胸腺五肽对老年慢性病患者免疫调节的疗效和安全性研究

Effectiveness and Safety Research in Immunologic Function of Thymopentin on Senile Patients with Chronic Illnesses

目的评价胸腺五肽注射液(依妙宁)调节老年慢性病患者免疫功能的安全性和疗效。方法选取140例细胞免疫功能低下的老年慢性病患者,将其随机分为A、B两组,各70例。A组患者给予胸腺五肽注射液静脉滴注,1 mg/d,1次/d;B组患者仅给予安慰剂(0.9%氯化钠注射液)。均治疗14 d。分别在治疗前、治疗第7天、治疗第14天及停药后第14天检测两组患者的CD4细胞计数(采用玻片法),比较CD4/CD8,并观察不良反应。结果 (1)A组患者治疗第7天、第14天及停药后第14天CD4细胞数量均显著高于治疗前,差异有统计学意义(P均<0.01);且治疗第14天患者的CD4细胞数量显著高于治疗第7天及停药后第14天,差异有统计学意义(P均<0.01);停药后第14天A组患者CD4细胞数量与治疗第7天比较,差异无统计学意义(P>0.05)。(2)A组患者治疗前CD4/CD8与治疗第14天比较、治疗第7天与治疗第14天比较,差异均有统计学意义(P均<0.05)。(3)B组患者治疗前、后CD4细胞数量及CD4/CD8比较,差异均无统计学意义(P>0.05)。(4)A组患者治疗中无明显不良反应发生。结论胸腺五肽能够提高老年慢性病患者细胞免疫功能,临床应用疗效显著、持续稳定,且安全性较高。

Objective To evaluate the effectiveness and safety of immunologic function of thynmpentin （ TP - 5 ） injection （Yi Miaoning） on senile patients with chronic illnesses. Methods 140 senile patients with low immunologic function were divided into group A and group B, with each 70 cases. Group A were given thymopentin injection （Yi Miaoning） by intravenous drip, with 1 mg/d and once a day; Group B were only given placebo （0. 9% Sodium Chloride Injection）. Both groups were treated for 14 days. CD4 cell counting in the two groups were tested before treatment, the 7th day during treatment, the 14th day during treatment and 14 days after treatment （using slide method）. The CDJCDs of the two groups were compared and the adverse effects were observed. Results （ 1 ） The cell number of CD4 in the 7th day and 14th day during treatment and 14 days after treatment was significantly higher than that before treatment （ all P 〈 0. 01 ） ; the cell number of CD4 in the 14th day during treatment was significantly higher than that in the 7th day during treatment and 14 days after treatment （ all P 〈 0. 01 ） ; the cell number of CD4 in A group 14 days after treatment showed no statistical difference with that in the 7th day during treatment （P 〉0.05） ; （2） The CD4/CD8 in group A before treatment showed statistical difference with that in the 7th day and 14th day during treatment and 14 days after treatment （all P 〈 0. 05）. （3） The cell number of CD4 and CD4/CD8 in group B showed no statistical difference before and after treatment （P 〉0. 05）. （4） There was no obvious adverse effect in group A during treatment. Conclusion TP - 5 can raise cell - immunologic function on senile patients with chronic illnesses. And its effectiveness is clear and steady. It is safe to be used clinically.