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目的:观察胸腺肽辅助治疗慢性湿疹的临床疗效及安全性,从外周血T淋巴细胞亚群变化探讨该药的治疗机制。方法:将160例慢性湿疹患者按随机数字表法分成观察组和对照组,各80例。两组患者均给予咪唑斯汀、地奈德乳膏等常规治疗;观察组患者加用胸腺肽肠溶片20 mg,po,tid;对照组患者给予与胸腺肽肠溶片外观一致的安慰剂治疗。两组患者疗程均为4周。比较两组患者T淋巴细胞亚群的变化、临床疗效和不良反应发生情况,以及随访1年的复发率。结果:观察组患者的有效率(91.25%)显著高于对照组(77.50%),差异有统计学意义(P<0.05);治疗后,两组患者的CD4+和CD4+/CD8+均较治疗前显著升高,CD8+较治疗前显著降低,且观察组患者的CD4+和CD4+/ CD8+均显著高于对照组,差异均有统计学意义(P<0.05),但组间CD8+比较差异无统计学意义(P>0.05)。两组患者的不良反应发生率比较,差异无统计学意义(P>0.05),但随访期间观察组患者的复发率(31.51%)显著低于对照组(64.52%),差异有统计学意义(P<0.05)。结论:胸腺肽可通过改善T淋巴细胞亚群来提高慢性湿疹患者的临床疗效、降低复发率,且用药安全。
OBJECTIVE: To observe clinical efficacy and safety of thymosin in adjunctive treatment of chronic eczema, and to investigate its mechanism from the change of peripheral T lymphocyte subsets. METHODS: 160 patients with chronic eczema were randomly divided into observation group and control group, with 80 cases in each group. Both group received conventional therapy as mizolastine, Desonide cream. Observation group additionally received Thymosin enteric-coated tablet 20 mg,po, tid; control group was given placebo the appearance of which was same with Thymosin enteric-coated tablet. Treatment course lasted for 4 weeks. The change of T lymphocyte subsets, clinical efficacy and the occurrence of ADR were compared between 2 groups. Recurrence rate of both groups were followed up for 1 year. RESULTS: The effective rate of observation group (91.25%) was significantly higher than that of control group(77.50%), with statistical significance(P<0.05). After treatment, CD4+ and CD4+/ CD8+ of 2 groups were significantly increased, while CD8+ was decreased significantly; CD4+ and CD4+/ CD8+ of observation group were significantly higher than those of control group, with statistical significance (P<0.05), but there was no statistical significance in CD8+ between 2 groups (P>0.05). There was no statistical significance in the incidence of ADR between 2 groups (P>0.05). Recurrence rate of observation group (31.51%) was significantly lower than that of control group (64.52%) during follow-up period, with statistical significance(P<0.05). CONCLUSIONS: In summary, thymosin can improve clinical efficacy and reduce recurrence rate by regulating T lymphocyte subsets with good safety.
胸腺肽慢性湿疹T淋巴细胞亚群临床疗效复发
ThymosinChronic eczemaT lymphocyte subsetsClinical efficacyRecurrence
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