派特灵联合重组人干扰素α2b栓治疗老年低度宫颈上皮内瘤变的临床研究

Clinical trial of Trane combined with recombinant human interferon α2b vaginal suppository in the treatment of elderly patients with low-grade cervical intraepithelial neoplasia

目的观察派特灵联合重组人干扰素α2b栓治疗老年低度宫颈上皮内瘤变(CIN)的临床疗效及安全性。方法将48例老年低度CIN患者随机分为对照组24例和试验组24例。对照组予以重组人干扰素α2b栓1.0×105U,每2天1次,睡前置于阴道后穹隆;试验组在对照组治疗的基础上,加用派特灵0.5mL,qd,局部湿敷,1个月后改为每2天1次。2组患者均治疗3个月。比较2组患者的临床疗效、血清脂肪细胞因子Chemerin、白细胞介素-10(IL-10)、IL-18水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的有效率分别为83.34%(20/24例)和54.17%(13/24例),差异有统计学意义(P<0.05)。治疗后,试验组和对照血清Chemeri分别为(939.47±104.43),(1204.54±115.34)ng·L^(-1);IL-10分别为(210.47±30.06),(262.45±29.77)pg·mL^(-1);IL-18分别为(181.23±22.34),(235.34±23.17)pg·mL^(-1),差异均有统计学意义(均P<0.05)。试验组的药物不良反应为局部轻微疼痛,对照组的药物不良反应为一过性低热,2组患者的药物不良反应发生率均为4.17%,差异无统计学意义(P>0.05)。结论派特灵联合重组人干扰素α2b栓治疗老年低度CIN的临床疗效显著,其能够显著降低患者的血清Chemerin、IL-10和IL-18水平,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of Trane combined with recombinant human interferon α2b vaginal suppository in the treatment of elderly patients with low-grade cervical intraepithelial neoplasia（CIN）. Methods Forty-eight elderly patients with low-grade CIN were randomly divided into control group and treatment group with 24 cases per group. Control group was given recombinant human interferon α 2b vaginal suppository 1. 0 × 10^5 U,once two days,placed in the posterior fornix of vagina before bedtime. Treatment group was given Trane 0. 5 mL,qd,local wet dressing,and 1 month after treatment changed to once every two days,on the basis of control group.Two groups were treated for 3 months. The clinical efficacy,serum levels of Chemerin,interleukin-10（IL-10） and IL-18,adverse drug reactions were compared between two groups. Results After treatment,the effective rates in treatment and control groups were 83. 34%（20/24cases） and 54. 17%（13/24 cases） with significant difference（P〈0. 05）. After treatment,the main indexes in treatment and control groups were compared： the Chemerin were（939. 47 ± 104. 43）,（1204. 54 ± 115. 34） ng ·L^-1;IL-10 were（210. 47 ± 30. 06）,（262. 45 ± 29. 77） pg · mL^-1; IL-18 were（181. 23 ± 22. 34）,（235. 34 ± 23. 17）pg·mL^-1,the differences were statistically significant（P〈0. 05）. The adverse drug reaction in treatment group was minor local pain,which in control group was transient low-grade fever. The incidences of adverse drug reactions in two groups were 4. 17%,without significant difference（P〉0. 05）. Conclusion Trane combined with recombinant human interferon α2b vaginal suppository has a definitive clinical efficacy in the treatment of elderly patients with low-grade CIN,which can reduce the serum levels of Chemerin,IL-10 and IL-18,without increasing the incidence of adverse drug reactions.