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匹多莫德联合注射用更昔洛韦治疗传染性单核细胞增多症的临床研究 被引量:21

Clinical trial of pidotimod combined with ganciclovir for injection in the treatment of children with infectious mononucleosis
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摘要 目的观察匹多莫德联合注射用更昔洛韦治疗传染性单核细胞增多症的临床疗效及安全性。方法将94例传染性单核细胞增多症的患儿随机分为对照组和试验组,每组47例。对照组给予注射用更昔洛韦5 mg·kg^(-1),q12 h,静脉滴注;试验组在对照组的基础上给予匹多莫德口服液400 mg,bid,口服。2组患者均治疗2周。治疗前后测定免疫功能、细胞因子及心肌酶谱指标,观察并记录临床症状、体征缓解状况,同时比较2组患者的临床疗效及药物不良反应发生情况。结果治疗后,试验组有效率为91.49%(43例/47例),对照组为74.47%(35例/47例),差异有统计学意义(P<0.05)。治疗后,试验组与对照组血清CD4^+分别为(34.52±7.24)%和(29.83±6.65)%,CD8^+分别为(26.27±6.36)%和(31.82±6.73)%,CD4^+/CD8^+分别为1.38±0.40,0.93±0.35,差异均有统计学意义(均P<0.05)。试验组与对照组免疫球蛋白A(IgA)分别为(1.21±0.25)和(0.99±0.23)g·L^(-1),免疫球蛋白G(IgG)分别为(10.03±1.50)和(8.94±±1.42)g·L^(-1),血清肿瘤坏死因子α(TNF-α)分别为(1.14±0.52)和(1.81±0.63)ng·L^(-1),血清白细胞介素-6(IL-6)分别为(11.20±3.56)和(14.08±3.75)ng·L^(-1),差异均有统计学意义(均P<0.05)。试验组药物不良反应为轻微恶心、呕吐等胃肠道反应,药物不良反应发生率为10.64%(5例/47例);对照组药物不良反应为轻微恶心、呕吐等胃肠道反应及皮疹,药物不良反应发生率为8.51%(4例/47例),2组药物不良反应发生率差异无统计学意义(P>0.05)。结论匹多莫德联合更昔洛韦治疗传染性单核细胞增多症疗效确切,能提高免疫功能,降低心肌酶谱及炎症指标。 Objective To investigate the clinical effect and safety of pidotimod combined with ganciclovir for injection in the treatment of children with infectious mononucleosis. Methods Ninety-four children with infectious mononucleosis were divided into control group and treatment group,each group 49 cases. Control group was treated with ganciclovir for injection 5 mg·kg^-1+ 5% glucose injection 100 m L,q12 h,intravenous drip. On the basis of control group,treatment group was treated with pidotimod oral solution 400 mg,bid,orally. All children were treated for 2 weeks. The immune function,cytokines and myocardial enzymes were measured before and after treatment,the symptoms and signs of remission were observed and recorded,the clinical efficacy andadverse drug reactions were compared in two groups. Results After treatment,the clinical efficacy in treatment group and control group were 91. 49%( 43 cases/47 cases),74. 47%( 35 cases/47 cases),with significant difference( P〈0. 05). After treatment,the serum CD4^+in treatment group and control group were( 34. 52 ± 7. 24) % and( 29. 83 ± 6. 65) %,CD8^+were( 26. 27 ± 6. 36) % and( 31. 82 ± 6. 73) %,CD4^+/CD8^+were 1. 38 ± 0. 40 and0. 93 ± 0. 35,immunoglobulin A( IgA) were( 1. 21 ± 0. 25) and( 0. 99 ± 0. 23) g·L^-1,immunoglobulin G( IgG) were( 10. 03 ± 1. 50) and( 8. 94 ± 1. 42) g ·L^-1,serum tumor necrosis factor-α( TNF-α) were( 1. 14 ± 0. 52) and( 1. 81 ± 0. 63) ng·L^-1,serum interleukin-6( IL-6) were( 11. 20 ± 3. 56) and( 14. 08 ± 3. 75) ng·L^-1,all with significant difference( all P〈0. 05). The adverse drug reactions were mild nausea,vomiting and other gastrointestinal reactions in treatment group,with the incidence of 10. 64%( 5 cases/47 cases). The adverse drug reactions were mild nausea,vomiting and other gastrointestinal reactions and rash in control group,with the incidence of 8. 51%( 4 cases/47 cases). There was no significant difference between the two groups( P〉0. 05). Conclusion The clinical effect of pidotimod combined with antiviral drugs in the treatment of children with infectious mononucleosis is exact,it can improve the immune function and reduce the myocardial enzymes and inflammatory markers.
作者 张余转 游海星 李燕 ZHANG Yu - zhuan, YOU Hai - xing, LI Yan(Department of Pediatrics, The Third People' s Hospital of Hainan, Haikou 571100, Chin)
出处 《中国临床药理学杂志》 CAS CSCD 北大核心 2018年第9期1014-1017,共4页 The Chinese Journal of Clinical Pharmacology
基金 海南省自然科学基金资助项目(2012-812172)
关键词 匹多莫德 传染性单核细胞增多症 免疫功能 细胞因子 心肌酶谱 pidotimod infectious mononucleosis immune function cytokines myocardial enzymes
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