泼尼松联合静注人免疫球蛋白(pH4)治疗特发性血小板减少性紫癜的临床观察

Clinical Observation of Prednisone Combined with Human Immunoglobulin(pH4) for Intravenous Injection in the Treatment of Idiopathic Thrombocytopenic Purpura

目的:观察泼尼松联合静注人免疫球蛋白(p H4)治疗特发性血小板减少性紫癜的疗效和安全性。方法:85例特发性血小板减少性紫癜患者随机分为对照组(42例)和观察组(43例)。对照组患者给予泼尼松片1.6 mg/(kg·d),口服,连用4周;观察组患者给予静注人免疫球蛋白(pH4)400 mg/(kg·d),静脉注射,连用5 d后给予泼尼松片1.6 mg/(kg·d),口服,连用4周。两组患者治疗期间均给予肾上腺色腙片、维生素C片等常规治疗。观察两组患者的临床疗效,治疗前后血小板数量、T淋巴细胞(CD3^+、CD3^+CD4^+、CD3^+CD8^+、CD19^+)、肿瘤坏死因子(TNF)-α、白细胞介素(IL)-6,血小板数量达到正常时间、血小板数量达到峰值时间、血小板数量峰值及不良反应发生情况。结果:观察组患者总有效率、血小板数量峰值均显著高于对照组,血小板数量达到正常时间、血小板数量达到峰值时间均显著短于对照组,差异均有统计学意义(P<0.05)。治疗前,两组患者血小板数量、T淋巴细胞、IL-6、TNF-α水平比较,差异均无统计学意义(P>0.05);治疗后,两组患者血小板数量、CD3^+、CD3^+CD4^+均显著高于同组治疗前,且观察组高于对照组,IL-6、TNF-α水平和CD3^+CD8^+、CD19^+均显著低于同组治疗前,且观察组低于对照组,差异均有统计学意义(P<0.05)。两组患者不良反应发生率比较差异无统计学意义(P>0.05)。结论:泼尼松联合静注人免疫球蛋白(p H4)治疗特发性血小板减少性紫癜的疗效优于单用泼尼松,可增加患者血小板数量,调节免疫功能,且不增加不良反应的发生。

OBJECTIVE： To observe the efficacy and safety of prednisone combined with human immunoglobulin （pH4） for intra- venous injection in the treatment of idiopathic thrombocytopenic purpura. METHODS ： 85 patients with idiopathic thrombocytopenic purpura were divided into control group （42 cases） and observation group （43 cases）. Control group received 1.6 mg/（kg·d） Predni- sone tablet, orally, for continuous 4 weeks; observation group received 400 mg/（kg· d） human imrnunoglobulin（pH4） for intravenous injection, intravenous injection, for continuous 5 d, then 1.6 mg/（kg·d） Prednisone tablet, orally, for continuous 4 weeks. All pa- tients were given Adrenal color hydrazone tablet, Vitamin C tablet and other conventional treatment. Clinical efficacy, platelet number, T lymphocyte subsets （CD3＋, CD3＋CD4＋, CD3＋CD8＋, CD19＋）, TNF-a, IL-6 before and after treatment, time of platelet number reached normal and reached peak value, peak value of platelet number and the incidence of adverse reactions in 2 groups were ob- served. RESULTS ： The total effective rate and peak value of platelet number in observation group were significantly higher than control group, time of platelet number reached normal and reached peak value were significantly shorter than control group, the differences were statistically significant （P〈0.05）. Before treatment, there were no significant differences in platelet number, T lymphocyte sub- sets, IL-6 and TNF-a level in 2 groups （P〉0.05） ; after treatment, platelet number, CD3＋ and CD3＋CD4＋ in 2 groups were significant- ly higher than before, and observation group was higher than control group, IL-6, TNF-a level, CD3＋CD8＋ and CD19＋ were signifi- cantly lower than before, and observation group was lower than control group, the differences were statistically significant （P〈0.05）. And there was no significant difference in the incidence of adverse reactions in 2 groups （P〉0.05）. CONCLUSIONS： Prednisone com- bined with human immunoglobulin（pH4） for intravenous injection shows better efficacy than prednisone alone in the treatment of idio- pathic thrombocytopenic purpura, it can increase platelet number, adjust immune function, and do not increase the incidence of a verse reactions.