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目的:观察清热解毒制剂宫颈用药对人乳头状瘤病毒(HPV)感染者的临床疗效及对局部免疫因子的影响。方法:将高危型人乳头状瘤病毒(HR-HPV)持续感染而无宫颈组织学病变患者100例随机分为治疗组和对照组,治疗组以中药清热解毒制剂宫颈局部上药处理,对照组仅随访观察。采用酶联免疫法(ELISA)测定入组时及随访6、12个月时两组患者宫颈局部环境中γ-干扰素(IFN-γ)及白介素-4(IL-4)的水平;随访6、12个月复查HR-HPV及宫颈液基细胞(TCT),以HPV清除率为指标评价临床疗效。结果:与入组时比较,随访期间两组患者宫颈局部环境中IFN-γ水平均明显升高,IL-4水平均明显下降,IFN-γ/IL-4均明显升高(P<0.01),其中治疗组各指标与对照组同期比较均有显著性差异(P<0.05或P<0.01);在随访期间,治疗组6个月时的HPV转阴率明显高于对照组(P<0.01),随访12个月时治疗组仍优于对照组(P<0.05)。在随访6和12个月时,HPV清除者的IFN-γ水平和IFN-γ/IL-4均明显高于未清除者(P<0.01),而IL-4的水平明显低于未清除者(P<0.01);所有患者在治疗过程中均无严重不良反应。结论:清热解毒制剂宫颈局部上药可清除HPV感染,且安全有效;其作用可能与上调IFN-γ表达、下调IL-4表达,扭转IFN-γ/IL-4比值有关。
Objective: To observe the clinical effect of detoxification preparation on cervical HPV infection and its effect on local immune factors. Methods: One hundred patients with persistent infection of high-risk human papillomavirus (HR-HPV) without cervical histopathology were randomly divided into treatment group and control group. The treatment group was treated with topical medicine of detoxification preparation of cervix and cervix, Only follow-up observation. The levels of IFN-γ and IL-4 in the cervix of the two groups were measured by enzyme-linked immunosorbent assay (ELISA) at 6 and 12 months of follow-up. Follow-up 6 HR-HPV and cervical liquid-based cells (TCT) were reviewed at 12 months, and the clinical efficacy was evaluated with HPV clearance as an index. Results: Compared with the control group, the levels of IFN-γin the cervix of the two groups were significantly increased, the levels of IL-4 were significantly decreased and the levels of IFN-γ / IL-4 were significantly increased at follow-up (P <0.01) (P <0.05 or P <0.01). During the follow-up period, the HPV negative conversion rate of the treatment group at 6 months was significantly higher than that of the control group (P <0.01) ), The treatment group was still superior to the control group at 12 months of follow-up (P <0.05). At 6 and 12 months of follow-up, the levels of IFN-γ and IFN-γ / IL-4 in patients with HPV clearance were significantly higher than those without HPV infection (P <0.01), while the levels of IL-4 were significantly lower than those without HPV infection (P <0.01). All patients had no serious adverse reactions during the course of treatment. Conclusion: Local cervical topical detoxification preparation can clear HPV infection and is safe and effective. It may be related to up-regulating the expression of IFN-γ, down-regulating the expression of IL-4 and reversing the ratio of IFN-γ / IL-4.