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中华消化杂志 1991年第2期11卷 107-108页

作者： Mied.,SE 王国良德国波恩医院

CMH统计分析方法在多中心试验2×2表资料的应用

维普期刊数据库评论

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中国卫生统计 1999年第2期16卷 96-97页

作者：史周华汪涛刘勤吴翠珍山东中医药大学预防医学教研室上海医科大学卫生统计与社会医学教研室

ＣＭＨ统计分析（Ｃｏｃｈｒａｎ－Ｍａｎｔｅｌ－ＨａｅｎｓｅｌＳｔａｔｉｓ－ｔｉｃｓ），是Ｍａｎｔｅｌ于１９６３年在原有ＭＨ统计分析方法（１９５９年）的基础上提出来的，Ｋｏｃｈ等统计学家于１９７８至１９８８年使之发展和... 详细信息

ＣＭＨ统计分析（Ｃｏｃｈｒａｎ－Ｍａｎｔｅｌ－ＨａｅｎｓｅｌＳｔａｔｉｓ－ｔｉｃｓ），是Ｍａｎｔｅｌ于１９６３年在原有ＭＨ统计分析方法（１９５９年）的基础上提出来的，Ｋｏｃｈ等统计学家于１９７８至１９８８年使之发展和完善，现在习惯称之为扩展的ＭＨ卡方...

关键词： CMH统计分析多中心试验 2*2表资料卫生统计

热敏灸治疗慢性持续期哮喘多中心试验设计特点与方案优化

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辽宁中医杂志 2011年第7期38卷 1339-1341页

作者：熊俊迟振海陈日新张波江西中医学院附属医院国家中医药管理局热敏灸重点研究室国家中医药管理局腧穴敏化三级实验室江西南昌330006

科学规范的设计方案是确保临床试验内在真实性的关键。以国家"十一五"科技支撑计划资助的腧穴热敏化艾灸治疗慢性持续期哮喘的优化方案研究为例,从随机化、盲法运用、对照设置、重复性等方面介绍试验设计特点,同时围绕中医临床研究优化... 详细信息

科学规范的设计方案是确保临床试验内在真实性的关键。以国家"十一五"科技支撑计划资助的腧穴热敏化艾灸治疗慢性持续期哮喘的优化方案研究为例,从随机化、盲法运用、对照设置、重复性等方面介绍试验设计特点,同时围绕中医临床研究优化的理念、过程和方法进一步阐述方案优化的具体措施。

关键词：灸法多中心试验方案优化方法学

食管内Enteryx植入治疗GERD:扩大的多中心试验和核准后24个月的期中随访

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世界核心医学期刊文摘（胃肠病学分册） 2005年第9期1卷 28-29页

作者： Cohen L.B. JohnsonD.A. Ganz R.A. 赵天智 311 East 79th St New York NY 10021 United States Dr.

Background: Enteryx implantation in the esophagus is an alternative therapy for patients with proton pump inhibitor (PPI) dependent GERD. Although this treatment resulted in highly significant improvement at 6 and 12 months, longer follow-up is needed to more fully assess the durability of these positive effects. Methods: An open-label, international clinical trial was conducted in 144 PPI-dependent patients with GERD with follow-up at 6 and 12 months. In addition, the durability and the safety of the treatment were assessed for 24 months in 64 patients enrolled in a postapproval study. The primary study outcome measure was usage of PPI. Secondary outcomes in the multicenter trial were GERD health-related quality of life (GERD-HRQL) symptom score and esophageal acid exposure. Results: At 12 months, PPI use was reduced ≥50%in 84%: 95%confidence interval (CI) [76%, 90%] and was eliminated in 73%: 95%CI[64%, 81%] of evaluable patients (intent-to-treat analysis 78%: 95%CI[70%, 84%] and 68%: 95%CI[60%, 76%], respectively). A GERD-HRQL ≤11 was attained in 78%: 95%CI[69%, 85%] of evaluable patients. Esophageal acid exposure (total time pH <4) was reduced by 31%: 95%CI[17%, 43%]. At 24 months, a ≥50%or greater reduction in PPI use was achieved in 72%: 95%CI[59%, 82%] and PPI use was eliminated in 67%: 95%CI[54%, 78%] of patients. Conclusions: This investigation provides evidence for sustained effectiveness and safety of implantation of Enteryx in the esophagus in PPI-dependent patients with GERD.

关键词：多中心试验 Enteryx 次要指标研究指标持久性安全性评估生活质量

超声内镜引导胰腺转移瘤的细针穿刺:一项多中心试验

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世界核心医学期刊文摘（胃肠病学分册） 2005年第9期1卷 31-32页

作者： DeWitt J. Jowell P. LeBlanc J. 徐瑞 Department of Medicine Division of Gastroenterology Indiana University Medical Center 550 N. Universi ty Blvd Indianapolis IN 46202-5121 United States Dr.

Background: Metastatic lesions of the pancreas are a rare but important cause of focal pancreatic lesions. The purpose of this study is to describe the EUS features, cytologic diagnoses, and clinical impact of a cohort of patients with pancreatic metastases diagnosed by EUS-guided FNA (EUS-FNA). Methods: Over a 6-year period, in a retrospective, multicenter study, patients had the diagnosis of pancreatic metastases confirmed with EUS-FNA. All examinations were performed by one of 5 experienced endosonographers. The EUS and the clinical findings of pancreatic metastases were compared with those of a cohort with primary pancreatic malignancy. Results: Thirty-seven patients with possible metastases were identified, and 13 were excluded because of diagnostic uncertainty. The remaining 24 underwent EUS-FNA (mean passes 4.1) of a pancreatic mass without complications. Diagnoses included metastases from primary kidney (10), skin (6), lung (4), colon (2), liver (1), and stomach (1) cancer. In 4 (17%), 16 (67%), and 24 (100%) patients, EUS-FNA provided the initial diagnosis of malignancy, tumor recurrence, and pancreatic metastases, respectively. Four (17%) metastases initially were discovered by EUS after negative (n = 3) or inconclusive (n = 1) CT scans. Compared with primary cancer, pancreatic metastases were more likely to have well-defined margins (46%vs. 4%) compared with irregular (94%vs. 54%; p < 0.000 1) margins. No statistically significant difference between the two populations was noted for tumor size, echogenicity, consistency, location, lesion number, or number of FNA passes performed. Conclusions: Pancreatic metastases are an important cause of focal pancreatic lesions and may occasionally be discovered during EUS examination after previously negative or inconclusive CT. Use of immunocytochemistry, when available, may help to confirm a suspected diagnosis. These lesions are more likely to have well-defined EUS margins compared with primary pancreatic cancer.

关键词：多中心试验超声内镜细针穿刺免疫细胞化学法可疑诊断恶性瘤原发肿瘤细胞学诊断结肠癌团块影

胃内折叠缝合术的远期结果:一项美国多中心试验

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世界核心医学期刊文摘（胃肠病学分册） 2005年第9期1卷 29-30页

作者： Raijman I. Ben-Menachem T. 赵天智

Background: Endoluminal gastroplication has shown promise for the treatment of GERD in short-term studies. Until now, long-term outcome data have been lacking. Methods: A prospective, multicenter trial enrolled 85 patients with GERD to be treated with endoluminal gastroplication. Inclusion criteria were 3 or more heartburn or regurgitation episodes per week, >4.2%time in 24 hours with esophageal pH < 4, and dependency on antisecretory medications. Exclusion criteria were the presence of varices, achalasia, aperistalsis, or previous gastric resection. Patients underwent manometry, 24-hour pH monitoring, and symptom severity scoring before and after the procedure. Patient diaries were used to assess medication use and to estimate annual medication cost. Results: At 1-and 2-year follow-up, patients had significant reductions in median heartburn symptom scores (72 at baseline [interquartile range (IQR) 90-48] vs. 4 at 12 months [IQR 43-0] and 16 at 24 months [IQR 53-3.5]; p < 0.000 1 vs. baseline) and median regurgitation symptoms (2 at baseline [IQR 3-1] vs. 0 at 12 months (IQR 1-0) and 1 at 24 months [IQR 1-0]; p < 0.000 1 vs. baseline). Of all patients, 59%and 52% showed heartburn symptom resolution at 12 and 24 months, respectively (p < 0.000 1 vs. baseline). Also, 83%and 77%had regurgitation symptom resolution at 12 and 24 months, respectively (p < 0.000 1 vs. baseline). Proton pump inhibitor use also was significantly reduced at 12 and 24 months after the procedure. At 2-year follow-up, median annualized medication costs were reduced by 88%(＄1381) (p < 0.000 1). Endoluminal gastroplication significantly reduced the duration and the number of episodes of esophageal acid exposure (P< 0.000 1 vs. baseline). Only 7 patients experienced adverse events. Conclusions: Endoscopic gastroplication is safe and effective, and is associated with symptom reductions in patients with GERD for at least 24 months.

关键词：远期结果多中心试验缝合术胃切除术胃灼热食管测压症状严重度蠕动消失反流症状排除标准

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婴儿纤维性错构瘤:一项意大利多中心试验

世界核心医学期刊文摘（皮肤病学分册） 2006年第8期2卷 42-43页

作者： Carretto E. Dall'Igna P. Alaggio R. 朱国兴 Department of Paediatrics Division of Paediatric Surgery University of PaduaPadua Italy Dr.

Background: Fibrous hamartoma (FH) of infancy is a benign mesenchymal tumor, occurring as a superficial mass. Complete excision is curative. Objective and Methods: The clinical features and treatment results of 18 children with FH are described. Results: Local excision was the most common procedure. Surgery was radical in 10 patients, with microscopic residual disease in 6; all of them are alive with no evidence of disease 2 to 49 months after diagnosis. One patient, treated with a local reexcision for macroscopic residual disease (and chemotherapy for a synchronous desmoid fibromatosis) is well 83 months after diagnosis; the last patient, with a lesion of the labia majora, only underwent biopsy and is doing well, awaiting plastic surgery. Limitations: The results did not reach statistical significance due to difficulties in collecting cases. Conclusions: FH should be treated by complete excision; in our experience a nonradical excision was also able to achieve the cure. An aggressive approach should be avoided, as the overall prognosis is excellent.

关键词：纤维性错构瘤多中心试验婴儿意大利整形外科手术根治性切除治疗效果良性间质瘤完全切除临床特征

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医学顾问:国际多中心试验不可或缺的角色

中国处方药 2007年第9期6卷 24-25页

作者：范大超《中国处方药》特约撰稿人

怎样让这些差异性不影响到国际多中心试验的"一致性",使临床试验最终获得科学、严谨的数据,是一个十分重要的问题。

关键词：多中心试验医学顾问国际临床试验一致性

比较植入ICD的自发性室性心动过速患者中经验性抗心动过速起搏与电除颤的前瞻性随机多中心试验:快速性室性心律失常起搏治疗降低除颤研究(PainFREE RxⅡ)试验结果

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世界核心医学期刊文摘（心脏病学分册） 2005年第3期1卷 36-37页

作者： Wathen M.S. DeGroot P.J. Sweeney M.O. 腾增辉 Vanderbilt Page-Campbell Heart Inst. Vanderbilt University Medical Center 2220 Pierce Nashville TN 37232 United States Dr.

Background-Successful antitachycardia pacing(ATP) terminates ventricular tachycardia(VT) up to 250 bpm without the need for painful shocks in implantable cardioverter-defibrillator(ICD) patients. Fast VT(FVT) >200 bpm is often treated by shock because of safety concerns, however. This prospective, randomized, multicenter trial compares the safety and utility of empirical ATP with shocks for FVT in a broad ICD population. Methods and Results-We randomized 634 ICD patients to 2 arms-standardized empirical ATP(n=313) or shock (n=321)-for initial therapy of spontaneous FVT. ICDs were programmed to detect FVT when 18 of 24 intervals were 188 to 250 bpm and 0 of the last 8 intervals were >250 bpm. Initial FVT therapy was ATP (8 pulses, 88%of FVT cycle length) or shock at 10 J above the defibrillation threshold. Syncope and arrhythmic symptoms were collected through patient diaries and interviews. In 11±3 months of follow-up, 431 episodes of FVT occurred in 98 patients, representing 32%of ventricular tachyarrhythmias and 76%of those that would be detected as ventricular fibrillation and shocked with traditional ICD programming. ATP was effective in 229 of 284 episodes in the ATP arm(81%, 72%adjusted). Acceleration, episode duration, syncope, and sudden death were similar between arms. Quality of life, measured with the SF-36, improved in patients with FVT in both arms but more so in the ATP arm. Conclusions-Compared with shocks, empirical ATP for FVT is highly effective, is equally safe, and improves quality of life. ATP may be the preferred FVT therapy in most ICD patients.

关键词：抗心动过速起搏 ICD PainFREE Rx 起搏治疗电除颤多中心试验试验结果快速性心室颤动复律

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抗痴呆药物多中心试验

国外医学情报 1992年第13期13卷 13-14页

作者：雅德

加拿大15个医疗中心正准备进行一项试验研究,750名轻度至中度的老年痴呆患者将分别在美国和加拿大参加这项抗痴呆药Linoirine的多中心试验。

关键词：抗痴呆多中心试验痴呆患者加拿大医疗中心试验研究受试者药物试验老年痴呆病年龄