派特灵治疗宫颈病变术后高危型人乳头瘤病毒持续呈阳性的临床研究

Clinical research of Paiteling in treatment of high risk-human papillomavirus persistent infection after cervical lesion surgery

目的探讨中药制剂派特灵对宫颈病变术后高危型人乳头瘤病毒(HR-HPV)持续呈阳性患者的临床治疗效果。方法选择2014年4月至2016年6月,于清华大学附属北京清华长庚医院、首都医科大学附属北京友谊医院、吉林大学第一医院、青岛大学附属医院、江苏省江阴市人民医院妇科门诊就诊,因宫颈病变进行宫颈锥切术或子宫全切术前HR-HPV呈阳性,术后3~12个月HR-HPV持续呈阳性,而术后阴道镜下组织病理学检查结果为宫颈上皮内瘤变(CIN)1或正常宫颈组织的188例患者为研究对象,包括接受宫颈锥切术患者122例与子宫全切术患者66例。根据术后对其HR-HPV持续呈阳性采取的感染药物治疗方案,将接受宫颈锥切术治疗的122例患者,分为研究组1(n=86)和对照组1(n=36);将接受子宫全切术治疗的66例患者,分为研究组2(n=43)和对照组2(n=23)。对研究组1、2患者,采取派特灵治疗,对照组1、2患者,采取重组人干扰素治疗。分别于治疗结束后第(60±7)、(120±7)天,采用第2代杂交捕获技术(HC2),对所有患者进行HR-HPV检测。4组患者术后HR-HPV感染治疗有效率,采用χ^2检验进行比较。本研究遵循的程序符合2013年新修订的《世界医学协会赫尔辛基宣言》要求。患者接受药物治疗前,均签署临床研究知情同意书。研究组1与对照组1,研究组2与对照组2患者的年龄、术前宫颈病变分级构成比等一般临床资料分别比较,差异均无统计学意义(P>0.05)。结果研究组1患者术后HR-HPV持续呈阳性的治疗有效率为77.9%(67/86),显著高于对照组1的27.8%(10/36),并且差异有统计学意义(χ^2=27.393、P<0.001)。研究组2与对照组2患者术后HR-HPV持续呈阳性的治疗有效率分别为62.8%(27/43)与39.1%(9/23),2组比较,差异无统计学意义(P>0.05)。结论派特灵对因宫颈病变行宫颈锥切术和子宫全切术后HR-HPV持续呈阳性治疗有效,尤其是对于宫颈锥切术后患者。由于本研究纳入患者相对较少,派特灵治疗宫颈病变术后HR-HPV持续呈阳性的疗效,仍然有待大样本、多中心、随机对照试验进一步研究、证实。

Objective To explore the clinical efficacy of Chinese traditional medicine Paiteling in treatment of high risk-human papillomavirus(HR-HPV)persistent infection after cervical lesion surgery.Methods From April 2014 to June 2016,a total of 188 patients who were positive with HR-HPV before and 3-12 months after cervical conization or hysterectomy,while the postoperative histopathology results were cervical intraepithelial neoplasm(CIN)1 or normal cervical tissue in Beijing Tsinghua Changgung Hospital,School of Clinical Medicine,Tsinghua University,Beijing Friendship Hospital of Capital Medical University,The First Bethune Hospital of Jilin University,The Affiliated Hospital of Qingdao University and Jiangsu Jiangyin People′s Hospital,were selected as research subjects,including 122 patients undergoing cervical conization and 66 patients undergoing hysterectomy.According to the medication plan of postoperative HR-HPV persistent infection,122 patients who received cervical conization were divided into study group 1(n=86)and control group 1(n=36);66 patients who received hysterectomy were divided into study group 2(n=43)and control group 2(n=23).Patients in study group 1 and 2 were treated with Paiteling,while patients in control group 1 and 2 were treated with recombinant human interferon.The first and second postoperative HR-HPV detection were conducted by the second generation hybrid capture 2(HC2),which were performed on the(60±7)days,(120±7)days after treatment,respectively.The effective rates of postoperative HR-HPV persistent infection treatment for patients in 4 groups were compared by chi-square test.The procedures followed in this study were in line with the requirements of newly revised World Medical Association Declaration of Helsinki in 2013.All patients signed clinical research informed consent before treatment.There were no significant differences in age and preoperative cervical lesion grading between study group 1 and control group 1,study group 2 and control group 2(P>0.05).Results For patients in study group 1,effective rate of postoperative HR-HPV persistent infection treatment was 77.9%(67/86),which was statistically higher than that in control group 27.8%(10/36),and the difference was statistically significant(χ^2=27.393,P<0.001).For patients in study group 2 and control group 2,effective rates of postoperative HR-HPV persistent infection treatment were 62.8%(27/43)and 39.1%(9/23),respectively,but there was no statistical difference(P>0.05).Conclusions Paiteling is effective for treatment of HR-HPV persistent infection after cervical conization or hysterectomy for cervical lesions surgery,especially for patients who underwent cervical conization.Due to the relatively small number of patients enrolled in this study,the efficacy of Paiteling in treatment of HR-HPV persistent infection after cervical lesion surgery remains to be further confirmed by large-sample size,multi-center,and randomized controlled trials.