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医药导报
医药导报, 2017, 36(9): 993-996
doi: 10.3870/j.issn.1004-0781.2017.09.011
定标活检结合瘦素评价雷贝拉唑联合替普瑞酮对胃溃疡的疗效
Evaluation of Clinical Effect of Rabeprazole Combined with Teprenone Capsules in Treatment of Gastric Ulcer by Marking Targeting Biopsy and Leptin
秦文燕1,2,, 林琪2, 劳波2, 许春芳1,
1.苏州大学第一附属医院消化内科,苏州 215006
2.宁波市鄞州区第二医院消化内科,宁波 315040
QIN Wenyan1,2,, LIN Qi2, LAO Bo2, XU Chunfang1,
1.Department of Gastroenterology,the First Affiliated Hospital of Suzhou University, Suzhou 215006,China
2. Department of Gastroenterology,the Second Hospital of Yinzhou District, Ningbo City , Ningbo 315040,China
通信作者 许春芳(1964-),女,江苏苏州人,主任医师,博士生导师,专业方向:消化内科。电话:0512-67781055,E-mail:xcf601@163.com。

作者简介 秦文燕(1978-),女,内蒙古包头人,副主任医师,在读博士,专业方向:消化内科。 电话:0574-55662141,E-mail:tinaqinwenyan@126.com。
中图分类号: R975     文献标识码: B     文章编号: 1004-0781(2017)09-0993-04
摘要:

目的 探讨定标活检结合瘦素评价雷贝拉唑联合替普瑞酮胶囊对胃溃疡的疗效。方法 活动性胃溃疡且幽门螺杆菌(Hp)为阴性患者118例,随机分为两组。治疗组60例,给予雷贝拉唑10 mg,bid,po,替普瑞酮胶囊50 mg,tid,po;对照组58例,给予雷贝拉唑10 mg,bid,po,两组均连续治疗56 d,治疗前后均定标活检,记录临床疗效及同一部位的治疗有效率、病理组织优良率、瘦素的表达,比较复发率。结果 治疗10 d后,两组临床疗效差异无统计学意义(P>0.05),治疗56 d后,治疗组的治疗有效率(93.33%)高于对照组(72.41%)(P<0.05);治疗组的病理组织优良率(93.33%)高于对照组(58.62%)(P<0.05);治疗组瘦素水平低于对照组(P<0.05);治疗组胃溃疡复发率(3.8%)低于对照组(24.0%)(P<0.05)。结论 雷贝拉唑联合替普瑞酮治疗胃溃疡疗效较好。定标活检技术结合瘦素的表达,可以更精确地评价胃溃疡的愈合质量,可以作为评价胃溃疡愈合质量的指标。
关键词: 雷贝拉唑 ; 替普瑞酮 ; 溃疡,胃 ; 愈合质量 ; 瘦素 ; 定标活检

Abstract:

Objective To evaluate clinical effect of rabeprazole combined with teprenone capsules in treatment of gastric ulcer by marking targeting biopsy and leptin. Methods A total of 118 patients with active gastric ulcer confirmed by endoscopy were randomly divided into two groups. Patients in the treatment group (n=60) were given rabeprazole 10 mg, bid ,and teprenone capsules 50 mg, tid. Patients in the control group (n=58) were given rabeprazole 10 mg, bid. Both groups were treated continuously for 56 days. Before and after treatment, 2 groups were labeled with biopsy, the clinical efficacy and the healing rate of two groups were recorded, the quality of healing and the expression of leptin were compared. The level of leptin was tested after treatment. Results After 10 days, the difference of clinical curative effect was not statistically significant (P>0.05). After 56 days, the difference of clinical curative effect was statistically significant (P<0.05); ulcer healing rate (93.33%)in treatment group was higher than that of control group (72.41%); ulcer healing quality (93.33%) in treatment group was higher than that of control group (58.62%); leptin level of treatment group was lower than that of the control group; gastric ulcer recurrence rate (3.8%) in treatment group was lower than that of the control group (24.0%) (all P<0.05). Conclusion Rabeprazole combined with teprenone in the treatment of gastric ulcer is better than rabeprazole. Marking targeting biopsy and leptin can be used to evaluate the healing quality of gastric ulcer more accurately, which can be an evaluation index of the quality of gastric ulcer healing and used as an indicator of the quality of gastric ulcer healing.
Key words: Rabeprazole ; Teprenone ; Ulcer, gastric ; Healing quality ; Leptin ; Marking targeting biopsy

胃溃疡(gastric ulcer)发病率较高,目前临床上治疗主要注重患者胃溃疡愈合质量的改善程度,降低复发率,但对患者的胃溃疡愈合质量的评价缺乏统一的标准,尤其病理活检的部位的不同,使药效的评价缺乏一定的可比性。定标活检技术可同时于同点染色标定,便于复检识别。而瘦素在炎症早期分泌迅速,对胃黏膜损伤具有较好的应激效果。2013年6月—2015年6月,笔者应用定标活检结合瘦素随访监测,评价雷贝拉唑片联合替普瑞酮胶囊对胃溃疡患者与愈合质量的影响,分析其对胃溃疡同一活检部位病理组织学治疗效果。

1 资料与方法
1.1 临床资料

选择在宁波市鄞州区第二医院内镜中心胃镜确诊为胃溃疡的患者,纳入标准:①1或2个溃疡,溃疡直径<2 cm,病理证实为良性溃疡;②病理检测幽门螺杆菌(Helicobacter pylori,Hp)为阴性;③13C呼气试验证实Hp感染阴性;④年龄18~65岁;⑤愿意配合使用定标活检钳,签署知情同意书并完成规定疗程者;⑥未曾使用试验药物。排除标准:①有严重心、肝、肾功能不全的;②有食管疾病、十二指肠炎症和溃疡患者;③肿瘤患者;④治疗前2周使用过质子泵抑制药、H2受体阻断药、铋剂、抗菌药物的患者;⑤受试期间违反研究方案使用禁用药物以致疗效无法判断者。共入选118例,其中男62例,女56例,年龄22~65岁,平均(44.7±8.5)岁。所有患者采用随机数字表分成两组,治疗组60例,对照组58例,患者治疗前告知并签署知情同意书,医院医学伦理委员会批准。两组患者在性别、年龄、病程等方面比较,差异无统计学意义(P>0.05)。见表1。

表1 两组患者一般资料比较
Tab.1 Comparison of general information between two groups of patients 例
组别 例数 性别 疾病发作时间
男 女 <1个月 1~3个月
对照组 58 28 30 26 32
治疗组 60 32 28 22 38
组别 年龄
<30岁 30~50岁 >50~65岁
对照组 16 24 18
治疗组 14 26 20

表1 两组患者一般资料比较

Tab.1 Comparison of general information between two groups of patients 例

1.2 治疗方法

治疗组给予雷贝拉唑片(江苏豪森药业股份有限公司,规格:10 mg,批准文号:国药准字H20020330)10 mg,bid;替普瑞酮胶囊(卫材医药股份有限公司,规格:50 mg,批准文号:国药准字H20093656)50 mg,tid,连续口服治疗56 d。对照组给予雷贝拉唑片(江苏豪森药业股份有限公司,规格:10 mg,批准文号:国药准字H20020330)10 mg,bid,连续口服治疗56 d。治疗结束后,行胃镜复查,由胃镜医生进行内镜下治疗效果评价,并于定标处再行活检,行病理检查,3位病理医生采取“双盲法”读片。

1.3 观察指标及判定标准

1.3.1 临床疗效 观察患者临床症状,治疗10,56 d门诊各复诊1次,依据证候疗效评估标准进行评分。显效:患者症状积分降低>75%;有效:患者的症状积分降低50%~75%;无效:症状总积分降低<50%。

1.3.2 胃镜检查 治愈:溃疡以及周边炎症消失,S1、S2期;有效:H1、H2期,且患者的溃疡面积缩小>50%;无效:胃溃疡面积缩小<50%。总有效率(%)=(治愈例数+有效例数)/总例数×100%。

1.3.3 病理组织优良率比较 优:绒毛比较完整,腺体和结构比较完好,较多的毛细血管,少量的炎症细胞浸润;良:绒毛比较矮小,腺体及结构紊乱,存在较少的毛细血管,炎症细胞浸润为中度;差:少量的新生上皮细胞,无或少量的绒毛及腺体结构,存在少量的毛细血管,炎症细胞浸润较多。溃疡愈合率(%)=(优例数+良例数)/总例数×100%。

1.3.4 瘦素检测 治疗前后胃镜检查时,在定标位,取胃黏膜活检1块,石蜡包埋后切片,采用双花扁豆凝集素免疫组织化学法检测瘦素的表达。

1.3.5 随访 病例随访1年,统计复发率。

1.4 统计学方法

使用SPSS15.0 版统计软件进行分析。计量资料以均数±标准差( x ¯ ±s)表示,组间和同组治疗前后均数的差异比较用t检验;计数资料采用相对数表示,采用χ2检验;临床疗效采用秩和检验,以P<0.05为差异有统计学意义。

2 结果
2.1 临床疗效

治疗10 d,治疗组和对照组临床疗效比较,差异无统计学意义(Z=0.238,P>0.05);治疗56 d后,治疗组和对照组患者疗效比较,差异有统计学意义(Z=13.183,P<0.05)。见表2。

表2 两组患者治疗后不同时间段临床疗效比较
Tab.2 Comparison of clinical efficacy at different time points after treatment between two groups of patients 例
组别 例数 治疗10 d 治疗56 d
显效 有效 无效 总有效率/% 显效 有效 无效 总有效率/%
对照组 58 20 19 19 67.2 26 14 18 69.0
治疗组 60 28 14 18 70.0 48 5 7 88.3

表2 两组患者治疗后不同时间段临床疗效比较

Tab.2 Comparison of clinical efficacy at different time points after treatment between two groups of patients 例

2.2 胃镜检查和病理组织检查比较

治疗56 d后,治疗组胃镜检查总有效率明显高于对照组治疗总有效率(Z=11.581,P<0.05)。治疗56 d后,复查胃镜,取活检,电镜下观察,治疗组病理组织优良率明显高于对照组病理组织优良率,两组病理组织优良率比较差异有统计学意义(Z=15.472,P<0.05)。见表3。

表3 两组患者胃镜检查和病理组织检查比较
Tab.2 Comparison of the gastroscopy and pathological tissue examination between two groups of patients
组别 例数 胃镜检查 病理组织检查
治愈 有效 无效 总有效率/% 优 良 差 优良率/%
对照组 58 34 8 16 72.41 24 10 24 58.62
治疗组 60 46 10 4 93.33 34 22 4 93.33

表3 两组患者胃镜检查和病理组织检查比较

Tab.2 Comparison of the gastroscopy and pathological tissue examination between two groups of patients

2.3 病理免疫学评价瘦素的表达

治疗组治疗前瘦素的表达水平分别为1 123.00±558.73,143.62±83.83;对照组治疗前后瘦素的表达水平分别为1 134.29±556.14,212.83±142.35,治疗前两组患者的瘦素表达水平差异无统计学意义(P>0.05);治疗后,治疗组瘦素表达水平明显低于对照组瘦素表达水平(t=11.124,P<0.05)。

2.4 溃疡复发率

1年后治疗组完成胃镜复查52例,复发2例,占3.8%;对照组完成胃镜复查50例,复发12例,占24.0%。2组比较差异有统计学意义(χ2=4.59,P<0.05)。

3 讨论

抑酸和根治Hp是治疗胃溃疡的重要手段,但改善患者的溃疡愈合质量和减少复发,依然是目前的研究热点。胃溃疡的愈合质量以实验研究为多[1-2],临床研究较少,大样本且多中心分析较少。而且对溃疡的愈合质量多以单方面的评价为主,临床结果报道不一[3]。一方面可能与入选患者的诊断标准、病变程度和随访时间有关;另一方面,治疗前后胃黏膜活检部位的差异导致病理组织治疗前后可比性较差。定标活检技术通过特制的定标活检钳进行活检,同时于同点染色标定,便于复检识别[4]。

雷贝拉唑和替普瑞酮为临床上治疗胃溃疡的常用药物,青建国等[5]研究发现,对于胃溃疡患者单用替普瑞酮治疗6周后的总有效率为63.49%,而泮托拉唑钠联合替普瑞酮治疗6周后有效率为91.04%。因为在临床上已有相关研究,这两种常用药物和既往的研究可横向比较,进一步确定定标活检结合瘦素评价胃溃疡愈合质量的可行性。本研究选择Hp为阴性的胃溃疡患者为研究对象,希望可以避免因抗Hp效果的好坏对胃溃疡愈合的干扰。同时,胃黏膜定标活检时钳取定标点清晰黏膜1块,确保病理组织学的可比性。本研究结果显示,治疗组和对照组治疗10 d临床症状缓解无明显区别,但治疗56 d后,治疗组临床症状缓解及内镜下溃疡愈合率明显优于对照组,表明雷贝拉唑联合替普瑞酮治疗胃溃疡能有效地改善患者的溃疡愈合率。同时从病理上分析,治疗组患者的胃溃疡愈合质量显著高于对照组。随访1年后,治疗组患者的胃溃疡复发率显著低于对照组,提示溃疡愈合质量的改善,对患者的溃疡复发预防效果明显,同时也表明雷贝拉唑联合替普瑞酮能提高溃疡患者的愈合率,改善溃疡患者的愈合质量,降低患者复发率,与国内研究一致[6]。

瘦素在胃黏膜局部可发挥类似转化生长因子(TGF)-α和表皮生长因子(EGF)的作用,改善黏膜上皮完整性和增生,也可能通过一氧化氮或前列腺素E2通路发挥作用[7]。郭晓云等[8]发现瘦素在炎症早期分泌迅速,对胃黏膜损伤具有一定的应激效果。随着溃疡的愈合和局部炎症反应的减轻,瘦素分泌量逐渐减少。本研究结果显示溃疡周边黏膜中瘦素的表达水平显著高于正常胃黏膜,提示瘦素可能通过促进溃疡周边黏膜细胞的分裂增殖加速溃疡愈合。定标活检组织病理组织学分析结果显示,治疗前溃疡组织的瘦素表达均较强,且治疗组和对照组无明显差异,治疗后治疗组的瘦素表达明显低于对照组,这与治疗组的溃疡愈合质量较对照组的明显提高相一致,表明胃溃疡愈合质量提高后,瘦素表达明显下降,瘦素表达越少,胃溃疡愈合质量越高,与国内外报道一致[9-11]。

综上所述,采用定标活检技术可以更精确地评价胃溃疡的愈合质量。胃溃疡愈合质量越高,瘦素表达越少,与内镜下表现及病理表现一致,从而通过检查瘦素的表达,可以提示胃溃疡愈合的质量的好坏,为临床病程的长短提供依据,减少胃溃疡的复发。因此,定标活检技术结合瘦素可能成为临床上检查胃溃疡愈合质量的一个评价指标。

The authors have declared that no competing interests exist.
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目的 观察泮托拉唑钠联合替普瑞酮在治疗胃溃疡中的作用.方法 取130例经胃镜证实的活动性胃溃疡的患者随机分为对照组63侧,给予替普瑞酮50mg,3次/d,6周为1个疗程;治疗组67例,除同样服用上述药物 外,加服泮托拉唑钠40mg,早饭前0.5h顿服,6周后复查胃镜.结果 治疗组胃溃疡治愈率为91.04%,优于对照(63.49%,P<0.01).结论 泮托拉唑钠联合替普瑞酮治疗胃溃疡可有效减轻胃黏膜损伤,促进胃溃疡愈合,提高治疗质量,减少复发率.
DOI:10.3969/j.issn.1674-0742.2008.24.058      URL    
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[6] 卢英军,李树义,王静.替普瑞酮联合奥美拉唑对胃良性溃疡愈合质量的影响[J].中国药业,2014,23(15):27-29.
目的：探讨胃黏膜保护剂替普瑞酮对胃溃疡患者愈合质量的影响。方法将177例胃溃疡患者随机分为对照组88例和观察组89例。对照组患者给予替普瑞酮治疗，观察组患者给予奥美拉唑联合替普瑞酮治疗，随访1年，比较两组患者的临床疗效、胃溃疡的愈合质量、不良反应及复发情况。结果观察组患者治疗总有效率为97.75%，明显高于对照组的89.77%（ P ﹤0.05）；S2期获得率观察组为66.29%，明显高于对照组的27.27%（ P ﹤0.05）；观察组患者恶心、腹痛、腹泻、皮疹发生率均分别高于对照组，出血发生率低于对照组，但差异均无统计学意义；观察组患者溃疡复发率明显低于对照组（ P ﹤0.05）。结论胃黏膜保护剂替普瑞酮与质子泵抑制剂奥美拉唑联用可明显提高胃良性溃疡的治愈率，不良反应少且安全性高，还可显著降低复发率，值得临床推广。
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[7] SOGHRA F,FATEMEH N,SEYED S S,et al.The effects of leptin on gastric ulcer due to physical and psychological stress:involvement of nitric oxide and prostaglandin E2[J].Stre Phys Biochem,2011,7(2):301-310.
The present study aimed to assess the effects of Leptin on physical and psychological stresses inducing gastric ulcer. The potential role of endogenous nitric oxide (NO) and prostaglandin E2 (PGE2) in the effects of Leptin on the gastric ulcer in rats are also investigated. In this study, fifty-four male Wistar rats were equally divided into 9 groups and Leptin (10 碌g/kg, s.c.) was administered twice a day for 14 days in advance of physical and psychological stress. Also, NG- nitro-l-arginine-methyl ester (L-NAME, 10 mg/kg, an inhibitor of NO synthase) and indomethtacin (5 mg/kg, in order to inhibit PG synthesis) were applied before Leptin administration. Ulcer index, gastric acid secretion, NO metabolites and PGE2 of stomach tissue suspension were all measured. Results indicated that ulcer index and gastric acid secretion were significantly decreased (p0.05) in Leptin in compare with those of single stress groups. Also, NO metabolites and PGE2 were increased (p0.05) in Leptin groups than both L-NAME and Indomethacin+Leptin groups. Conclusively, data of this study emphasized the healing ability of Leptin on gastric ulcer induced by physical and psychological stresses involves the NO and PGE2 pathways.
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[8] 郭晓云,刘南植,沈关心,等.胃溃疡黏膜细胞瘦素的表达及其与溃疡愈合的关系[J].华中科技大学学报(医学版),2005,34(5):558-560.
目的研究瘦素(leptin) 在人及大鼠胃溃疡黏膜细胞中的表达情况。方法Western blot法及免疫组化方法(DAB显色法)检测瘦素在人胃溃疡周边黏膜细胞中的表达。采用磺基水杨酸-盐酸灌胃的方法建立大鼠急性胃溃疡模型,流式细胞术 (FCM)、Western blot法及免疫组化方法检测大鼠胃溃疡形成不同阶段的溃疡周边黏膜细胞中瘦素的表达。结果Western blot法检测到人和大鼠胃溃疡周边黏膜细胞中均有瘦素蛋白表达,免疫组化可见溃疡周边黏膜细胞中有瘦素的阳性表达,与正常胃黏膜组织相比有显著性差异 (均P0.05)。急性胃溃疡大鼠胃黏膜瘦素的表达量随时间延长而呈现出明显曲线变化,其峰值在24 h附近。结论瘦素在胃溃疡周边组织中表达明显高于正常组织,可能与胃溃疡发展及修复有一定相关性。
DOI:10.3870/j.issn.1672-0741.2005.05.013      URL    
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[9] TANIGAWA T,WATANABE T,OTANI K,et al.Leptin promotes gastric ulcer healing via upregulation of vascular endothelial growth factor[J].Digestion,2010,15(2):86-95.
Abstract BACKGROUND AND AIM: Leptin, a key hormone in regulation of food intake and energy expenditure, exerts pleiotropic cytokine-like biological effects. Its role in gastric ulcer healing is unclear. In this study, we investigated the role of leptin in gastric ulcer healing. METHODS: Experimental gastric ulcer was induced by focal serosal application of acetic acid in leptin-deficient ob/ob mice and wild-type mice. Healing of gastric ulcer and angiogenesis in the ulcer tissue was evaluated. RESULTS: Gastric ulcer healing was delayed in ob/ob mice compared with that in wild-type mice. The impairment of ulcer healing observed in ob/ob mice was characterized by reduced expression of vascular endothelial growth factor (VEGF) and impairment of angiogenesis. Systemic administration of leptin to ob/ob mice reversed the impairment of gastric ulcer healing; this reversal was accompanied by an increase in VEGF expression and angiogenesis. Although mRNA for leptin was not expressed in normal gastric mucosa and not induced in ulcerous tissue, leptin receptor expression was markedly upregulated in gastric epithelial cells at ulcer margins, and was colocalized with VEGF. CONCLUSION: These findings suggest that leptin promotes gastric ulcer healing by induction of angiogenesis in the granular tissue of ulcers via upregulation of VEGF expression. Copyright (c) 2010 S. Karger AG, Basel.
DOI:10.1159/000243719      PMID:20068308      URL    
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[10] DUDAR G K,D'ANDREA L D,DI STASI R,et al.A vasc-ular endothelial growth factor mimetic accelerates gastric ulcer healing in an iNOS-dependent manner[J].Am J Physiol Gastr Liver Physiol,2008,295(2):374-381.
Abstract Angiogenesis is crucial to all types of wound healing, including gastric ulcer healing. The most potent promoter of angiogenesis is vascular endothelial growth factor (VEGF). We hypothesized that a 15-amino acid peptide designed to mimic the angiogenic action of VEGF would accelerate gastric ulcer healing. Gastric ulcers were induced in mice by serosal application of acetic acid. Treatment with the VEGF mimetic accelerated gastric ulcer healing when administered orally or intraperitoneally, at a dose of 50 ng/kg or greater. Such healing was not observed when the reverse sequence pentadecapeptide or the full-length VEGF protein was administered. Contrary to our hypothesis, the VEGF mimetic did not significantly increase angiogenesis in the ulcerated stomach. The enhancement of ulcer healing by the VEGF mimetic occurred independently of cyclooxygenase-2 (COX-2) activity but was blocked by inhibitors of inducible nitric oxide synthase (iNOS). These results demonstrate that a VEGF mimetic is a potent stimulus for gastric ulcer healing, even when given orally. The effects of the mimetic were independent of stimulatory effects on angiogenesis and COX-2 activity but were dependent on iNOS-derived NO production.
DOI:10.1152/ajpgi.90325.2008      PMID:18583458      URL    
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[11] 赵春红,鲍秀琦.消化性溃疡患者Leptin水平与Hp感染的相关性研究[J].黑龙江医药科学,2014,35(2):74-75.
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关键词（key words）
雷贝拉唑
替普瑞酮
溃疡,胃
愈合质量
瘦素
定标活检
Rabeprazole
Teprenone
Ulcer, gastric
Healing quality
Leptin
Marking targeting biopsy
作者
秦文燕
林琪
劳波
许春芳
QIN Wenyan
LIN Qi
LAO Bo
XU Chunfang