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目的探讨匹多莫德联合干扰素治疗对宫颈人乳头瘤病毒(HPV)感染患者免疫功能和复发的影响。方法选取2013年12月至2016年12月西安医学院第一附属医院收治的宫颈HPV病毒感染患者120例,依据随机数表法随机分为匹多莫德联合干扰素组和单干扰素组,每组60例,单干扰素组患者给予50万U的重组人干扰素α-2b栓阴道后穹窿置入治疗,匹多莫德联合干扰素组患者在此基础上给予0.8g匹多莫德口服治疗,随访24个月,采用流式细胞技术检测血浆中T淋巴细胞亚群(CD3+、CD4+、CD8+)水平,采用聚合酶链式反应法(PCR)检测HPV,采用酶联免疫吸附法(ELISA)检测血浆中肿瘤坏死因子-α(TNF-α)、白介素-6(IL-6)、C反应蛋白(CRP)水平,统计分析所有患者治疗疗效、治疗前后血浆TNF-α、IL-6、CRP、T淋巴细胞亚群水平和治疗后12、24个月的HPV DNA载量、复发情况及治疗期间不良反应发生情况。结果匹多莫德联合干扰素组患者治疗有效率(96.67%)明显高于单干扰素组(83.33%),差异有统计学意义(P<0.05);匹多莫德联合干扰素组患者治疗后血浆TNF-α[(87.29±10.33)ng/L vs(100.72±11.20)ng/L]、[IL-6(4.26±1.02)ng/ml vs(5.66±1.18)ng/ml]、CRP[(6.73±1.73)mg/Lvs(8.54±2.12)mg/L]水平明显低于单干扰素组,差异有统计学意义(P<0.05);匹多莫德联合干扰素组患者治疗后血浆CD3[(57.68%±7.52%)vs(50.01%±6.54%)]、CD4[(39.21%±5.32%)vs(35.17%±4.28%)]、CD4/CD8[(1.58±0.34)vs(1.32±0.32)]水平明显高于单干扰素组,差异有统计学意义(P<0.05);匹多莫德联合干扰素组和单干扰素组治疗期间不良反应发生率(15.00%vs 10.00%)基本相同,差异无统计学意义(P>0.05);匹多莫德联合干扰素组患者治疗后12、24个月的HPV DNA载量[(0.42±0.13)×102拷贝/ml vs(0.54±0.16)×102拷贝/ml、(0.49±0.17)×102拷贝/ml vs(0.66±0.20)×102拷贝/ml)、累积复发率(3.33%vs 15.00%、6.67%vs26.67%)明显低于单干扰素组,差异有统计学意义(P<0.05)。结论匹多莫德联合干扰素治疗可有效提高宫颈HPV病毒感染患者的治疗疗效,可有效改善患者的免疫功能和炎症状态,有利于减少患者复发的风险,且无增加患者不良反应发生的风险,值得临床进一步推广。
Objective To investigate the effect of pidotimod combined with interferon on immune function and recurrence in patients with cervical papillomavirus (HPV) infection. Methods One hundred and twenty patients with cervical HPV infection who were admitted to the First Affiliated Hospital of Xi’an Medical College from December 2013 to December 2016 were randomly divided into two groups according to the random number table: pidotimod combined with interferon group and single interferon group, Each group of 60 patients, single interferon group given 500000 U of recombinant human interferon α-2b suppository vaginal fornix treatment, Pidotimod combined with interferon group patients on this basis to give 0.8g Pidotimod The patients were followed up for 24 months. The levels of T lymphocyte subsets (CD3 +, CD4 +, CD8 +) in plasma were detected by flow cytometry. HPV was detected by polymerase chain reaction (PCR) and enzyme linked immunosorbent assay (TNF-α), interleukin-6 (IL-6) and C-reactive protein (CRP) in plasma were measured by ELISA. The therapeutic effect of all the patients was statistically analyzed. The levels of plasma TNF-α and IL- , The level of CRP, T lymphocyte subsets and the HPV DNA load, relapse and the adverse reactions during treatment of 12 and 24 months after treatment. Results The effective rate (96.67%) of the pidotimod interfering group was significantly higher than that of the single interferon group (83.33%), the difference was statistically significant (P <0.05); Pidotimod combined with interferon treatment The plasma levels of TNF-α [(87.29 ± 10.33) ng / L vs (100.72 ± 11.20) ng / L], IL-6 (4.26 ± 1.02) ng / ml vs (5.66 ± 1.18) ng / (6.73 ± 1.73) mg / L vs (8.54 ± 2.12) mg / L] were significantly lower than those in the single interferon group (P <0.05). After treatment, the plasma levels of CD3 (57.68% ± 7.52% vs 50.01% ± 6.54%), CD4 (39.21% ± 5.32% vs 35.17% ± 4.28%, CD4 / CD8 0.32)] was significantly higher than that of the single interferon group (P <0.05). The incidence of adverse reactions (15.00% vs 10.00%) in the Pidotimod plus interferon group and the single interferon group during the treatment period was significantly higher than that in the single interferon group (P> 0.05). The HPV DNA load at 12 and 24 months after treatment in Pidotimod and interferon groups [(0.42 ± 0.13) × 102 copies / ml vs (0.54 ± 0.16) ) × 102 copies / ml, (0.49 ± 0.17) × 102 copies / ml vs (0.66 ± 0.20) × 102 copies / ml), with a cumulative recurrence rate of 3.33% vs 15.00%, 6.67% vs26. 67%) was significantly lower than the single interferon group, the difference was statistically significant (P <0.05). Conclusion Pidotimod combined with interferon treatment can effectively improve the therapeutic effect of HPV infection in patients with cervical HPV infection, which can effectively improve the immune function and inflammatory status of patients and reduce the risk of relapse and without increasing the risk of adverse reactions. Worth further clinical promotion.