派特灵治疗宫颈锥切术后高危型人乳头瘤病毒感染的临床观察研究

Clinical observation study of Paiteling on high-risk HPV infection clearance of cervical lesions after conization

目的评价中药制剂派特灵治疗宫颈锥切术后(冷刀锥切/LEEP术)高危型人乳头瘤病毒(high-risk human papillomavirus,HR-HPV)持续感染的临床疗效。方法采用多中心随机对照方法,将符合纳入标准的77例患者随机分为实验组和对照组。实验组41例患者采用派特灵治疗,对照组36例患者采用重组人干扰素(辛复宁)治疗。两组患者分别于入组后第3个月±7天、第5个月±7天进行第一次和第二次HR-HPV检测,以分析宫颈锥切术后HR-HPV感染的转阴情况。结果实验组41例患者中,脱落1例,HR HPV感染的转阴率为77.5%(31/40);对照组36例患者中,脱落0例,HR-HPV转阴率为27.8%(10/36)。两组患者HR-HPV感染转阴率比较,其差异具有统计学意义(P<0.05)。结论派特灵对宫颈锥切术后HR HPV持续感染的清除是安全有效的。

Objective To evaluate the clinical efficacy of Paiteling on eliminating persistent HR-HPV infection after cervical conization(cold knife conization/LEEP). Methods A multi-center randomized method was applyed to patients who meet the inclusion and exclusion criteria of the study and were randomly assigned into two groups. One group with Paiteling treatment as experimental group, the other with recombinant human interferon(Xinfuning) therapy as the control group. The first and second HR-HPV DNA tests were performed respectively 3 months±7 days and 5 months±7 days after the initial treatment, to analyze the negative conversion rate of HR-HPV infection after conization of cervix. Results There were 41 patients enrolled in experimental group totally, 1 subject dropped out, HR-HPV infection negative rate was 77.5%(31/40);There were 36 patients enrolled in interferon control group, 0 subject dropped out, HR-HPV negative rate was 27.8%(10/36), there were statistical differences of HR-HPV negative rate(P<0.05) between two groups. Conclusions Paiteling is safe and effective on eliminating HR-HPV persistent infection after cervical conization.