introduction怎么写?文章的introduction是作为全文的开头部分,从论文读者角度它是读者最先看到的部分;从编辑和审稿人角度看,它能让编辑和审稿人更进一步了解文章研究意义,所以写好introduction也是论文写作的重要一部分,在著名的杂志Science官网我们可以看到它对于introduction的要求如下:

它这段话可以浓缩为两点:清楚易懂(intelligible)和研究意义(significance),即introduction部分既要写得清楚易懂,逻辑通顺,又要展示出研究的意义和重要性。

我们以一些顶级杂志上的肿瘤相关研究举例看看,introduction部分应该包括哪些内容,又该如何进行写作呢?

01

第一篇是新英格兰发表的第三代ALK抑制剂劳拉替尼(Lorlatinib)与第一代ALK抑制剂克唑替尼(crizotinib)治疗晚期ALK阳性的非小细胞肺癌的疗效对比的III期临床试验结果,该研究结果显示,劳拉替尼相比于克唑替尼治疗晚期ALK阳性的非小细胞肺癌具有更好的无进展生存期和更好的颅内治疗反应。

Chromosomal rearrangements involving the anaplastic lymphoma kinase (ALK) gene define a subset of non–small-cell lung cancers (NSCLCs) that are highly sensitive to small-molecule ALK tyrosine kinase inhibitors. (大背景:在肺癌治疗中ALK和ALK抑制剂是什么)

One trial showed that the efficacy of the first-generation ALK inhibitor crizotinib as first-line therapy was superior to that of platinum–pemetrexed chemotherapy; this finding established crizotinib as a standard first-line treatment for advanced ALK-positive NSCLC. (既往研究回顾,第一代ALK抑制剂在治疗晚期ALK阳性非小细胞肺癌的意义)

Subsequently, several randomized, phase 3 studies showed that more potent second-generation ALK inhibitors, including alectinib, brigatinib, and ensartinib, were superior to crizotinib as first-line therapy; these findings led to the adoption of second-generation inhibitors as standard first-line treatments. (第二代ALK抑制剂在治疗晚期ALK阳性非小细胞肺癌的意义)

However, despite the improved efficacy of second-generation inhibitors, drug resistance and recurrent disease — including central nervous system (CNS) progression, a major cause of illness and death — still develop.(小背景:指出现有的问题所在,耐药和疾病复发,尤其是神经系统进展仍然是亟待解决的难题)

Lorlatinib (Pfizer) is a novel third-generation ALK inhibitor that is more potent than second-generation inhibitors in biochemical and cellular assays and has the broadest coverage of ALK resistance mutations that have been identified. (自然而然地既然有上述问题,第三代ALK抑制剂劳拉替尼就来了)

Lorlatinib was designed to cross the blood–brain barrier in order to achieve high exposures in the CNS.(跨血脑屏障,为CNS进展而生,呼应以上难题)

In phase 1 and 2 studies, lorlatinib had potent antitumor activity after the failure of previous ALK inhibitors (first-generation, second-generation, or both). (已经有了研究基础,1期和2期研究都发在柳叶刀肿瘤上,有兴趣的读者可以自己去查查)

In particular, lorlatinib had marked intracranial activity in previously treated patients with baseline CNS disease, including leptomeningeal disease. (重要的研究结局告诉我们,颅内治疗反应很好)

Because of its efficacy and safety, lorlatinib is a standard treatment option for ALK-positive patients in whom one or more ALK inhibitors have failed.(基于lorlatinib的优点,我们推荐用于相关患者的治疗)

The CROWN trial is a global, randomized, phase 3 trial comparing lorlatinib with crizotinib (the standard-of-care first-line treatment at the time of trial initiation) in patients with previously untreated advanced ALK-positive NSCLC. Here, we report the results of a planned interim analysis of the CROWN trial.(这段重申一下这次研究的目的和内容,报告这次三期临床的结果)

02

第二篇研究来自JCO杂志上研究新辅助放化疗后手术与单独手术相比对于局部晚期食管鳞癌的治疗效果,研究结果显示新辅助放化疗后手术可以让局部晚期食管鳞癌患者有更好的生存获益。

Esophageal cancer (EC) is the sixth most common cancer worldwide. China has a high prevalence of EC that accounts for > 50% of the global morbidity and mortality. (大背景:先交代食管癌这种疾病的危害性和严重程度,世界+国内)

More than 90% of patients with EC in China have esophageal squamous cell carcinoma (ESCC). (背景:指出中国食管癌的特点,食管鳞癌为主)

After surgery alone, the prognosis for patients with locally advanced EC remains poor, with a 5-year survival rate of only 25%.(单独手术对于局部晚期预后差,这是要解决的问题所在)

Recent evidence has suggested a survival benefit from neoadjuvant concurrent chemoradiotherapy followed by surgery. (既往研究:有过尝试新辅助加手术)

However, the results from randomized controlled trials comparing neoadjuvant chemoradiotherapy (NCRT) followed by surgery with surgery alone have been inconsistent. Moreover, most studies were conducted in Western countries, which have a high prevalence of esophagogastric junction adenocarcinoma. The sample size of ESCC was relatively small in most trials; there were usually no more than 80 cases of patients with ESCC receiving NCRT in each study. (指出既往研究一堆的缺点)

Whether the results could be applied to East Asian countries such as China where the incidence of ESCC is extremely high remains to be elucidated. (有很多缺点,所以他们的研究并没有很好的回答背景提到的问题)

A well-designed, large-scale, randomized control trial is needed to evaluate the usefulness of NCRT for ESCC. (我们的比之前更高级的研究是什么,大型ESCC的RCT,高级别证据)

The current phase III trial enrolled patients with locally advanced ESCC. The primary goal was to compare the survival benefit of NCRT plus surgery versus surgery alone in locally advanced ESCC.(重申我们研究的目的是什么)

03

第三个我们来看看刚刚来自徐兵河教授等大年发表在柳叶刀肿瘤学上的PHOEBE研究(对的,和老友记Phoebe同名),该3期临床研究显示,吡咯替尼(Pyrotinib)+卡培他滨与拉帕替尼(Lapatinib)+卡培他滨相比,治疗HER-2阳性转移性乳腺癌患者,具有更好的无进展生存期。

HER2 (also known as ERBB2) is well established as a therapeutic target for drugs used to treat HER2-positive breast cancer, with genetic aberrations occurring in about 15–20% of all patients with breast cancer. (大背景:HER2是什么开始介绍)

For patients with metastatic disease, the standard first-line treatment consists of the monoclonal antibodies pertuzumab and trastuzumab plus a taxane, but resistance to trastuzumab inevitably develops as a consequence of alterations in the active target receptor or in the downstream components in the PI3K/Akt/mTOR signalling pathway. (一线治疗是什么,但是缺点是耐药,这是问题所在)

There is an urgent unmet need for developing additional anti-HER2 drugs to treat patients who have received previous treatment with trastuzumab or pertuzumab.(所以发展其他的抗HER-2的新药刻不容缓)

In the second-line setting, trastuzumab emtansine (T-DM1; an antibody–drug conjugate) after trastuzumab-based therapy is the preferred regimen recommended by international treatment guidelines. However, in some countries in South America, Eastern Europe, and Asia, T-DM1 is not approved for use in the metastatic setting, whereas trastuzumab combined with chemotherapy, lapatinib plus capecitabine, and trastuzumab plus lapatinib are recommended as appropriate interventions in the second-line setting.(目前二线治疗的现状和存在的问题)

Pyrotinib is a second-generation, irreversible, well absorbed, pan-HER receptor tyrosine kinase inhibitor targeting EGFR, HER2, and HER4. (文章主角登场,Pyrotinib介绍)

Phase 1 studies preliminarily demonstrated the safety and antitumour activity of pyrotinib, as monotherapy and in combination with capecitabine, in patients with heavily pretreated HER2-positive metastatic breast cancer. In an open-label, multicentre, randomised, phase 2 study, pyrotinib plus capecitabine significantly improved the objective response rate (78·5% vs 57·1%) and progression-free survival (hazard ratio [HR] per investigator 0·36 [95% CI 0·23–0·58]) compared with those for lapatinib plus capecitabine in patients previously treated with taxanes and anthracyclines, with or without previous trastuzumab treatment. The HR of progression-free survival in patients who had previously received trastuzumab was 0·37 (95% CI 0·19–0·74). Pyrotinib was generally well tolerated. Similar to other HER2-targeted drugs, diarrhoea was the most common adverse event with pyrotinib alone or in combination with capecitabine. Most diarrhoea events were grade 1 or 2, 10·7–15·4% were grade 3, and no grade 4 or 5 diarrhoea was reported. Grade 3 diarrhoea occurred mainly during the first cycle of treatment and its incidence gradually decreased thereafter, which was generally manageable. (这段都是既往的研究基础介绍Pyrotinib治疗效果)

On the basis of these findings, pyrotinib in combination with capecitabine was approved in China on the condition that a confirmatory phase 3 study be done.(所以才会有这个3期临床试验)

We conducted the PHOEBE phase 3 study to further investigate the efficacy and safety of pyrotinib plus capecitabine compared with lapatinib plus capecitabine in patients with HER2-positive metastatic breast cancer after treatment with trastuzumab and taxanes.(重申一下本次研究的内容和目的)

总结Introduction的写作主要包括:

1、必要的背景介绍:疾病的严重和危害性(按逻辑第一篇和第三篇应该从肺癌和乳腺癌危害说起,但是可能这两个疾病已经众所周知,危害性不言而喻了吧),研究分子和通路可能还需要介绍它们的基本情况,基本就是把研究内容涉及的名词都大概用相关逻辑解释一下,第一篇是ALK,非小细胞肺癌和ALK抑制剂;第二篇是食管鳞癌,新辅助放化疗;第三篇是HER-2,乳腺癌和抗HER-2药物 ,同时提出大背景的问题:ALK抑制剂肺癌治疗耐药,食管癌手术后预后差;一线治疗晚期乳腺癌耐药(绝大部分癌症研究大背景都是为了提高生存)。

2、既往的研究情况,总结提要相关的既往结果,他们已经解决了大背景问题的哪些部分。

第一篇:从化疗到一代ALK抑制剂到二代ALK抑制剂的进步,1期和2期临床试验;第二篇总结了既往的新辅助放化疗研究取得的成就;第三篇总结了之前的1期和2期临床试验;

3、还有哪些问题没有解决:即我们研究的小背景问题。第一篇是第二代ALK抑制剂的神经系统治疗反应不佳,同时还需要继续提高生存(永恒的生存话题);第二篇是既往研究人群与中国食管癌特点不一样,因为中国以鳞癌为主,且既往研究证据强度不如本研究;第三篇是不同国家指南推荐新药使用还有待进步,转移性乳腺癌更好推荐的二线治疗亟待发展

4、这个问题的意义和重要性(即本次研究)是什么:自然而然就可以写出这个研究的意义了。

5、时刻记得前面所述introduction部分写作的原则就是要清楚易懂(intelligible)的同时交代好本次研究的意义(significance)。

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