重组人干扰素α-2b凝胶联合匹多莫德治疗宫颈低级别鳞状上皮内病变的临床研究

Clinical evaluation of recombinant human interferon-α-2b gel combined with pidotimod for the treatment of low-grade squamous intraepithelial lesions of the cervix

摘要:

目的 评估重组人干扰素α-2b凝胶联合匹多莫德治疗宫颈低级别鳞状上皮内病变（LSIL/CIN1）的临床疗效。方法 选取2020年1月—2024年1月聊城市第二人民医院收治的88例LSIL/CIN1患者。按随机数字表法分为对照组和PID组，各44例。对照组给予重组人干扰素α-2b凝胶治疗，PID组在对照组基础上给予匹多莫德治疗。比较两组患者的临床疗效，治疗前后的阴道微生态情况、免疫功能、灌洗液炎症水平及不良反应发生率。结果 PID组的治疗总有效率高于对照组（P <0.05）。PID组的阴道微生态恢复率高于对照组（P <0.05），PID组阴道分泌物pH值、Nugent评分均低于对照组（P <0.05）。PID组治疗前后CD4⁺、CD8⁺、Treg、Th17的差值均高于对照组（P <0.05）。PID组治疗前后IFN-γ、IL-10和TNF-α的差值均高于对照组（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）。结论 重组人干扰素α-2b凝胶联合匹多莫德治疗LSIL/CIN1患者，能有效改善患者免疫水平，减少炎症反应，且安全性好，适合在临床上广泛应用。

Abstract:

Objective To evaluate the clinical efficacy of recombinant human interferon-α-2b gel combined with pidotimod in treating cervical low-grade squamous intraepithelial lesions (LSIL/CIN1).Methods This study included 88 patients with LSIL/CIN1 admitted to the Second People’s Hospital of Liaocheng from January 2020 to January 2024. Patients were randomly divided into a control group (n =44, treated with recombinant human interferon-α-2b gel) and a PID group (n =44, receiving pidotimod in addition to the control group treatment). Clinical efficacy, vaginal microecology, immune function, inflammatory levels in lavage fluid, and incidence of adverse reactions were compared between the two groups.Results The total effective rate in the PID group was higher than that in the control group (P <0.05). The recovery rate of vaginal microecology in the PID group was greater than that in the control group (P <0.05). The vaginal secretion pH and Nugent score in the PID group were lower than those in the control group (P <0.05). The differences in CD4⁺, CD8⁺, Treg, and Th17 levels before and after treatment were greater in the PID group compared to the control group, with a significant increase in CD4⁺ levels and a notable decrease in CD8⁺, Treg, and Th17 levels (P <0.05). The differences in IFN-γ, IL-10, and TNF-α levels before and after treatment were also higher in the PID group, with a significant increase in IFN-γ and a notable decrease in IL-10 and TNF-α compared to the control group (P <0.05). No significant difference was found in the incidence of adverse reactions between the two groups (P >0.05).Conclusion The combination of recombinant human interferon-α-2b gel and pidotimod is effective in improving immune levels and reducing inflammation in patients with LSIL/CIN1, with good safety and suitability for widespread clinical application.