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目的探讨胸腺五肽(TP-5)对恶性肿瘤患儿化疗停药后免疫功能和用药的安全性。方法随机抽取20例恶性肿瘤化疗停药患儿,予TP-5肌肉注射(<30kg患儿10mg/次,1次/周;≥30kg患儿10mg/次,2次/周,3个月为1个疗程,连用2个疗程)作为治疗组。20例肿瘤化疗停药患儿不做任何免疫调节治疗作为对照组。于停药后3个月检查细胞免疫(CD3、CD4+、CD8+、CD4+/CD8+)、自然杀伤(NK)细胞(CD56)、体液免疫(IgG、IgM、IgA)功能。定期检测肝肾功能、心电图、血常规。结果1.治疗组治疗前与对照组细胞免疫、NK细胞及体液免疫比较无显著性差异(Pa>0.05);2.治疗组治疗3个月与同期对照组比较,细胞免疫均无显著性差异(Pa>0.05),而NK细胞及体液免疫均较对照组显著提高(Pa<0.05);3.治疗组治疗6个月细胞免疫、NK细胞及体液免疫均较同期对照组显著提高(Pa<0.01);4.治疗组治疗6个月较治疗3个月细胞免疫、NK细胞及体液免疫均有显著提高(P<0.01,P<0.05);5.治疗组治疗3个月期间患儿感染发生率为15%(3/20例),感染控制时间为3～5d(平均3.8d);对照组感染发生率为65%(13/20例),感染控制时间为5～10d(平均6.5d),对照组感染发生率显著高于治疗组(χ2=9.30P<0.01),感染控制时间长于治疗组(t=4.40P<0.01);6.治疗组治疗6个月期间仅1例出现注射局部疼痛,二组均未出现肝肾功能及心电图改变。结论TP-5具有改善肿瘤化疗停药后患儿免疫功能的作用,减低感染发生率,且临床应用安全。
Objective To investigate the safety of thymopentin (TP-5) on immune function and medication in patients with malignant tumor after drug withdrawal. Methods Twenty patients with chemotherapy-refractory malignant tumors were randomly divided into three groups: intramuscular injection of TP-5 (10 mg / time, 10 mg / time, ≥30 kg / time, 1 course of treatment, used in conjunction with 2 courses) as a treatment group. Twenty patients with chemotherapy-free chemotherapy did not receive any immunomodulatory therapy as control group. Cellular immunity (CD3, CD4 +, CD8 +, CD4 + / CD8 +), natural killer (NK) cells (CD56) and humoral immunity (IgG, IgM, IgA) were examined at 3 months after discontinuation. Regular testing liver and kidney function, ECG, blood routine. There was no significant difference in NK cell and humoral immunity between the treatment group and the control group before treatment (Pa> 0.05) .2. There was no significant difference in cellular immunity between the treatment group and the control group at 3 months (Pa> 0.05), NK cell and humoral immunity were significantly increased compared with the control group (Pa <0.05) .3. The cellular immunity, NK cell and humoral immunity in the treatment group were significantly higher than those in the control group at 6 months (Pa < 0.01) .4. The cellular immunity, NK cell and humoral immunity of the treatment group were significantly improved (P <0.01, P <0.05) at 6 months after treatment for 3 months; 5. The infection rate was 15% (3/20 cases) and infection control time was 3-5 days (average 3.8 days). The incidence of infection in the control group was 65% (13/20 cases) and the infection control time was 5 ~ 10 days d). The incidence of infection in the control group was significantly higher than that in the treatment group (χ2 = 9.30P <0.01), and the infection control time was longer than that in the treatment group (t = 4.40P <0.01) Injection of local pain, two groups did not appear liver and kidney function and ECG changes. Conclusion TP-5 has the effect of improving immunological function in children with chemotherapy after stopping chemotherapy, reducing the incidence of infection, and its clinical application is safe.