Clinical trial of thymopeptide enteric-coated capsules combined with human interferon α2b vaginal effervescent tablets in the treatment of patients with high-risk HPV infection-related cervical lesions
Objective To observe the therapeutic effect of thymopeptide enteric-coated capsules combined with human interferon α2b vaginal effervescent tablets in the treatment of patients with high-risk human papillomavirus(HPV)infection-related cervical lesions and the impact on T lymphocyte subsets.Methods The patients with high-risk HPV infection-related cervical lesions were divided into the treatment group and the control group according to the cohort method.The control group was given human interferon α2b vaginal effervescent tablets 5 × 105 U,once daily,for 2 months.On this basis,the treatment group was treated with thymopeptide enteric-coated capsules at a dose of 30 mg·time-1,three times a day,for 2 months.Therapeutic effects,cervical vaginal microecology indicators[pH values of vaginal secretions,Nugent scores and white blood cell count],T lymphocyte subsets,cytokines[interleukin-4(IL-4),IL-6,IL-10,tumor necrosis factor-α(TNF-α)and interferon-γ(IFN-γ)]were compared between the two groups,and the safety were evaluated.Results Seventy cases in the treatment group and 72 cases in the control group.After treatment,the total effective rate of the treatment group was 94.29％(66 cases/70 cases),which was higher than the control group's 80.56％(58 cases/72 cases),the differences were statistically significant(P＜0.05).After treatment,pH values of vaginal secretions in treatment group and control group were 4.26±0.19 and 4.38±0.17;Nugent scores were(2.53±0.36)and(2.79±0.40)scores;Blood cell count were 5.12±1.14 and 6.03±1.21;CD3+were(69.32±8.10)％and(66.54±7.03)％;CD4+were(37.25±5.03)％and(34.67±4.82)％;CD4+/CD8+were 1.50±0.35 and 1.42±0.33;serum IL-4 levels were(7.49±1.64)and(9.20±2.18)pg·mL-1;serum IL-6 levels were(20.95±5.03)and(26.64±6.22)pg·mL-1;serum IL-10 levels were(11.72±2.46)and(13.43±2.97)pg·mL-1;serum TNF-α levels were(16.48±3.75)and(13.25±2.03)pg·mL-1;serum IFN-γ levels were(13.35±2.11)and(10.93±2.86)pg·mL-1;the differences were statistically significant(all P＜0.05).Adverse drug reactions in the treatment group included nausea,fever,vaginal itching and pain;which in the control group included vaginal itching and pain.The total incidence rates of adverse reactions in the treatment group and the control group were 8.57％(6 cases/70 cases)and 5.56％(4 cases/72 cases),without statistically significant difference(P＞0.05).Conclusion Thymopeptide enteric-coated capsules combined with human interferon α2b vaginal effervescent tablets can improve immune function,reduce inflammatory reactions,and improve cervical and vaginal micro-ecological environment in patients with high-risk HPV infection-related cervical lesions.
万方数据
维普
