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摘要:目的 筛查中国女性乳腺癌发病相关危险因素, 为个体化评估中国女性乳腺癌发病危险性提供依据。方法 在全国8个省市14家研究中心开展1:m配对病例对照研究, 采用调查问卷通过面对面交流收集乳腺癌发病相关危险因素信息。乳腺癌患者及其配对健康对照女性年龄、生活环境相匹配。应用1:m条件Logistic回归分析乳腺癌相关危险因素在病例组和对照组间的分布特点, 明确其与乳腺癌发病危险性的相关性。结果 共纳入416例乳腺癌患者及1156例健康对照女性。中国女性乳腺癌发病相关危险因素包括体重指数(body mass index, BMI)≥24(OR=4.07, 95% CI:2.98~5.55), 乳腺良性病变活检史(OR=1.68, 95% CI:1.19~2.38), 初潮年龄≥14岁(OR=1.41, 95% CI:1.07~1.87), 生存压力大(1~4级, OR=2.15, 95% CI:1.26~3.66;5~9级, OR=3.48, 95% CI:2.03~5.95), 绝经(OR=2.22, 95% CI:1.50~3.28)(P < 0.05), 乳腺癌家族史(OR=1.72, 95% CI:1.15~2.58), 肿瘤家族史(乳腺癌除外)(OR=1.55, 95% CI:1.22~1.98)。口服避孕药(OR=1.59, 95% CI:0.83~3.05)亦增加乳腺癌发病危险性, 但差异未达到显著统计学意义(P>0.05)。结论 中国女性乳腺癌发病相关危险因素包括BMI≥24、乳腺良性病变活检史、初潮年龄≥14岁、生存压力大、绝经、乳腺癌家族史及其他肿瘤家族史。本研究为个体化评估中国女性罹患乳腺癌危险性及广泛开展乳腺癌防治工作提供了依据。Abstract:Objective To screen the risk factors associated with breast cancer among Chinese women, with an attempt to provide evidence for the evaluation of breast cancer risks among Chinese women on an individual level.Methods A case-control study on 416 breast cancer patients and 1156 age-and region-matched controls was conducted in 14 hospitals in 8 provinces/municipalities of China.Conditional logistic regression was applied to analyze the association between risk factors and breast cancer.Results The risk factors of breast cancer among Chinese women included higher body mass index(BMI ≥ 24)(OR=4.07, 95%CI:2.98-5.55), history of benign breast disease biopsy(OR=1.68, 95%CI:1.19-2.38), age of menarche ≥ 14 years(OR=1.41, 95%CI:1.07-1.87), psychological depression(for grade 1-4, OR=2.15, 95% CI:1.26-3.66;for grade 5-9, OR=3.48, 95% CI:2.03-5.95), menostasia(OR=2.22, 95% CI:1.50-3.28), family history of breast cancer(OR=1.72, 95%CI:1.15-2.58), and family history of cancer other than breast cancer(OR=1.55, 95%CI:1.22~1.98)(all P < 0.05 when compared between the 416 breast cancer patients and 1156 controls).Although use of oral contraceptives(OC)(OR=1.59, 95% CI:0.83-3.05)was associated with an increased risk of breast cancer, the difference was not statistically significant(P > 0.05).Conclusions Many risk factors including BMI ≥ 24, history of benign breast disease biopsy, age of menarche ≥ 14 years, psychological depression, menostasia, family history of breast cancer, and family history of cancer other than breast cancer may contribute to breast cancer among Chinese women.This research provides a basis for the individualized evaluation of risks of breast cancer and the population-based interventions in China.
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Keywords:
- breast cancer /
- risk factors /
- case-control study
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相对于直肠肿瘤的根治性手术, 局部切除术兼有手术损伤小、风险低、能保肛、术后无排尿功能和性功能障碍等多项优点。但由于直肠的特殊解剖部位, 传统的外科手术行局部切除时在技术上尚有一定的困难, 其疗效也不尽如人意。上世纪80年代, 德国学者Buess等[1]设计和研制了一套经肛门内镜微创手术(transanal endoscopic microsurgery, TEM)系统, 专门用于局部治疗直肠肿瘤。该系统集内镜、腹腔镜和显微手术3种先进技术于一身, 突破了传统直肠肿瘤局部切除遇到的技术难点, 是目前国际上最为盛行的直肠肿瘤局部切除方式之一。北京协和医院基本外科自2006年4月开始在内地率先采用TEM, 共为120例直肠疾病患者施行手术, 取得了良好的疗效。
资料和方法
对象
2006年4月至2009年11月在本科接受TEM的直肠肿瘤患者120例, 其中男性67例, 女性53例; 年龄27~81岁, 平均为59.3岁。所有患者术前均经结肠镜检查和肛门指检, 结合结肠镜下活组织病理学检查结果, 术前诊断为直肠腺瘤(包括腺管状腺瘤和绒毛管状腺瘤) 61例, 早期直肠癌和腺瘤癌变22例, 直肠类癌15例, 直肠息肉及直肠黏膜下结节等22例。病灶距肛缘距离平均(7.5±2.6) cm (4~20 cm), 病灶直径平均(1.8±0.8) cm (0.5~5.5 cm); 病灶在直肠的部位:直肠前壁43例, 后壁30例, 左侧壁26例, 右侧壁21例。
入选TEM标准
距肛缘5~15 cm各种直肠良性腺瘤、早期直肠癌(Tis期和T1期癌)、早期直肠类癌、早期直肠间质瘤等, 瘤体直径≤3 cm。对于术前病理学诊断为直肠癌和腺瘤癌变者, 以及肿瘤瘤体直径≥2 cm者术前均常规行直肠腔内B超检查。
TEM手术方法
麻醉和体位:全身或椎管内麻醉, 对采取俯卧位的患者采用全身麻醉。根据病灶在直肠内的位置决定术中体位, 原则上将病灶放在术野正下方, 如病灶位于直肠后壁采取膀胱截石位, 病灶位于前壁采用俯卧位, 病灶位于左侧或右侧壁则分别采取左侧或右侧卧位。
操作方法:轻缓扩肛两指宽后, 将已润滑的直肠镜缓慢插入直肠, 找到病灶后将直肠镜固定在手术床上。盖上直肠镜后面板, 插入双目镜和电视镜, 接上各种管线并向直肠内注入CO2气体, 将气压控制在12~15 mm Hg (1 mm Hg=0.133 kPa)。在显示屏上仔细观察病灶的形态、大小, 并确认直肠镜的位置合适后, 将针形点刀等操作器通过后面板上的孔隙插入直肠。先用电刀在病灶四周电灼出拟切除界线, 如为良性病灶此切线可距病灶边缘0.5 cm以外, 如病灶为恶性则须距病灶边缘1 cm以外。用电刀在切线的某点加深切口(通常选择在病灶右下缘), 切口深度依据病情而定, 如为良性切至黏膜下或深浅肌层, 如为恶性则切至肠壁外脂肪, 即全层切除。切口加深处可作为病灶切除的起始点, 沿着已设定的切除线, 逐渐将包含病灶在内的整块肠壁完整切除, 切除用电刀或选用超声刀, 后者止血效果更好。操作时若能遵循从右向左, 由浅入深, 由远(肛门侧)及近的步骤则可使手术更容易[2]。用针线将留下的直肠创面连续缝合, 最好选用可吸收线的滑线, 以便边缝边收紧创口。严密可靠的缝合以防止术后创面裂开和创面出血, 横向行进的缝合方式以最大程度地避免术后出现肠腔狭窄。
术后病理检查
将手术切除的肿瘤标本用大头钉将其周边固定在小块塑料泡沫上, 浸泡福尔马林溶液后及时送检, 做精确病理分期(T分期)。
术后随访
全组120例患者均获术后随访, 随访时间3~40个月, 平均13.5个月。随访方式为电话联系和门诊复查, 复查内容主要以结肠镜检查和肛门指检为主。对T2期直肠癌患者除定期作上述检查外, 还定期检查肝胆B超和血清癌胚抗原水平监测。
结果
手术方式, 本组120例患者中行TEM肠壁全层切除术106例, 肠壁部分切除包括黏膜下切除术14例。TEM平均手术时间(73.4±31.0) min (25~180 min), 术中平均失血(10.7±7.8) ml (3~60 ml)。术中切穿肠壁致直肠穿孔4例, 经术中一期缝合修补后(未中转开腹)均顺利康复出院。全组术后平均住院(3.4±1.0) d (2~8 d)。术后无1例使用止痛剂。2例于术后2周时发生直肠出血, 出血量300~400 ml, 经保守治疗血止而愈; 另有2例术后分别发生肺部和泌尿系感染, 术后并发症发生率为3.3% (4/120)。
术后病理学检查显示:直肠腺瘤43例, 直肠腺瘤癌变和直肠癌39例, 直肠类癌15例, 直肠间质瘤2例, 直肠平滑肌瘤1例, 另有增生性息肉、直肠子宫内膜异位以及黏膜慢性炎症等共20例。在39例直肠癌中, Tis期22例, T1期8例, T2期9例。9例T2期患者中3例于术前已明确为T2期癌, 其中1例因高龄且又合并严重手术禁忌证而采用TEM行姑息性治疗, 另2例出于患者强烈保肛意愿而采取本手术; 另6例术前腔内B超将T2期误认为T1期, 4例于首次术后1~2周接受了补救性根治术, 另2例因拒绝再次手术而接受术后化放疗。对所有手术标本切缘均进行病理学检查, 未发现标本切缘有病灶残留。
62例患者术前接受直肠腔内B超检查的结果与术后病理检查结果比较(表 1), 发现术前腔内B超对肿瘤T分期检查的正确率为87.1% (54/62), 与术后病理T分期不符者8例, 其中T分期高估2例(T0期误认为T1期), 低估6例(T2期误认为T1期)。
表 1 经肛门内镜微创手术直肠肿瘤患者术前直肠腔内B超与术后病理检查比较
随访至今, 除1例因姑息性切除的T2期直肠癌患者于术后2年死于呼吸衰竭外, 另7例T2期直肠癌患者与其他112例患者均未发现肿瘤或疾病复发; 且随访中均未发现控便和排便功能障碍。
讨论
长期以来对于某些行局部切除即可治愈的直肠肿瘤, 在选择何种手术方法和何种手术途径上一直令外科医生感到迷茫。几种传统的直肠肿瘤局部切除术, 如经肛门途径、经肛门括约肌途径及经骶尾部途径等直肠肿瘤局部切除术, 在实际应用过程中均有这样或那样的问题和缺憾。自上世纪80年代, 德国外科医生Buess等[1]首先倡导用TEM技术行直肠肿瘤局部切除术以来, 经过20多年的临床实践证明, 同传统的局部切除术相比, TEM无论是在肿瘤学疗效上还是在控制术后并发症方面, 以及在微创效果方面均有了明显的改进。TEM后肿瘤局部复发率和5年存活率分别为6%和96%[3], 远优于经肛门途径等传统切除术后的18%和64%[4]; 术后总并发症发生率为4%[5], 明显低于经肛门切除的14%[6], 更低于经骶尾直肠后切除的30%[7]。本组患者术后总并发症发生率为3.3%, 术后平均住院日为3.4 d, 经平均13.5个月的随访未发现肿瘤复发, 但长期疗效尚待继续观察。
TEM最佳的指征应是直肠良性腺瘤, 以及经腔内B超等检查除外有浸润的早期直肠类癌、直肠间质瘤以及诊断不明的直肠黏膜下结节等。对于直肠癌, 目前认为直肠原位癌(Tis期)和T1期中组织分化良好、无血管和淋巴浸润、无盆腔淋巴结肿大者是TEM最佳的适应证。对T2期直肠癌, 因术后有较高的肿瘤局部复发率, 故需谨慎选择[3]。然而, 近年来也有研究证实, 对T2期直肠癌若先行新辅助治疗后再行TEM局部切除也可收到良好的疗效[8]。因此, 术前需通过联合多种检查, 如结肠镜下活组织检查、直肠腔内B超检查以及直肠CT、MRI, 甚至PET/CT等, 尽量对直肠癌的组织学分级和TNM分期作出准确和客观的评估, 以甄别和选择病例, 其中直肠腔内B超检查对直肠癌T分期具有很好的诊断价值, 其正确率可达95%[9], 本组患者为86%。但在临床工作中仍有一些在术前评估为T1期而术后病理诊断为T2期直肠癌患者, 如本组就有6例T2期患者术前误诊为T1期。有研究认为未经新辅助治疗的T2期直肠癌患者淋巴结转移率高达12%~40%, 局部切除术后复发率高达47%[3]。因此, 对于那些未行新辅助治疗的T2期直肠癌患者, 由于术前分期失误而施行局部切除术者, 原则上需行补救性根治术[10]。本组9例T2期接受TEM治疗的直肠癌患者因上述原因, 6例术后被建议行补救性根治术, 其中4例接受了补救性根治术, 另2例因拒绝再次手术而予以放化疗并密切随访, 目前尚未发现肿瘤复发。
TEM术后常见并发症有: (1)经肛门出血。造成出血的原因大多是因直肠创面缝合后裂开或缝合不严密所致, 该并发症大多发生在TEM应用的初期, 可能与缝合技术不熟练有关。本组2例术后肛门出血的患者为本组早期病例, 可能与选择的缝线不当及缝合技术有关。提示熟练掌握缝合技术, 选择适当的缝线, 确保创面缝合严密等是预防术后出血最为有效的办法。本组后期病例未再出现类似的并发症。对小量出血可行保守治疗, 对中大量出血则视病情可采取手术干预。(2)直肠阴道瘘。当直肠内病灶位于直肠前壁的直肠阴道相交段, 且病情又需要作肠壁全层切除时, 手术易伤及阴道后壁, 严重者可并发直肠阴道瘘。预防方法是术中严格掌握位于直肠阴道相交段直肠病灶的切除深度, 以切至直肠外脂肪为度。(3)盆腹腔内直肠或乙状结肠穿孔。对位于腹膜返折以上直肠或下段乙状结肠的病灶, 尤其当其位于前壁或侧壁时, 只要是全层肠壁切除就不可避免地会切破直肠或结肠进入盆腹腔。本组患者中4例在术中切破肠壁进入盆腹腔, 所幸经积极处理均顺利康复。笔者以为对此类患者应特别谨慎, 术前必须作严格和完善的肠道准备, 以防在切破肠壁后减少盆腹腔污染, 术中如病情许可尽量不作肠壁全层切除, 并事先在手术部位近端肠腔放置1块纱布以阻挡一旦切破肠壁时近端肠内容物流入盆腹腔, 并应以最快的速度将破口缝合。是否需要转开腹完全根据盆腹腔被污染的程度, 只要无肠内容物流入盆腹腔, 就无需转开腹, 如本组4例患者均未转开腹。然而, 若盆腹腔严重污染, 则盆腹腔冲洗和放置引流可能是明智之举。
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