保妇康栓和干扰素栓对低度子宫颈上皮内瘤变1级作用的临床研究

The clinical observation for Baofukang and interferon in promoting the regression of low-grade cervical intraepithelial neoplasia

目的比较保妇康栓和干扰素栓对低度宫颈上皮内瘤变（CIN）转归的疗效。方法选取2004年3月至2011年3月北京大学深圳医院经阴道镜下活检诊断为CIN1的高危HPV感染患者369例，分为保妇康栓组（113例）、干扰素栓组（143例）和对照组（113例），疗程3个月，治疗结束后每6～12个月监测患者的宫颈液基细胞学（LCT）和高危HPVDNA。对宫颈细胞学ASCUS及以上病变及／或高危HPV阳性者行阴道镜下多点活检，病理诊断确定转归。结果保妇康栓组、干扰素栓组和对照组治疗后6个月均未见病变进展。3组患者的病变逆转率与持续率比较，差异均无统计学意义（P〉0．05）。保妇康栓组治疗后12、24个月病变逆转率明显高于对照组（P〈0．05），病变持续率明显低于对照组（P〈0．05）；干扰素栓组病变逆转率、持续率与对照组比较，差异均无统计学意义（P〉0．05）；3组患者的病变进展率比较，差异无统计学意义（P〉0．05）。保妇康栓组治疗后24个月HPV转阴率高于干扰素栓组和对照组（P〈0．05）。结论保妇康栓有促进CIN1逆转和清除HPV的作用，明显提高HPV的临床转阴率。

Objective To investigate the curative effect of baofukang suppository and interferon in low- grade cervical intraepithetial neoplasia （CIN1） and to compare their effects in clearing human papilloma virus （HPV）. Methods From March 2004 to March 2011, 369 cases with CIN1 and HPV infection were enrolled in this study. Patients were divided into baofukang group （group 1, 113 cases）, interferon group （group 2, 143 cases） and control group （group 3, 113 cases）. All patients were under follow- up for 24 months by using liquid- based cytology test combined with high- risk HPV test （HC-Ⅱ ） every 6 to 12 months. If the cervical cytology indicated as ASC- US or more severe lesion and/or HR- HPV positive, colposcopy and biopsies were performed. Results There was no progression case and the persistence and regression rate of CIN1 had no statistical difference between three groups at 6 months. At 12 months and 24 months, patients in group 1 had lower rate of persistence and high- er rate of regression than that in the other two groups, and they had statistical differences, hut not between group 2 and group 3; as for the progression rate, no statistical difference between the three groups. At 24 months, group 1 had higher clearance rate of HPV than that in the other two groups （P〈0. 05）. Conclusions Baofukang supposi- tory can promote the CIN1 regression and HPV clear, and increase the rate of negative- inverted distinctly, while interferon had no such effects.