重组人干扰素-α2b联合5-氨基酮戊酸光动力疗法治疗宫颈上皮内病变合并HPV感染患者的临床研究  

Clinical trial of recombinant human interferon 2b combined with 5-aminolaevulinic acid photodynamic therapy in the treatment of patients with cervical intraepithelial lesions complicated with HPV infection

作　　者：刘亚南[1] 卢艳阳 张荣[1] 杜依蓓 高瑜佳 魏莹 LIU Ya-nan;LU Yan-yang;ZHANG Rong;DU Yi-bei;GAO Yu-jia;WEI Ying(Department of Obstetrics and Gynecology,the Second Affiliated Hospital of Suzhou University,Suzhou 215000,Jiangsu Province,China)

机构地区：[1]苏州大学附属第二医院妇产科,江苏苏州215000

出　　处：《中国临床药理学杂志》2024年第10期1414-1418,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的观察重组人干扰素-α2b(rhIFN-α2b)联合5-氨基酮戊酸光动力疗法(ALA-PDT)治疗宫颈上皮内病变合并人乳头状瘤病毒(HPV)感染患者的临床疗效及安全性。方法回顾性分析宫颈上皮内病变合并HPV感染患者临床资料,按队列法分为对照组和试验组。对照组给予重组人干扰素α2b凝胶1支放置于阴道后穹窿,每天1次;试验组在对照组的基础上给予ALA-PDT治疗,将盐酸氨酮戊酸外用散(118 mg)温敏凝胶配制成5%浓度ALA温敏凝胶湿敷于阴道表面,并进行光疗,每周1次。比较2组患者的临床疗效、临床症状恢复时间、复发率、治疗前后细胞因子[白细胞介素-6(IL-6)、白细胞介素-8(IL-8)、γ-干扰素(IFN-γ)]和免疫功能[T细胞亚群CD3^(+)、CD4^(+)、CD8^(+)及CD4^(+)/CD8^(+)]变化,并比较2组的安全性。结果试验组98例,对照组100例。治疗后,试验组和对照组的总有效率分别为93.88%和83.00%,在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组的小腹坠痛缓解时间分别为(3.65±0.52)和(5.26±0.65)d,白带异常恢复时间分别为(5.77±0.83)和(7.16±0.92)d,阴道不规则流血恢复时间分别为(4.82±0.62)和(6.94±0.77)d,HPV清除率分别为58.16%和42.00%,IL-6分别为(0.16±0.09)和(0.23±0.05)mg·L^(-1),IL-8分别为(0.47±0.05)和(0.66±0.07)mg·L^(-1),IFN-γ分别为(10.07±0.98)和(7.24±0.65)ng·mL^(-1),CD3^(+)分别为(71.06±8.29)%和(61.36±6.88)%,CD4^(+)分别为(48.25±5.94)%和(42.25±5.13)%,CD8^(+)分别为(20.37±2.42)%和(24.69±2.51)%,CD4^(+)/CD8^(+)分别为2.11±0.27和1.36±0.16,在统计学上差异均有统计学意义(均P<0.05)。试验组和对照组的复发率分别为5.10%和14.00%,在统计学上差异有统计学意义(P<0.05)。试验组和对照组的总药物不良反应发生率分别为26.53%和21.00%,在统计学上差异无统计学意义(P>0.05)。结论rhIFN-α2b联合ALA-PDT治疗宫颈上皮内病变合并HPV感染患者临床疗效较好,在提高患者免疫�Objective To observe the clinical effect and safety of recombinant human interferon-α2b(rhIFN-α2b)combined with 5-aminolaevulinic acid photodynamic therapy(ALA-PDT)in the treatment of patients with cervical intraepithelial lesions and human papilloma virus(HPV)infection.Methods The clinical data of patients with cervical intraepithelial lesions and HPV infection were analyzed retrospectively.The patients were divided into control group and treatment group according to cohort method.The control group was treated with rhIFN-α2b gel at posterior fornix,qd.On this basis,the treatment group was treated with ALA-PDT,namely applying 5%ALA temperature-sensitive gel prepared by 118 mg of ketone valerate hydrochloride powder for external use on vaginal surface,combined with photodynamic therapy,once a week.The clinical efficacy,time to recovery from clinical symptoms,recurrence rate,changes in cytokines[interleukin-6(IL-6),interleukin-8(IL-8)and interferon-(IFN-)]and immune function[T cell subsets CD3^(+),CD4^(+),CD8^(+)and CD4^(+)/CD8^(+)],and safety were compared between the two groups.Results There were 98 cases in treatment group and 100 cases in control group.The total effective rates in treatment group and control group were 93.88%and 83.00%,with statistically significant difference(P<0.05).The relief time of lower abdominal pain in treatment group and control group were(3.65±0.52)and(5.26±0.65)d;the time to recovery from abnormal vaginal discharge were(5.77±0.83)and(7.16±0.92)d;the time to recovery from irregular vaginal bleeding were(4.82±0.62)and(6.94±0.77)d;HPV clearance rates were 58.16%and 42.00%;IL-6 levels were(0.16±0.09)and(0.23±0.05)mg·L^(-1);IL-8 levels were(0.47±0.05)and(0.66±0.07)mg·L^(-1);IFN-levels were(10.07±0.98)and(7.24±0.65)ng·mL^(-1);CD3^(+)were(71.06±8.29)%and(61.36±6.88)%;CD4^(+)were(48.25±5.94)%and(42.25±5.13)%;CD8^(+)were(20.37±2.42)%and(24.69±2.51)%;CD4^(+)/CD8^(+)were 2.11±0.27 and 1.36±0.16;the differences were all statistically significant(all P<0.05).Recurrence r

关 键 词：重组人干扰素-α2b凝胶 5-氨基酮戊酸光动力疗法 宫颈上皮内病变 人乳头状瘤病毒感染 

分 类 号：R97[医药卫生—药品]