中文English
ISSN 1001-5256 (Print)
ISSN 2097-3497 (Online)
CN 22-1108/R

Advances in radiotherapy for pancreatic cancer from 2019 to 2020

DOI: 10.3969/j.issn.1001-5256.2021.03.048
  • Received Date: 2020-08-25
  • Accepted Date: 2020-09-27
  • Published Date: 2021-03-20
  • With the rapid development of radiotherapy equipment, imaging technology, and artificial intelligence, radiotherapy has entered the era of precision therapy. Radiotherapy is one of the important methods for the treatment of pancreatic cancer, and rapid progress has been made in related concepts and technical models of radiotherapy in recent years. With reference to the latest advances in radiotherapy technology and the change of radiotherapy dose mode, which the experts in the field of radiotherapy are concerned with, this article reviews and analyzes recent articles and points out that multimodal images play an important role in guiding radiotherapy for pancreatic cancer, and the dose mode of radiotherapy develops to high-dose hypofractionated radiotherapy. The effect of neoadjuvant radiotherapy has been further confirmed, and strong chemotherapy with the combination of multiple drugs is the main radiotherapy regimen for pancreatic cancer.

     

  • 第三代头孢菌素(third generation cephalosporin,3rd GC)是治疗自发性细菌性腹膜炎(spontaneous bacterial peritonitis,SBP)的经典用药,尽管已不适合用于院内获得性SBP的经验性治疗,但目前多项指南1-2仍将3rd GC作为社区获得性SBP(community-acquired SBP,CASBP)经验性治疗的推荐用药。然而,近期研究3提示,3rd GC经验性治疗CASBP的初治有效率仅为64.6%,疗效并不理想。本团队前期构建了一个针对CASBP的3rd GC疗效预测模型4,旨在协助临床医生筛选3rd GC治疗的优势患者,提高疗效,回顾性验证提示该模型预测准确性良好。现为进一步检验该模型的临床应用价值,拟开展一项随机对照研究,以期为3rd GC治疗CASBP的优化策略提供依据。

    前瞻性选取2021年1月—2022年6月南昌市第九医院新入院的肝硬化伴CASBP患者。纳入标准:(1)年龄18~70岁;(2)基于影像学证据确诊为肝硬化,腹腔穿刺证实为CASBP。排除标准:(1)具有腹腔以外部位感染者;(2)存在肝性脑病、消化道出血、肝肾综合征、肝癌、休克等严重并发症者;(3)存在心、肺、肾、脑严重基础疾病者;(4)头孢菌素过敏者;(5)合并艾滋病或使用免疫抑制剂等明显免疫功能受抑患者;(6)本次发病已使用抗生素治疗;(7)临床医生认为具有不合适入组的其他情况者。退出标准:腹水培养及药敏结果与本研究抗菌方案相冲突或提示结核菌、真菌、寄生虫等其他病原感染,或治疗48 h内患者死亡,或患者拒绝继续参加本研究。

    CASBP定义为入院48 h内腹水多形核细胞(polymorphonuclear,PMN)计数≥0.25×109/L,且排除腹腔继发性感染5。初治有效定义为初始抗菌治疗48 h后复查腹水PMN计数较基线下降≥25%2;第5天治愈定义为抗菌治疗至第5天复查腹水PMN计数<0.25×109/L6。广谱抗生素暴露定义为本次发病前3个月内曾接受过广谱抗生素治疗。3rd GC治疗CASBP的疗效预测模型4:Y=-1.844×SBP首次发病(是=1,否=0)-0.318×腹水PMN计数(×109/L)+2.214×广谱抗生素暴露(是=1,否=0)+0.012×血小板(×1012/L)-0.543,预测评分=exp(Y)/[1+exp(Y)],预测评分≥0.207为治疗无效,反之为有效。Child-Pugh评分7与终末期肝病模型(MELD)评分8参照文献计算。

    将入选患者按照随机数字表法分为优化治疗组与传统治疗组,两组的干预措施详见图1。两组基础治疗按实际病情执行,两组在第5天后终止试验性干预,后续治疗由临床医生依实际病情决定。头孢他啶的标准剂量为2.0 g加入生理盐水100 mL静脉滴注,1次/12 h;亚胺培南标准剂量为0.5 g加入生理盐水100 mL静脉滴注,1次/8 h;万古霉素的标准剂量为1.0 g加入生理盐水100 mL静脉滴注,1次/12 h,均需依据肾功能或体质量调整剂量。

    图  1  两组的干预措施
    Figure  1.  Interventions of the two groups

    主要研究终点:初治有效率。次要研究终点:第5天治愈率,30天病死率。

    收集患者的姓名、性别、年龄、病因、基础疾病等一般数据。试验第1天(抗生素治疗前、SBP确诊当日)需采集的数据包括生命体征、SBP相关症状及体征、血常规、凝血功能、血生化、腹水常规及腹水培养,第3天和第5天复查腹水常规及腹水培养,血液检查按需复查。试验开始后共随访30天,除上述数据外,还需记录抗生素使用情况和生存情况。

    本研究拟比较优化治疗组的初治有效率是否优于传统治疗组,故采用优效性定性试验样本计算方法,每组样本量的计算方法及参数参考相关文献49-10。经计算,两组例数应分别至少22例。

    采用SPSS 26.0软件进行统计分析。正态分布的计量资料以x¯±s表示,两组间比较采用成组t检验;非正态分布的计量资料以MP25P75)表示,两组间比较采用Mann-Whitney U检验。计数资料两组间比较采用χ2检验或Fisher精确概率法。P<0.05为差异有统计学意义。

    共纳入50例肝硬化伴CASBP患者,优化治疗组和传统治疗组各25例,所有病例均完成研究,中途无退出。两组患者性别比、年龄、肝硬化病因、临床特征等基线资料比较,差异均无统计学意义(P值均>0.05)(表1)。优化治疗组腹水培养3例阳性,包括非多重耐药菌2例(大肠埃希菌1例、溶血性链球菌1例)和多重耐药菌1例(产超广谱β内酰胺酶的大肠埃希菌)。传统治疗组腹水培养3例阳性,包括非多重耐药肺炎克雷伯菌2例和多重耐药菌1例(产超广谱β内酰胺酶的大肠埃希菌)。

    表  1  两组患者基线情况比较
    Table  1.  Comparison of baseline between two groups of patients
    指标 传统治疗组(n=25) 优化治疗组(n=25) 统计值 P
    男性[例(%)] 17(68.0) 22(88.0) χ2=2.914 0.088
    年龄(岁) 50.2±9.8 55.3±11.9 t=-1.625 0.111
    肝硬化病因[例(%)] 0.220
    HBV 17(68.0) 15(60.0)
    酒精 4(16.0) 4(16.0)
    HCV 1(4.0) 0(0.0)
    HBV+酒精 3(12.0) 1(4.0)
    HBV+HCV 0(0.0) 1(4.0)
    隐源性 0(0.0) 4(16.0)
    2型糖尿病[例(%)] 4(16.0) 1(4.0) χ2=0.889 0.346
    脾切除术[例(%)] 1(4.0) 4(16.0) χ2=0.889 0.346
    广谱抗生素暴露[例(%)] 9(36.0) 8(32.0) χ2=0.089 0.765
    SBP首次发病[例(%)] 18(72.0) 20(80.0) χ2=0.439 0.508
    腹痛[例(%)] 7(28.0) 9(36.0) χ2=0.368 0.544
    腹部压痛[例(%)] 16(64.0) 14(56.0) χ2=0.333 0.564
    腹部反跳痛[例(%)] 15(60.0) 14(56.0) χ2=0.082 0.774
    腹水量[例(%)] χ2=0.082 0.470
    少量 0(0.0) 2(8.0)
    中大量 25(100.0) 23(92.0)
    体温(℃) 36.6(36.4~37.9) 36.6(36.4~38.0) Z=-0.234 0.815
    白细胞(×109/L) 4.7(3.7~7.6) 4.9(3.2~9.3) Z=-0.116 0.907
    血小板(×1012/L) 72.0(41.5~94.5) 80.0(47.0~108.5) Z=-0.951 0.342
    凝血酶原时间(s) 15.5(13.4~20.3) 15.3(14.4~18.3) Z=-0.301 0.763
    国际标准化比值 1.4(1.2~1.8) 1.3(1.2~1.5) Z=-1.068 0.286
    谷丙转氨酶(U/L) 24.5(17.3~57.9) 26.0(14.7~35.3) Z=-0.990 0.322
    谷草转氨酶(U/L) 34.8(28.8~89.0) 38.6(24.7~85.2) Z=-0.252 0.801
    总胆红素(μmol/L) 37.8(17.7~69.3) 31.8(20.7~58.4) Z=-0.602 0.547
    白蛋白(g/L) 29.5(23.7~33.7) 31.4(24.8~34.1) Z=-0.466 0.641
    血肌酐(μmol/L) 71.2(66.1~106.2) 70.1(62.9~96.4) Z=-0.961 0.337
    尿素氮(mmol/L) 5.2(4.5~7.1) 4.7(4.1~6.5) Z=-1.029 0.304
    腹水白细胞(×109/L) 0.857(0.596~1.637) 1.034(0.713~2.345) Z=-1.145 0.252
    腹水PMN(×109/L) 0.616(0.361~1.216) 0.700(0.518~1.417) Z=-1.009 0.313
    MELD评分 9.3(6.7~18.6) 9.3(6.3~13.4) Z=-0.660 0.509
    Child-Pugh评分 10(8~11) 9(8~11) Z=-1.243 0.214
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    优化治疗组初治有效率为88.0%(22/25),明显高于传统治疗组的60.0%(15/25)(χ2=5.094,P=0.024);优化治疗组第5天治愈率为80.0%(20/25),传统治疗组第5天治愈率为56.6%(14/25),两组比较差异无统计学意义(χ2=3.309,P=0.069)。两组抗生素使用及疗效详见图2。在使用头孢他定初治的患者中,优化治疗组的初治有效率高于传统治疗组(88.9% vs 60.0%),差异有统计学意义(χ2=4.341,P=0.037),两组第5天治愈率比较,差异无统计学意义(83.3% vs 56.0%,χ2=2.425,P=0.119)。

    图  2  两组抗生素使用及治疗效果
    Figure  2.  Use and efficacy of antibiotics in the two groups

    所有纳入研究的患者中,初治有效者的第5天治愈率[81.1%(30/37)]高于初治无效者[30.8%(4/13)],差异有统计学意义(χ2=8.998,P=0.003),初治有效与第5天治愈关联明显(OR=9.643,95%CI:2.292~40.564)。

    第5天终止试验性干预后,两组患者均继续抗感染治疗,总疗程至少2周,按图2所示,路径1为继续头孢他啶治疗,后有1例因疗效不佳换用美罗培南;路径2为换用亚胺培南治疗,后降阶梯为头孢哌酮舒巴坦;路径3为继续亚胺培南治疗,后有1例因疗效不佳而联用万古霉素及伏立康唑,余5例降阶梯为头孢哌酮舒巴坦(3例)或哌拉西林舒巴坦(2例);路径4为亚胺培南联合万古霉素治疗,后因疗效不佳而换用替加环素联合头孢哌酮舒巴坦及卡泊芬净;路径5为继续头孢他啶治疗,后有3例因疗效不佳而换用亚胺培南(2例)或美罗培南(1例),换用美罗培南者因疗效不佳而联用利奈唑胺;路径6为换用亚胺培南治疗,后有2例因疗效不佳而联用万古霉素(1例)或利奈唑胺(1例),2例因疗效不佳而换用替加环素联合头孢哌酮舒巴坦及氟康唑,余6例降阶梯为头孢哌酮舒巴坦(4例)或哌拉西林舒巴坦(2例)。

    优化治疗组的30天病死率为8.0%(2/25),传统治疗组的30天病死率为20.0%(5/25),两组比较差异无统计学意义(χ2=0.664,P=0.415)。优化治疗组患者死因包括感染性休克1例和上消化道出血1例;传统治疗组患者死因包括感染性休克2例,肝性脑病1例,肝肾综合征1例及肝性脑病合并上消化道出血1例。

    将所有患者分为生存组与死亡组,对表1中的各项指标行组间比较,结果显示各项指标差异均无统计学意义(P值均>0.05)。生存组初治有效率为79.1%(34/43),死亡组为42.9%(3/7),两组比较差异无统计学意义(χ2=2.437,P=0.119)。生存组第5天治愈率为74.4%(32/43),死亡组为28.6%(2/7),两组比较差异有统计学意义(χ2=3.899,P=0.048);第5天治愈与患者30天死亡关联明显(OR=0.138,95%CI:0.023~0.813)。

    本研究结果发现,在CASBP的经验性抗菌治疗中,优化治疗组的初治有效率明显高于传统治疗组。由于优化治疗组中包含亚胺培南初治的患者,而传统治疗组均为头孢他啶初治,故上述疗效差异可能是抗生素固有差异导致。但进一步行亚组分析显示,在均使用头孢他啶的初治患者中,优化治疗组的初治有效率仍明显高于传统治疗组(有效率提高超过20%),故证实3rd GC治疗CASBP的疗效预测模型具备协助临床医生筛选3rd GC治疗的优势患者、提高3rd GC经验性初治疗效的实用价值。在其他感染治疗领域,也有利用临床数据构建疗效预测模型或筛选影响因素以协助医生提高疗效的研究。林清婷等11构建了院内获得性耐甲氧西林金黄色葡萄球菌肺炎的初始治疗效果预测模型,其受试者工作特征曲线下面积为0.841,认为该模型预测效能良好,可用于早期识别疗效不佳患者并提前干预。李晨等12构建了慢加急性肝衰竭合并细菌感染抗菌治疗72 h的效果预测模型,其受试者工作特征曲线下面积为0.764,预测效能优于MELD评分,认为可依据该模型积极调整抗菌方案从而提高疗效。因此,本研究涉及的疗效预测模型具备相当的可行性,临床医生可以试用。

    抗生素初治疗效对改善SBP患者预后至关重要。Lee等13研究表明,抗生素初治疗效是SBP患者30天死亡的独立影响因素,与初治成功的患者相比,初治失败患者死亡风险升高18.72倍。Piano等14研究证实,抗生素初治有效的SBP患者比初治无效者具有更高的90天非肝移植生存率(93.8% vs 50.0%)。本团队前期研究3发现,3rd GC治疗SBP初治有效者比初治无效者有着更高的30天生存率(86.2% vs 72.5%)。本研究也发现,在CASBP患者中,抗生素初治有效者的第5天治愈概率是无效者的9.643倍,而第5天治愈者的30天死亡风险仅为未愈者的13.8%。上述研究结果证明,提高3rd GC治疗SBP的初治疗效率有助于提高患者生存率,因此认为3rd GC治疗CASBP的效果预测模型可协助改善患者预后。

    在临床实践中,医生可在该模型协助下,对筛选为3rd GC治疗有效的CASBP患者合理选用3rd GC经验性初治,既保证了疗效,也可降低医疗费用;而针对筛选为3rd GC治疗无效的CASBP患者,则可弃用3rd GC经验性初治步骤、避免无效治疗,直接选用强效抗生素(如加酶抑制剂的3rd GC或碳青霉烯类等)治疗,有助于尽早控制病情、改善预后。针对筛选为3rd GC治疗有效的CASBP患者,目前尚无证据推荐选择何种3rd GC最为合适,近期有研究15认为头孢噻肟、头孢曲松以及环丙沙星经验性治疗SBP的疗效相仿,可供参考。另外,选用诸如亚胺培南、第四代头孢菌素和万古霉素等强效抗生素行SBP经验性治疗虽能提高初治疗效,但有研究16表明此类抗生素可能会增加SBP患者死亡风险,推测与诱导多重耐药菌及真菌二重感染有关,故而基于本预测模型的个体化抗生素选择具有必要性。

    本研究亦存在一些不足之处。为单中心研究,若开展多中心研究将使研究结果更具说服力。优化治疗组与传统治疗组的第5天治愈率和30天预后以及生存组与死亡组的初治有效率均未显示出组间统计学差异,该阴性结果不符合抗菌初治有效可改善SBP预后的一般规律,可能与针对次要研究终点的样本量相对不足有关。此外,SBP患者的预后除了与抗菌疗效有关以外,还与胆红素、Child-Pugh评分、MELD评分、年龄、血循环细菌负载量等多种因素有关16-18,这也可能是造成上述阴性结果的原因之一。

    综上所述,本疗效预测模型有助于提高3rd GC经验性治疗CASBP的初治效果,可协助临床医生合理选用抗生素。

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