Objectives: To identify the histologic and ultrastructural features of surgica lly excised subfoveal choroidal neovascular lesions from patients enrolled in th e Submacular Surgery Trials and to compare them with clin...Objectives: To identify the histologic and ultrastructural features of surgica lly excised subfoveal choroidal neovascular lesions from patients enrolled in th e Submacular Surgery Trials and to compare them with clinical data. Methods: Sur gically excised subfoveal choroidal neovascular lesions from patients enrolled i n the Submacular Surgery Trials group N trial (lesion predominantly choroidal ne ovascularization [CNV] with evidence of classic CNV from age-related macular de generation), group B trial (lesion predominantly hemorrhagic from age-relatedma cular degeneration), and groupHtrial (idiopathic subfoveal CNV or subfoveal CNV from ocular histoplasmosis syndrome) between October 1, 1999, and September 1, 2 001, were submitted to the pathology center. The lesion growth pattern (subretin al pigment epithelial [sub-RPE], subretinal, combined, or indeterminate) and th e cellular and extracellular constituents were classified independently. Demogra phic, clinical, and fluorescein angiographic characteristics of patients, eyes, and lesions, respectively, were compared with the pathologic features. Results: Of 269 patients assigned to surgery during the 24 months that pathologic specime nswere collected, surgical specimens from study eyes of 199 were submitted to th e pathology center. Of the 199 routine histologie specimens processed, 144 (72% ) were classified as CNV, 51 (26%) as fibrocellular tissue, and 4 (2%) as hemo rrhage. The median specimen size was smaller in group H (932 X 208 μm) than in groups N (1980 X 325 μm) and B (1800 X 395 μm). The CNV growth pattern was det ermined in 91 (46%) of 199 specimens. Of 159 group N and group B lesions, 76 (4 8%) had an indeterminate growth pattern, 28 (18%) had a sub-RPE growth patter n, and 33 (21%) had sub-RPE and subretinal growth patterns. Of 40 group H lesi ons, 32 (80%) had an indeterminate growth pattern, 7 (18%) had a subretinal gr owth pattern, and 1 (2%) had a combined sub-RPE and subretinal pattern. Based on electron microscopy, the most common cellular lesion components were RPE, mac rophages, erythrocytes, fibrocytes, and vascular endothelium; the most common ex tracellular components were 24-nm collagen and fibrin. Basal laminar and linear deposits were found in 80%(40/ 50) and 16%(8/49) of group N specimens, 66%(4 3/65) and 5%(3/65) of group B specimens, and 8%(2/26) and 0%(0/26) of group H specimens, respectively. Conclusions: Most surgically excised subfoveal specime ns had evidence of CNV or tissue associated with CNV. The constituents in CNV we re consistent with granulation tissue proliferation. The presence of basal depos its in surgically excised specimens suggested a clinical diagnosis of agerelated macular degeneration, even when blood was the predominant component of the lesion. Correlation of growth patterns above or below the RPE with fluoresc ein angiographic patterns of classic or occult CNV was limited because most spec imens had insufficient material to determine these patterns.展开更多
目的：对比单病例随机对照试验（N-of-1）、系列单病例随机对照试验（Series of N-of-1）与随机对照试验（RCT）样本量概念的异同;尝试总结出N-of-1、Series of N-of-1优效性试验的样本量估算方法。方法：查阅国内外相关文献,运用比较...目的：对比单病例随机对照试验（N-of-1）、系列单病例随机对照试验（Series of N-of-1）与随机对照试验（RCT）样本量概念的异同;尝试总结出N-of-1、Series of N-of-1优效性试验的样本量估算方法。方法：查阅国内外相关文献,运用比较研究法对三者从样本量估算方法及试验背景上进行比较。结果：N-of-1的样本量是指轮次数或疗效评价指标测量的次数; Series of N-of-1的样本量是指参与者数量。目前,临床试验过程中,N-of-1很少估算样本量,而Series of N-of-1样本量估算的方法是在RCT基础上改进得到的。结论：N-of-1是对病案描述的科学提炼与完善,在中医药临床研究中有着广泛的应用前景。N-of-1中样本量估算方法虽然还未形成理论体系,但随着研究的不断深入,最终会为样本量估算理论体系的完善提供方法学支持。展开更多
文摘Objectives: To identify the histologic and ultrastructural features of surgica lly excised subfoveal choroidal neovascular lesions from patients enrolled in th e Submacular Surgery Trials and to compare them with clinical data. Methods: Sur gically excised subfoveal choroidal neovascular lesions from patients enrolled i n the Submacular Surgery Trials group N trial (lesion predominantly choroidal ne ovascularization [CNV] with evidence of classic CNV from age-related macular de generation), group B trial (lesion predominantly hemorrhagic from age-relatedma cular degeneration), and groupHtrial (idiopathic subfoveal CNV or subfoveal CNV from ocular histoplasmosis syndrome) between October 1, 1999, and September 1, 2 001, were submitted to the pathology center. The lesion growth pattern (subretin al pigment epithelial [sub-RPE], subretinal, combined, or indeterminate) and th e cellular and extracellular constituents were classified independently. Demogra phic, clinical, and fluorescein angiographic characteristics of patients, eyes, and lesions, respectively, were compared with the pathologic features. Results: Of 269 patients assigned to surgery during the 24 months that pathologic specime nswere collected, surgical specimens from study eyes of 199 were submitted to th e pathology center. Of the 199 routine histologie specimens processed, 144 (72% ) were classified as CNV, 51 (26%) as fibrocellular tissue, and 4 (2%) as hemo rrhage. The median specimen size was smaller in group H (932 X 208 μm) than in groups N (1980 X 325 μm) and B (1800 X 395 μm). The CNV growth pattern was det ermined in 91 (46%) of 199 specimens. Of 159 group N and group B lesions, 76 (4 8%) had an indeterminate growth pattern, 28 (18%) had a sub-RPE growth patter n, and 33 (21%) had sub-RPE and subretinal growth patterns. Of 40 group H lesi ons, 32 (80%) had an indeterminate growth pattern, 7 (18%) had a subretinal gr owth pattern, and 1 (2%) had a combined sub-RPE and subretinal pattern. Based on electron microscopy, the most common cellular lesion components were RPE, mac rophages, erythrocytes, fibrocytes, and vascular endothelium; the most common ex tracellular components were 24-nm collagen and fibrin. Basal laminar and linear deposits were found in 80%(40/ 50) and 16%(8/49) of group N specimens, 66%(4 3/65) and 5%(3/65) of group B specimens, and 8%(2/26) and 0%(0/26) of group H specimens, respectively. Conclusions: Most surgically excised subfoveal specime ns had evidence of CNV or tissue associated with CNV. The constituents in CNV we re consistent with granulation tissue proliferation. The presence of basal depos its in surgically excised specimens suggested a clinical diagnosis of agerelated macular degeneration, even when blood was the predominant component of the lesion. Correlation of growth patterns above or below the RPE with fluoresc ein angiographic patterns of classic or occult CNV was limited because most spec imens had insufficient material to determine these patterns.
文摘目的：对比单病例随机对照试验（N-of-1）、系列单病例随机对照试验（Series of N-of-1）与随机对照试验（RCT）样本量概念的异同;尝试总结出N-of-1、Series of N-of-1优效性试验的样本量估算方法。方法：查阅国内外相关文献,运用比较研究法对三者从样本量估算方法及试验背景上进行比较。结果：N-of-1的样本量是指轮次数或疗效评价指标测量的次数; Series of N-of-1的样本量是指参与者数量。目前,临床试验过程中,N-of-1很少估算样本量,而Series of N-of-1样本量估算的方法是在RCT基础上改进得到的。结论：N-of-1是对病案描述的科学提炼与完善,在中医药临床研究中有着广泛的应用前景。N-of-1中样本量估算方法虽然还未形成理论体系,但随着研究的不断深入,最终会为样本量估算理论体系的完善提供方法学支持。
