克林霉素注射液联合重组人干扰素α2b阴道泡腾胶囊治疗宫颈人乳头瘤病毒感染的临床研究

Clinical trial of clindamycin injection combined with recombinant human interferon alpha 2b vaginal effervescent capsules in the treatment of cervical human papillomavirus infection

目的观察克林霉素注射液联合重组人干扰素α2b阴道泡腾胶囊治疗宫颈人乳头瘤病毒(HPV)感染的临床疗效及安全性。方法将93例宫颈HPVDNA阳性患者随机分为对照组44例和试验组49例。对照组予以克林霉素注射液每次1. 2 g,静脉滴注,bid,1个疗程为7 d,持续2个疗程;试验组在对照组治疗的基础上,于阴道内放置重组人干扰素α2b阴道泡腾胶囊每次8. 0×105U,qd,1个疗程为10 d,持续3个疗程。比较2组患者的临床疗效,白细胞介素-17(IL-17)、IL-23和转化生长因子-β(TGF-β)的水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为89. 80%(44例/49例)和72. 73%(32例/44例),差异有统计学意义(P <0. 05)。治疗后,试验组和对照组的IL-17分别为(34. 67±4. 33)和(54. 78±6. 48) pg·mL^-1,IL-23分别为(13. 94±1. 37)和(18. 83±2. 29) pg·mL^-1,TGF-β分别为(19. 15±2. 47)和(24. 64±3. 69) ng·L^-1,差异均有统计学意义(均P <0. 05)。试验组发生的药物不良反应以腰腹酸痛、胃肠道反应和皮肤瘙痒为主,对照组发生的药物不良反应以腰腹酸痛为主。试验组和对照组的总药物不良反应发生率分别为12. 24%和2. 27%,差异无统计学意义(P>0. 05)。结论克林霉素注射液联合重组人干扰素α2b阴道泡腾胶囊治疗宫颈HPV感染的临床疗效明显优于单用克林霉素注射液,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of clindamycin injection combined with recombinant human interferon alpha 2b vaginal effervescent capsules in the treatment of cervical human papillomavirus( HPV) infection. Methods A total of 93 patients with cervical HPV - DNA positive were randomly divided into control group ( n = 44 cases) and treatment group ( n = 49 cases). Control group was given clindamycin injection 1. 2 g per time,intravenous infusion,bid,lasting 2 courses with 7 days per course. Treatment group placed the recombinant human interferon α2b vaginal effervescent capsule in the vagina 8. 0 × 105 U per time,qd and the course of treatment was 10 days for 3 courses, on the basis of control group. The clinical efficacy,the levels of interleukin- 17 ( IL-17),IL - 23 and transforming growth factor -β( TGF -β),and adverse drug reactions were compared between two groups. Results After treatment,the total effective rates of treatment and control groups were 89. 80%( 44 cases / 49 cases) and 72. 73%( 32 cases / 44 cases) with significant difference ( P < 0. 05). After treatment,the main indexes of treatment and control groups were compared: IL-17 were ( 34. 67 ± 4. 33) and ( 54. 78 ± 6. 48) pg·mL^-1,IL - 23 were ( 13. 94 ± 1. 37) and ( 18. 83 ± 2. 29) pg·mL^-1,TGF -β were ( 19. 15 ± 2. 47) and ( 24. 64 ± 3. 69) ng·L^-1,the differences were statistically significant ( all P < 0. 05). The adverse drug reactions of treatment group were lumbar and abdominal pain,gastrointestinal reactions and pruritus,which in control group were lumbar and abdominal pain. The total incidences of adverse drug reactions in the treatment and control groups were 12. 24% and 2. 27% without significant difference ( P > 0. 05). Conclusion The clinical efficacy of clindamycin injection combined with recombinant human interferon α2b vaginal effervescent capsules in the treatment of cervical HPV infection is better than that of clindamycin alone,without increasing the incidence of adverse drug reactions.