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研究生:黃姜菊
研究生(外文):HUANG, CHIANG-CHU
論文名稱:肝癌病人接受標靶治療其不良事件之系統性文獻回顧及統合分析
論文名稱(外文):Adverse events in hepatocellular carcinoma patient who receving target therapy: a systematic review and meta-analysis
指導教授:許心恬許心恬引用關係
指導教授(外文):HSU, HSIN-TIEN
口試委員:李金德林佩昭
口試委員(外文):LEE, KING-TEHLIN, PEI-CHAO
口試日期:2022-07-04
學位類別:碩士
校院名稱:高雄醫學大學
系所名稱:護理學系碩士班
學門:醫藥衛生學門
學類:護理學類
論文種類:學術論文
論文出版年:2022
畢業學年度:110
語文別:中文
論文頁數:139
中文關鍵詞:肝癌標靶治療不良事件
外文關鍵詞:Hepatocellular carcinomatarget therapyadverse event
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背景:肝癌是世界上位居第七位的癌症,在台灣,肝癌位居十大癌症死因第三位。標靶藥物抑制肝癌血管生成、延長肝癌病人的生存期,是確立的治療方式之一,但治療中所出現的藥物不良事件會降低病人接受標靶治療的意願,中斷療程。許多系統性文獻回顧文章,著重於標靶藥物治療成效、存活率等,內文雖有提及不良事件,但均非研究的主軸,而臨床上醫療團隊對於標靶藥物引起的不良事件並不熟悉,對於照顧相關病人感到吃力。
目的:探討肝癌病人接受標靶治療其不良事件的症狀及發生率、嚴重分級程度、發生率危險比、藥物減量危險比、藥物停藥危險比。
方法:利用關鍵字搜尋Cochrane Library、Embase、Pubmed、Web of Science databases、華藝線上圖書館、中文電子學位論文服務線上資料庫,搜尋截止日期為2022年4月20日。納入條件為:(1)肝癌病人;(2)接受sorafenib、lenvatinib、bevacizumab、regorafenib、cabozantinib、ramucirumab標靶治療;(3)研究族群為人類;(4)年齡大(等)於18歲;(5)文獻中需有不良事件的報告;(6)研究方法為隨機對照試驗;(7)語言為英文、中文。排除條件為:(1)轉移性(繼發性)肝癌病人(metastatic hepatic carcinoma);(2)樣本同時納入非肝癌病人;(3)接受過肝移植的病人;(4)罹患人類免疫缺乏病毒病人;(5)同時接受其他肝癌治療方式;(6)療程合併其他藥物;(7)文獻類型為文獻回顧、會議摘要、海報(poster);(8)文獻為臨床試驗的亞群組分析;(9)臨床試驗未有成果發表;(10)文獻中針對實驗組和控制組未清楚提供分組樣本資料。三位專家使用RoB 2進行隨機對照試驗文獻的偏差風險評估。各個不良事件的發生率以百分比來呈現;標靶藥物與安慰劑在治療後不良事件的發生率、藥物減量率、藥物停藥率以相對危險比呈現,使用軟體Review Manager 5.4為統合分析工具。
結果:共10篇文獻符合資格,其中兩篇文獻為系統性文獻回顧、八篇文獻為隨機對照試驗,研究收案人數範圍為226~1114位。與sorafenib有關的研究文獻為四篇,使用劑量為400mg/次、一天服用兩次;與regorafenib有關的研究文獻為一篇,使用劑量160mg/次,服用三週,休息一週;與cabozantinib有關的研究文獻為一篇,使用劑量為60mg/次;與ramucirumab有關的研究文獻為兩篇,使用劑量為8mg/kg,兩週給藥一次。三位審核者評估文獻的整體偏差風險結果呈現七篇為低風險、一篇為有些疑慮。收案的病人中肝功能Child-Pugh分級大多為分級A、BCLC分期大多為分期C、ECOG大多為等級0為主、導致肝癌的影響因素則以B型肝炎、C型肝炎為主。研究結果接受sorafenib治療常見的不良事件為手足皮膚反應(54.5%)、腹瀉(33.4%)、掉髮(28%)、疹或脫皮(23%)、高血壓(18.5%);嚴重程度大(等)於三級不良事件為手足皮膚反應(21.8%)、腹瀉(6.5%)、高血壓(5.75%)較常見。接受ramucirumab治療特別關注不良事件以肝臟損傷或衰竭(29.5%)、出血(26%)、高血壓(19%)、蛋白尿(15.5%)、輸注相關反應(7%)為常見;嚴重程度大(等)於三級不良事件以高血壓(13.5%)、肝臟損傷或衰竭(12.5%)、出血(3.5%)、蛋白尿(2%)較常見。統合分析結果顯示:(1)肝癌接受標靶藥物治療者其不良事件發生率危險比顯著高於接受安慰劑治療者1.65倍(RR=1.65, 95%CI=1.13-2.42, p<0.01)、異質性高(τ2=0.02, p<0.05, I2=82%);(2)肝癌病人接受標靶藥物治療者其藥物減量危險比顯著高於接受安慰劑治療者4.77倍(RR=4.77, 95%CI=4.15-5.48, p<0.001)、同質性高(p=0.55, I2=0%);(3)肝癌病人接受標靶藥物治療者其藥物停藥危險比顯著高於接受安慰劑治療者2.69倍(RR=2.69, 95%CI=1.48-4.90, p<0.001)、異質性高(τ2=0.65, p<0.05, I2=92%)。在次群組分析中,肝癌病人接受sorafenib治療者其不良事件發生率危險比顯著高於接受安慰劑治療者1.78倍(RR=1.78, 95%CI=1.53-2.08, p<0.001),但接受sorafenib治療者其藥物停藥危險比未顯著高於接受安慰劑治療者(RR=2.39, 95%CI=0.96-5.94, p=0.06)。而肝癌病人接受ramucirumab治療者其藥物停藥危險比顯著高於接受安慰劑治療者2.62倍(RR=2.62, 95%CI=1.06-6.50, p=0.004)。
結論:經由此篇系統性文獻回顧及統合分析得知,接受sorafenib、regorafenib、cabozantinib治療,手足皮膚反應、腹瀉、高血壓是常見的不良事件;嚴重程度大(等)於三級不良事件以手足皮膚反應、高血壓較常見。接受ramucirumab治療,高血壓、肝臟損傷或衰竭、出血、蛋白尿為特別關注且嚴重程度大(等)於三級的不良事件。肝癌病人接受標靶治療後其不良事件發生率危險比、藥物減量危險比、藥物停藥危險比皆顯著高於安慰劑治療者,尤其是接受ramucirumab會因不良事件造成藥物減量以及藥物停藥;而接受sorafenib會因不良事件造成藥物減量。
實務應用:臨床上針對接受標靶藥物所引起之不良事件,需加強照護以及管理。定期舉辦在職教育訓練課程、團隊導向學習以提升專業知識;使用護理指導單張、手冊或是製作多媒體衛教,來增加衛教人員的一致性;利用跨領域團隊會議共同調整病人治療方向,並可增加醫療團隊成員的經驗;發展針對肝癌病人標靶治療用藥評估工具,讓臨床人員更有系統性的評估病人,增加評估的完整率。
Background: Hepatocellular carcinoma is the world’s 7th most prevalent cancer; in Taiwan, it is the 3rd most deadly cancer. Target therapy has been proven to prevent angiogenesis and delay stage progression. However, during the course of target therapy, adverse events may decrease patient compliance or lead to cessation of therapy altogether. Although the effectiveness of target therapy and the improvement in survival have been validated by numerous systematic reviews, adverse events associated with these medications have not been the major study endpoints and are often overlooked. As a result, medical teams may not be as familiar with the potential adverse events, which can complicate patient care.
Objective: Investigate the adverse events of patients receiving target therapy for hepatocellular carcinoma, including incidence rate, severity, and likelihood of reducing dosage and/or discontinuation of therapy.
Methods: A comprehensive review of the Cochrane Library, Embase, Pubmed, Web Science Databases, Airiti Library (Chinese), and Electronic Theses & Dissertations Service (Chinese) was performed. Human Randomized Control Trials published prior to April 20, 2022 were considered. Search inclusion criteria included: hepatocellular carcinoma patients, patients 18 years or older, receiving sorafenib, lenvatinib, bevacizumab, regorafenib, cabozantinib, or ramucirumab target therapy, adverse event reports, English and Chinese articles. Exclusion criteria included: metastatic hepatic carcinoma, non-hepatic carcinoma diagnoses, patients who received liver transplant, patients infected with human immunodeficiency virus, patients receiving other hepatocellular carcinoma treatment, patients receiving combined cancer therapy, and articles without clear case/control group definitions. Three researches used Risk-of-Bias 2 tool to assess biases within the included randomized control trials. The incidence rate of all adverse events, adverse events following target therapy and placebo, dose reduction rate, and discontinuation of treatment in the included studies were recorded and analyzed using Review Manager 5.4 software.
Results: There were ten studies included in the present study. Two studies were systematic review, the other were Randomized Control Trials. The patient population ranging from 226 to 1114 participants. Four of the studies used sorafenib with a dose of 400mg/time, taken twice a day, two studies used ramucirumab with a dose of 8 mg/kg, one study used regorafenib with a dose of 160mg/time, taken for three weeks and a week off, and one study used cabozantinib with a dose of 60 mg/time. The overall risk of bias assessment reported seven studies as low risk and one study as some concern by three reviewers. Most of the patients included in the were Child-Pugh grade A, BCLC stage C, and ECOG Performance status of 0. Most common risk factors for hepatocellular carcinoma were Hepatitis B and Hepatitis C. Common adverse events receiving sorafenib treatment were hand-foot skin reaction (54.5%), diarrhea (33.4%), hair loss (28%), rash or desquamation (23%), hypertension (18.5%). Grade 3 adverse events were hand-foot-skin reaction (21.8%), diarrhea (6.5%), and hypertension (5.75%), which were more common. Adverse events of special interest to ramucirumab treatment were liver injury or failure (29.5%), hemorrhage (26%), hypertension (19%), proteinuria (15.5%), and infusion-related reactions (7%) were common. Among the grade 3 adverse events, hypertension (13.5%), liver injury or failure (12.5%), hemorrhage (3.5%), and proteinuria (2%) were more common. A comprehensive analysis of results revealed: First, the relative risk of any adverse events of patients receiving target therapy versus placebo for hepatic carcinoma was 1.65 (RR=1.65, 95%CI=1.13-2.42, p<0.01), heterogeneity(τ2=0.02, p<0.05, I2=82%). Second, the relative risk of patients requiring target therapy dose reduction versus placebo was 4.77 (RR=4.77, 95%CI=4.14-5.48, p<0.001), homogeneity(p=0.55, I2=0%). Third, the risk ratio of discontinuation of target therapy was 2.69 (RR=2.69, 95%CI=1.48–4.90, p<0.001). In subgroup analysis, patients who received sorafenib were more likely to experience adverse events (RR=1.78, 95%CI=1.53–2.08, p<0.001), heterogeneity (τ2=0.65, p<0.05, I2=92%). Whilethe risk of sorafenib therapy requiring discontinuation of therapy appeared higher, risk levels were not statistically significant (RR=2.39, 95%CI=0.96–5.94, p<0.06). On the other hand, patients receiving ramucirumab were at a higher risk of requiring discontinuation of therapy (RR=2.62, 95%CI=1.06–6.50, p<0.004).
Conclusions: This review demonstrates that most common adverse events of patients receiving sorafenib, regorafenib, or cabozantinib regardless of severity were hand-foot skin reaction, diarrhea, hypertension. The most common adverse events with severity level grade 3 or higher were hand-foot skin reaction and hypertension. With ramucirumab therapy, hypertension, hepatocyte injury or hepatic failure, hemorrhage, and proteinuria were the most common adverse events and most likely to have a severity grade of at least 3. The relative risk of adverse events, risk of dose reduction, and risk of discontinuing therapy in hepatocellular carcinoma patients receiving target therapy are greater than those of patients receiving placebo. Ramucirumab is more likely to require dose reduction and/or discontinuation of therapy, while sorafenib is more likely to require dose reduction.
Clinical implications: Provide patient education and medical team training to prepare for and manage adverse events. Regularly hold inservice education training courses and team-based learning to enhance professional knowledge. Use nursing guidance leaflets, manuals or production of multimedia health education to increase the consistency of health education personnel. Use interprofessional collaborative practice meetings to jointly adjust the direction of patient treatment, and it can increase the experience of medical team members. Develop targeted therapy drug evaluation tools for hepatocellular carcinoma patients, so that clinical staff can evaluate patients more systematically and increase the completeness of evaluation.
第一章 緒論 1
第一節 問題背景及重要性 1
第二節 問題陳述 2
第三節 研究目的 5
第四節 研究問題 5
第二章 文獻查證 6
第一節 肝癌 6
第二節 肝癌標靶治療 8
第三節 不良事件 15
第四節 系統系文獻回顧及統合性分析步驟 18
第五節 名詞定義 33
第三章 研究方法 36
第一節 文獻搜尋策略 36
第二節 篩選文獻的標準 37
第三節 文獻品質的判定 37
第四節 文獻分析方法 38
第四章 研究結果 39
第一節 文獻搜尋結果 39
第二節 研究文獻特徵 40
第三節 研究品質 43
第四節 標靶治療不良事件 45
第五節 統合分析 47
第五章 討論 50
第一節 研究結果與研究目的的關聯性 50
第二節 研究過程 58
第三節 研究限制 59
第六章 結論 60
第一節 綜合重要研究發現 60
第二節 在護理實務或教育上的意涵或應用 60
第三節 未來研究方向 62
參考文獻 63
圖 93
圖一 PRISMA 2020 flow diagram 93
圖二 以RoB 2評估工具評讀納入分析文獻之文章品質 96
圖三 以RoB 2評估工具評讀納入分析文獻之文章品質- weighted bar plots 97
圖四 肝癌病人接受標靶治療與安慰劑治療不良事件發生率危險比 98
圖五 肝癌病人接受sorafenib治療與安慰劑治療不良事件發生率危險比-次群組分析 99
圖六 肝癌病人接受標靶治療與安慰劑治療不良事件發生率危險比-敏感度分析 100
圖七 肝癌病人接受標靶治療與安慰劑治療藥物減量危險比 101
圖八 肝癌病人接受標靶治療與安慰劑治療藥物停藥危險比 102
圖九 肝癌病人接受標靶治療與安慰劑治療藥物停藥危險比-次群組分析 103
圖十 肝癌病人接受標靶治療與安慰劑治療其藥物停藥危險比-敏感度分析 104
圖11 漏斗圖 105
表 106
表一 Common Toxicity Criteria: version2.0、 Common Terminology Criteria for Adverse Events version 3.0、4.0、5.0不良事件嚴重度分級比較 106
表二 PRISMA 2020 checklist 107
表三 隨機臨床試驗考科藍誤差風險評估工具第二版:五個構面、引導性問題、回應選項、偏差風險 111
表四 PICO Search Strategy 114
表五 納入系統性文獻回顧文獻之研究特徵 115
表六 各個研究文獻人口學與疾病特徵 118
表七 RoB 2評讀隨機分配文獻之結果- master student 120
表八 RoB 2評讀隨機分配文獻之結果- Expert I 121
表九 RoB 2評讀隨機分配文獻之結果- Expert II 122
表10 RoB 2評讀隨機分配文獻之整體性偏差風險結果 123
表11 服用sorfenib常見不良事件(不分嚴重度) 124
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