外用红色诺卡氏菌细胞壁骨架治疗宫颈高危型HPV持续感染的临床疗效及免疫效果评价

Evaluation of Clinical Efficacy and Immune Effect of Nocardia Rubra Cell Wall Skeleton for External Use in the Treatment of Persistent Cervical HPV Infection

摘要: 目的：探讨外用红色诺卡氏菌细胞壁骨架(红卡)治疗高危型人乳头瘤病毒(HPV)持续感染的临床疗效及免疫效果。方法：选取2019年5月~2020年5月青岛市妇女儿童医院诊治的80例宫颈高危型HPV持续感染患者作为研究对象，随机将其分成研究组和对照组，每组40例。研究组应用红卡治疗，对照组应用重组人干扰素α2b阴道泡腾片(金舒喜)联合保妇康栓治疗。比较两组患者的HPV转阴率、治疗有效率、治疗前后外周血免疫细胞水平变化、阴道灌洗液中免疫因子水平变化及不良反应的发生情况。结果：研究组临床治疗总有效率为76.92%，对照组47.37%，差异有统计学意义(P < 0.05)。研究组患者的 HPV转阴率61.54%，对照组31.58%，差异有统计学意义(P < 0.05)。两组治疗后CD4+T、CD4+/CD8+的数值均上升，较治疗前差异有统计学意义(P < 0.05)，且上升程度研究组显著高于对照组，差异有统计学意义(P < 0.05)，而CD8+T治疗前后两组患者均无明显差异(P > 0.05)。两组治疗后阴道灌洗液中IL-2、IFN-γ、TNF-α浓度均升高，IL-4浓度均降低，较治疗前差异有统计学意义(P < 0.05)，且研究组上述指标变化均显著高于对照组，差异有统计学意义(P < 0.05)；而IL-6、IL-10治疗前后两组患者均无明显差异(P > 0.05)。两组治疗均未发生严重的不良反应。结论：红卡可有效提高宫颈高危型HPV持续感染患者的转阴率，并能调节宫颈局部甚至机体的免疫功能，且无明显不良反应。

Abstract: Objective: To explore the clinical efficacy and immune effect of Nocardia rubra Cell Wall Skeleton for External Use (Nr-CWS) in the treatment of high-risk human papillomavirus (HPV) persistent infection. Methods: From May 2019 to May 2020, 80 patients with high-risk HPV persistent cervical infection who were diagnosed and treated at Qingdao Women and Children's Hospital were collected, and they were randomly divided into a study group and a control group with 40 cases in each group. The study group was treated with Nr-CWS, and the control group was treated with recombinant human interferon 2b vaginal effervescent tablets combined with Baofukangshuan. We compared the HPV conversion rate and effective rate of treatment in the two groups. We also analyze the changes of immune cell levels in peripheral blood and immune factor concentrations in vaginal lavage fluid, and the occurrence of adverse reactions. Results: The total effective rate was 76.92% in the study group and 47.37% in the control group, and the difference was statistically significant (P < 0.05). The HPV conversion rate was 61.54% in the study group and 31.58% in the control group, and the difference was statistically significant (P < 0.05). After treatment, the values of CD4+T and CD4+/CD8+ increased in both groups, with statistically significant difference compared with before treatment (P < 0.05), and the degree of increase in the research group was significantly higher than that in the control group (P < 0.05), while there was no significant difference in the two groups before and after CD8+T treatment (P > 0.05). After treatment, the concentrations of IL-2, IFN- and TNF- in vaginal lavage fluid in both groups were increased, while the concentrations of IL-4 were decreased, with statistical significance compared with before treatment (P < 0.05). The changes of the above indexes in the study group were significantly higher than those in the control group, with statistical significance (P < 0.05). There was no significant difference between the two groups before and after the treatment of IL-6 and IL-10 (P > 0.05). No serious adverse reactions occurred in the two groups, and they have high security. Conclusions: Nr-CWS can effectively improve the negative conversion rate of patients with high-risk HPV persistent infection of the cervix, and can regulate the local and even the body’s immune function, and there are no obvious adverse reactions.