紫蛇理冲汤合外洗方治疗宫颈癌伴人乳头瘤病毒感染随机对照研究  

Effect of Zishe Lichong Decoction Combined with External Washing Formula for Cervical Cancer with Human Papilloma Virus:A Randomized Controlled Trial

作　　者：陈秋叶 卢雯平[2] CHEN Qiu-ye;LU Wen-ping(College of Clinical Medicine,Beijing University of Chinese Medicine,Beijing,100029;Department of Oncology,Guang'anmen Hospital,Chinese Academy of Traditional Chinese Medicine,Beijing,100053)

机构地区：[1]北京中医药大学临床医学院,北京100029 [2]中国中医科学院广安门医院肿瘤科,北京100053

出　　处：《中国中西医结合杂志》2023年第8期916-921,共6页Chinese Journal of Integrated Traditional and Western Medicine

摘　　要：目的观察紫蛇理冲汤合外洗方治疗中晚期宫颈癌伴高危型人乳头瘤病毒(HR-HPV)感染的临床疗效,以及对免疫功能、生活质量的影响和安全性。方法94例均为2018年9月—2019年4月中晚期宫颈癌患者,符合纳入标准62例,按随机数字表法分为治疗组(紫蛇理冲汤合外洗方治疗)和对照组(重组人干扰素治疗),每组各31例。记录治疗前后HR-HPV状态、中医症状积分、免疫功能[T细胞亚群、自然杀伤(NK)细胞百分比]、无进展生存期(PFS)、生活质量评分(QLS-CCP)变化,并采用Kaplan-Meier曲线进行生存分析、用COX比例风险模型进行单因素、多因素分析影响PFS的相关因素,探究中药干预、HPV感染状态与PFS三者之间的关系。结果治疗过程中脱落2例(治疗组1例,对照组1例),共完成60例,每组各30例。治疗组在治疗结束1个月、随访21个月的HR-HPV转阴总有效率分别为60.00%(18/30)、93.33%(28/30),高于同期对照组的33.33%(10/30)、73.33%(22/30),差异均有统计学意义(χ^(2)_(1)=4.286,χ^(2)_(21)=4.320,P<0.05)。在降低中医症状积分方面,治疗组优于对照组(P<0.05)。两组治疗后CD3^(+)、CD3^(+)CD4^(+)、CD3^(+)CD4^(+)/CD3^(+)CD8^(+)比值、NK细胞水平均较治疗前升高,CD4^(+)CD25^(+)CD127^(-)水平均下降,且治疗组均较对照组更明显(P<0.05)。两组生存曲线,差异有统计学意义(Log-rankχ^(2)=4.647,P<0.05)。HPV阴性和HPV阳性对PFS有影响(Log-rankχ^(2)=7.618,P<0.05)。治疗组在改善QLS-CCP评分上优于对照组(P<0.05)。Cox单因素及多因素分析显示,年龄、入组类别、HPV感染状态、疗效评价、调节T细胞分别是宫颈癌患者PFS的影响因素及预后因素。结论紫蛇理冲汤合外洗方在治疗中晚期宫颈癌伴HR-HPV感染,可提高HR-HPV转阴率,调节机体免疫水平,减轻疾病症状,改善患者生活质量,延长宫颈癌患者PFS。Objective To observe the clinical efficacy of Zishe Lichong Decoction combined with external washing formula in the treatment of advanced cervical cancer with high risk human papilloma virus(HRHPV)infection,and its effects on immune function,quality of life,and safety.Methods Totally 94 patients with advanced cervical cancer were enrolled from September 2018 to April 2019.Sixty-two of them met the inclusion criteria,They were assigned to treatment group(treated with Zishe Lichong Decoction and external washing formula)and control group(treated with recombinant human interferon)according to random number table,31 cases in each group.The HR-HPV state,Chinese medicine(CM)symptoms score and immune functions[T cell subsets,natural killer(NK)cell percentage],progression-free surviva(l PFS),quality of life scale for cervical cancer patients(QLS-CCP)changes were recorded before and after treatment.Kaplan-Meier curve was used for survival analysis.COX proportional hazards model was used for univariate and multivariate analyses of related factors affecting PFS.The relationships between traditional Chinese medicine intervention,HPV infection state,and PFS were studied.Results Two cases dropped out during the treatment(1 case in the treatment group and 1 case in the control group),and 60 cases completed the treatment,30 cases in each group.The total effective rates of HR-HPV negative conversion at month 1 after treatment,and 21 months of follow-ups in the treatment group were 60.00%(18/30)and 93.33%(28/30),respectively,higher than those of the control group at the same time points[33.33%(10/30),73.33%(22/30)],showing statistical difference(χ^(2)_(1)=4.286,χ^(2)_(21)=4.320,P<0.05).The treatment group was superior to the control group in reducing the score of CM symptoms scores(P<0.05).After treatment the levels of CD3^(+),CD3^(+)CD4^(+),CD3^(+)CD4^(+)/CD3^(+)CD8^(+)and NK cells increased,while the levels of CD4^(+)CD25^(+)CD127^(-)decreased in both groups,and it was more obvious in the treatment group than the control group

关 键 词：宫颈癌 人乳头瘤病毒 紫蛇理冲汤 预后 中医 随机对照试验 

分 类 号：R273[医药卫生—中西医结合]