加味小柴胡汤联合索拉非尼治疗中晚期原发性肝癌的临床观察 临床医学专业.docx

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1、加味小柴胡汤联合索拉非尼治疗中晚期原发性肝癌的临床观察C1inica1ObservationofJiaweiXiaochaihuDecoctioncombinedwithsorafenibinthetreatmentofadvancedprimaryIivercancer摘要研究目的：本文采用前瞻性随机对照研究，通过对比加味小柴胡汤联合索拉非尼，与单用索拉非尼，观察其对中晚期原发性肝癌的疗效，评估中药联合索拉非尼对治疗中晚期原发性肝癌的疗效、不良反应，安全性，为中医药联合索拉非尼等靶向药物提供一定的临床依据。资料与方法：本研究采用前瞻性随机对照研究方法，纳入2018.9至2023.9于成都中医

2、药大学附属医院住院及门诊治疗的符合纳入标准的患者共53例，其中中药联合索拉非尼组（简称中药联合组）27例；索拉非尼靶向组26例；实验组给予索拉非尼400mg,每日2次，同时给予加味小柴胡汤为基本方的辩证中药汤剂口服，靶向组给予口服索拉非尼400mg,每日2次。2月后对入组患者进行随访,共观察2周期（2个月）,通过影像学检查评价肿瘤控制情况（DCAORR）,通过监测生化指标评价联合用药的安全性，依据美国国立癌症中心制定的不良反应评价标准（CTCAE50）监测服用索拉非尼发生过程中的不良反应。研究结果：1.临床资料基线资料：两组间比较，性别、年龄、烟酒史、肝炎病史、肝硬化、ECoG体能（PS）评分

3、、门脉癌栓、肝外转移、BC1C分期、ChidPUgh分级、腹水、高血压、治疗前安全性指标（血常规、肝肾功、凝血功能）既往治疗，AFP,中医症候方面经基线对比分析，两组间差异均无统计学意义（P0.05）,即两组间基线资料一致，具有可比性。2.疗效观察指标：（1）中医症候等级：中药联合组及靶向组治疗后患者8组中医证候均较治疗前有改善；其中中药联合组在胸闷太息、纳呆、食少、情志抑郁、恶心呕吐5组证候上改善明显，差异显著（PV0.05）,右胁痛、神疲乏力、腹胀3组证候较前有所改善，但差异不显著（P0.05）;靶向组在纳呆、食少2组证候上改善明显，差异显著（P0.05）,神疲乏力较前有所变差，但差异不显

4、著（P0.05）;两组患者治疗后组间对比，胸闷太息、情志抑郁、恶心呕吐改善情况差异显著P0.05）o（3） ChikI-PUgh分级：中药联合组治疗后组内对比，ChikI-PUgh分级较前显著提高（PV0.05）；靶向组治疗后组内对比，Chiki-PUgh分级较前有所提高，提高不显著（P0.05）;治疗后两组组间对比，中药联合组较靶向组Chi1d-PUgh分级显著提高（P0.05）,治疗后两组组间对比，中药联合组AFP较靶向组有所下降，但差异不显著（P0.05）o3 .毒副反应：两组组间对比，中药联合组手足皮肤综合征、腹泻、高血压、口腔溃疡4组的发生及严重程度较靶向组更低，差异显著（PV0.0

5、5）；中药联合组皮疹、鼻出血、蛋白尿3组的发生及严重程度较靶向组较低，但差异不显著（P0.05）o4 .安全性评价：主要包括治疗前后血常规、肝功、肾功、凝血功能等安全事件的发生情况。治疗后两组患者的血常规、肝功、肾功、凝血功能等较治疗前差异均不显著（P0.05）o结论：加味小柴胡汤联合索拉非尼与单药索拉非尼治疗中晚期原发性肝癌，虽未能显著提高患者的ORR、DCR,但能够显著改善患者中医症候症状、Chi1d-Pugh分级，降低肿瘤标志物AFP水平，发生更少的索拉非尼等相关的毒副反应，经安全性分析，加味小柴胡汤安全性良好，故该联合治疗方案值得在临床上进一步推广。关键词：加味小柴胡汤，索拉非尼，原发

6、性肝癌；国家药品监督管理局AbstractObjective:ToobservetheefficacyofJiaweiXiaochaihuDecoctioncombinedwithsorafenibandsorafeniba1oneinthetreatmentofadvancedprimary1ivercancer.DataandMethods:Aprospectiverandomizedcontro11edstudy,Atota1of53patientswereinc1udedintheinpatientandoutpatienttreatmentofChengduUniversityoft

7、raditiona1ChineseMedicinefrom2018.9to2023.9,Amongthem,27casesoftraditiona1Chinesemedicinecombinedwithsorafenibgroup;26casesofSo1afenibtargetinggroup;He1afenib400mg,inexperimenta1groupTwiceaday,AtthesametimegiveJiaweiXiaochaihudecoctionasthebasicprescriptionofdia1ectica1Chinesemedicinedecoctionora1,o

8、ra1sorafenib400mgzintargetedgroupTwiceaday.A代er2monthsoffo11ow-up,2cyc1es(2months),Eva1uationoftumorcontro1byimaging(DCRORR)zToeva1uatethesafetyofcombinationdrugsbymonitoringbiochemica1indicators,Accordingtotheadversereactioneva1uationcriteria(CTCAE.5.0)deve1opedbytheNationa1CancerCenter,theadverser

9、eactionsduringtheadministrationofsorafenibweremonitored.Resu1ts:1.Base1inedataofc1inica1data:sex,agezhistoryofa1coho1andtobacco,historyofhepatitis,1ivercirrhosis,ECOGbodyenergy(PS)score,porta1veintumorthrombus,extrahepaticmetastasis,BC1Cstage,Chi1d-Pughgrade,ascites,hypertension,safetyindexbeforetre

10、atment(b1oodroutine,1iverandkidneyfunction,coagu1ationfunction)werecomparedbetweenthetwogroups.Therewasnosignificantdifferencebetweenthetwogroups(P0.05),thatis,thebase1inedatabetweenthetwogroupswereconsistentandcomparab1e.2.curativeeffectObservationindex:main1yinc1udesTCMsymptomgrade,objectiveremiss

11、ionrate,diseasecontro1rate,Chi1d-Pughgrade,AFP.(I)ThesymptomsofTCMweresignificant1yimprovedin8groupsaftertreatment(P0.05),rightf1ankpain,fatigueandabdomina1distentionin5groups(PPO.O5)andsignificant1yimprovedin2groups(P0.05).Thesymptomsin2groupsofTCMgroupweresignificant1yimproved(0.05)Righthypochondr

12、iacpain,chesttightness,emotiona1depression,nausea,vomiting,abdomina1distensionwereimprovedin5groups,theimprovementwasnotsignificant(PP0.05),fatiguewasworsethanbefore,thedifferencewasnotsignificant(PP0.05).Aftertreatment,thedifferencebetweenthetwogroupswassignificantP0.05).(3)Chi1d-Pughgrade:theChi1d

13、-Pughgradewassignificant1yhigherinthegroupaftertreatment(P0.05),theChi1d-Pughgradewasnotsignificant1yhigherinthegroupaftertreatment(0.05),andthegradewassignificant1yhigherthanthatinthetargetgroup(PPP0.05).(4)theAFP：combinedgroupdecreasedsignificant1y(P0.05)ztheAFPofthegroupdecreasedsignificant1y(PP0

14、.05),butthedifferencewasnotsignificant(0.05)3.sideeffects:comparedbetweenthetwogroups,theoccurrenceandseverityofhandandfootskinsyndrome,diarrhea,hypertension,ora1u1cerinthecombinedgroupoftraditiona1Chinesemedicinewere1owerthanthoseinthetargetedgroup,andtheoccurrenceandseverityofrash,epistaxisandproteinuriainthecombinedgroupwere1owerthanthoseinthetargetedgroup,butthedifferencewasnotsignificant(PP0.05).4. safetyeva1uation:main1yinc1udestheoccurrenceofb1oodroutine,1iverfunction,kidneyfunction,coagu1ationfunctionandothersafetyeventsbeforeandaftertreatment.Aftertreatm