± 0. 77) d;the relief time ofdyspnea were(2. 14 ± 0. 23) and(3. 07 ± 0. 37) d;the levels of T helper cells CD4^(+)were(47. 76 ± 4. 87)% and(38. 38 ± 5. 54) %;the levels of T suppressor cells CD8^(+)were(28. 91 ± 8. 64) and(32. 78 ± 3. 78) %;the levelsof CD4^(+)/CD8^(+)were 1. 82 ± 0. 65 and 1. 19 ± 0. 23;there were statistically significant differences in the above indexesbetween the two groups(allP< 0. 05). The total incidences of adverse drug reactions in treatment group and controlgroup were 10. 00% and 13. 33%, with no statistical significance(P> 0. 05).Conclusion Human immunoglobulincombined with cefoperazone sodium and sulbactam sodium for injection can effectively improve the clinical symptoms ofneonates with infectious pneumonia, significantly reduce inflammation, improve immune function, and have highsafety.