用抗人结肠癌单克隆抗体检测血清和粪便中大肠癌相关抗原的研究

目的 研究抗人结肠癌MAb检测血清及粪液中癌相关抗原的价值。 方法 采用抗人结肠癌单抗SC_(3A)和SC_6检测47例结直肠癌、33例结直肠腺瘤、15例增生性息肉、14例炎性息肉及60例正常人群的血清和粪便中癌相关抗原。经ELISA双抗体夹心法检测。 结果 血清和粪便阳性率在结直肠癌组分别为66.0％和72.3％;腺瘤组为63.6％和60.6％;增生性息肉组为35.7％和57.1％;炎性息肉组为40.0％和33.3％;而正常对照组仅为11.7％和13.3％。45例大肠癌Dukes分期进行检测,早期癌粪便检测的阳性率为72.2％,而血清为50.0％。 结论 ELISA法检测不仅对大肠癌及癌前病变具有较好的敏感性,而且对早期癌及癌前期病变检测较血清学检测意义更大。此外,随腺瘤不典型增生程度加重而检测阳性率增高。粪便中检测大肠癌相关抗原,方法简便,取材容易,具较好敏感性,对大规模人群普查大肠癌具有一定的应用价值。     

Adjuvant therapy of pancreatic cancer using monoclonal antibodies and immune response modifiers

Summary Pancreatic cancer is a devastating disease with poor survival. At present, no effective adjuvant or palliative therapies are available. Unresponsiveness to chemotherapy, radiotherapy, and antihormonal treatment is one of the reasons that pancreatic cancer patients have an overall median survival time of 4–6 mo. This article summarizes clinical trials on immunotherapy of pancreatic cancer using the murine monoclonal antibodies (MAbs) 17-1A and BW 494. In addition, the use of MAb treatment in combination with immune response modifiers is discussed. In four clinical trials, MAb 17-1A was given by iv infusion to 100 patients with pancreatic cancer. In 30 of these patients, antibody treatment was accompanied, by γ-interferon, also given intravenously. Complete response, partial response, and stable disease were reported in 1, 5, and 23 patients, respectively. Passive immunotherapy using the MAb BW 494 was carried out in 148 pancreatic cancer patients in two phase I and two phase II trials. In 1 out of 75 patients a partial response and in 25 out of 74 paitents stable disease were reported. However, in a controlled, randomized trial enrolling, 61 patients following Whipple resection, comparable survival times in patients with, and without MAb BW 494 treatment led to the termination of further clinical trials with this antibody. New clinical studies using humanized MAbs in combination with immune response modifiers should be initiated to, further evaluate immunotherapy as a treatment option in pancreatic cancer.     

Nonoperative therapies for combined modality treatment of hepatocellular cancer: expert consensus statement

Although surgical resection and liver transplantation are the only treatment modalities that enable prolonged survival in patients with hepatocellular carcinoma (HCC), the majority of HCC patients presents with advanced disease and do not undergo resective or ablative therapy. Transarterial chemoembolization (TACE) is indicated in intermediate/advanced stage unresectable HCC even in the setting of portal vein involvement (excluding main portal vein). Sorafenib has been shown to improve survival of patients with advanced HCC in two controlled randomized trials. Yttrium 90 is a safe microembolization treatment that can be used as an alternative to TACE in patients with advanced liver only disease or in case of portal vein thrombosis. External beam radiation can be helpful to provide local control in selected unresectable HCC. These different treatment modalities may be combined in the treatment strategy of HCC and also used as a bridge to resection or liver transplantation. Patients should undergo formal multidisciplinary evaluation prior to initiating any such treatment in order to individualize the best available options.     

解读美国甲状腺协会2009年甲状腺结节和分化型甲状腺癌诊治指南

近期,美国甲状腺协会发表了第3版甲状腺结节和分化型甲状腺癌的临床诊治指南,总共提出了80项指南性的参考建议.指南强调了细针穿刺细胞学检查对鉴别甲状腺结节良、恶性的意义.提出了甲状腺癌手术方式以及是否进行淋巴结清扫的具体操作方案,并详细介绍了分化型甲状腺癌131I治疗的适应证、整个操作过程、不良反应、131I扫描联合甲状腺球蛋白测定的判读等.此外,指南还提出了甲状腺癌危险度三等级的判断标准.     

Meta‐analysis: The efficacy and safety of monoclonal antibody targeted to epidermal growth factor receptor in the treatment of patients with metastatic colorectal cancer

OBJECTIVE: To evaluate systematically the efficacy and safety of anti‐epidermal growth factor receptor (EGFR) monoclonal antibody added to a chemotherapeutic regimen in the treatment of patients with metastatic colorectal cancer (mCRC). METHODS: Eligible articles were identified by searching electronic databases. All randomized trials comparing the arm with an anti‐EGFR monoclonal antibody to the arm without an anti‐EGFR monoclonal antibody during the treatment of mCRC were included. A statistical analysis was performed with Review Manager 4.2.8. RESULTS: Seven randomized trials (n= 4186) were identified. The pooled response rates were 25.4% and 17.6% by intention‐to‐treat analyses for patients with or without an anti‐EGFR monoclonal antibody, respectively, the OR was 3.36 (95% CI 1.42–7.95); the incidence of grades 3–4 adverse events were 71.2% and 54.3% for two groups, respectively, the OR was 2.23 (95% CI 1.74–2.86). The incidence of diarrhea, skin toxicity, hypomagnesemia was 62.3% versus 55.7%; 79.3% versus 19.7%; 27.2% versus 5.6%; and the summary OR was 1.36 (95% CI 1.03–1.80); 33.47 (95% CI 14.81–75.61); 6.73 (95% CI 3.84–11.82), respectively. CONCLUSION: Our results confirmed that monoclonal antibody targeted to EGFR could be effective in increasing response rates and could be a key therapeutic agent in the optimal treatment of mCRC, despite a moderate increase in grades 3–4 adverse events.     

《世界卫生组织指南:慢性丙型肝炎感染者的筛查、护理和治疗(2016年更新版)》推荐意见

2014年4月世界卫生组织(WHO)发布了首份《丙型肝炎感染者的筛查、护理和治疗指南》,旨在帮助各国改进对肝炎的治疗和关护,并由此减少肝癌和肝硬化导致的死亡.近2年来,随着疗效更佳、疗程更短、使用方便、安全性好的直接抗病毒药物(direct-acting antiviral agent,DAA)陆续上市,WHO于2016年4月对丙型肝炎指南进行更新,此版指南主要在治疗推荐方面有了较大的改变,治疗中推荐了7种DAAs,包括西咪匹韦(simeprevir,SMV)、索非布韦(sofosbuvir,SOF)、雷迪帕韦(leidpasvir,LDV)、达卡他韦(daclatasvir,DCV)、翁比他韦(ombitasvir,OBV)、帕利瑞韦(paritaprevir,PTV)和达萨布韦(dasabuvir,DSV).笔者对本指南的推荐意见及部分图表内容进行了翻译,供业内同行参考.每条推荐建议后标注新或旧以区别2016年更新或未更新的内容.本指南依据的循证医学证据质量等级和推荐强度等级按照GRADE系统.     

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高尿酸血症(HUA)不仅是一种代谢性疾病,而且与众多心血管疾病密切相关。本文对无症状高尿酸血症合并心血管疾病诊治建议中国专家共识进行了解读,论述了HUA的危险因素、诊断标准、HUA与心血管疾病因果关系的流行病学、无症状HUA药物治疗相关临床研究及治疗建议等内容。     

International Association of Pancreatology (IAP)/European Pancreatic Club (EPC) consensus review of guidelines for the treatment of pancreatic cancer

BackgroundPancreatic cancer is one of the most devastating diseases with an extremely high mortality. Medical organizations and scientific societies have published a number of guidelines to address active treatment of pancreatic cancer. The aim of this consensus review was to identify where there is agreement or disagreement among the existing guidelines and to help define the gaps for future studies.MethodsA panel of expert pancreatologists gathered at the 46th European Pancreatic Club Meeting combined with the 18th International Association of Pancreatology Meeting and collaborated on critical reviews of eight English language guidelines for the clinical management of pancreatic cancer. Clinical questions (CQs) of interest were proposed by specialists in each of nine areas. The recommendations for the CQs in existing guidelines, as well as the evidence on which these were based, were reviewed and compared. The evidence was graded as sufficient, mediocre or poor/absent.ResultsOnly 4 of the 36 CQs, had sufficient evidence for agreement. There was also agreement in five additional CQs despite the lack of sufficient evidence. In 22 CQs, there was disagreement regardless of the presence or absence of evidence. There were five CQs that were not addressed adequately by existing guidelines.ConclusionThe existing guidelines provide both evidence- and consensus-based recommendations. There is also considerable disagreement about the recommendations in part due to the lack of high level evidence. Improving the clinical management of patients with pancreatic cancer, will require continuing efforts to undertake research that will provide sufficient evidence to allow agreement.     

《肝硬化门静脉高压食管胃静脉曲张出血的防治指南》解读

正肝硬化门静脉高压并发食管胃静脉曲张破裂出血(esophageal gastric variceal bleeding,EVB)是临床常见的危急症之一。尽管近10年来药物及内镜治疗成绩显著,但其6周内病死率达15%~20%,肝功能Child-Pugh C级合并EVB患者病死率高达30%~40%[1-2]。2008年中华医学会肝病学分会、消化内镜分会及消化病学分会(称为"三个学会")首次制订了我国《肝硬     

抗L3T4单抗对线粒体腺苷酸转移酶多肽诱导小鼠心肌病的免疫治疗

目的 :探讨抗L3T4单克隆抗体对线粒体腺苷酸转移酶 (adeninenucleotidetranslocator ,ANT)多肽诱导的小鼠心肌病是否有治疗作用。方法 :15只雄性Balb/c小鼠分为 3组 :①免疫应答组 (n =5 ) :予ANT多肽免疫诱导心肌病的产生 ;②免疫治疗组 (n =5 ) :先予ANT多肽免疫 ,喂养 3个月后再给予抗L3T4单抗进行治疗 ;③对照组 (n =5 ) :以不含ANT合成肽的空白免疫液免疫小鼠。采用ELISA法检测血清抗ANT多肽抗体动态变化 ,实验结束时在光镜和电镜下观察小鼠心肌组织的病理改变 ,计算组织中的胶原纤维容积分数。实验期半年。结果 :免疫应答组小鼠体内均有ANT抗自身抗体的产生 ,且抗体的光密度值 (A )明显增高 ,与对照组相比差异有统计学意义 (P <0 .0 1) ;免疫治疗组小鼠经抗L3T4单抗治疗后自身抗体出现反应性下降 ,其A值与免疫应答组及对照组比较差异均有统计学意义 (均P <0 .0 1) ;对照组抗体检测为阴性。病理结果显示 ,免疫应答组小鼠心肌组织出现弥漫性纤维化 ,心肌细胞线粒体和肌丝有明显损害 ,心肌胶原纤维容积分数明显高于对照组(P <0 .0 1) ;免疫治疗组小鼠心肌组织的病理改变略轻于免疫应答组 ,心肌胶原纤维容积分数介于免疫应答组和对照组之间 ;对照组心肌组织基本正常。结论 :ANT多肽可诱导小鼠产生抗AN     

Beyond KRAS: Predictive factors of the efficacy of anti-EGFR monoclonal antibodies in the treatment of metastatic colorectal cancer

Systematic analysis of the epidermal growth factor receptor (EGFR) pathway revealed that biomarkers could be used to predict the response to and outcome of anti-EGFR therapies in patients affected by metastatic colorectal cancer. We have conducted a review on the most recent findings and advances on this topic. To this aim, we searched the PubMed database for articles devoted to predictive and prognostic biomarkers for patients administered cetuximab- and panitumumab-based therapies. Here we review the state of the art and the controversies about the molecular factors known to be predictors of the efficacy of anti-EGFR therapy, namely, KRAS, BRAF, NRAS, PI3KCA and PTEN, and we discuss their prognostic value in colorectal cancer patients.     

A decision support tool for the detection of pancreatic cancer in general practice: A modified Delphi consensus

Background/objectivesDiagnosis of pancreatic cancer is often delayed, contributing to patient and family distress and leading to worse survival. We aimed to develop a decision support tool to support primary care providers to identify patients that should undergo investigations for pancreatic cancer, and to recommend initial diagnostic pathways.MethodsA modified Delphi process, including a series of three surveys, was undertaken to ascertain clinical expert opinion on which combinations of signs, symptoms and risk factors should be included in a tool for the early identification of pancreatic cancer. A group of clinical specialists finalised the development of the tool during a focus group meeting.ResultsThe tool presents individual or combinations of signs, symptoms, and risk factors in three tiers which direct the urgency of investigation. Tier 1 includes 5 clinical presentation and risk factors clusters that indicate the need for urgent investigation of the pancreas. A further five clusters are included as Tier 2 aiming to elimate other causes and reduce the time to investigating the pancreas. Tier 3 includes a list of non-specific signs, symptoms and risk factors that indicate the need to consider pancreatic cancer as a potential diagnosis, but without specific recommendations for investigation.ConclusionsProspective validation studies are now required prior to implementation in the primary care setting. Implementation into primary care practice and as an educational resource may facilitate rapid diagnosis and improve outcomes such as distress and survival.     

Passive protection against Taenia saginata infection in cattle by a mouse monoclonal antibody reactive with the surface of the invasive oncosphere

The surface, excretory/secretory and intracellular compartments of Taenia saginata oncospheres were analysed by a combination of immunochemical techniques and by the use of selected hybridoma antibodies. The surface proteins of the oncospheres were directly iodinated by the lactoperoxidase technique and the intracellular and excretory/secretory components were labelled biosynthetically by culture in vitro with 35S-methionine. Analysis of radiolabelled proteins by SDS-PAGE revealed a restricted number of components in all of these three compartments. Mouse derived monoclonal antibodies directed against the oncospheral stage of this parasite demonstrated both stage specific and common determinants on the surfaces of the oncospheres and the metacestodes. One monoclonal (IgM) antibody, reactive with the oncosphere surface, which had a half life of 4.1 days when injected into calves, conferred protection against oral infection with T. saginata eggs. A monoclonal antibody reactive with a major secreted component did not confer passive protection.     

Phase 1b dose-escalation,safety, and pharmacokinetic study of IC14, a monoclonal antibody against CD14, for the treatment of amyotrophic lateral sclerosis

Background:The primary objective was to demonstrate the safety and tolerability of monoclonal antibody against CD14 (IC14) (atibuclimab) in amyotrophic lateral sclerosis patients. The secondary objectives were pharmacokinetics, pharmacodynamics, and preliminary effects on disease status and biomarkers.Methods:In this open-label, dose-escalation trial, IC14 was administered at 2 mg/kg intravenous (IV) followed by 1 mg/kg/d IV × 3 (n = 3) and in subsequent patients at 4 mg/kg IV followed by 2 mg/kg/d IV × 3 (n = 7) ({"type":"clinical-trial","attrs":{"text":"NCT03487263","term_id":"NCT03487263"}}NCT03487263). Disease status was measured using the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale, forced vital capacity, sniff nasal pressure, Edinburgh Cognitive and Behavioural ALS Screen, and Revised ALS-Specific Quality-of-Life Score. Disease biomarkers included cerebrospinal fluid and serum levels of neurofilament light chain (NfL) and urinary p75 neurotrophin receptor.Results:IC14 was safe and well tolerated. No antidrug antibodies were detected. The drug target saturation of monocyte CD14 receptors was rapid and sustained through day 8. There was no significant change in Revised Amyotrophic Lateral Sclerosis Functional Rating Scale, forced vital capacity, sniff nasal pressure, or Revised ALS-Specific Quality-of-Life Score following a single cycle of treatment. Cerebrospinal fluid NfL levels decreased in 6 of 9 patients sampled with declines of 15% to 40% between baseline (not significant [ns]) and day 8 in 3 patients. Serum NfL modestly decreased in 5 of 10 patients (ns) at day 8 and was sustained in 4 (4%-37%, ns) over 33 days of follow up.Conclusion:IC14 quickly and durably saturated its target in all patients. This study demonstrated safety and tolerability in patients with amyotrophic lateral sclerosis. Even though only a single cycle of treatment was given, there were promising beneficial trends in the neurofilament light chain, a disease biomarker. The emerging understanding of the role of systemic inflammation in neurodegenerative diseases, and the potential for IC14 to serve as a safe, potent, and broad-spectrum inhibitor of immune dysregulation merits further clinical study.Clinical Trial Registration:{"type":"clinical-trial","attrs":{"text":"NCT03487263","term_id":"NCT03487263"}}NCT03487263     

The inhibitory effect of an EGF receptor-specific tyrosine kinase inhibitor on pancreatic cancer cell lines was more potent than inhibitory antibodies against the receptors for EGF and IGF I

Conclusion Epidermal growth factor (EGF) increased the cell number of the two pancreatic cancer cell lines, MiaPaCa-2 and LN-36, in vitro. A blockade of the EGF-R tyrosine kinase with tyrphostin was more efficient in reducing the cell number than inhibiting receptor antibodies. IGF-1 increased the cell number, and blockade of the IGF-1-R initially decreased the cell number that later was followed by an increase in LN-36. Background/Aim The receptors and ligands of EGF and insulin-like growth factor-1 (IGF-1) are overexpressed in pancreatic cancer tissue. The aim of the present experiments was to study the effects of EGF and IGF-1 on the cell number in two pancreatic cancer cell lines. Material and Methods MiaPaCa-2 cells were grown in 0.2% fetal calf serum (FCS) and the newly established LN-36 cells in serum-free medium (SFM). The cell number was measured with the XTT method. The effects of EGF and IGF-1 were studied in combination with inhibiting receptor antibodies and an EGF-R-specific tyrosine kinase inhibitor, tyrphostin B56. Results MiaPaCa-2 responded with increased cell number to stimulation with EGF, and at 10⁻⁸ M or higher concentrations a dose-response pattern was seen. Administration of B56 to MiaPaCa-2 decreased the cell number by 87%. The inhibiting EGF-R-Ab only inhibited EGF-induced increase in cell number. IGF-1 doubled the cell number of MiaPaCa-2 and increased the cell growth induced by EGF. The inhibiting IGF-1-R-Ab reduced the cell number by 10%. The LN-36 cell line responded to EGF with an increased cell number with a maximum at 5×10⁻⁹ M after 96 h. B56 reduced the cell number by 90% at 10⁻⁵ M, with less effect during stimulation with EGF. In contrast to B56, the inhibiting EGF-R-Ab in the same experiment did not reduce the cell number. LN-36 responded to IGF-1 with an increased cell number, but EGF-stimulated growth was not influenced. The inhibiting IGF-1-R-Ab reduced the cell number and suppressed the IGF-1 stimulated increase after 24 h and later it induced an increased cell number.     

内镜下植入缓释化疗粒子治疗晚期食管癌的临床疗效观察

[目的]观察内镜下植入缓释化疗粒子治疗晚期食管癌的临床疗效。[方法]选取13例晚期食管癌导致的食管管腔梗阻的患者行内镜下植入5-氟尿嘧啶（5-FU）缓释粒子治疗,每个植入点植入5～6粒,观察患者治疗后症状及梗阻缓解情况及近期疗效。[结果]全部病例均顺利完成治疗,未发生出血、穿孔等并发症;肝、肾功能及血常规检查未见异常。13例治疗前吞咽困难分级示Ⅱ级5例、Ⅲ级8例,治疗后Ⅱ级5例全部转为工级,Ⅲ级8例中转为Ⅰ级、Ⅱ级各3例;13例中完全缓解0例,部分缓解7例,病情稳定4例,2例无缓解,平均有效率为84．6％。[结论]晚期食管癌管腔梗阻的患者行内镜下植入5-FU缓释粒子治疗,是一种安全有效、毒副作用少、耐受性好的姑．息治疗方法。     

Efficacy of treatment with chimeric monoclonal antibody (Infliximab) to tumor necrosis factor-α for Crohn''s disease in Japan: Evaluation by rapid turnover proteins, and radiologic and endoscopic findings

BACKGROUND: Several studies have reported that the chimeric monoclonal antibody to tumor necrosis factor (TNF)-alpha (Infliximab) is extremely valuable in the treatment of Crohn's disease. The aim of this study was to clarify the efficacy of this treatment in Japanese patients with Crohn's disease. METHODS: A 12-week multicenter, open trial of Infliximab was carried out and involved 25 patients with moderate to severe Crohn's disease who were resistant to conventional treatment. Patients received a single 2-h intravenous infusion of Infliximab at a dose of 1, 3, 5 or 10 mg/kg bodyweight. Clinical evaluation of this treatment response was defined as a reduction in the index of the inflammatory bowel disease (IOIBD) and of the Crohn's disease activity index scores (CDAI), and in serum levels of C-reactive protein (CRP) at 2, 4, 8 and 12 weeks, and as an increase in serum levels of rapid turnover proteins as well as improvement of radiologic and endoscopic findings at 4 weeks. RESULTS: The IOIBD score was reduced after 4 weeks in 66.7% of the group receiving 1 mg/kg Infliximab, 71.4% in the group receiving 3 mg/kg, 80.0% in the group receiving 5 mg/kg, and 85.7% in the group receiving 10 mg/kg. Improvement was better maintained over 12 weeks in the 5 and 10 mg/kg groups compared with the 1 and 3 mg/kg groups. Similar results were obtained for the CDAI scores. Serum levels of rapid turnover proteins significantly increased to within the normal ranges after infusion in all groups. Seven of the 11 (63.6%) patients evaluated showed improvement of radiologic and endoscopic findings. CONCLUSIONS: A single infusion of Infliximab was effective for the treatment of Japanese patients with Crohn's disease. Serum rapid turnover proteins reflected the clinical response to antibody for TNF-alpha well.     

Fine epitope mapping of monoclonal antibodies to the NH2-terminal part of von Willebrand factor (vWF) by using recombinant and synthetic peptides: interest for the localization of the factor VIII binding domain

. Two different approaches were used in order to define the epitope of three monoclonal antibodies (MoAbs) against the NH₂-terminal part of the mature subunit of von Willebrand factor (vWF) which contains its factor VIII (FVIII) binding site. First, a vWF cDNA fragment library using the bacteriophage λgt11 expression vector was screened with radiolabelled MoAbs. The epitope of each MoAb was defined, following sequence analysis, by the overlapping DNA sequence of immunoreactive clones. MoAb 32B12, a potent inhibitor of FVIII/vWF interaction, binds within the Glu35-Ile81 sequence of vWF subunit. MoAb 14A12, a non-inhibitory antibody, recognizes a sequence within Thr141-Val220. MoAb 31H3, a partial inhibitory antibody, gives no positive clone. In the second method, a panel of 24 synthetic pentadecapeptides corresponding to the first NH₂-terminal 105 amino acid residues was used to block the binding of inhibitor MoAbs to immobilized vWF in an ELISA system. The localization of MoAb 32B12 epitope was confirmed and restricted to the Met51-Ala60 sequence, The MoAb 31H3 binding to vWF is inhibited by two synthetic peptides with the overlapping sequence Cys66-Gly76. All these data confirm that the FVIII binding site of vWF is not limited to the binding area (Thr78-Thr96) of the previously described MoAbs inhibiting FVIII/vWF interaction but is composed of several key sequences.     

原发性巨大肝癌与小肝癌立体定向放射治疗计划比较

目的比较原发性巨大肝癌与小肝癌立体定向放射治疗计划的设计。方法采用γ射线立体定向放射治疗原发性肝癌患者：A组43例患者,计划靶区体积（vptv）均≥300cm3;B组28例患者,31个vptv均≤100cm3。设计不同的立体定向放射治疗计划。结果 A组PTV均由50%～55%等剂量线包绕,PTV周边照射总剂量3200～3900cGy,分割处方剂量300～350cGy,每一计划需14～22个射野,靶区剂量均匀指数1.60～1.72;B组PTV均由70%～90%等剂量线包绕,PTV周边照射总剂量4000～5400cGy,分割处方剂量400～600cGy,每一计划至多需3个射野,靶区剂量均匀指数1.06～1.43。两组计划无正常组织受照剂量超过相应的耐受剂量。结论设计出合格的原发性巨大肝癌与小肝癌的立体定向放射治疗计划是可能的,然而,原发性巨大肝癌治疗计划所需射野数明显多于小肝癌治疗计划,小肝癌立体定向放射治疗计划靶区剂量均匀性优于巨大肝癌。     

Efficacy and safety of acupuncture and moxibustion combined with the external application of traditional Chinese medicine in the treatment of primary liver cancer: A protocol for systematic review and meta-analysis

Background:Primary liver cancer (PLC) is one of the most common malignant tumors in the world, and its incidence and fatality rate are increasing year by year. Due to the large population base in China, the aging population is severely affected by environmental pollution, eating habits, and unhealthy lifestyles. And many other influences have caused the number of new PLC cases and deaths in China to rank first in the world. Acupuncture combined with external application of Chinese medicine to treat PLC is currently one of the commonly used treatments in China. However, this combined treatment still lacks evidence-based medicine support. Therefore, this systematic review and meta-analysis aims to evaluate the efficacy and safety of acupuncture combined with external application of traditional Chinese medicine in the treatment of PLC.Method:We will search PubMed, Web of Science, GCBI, Embase, OVID, AMED, Cochrane Library, CNKI, VIP, CBM, and Wanfang databases. As of September 15, 2021, there are no restrictions on search language, publication time, and publication status. We will use the following medical keywords to search, including: “acupuncture”, “external application of traditional Chinese medicine”, and “primary liver cancer”. At the same time, we will manually search all reference lists from relevant systematic reviews to find other eligible studies. We will use the random effects model in REVMAN v5.3 for meta-analysis. The study for acupuncture combined with Chinese herbal medicine in the treatment of PLC was a randomized controlled study. Two researchers will independently review the research selection, data extraction, and research quality assessments. Finally, we will observe the outcome measures.Results:This study will provide evidence-based guidance for the treatment of PLC with acupuncture and the external application of traditional Chinese medicine and offers new ideas and methods for the treatment of PLC.