经椎弓根截骨凸侧悬臂梁技术治疗重度僵硬性先天性脊柱侧后凸

目的评估后路经椎弓根顶椎截骨凸侧悬臂梁技术治疗重度僵硬性先天性脊柱侧后凸的治疗效果及临床应用价值.方法回顾性分析2007年5月至2009年6月经椎弓根顶椎截骨凸侧悬臂梁技术治疗的重度僵硬性先天性脊柱侧后凸畸形患者的临床资料.其中男10例,女18例,平均年龄17岁(13～25岁).入组病例均为重度僵硬性先天性脊柱侧后凸患者.术中经椎弓根顶椎截骨技术截骨,并保留凹侧结构不完全离断作为门轴,在凸侧采用悬臂梁技术压棒矫正侧后凸畸形.通过术前术后X线片对矫形效果进行评价,并对术中、术后并发症情况进行统计分析.结果本组平均手术时间254min (220-420min),术中平均出血量1280ml (850～3200ml),平均随访28个月(18-40个月),术前主弯侧凸Cobb's角86.0°±16.5° (78°～135°),后凸角82.0°±13.6° (78°～110°),术前C7铅垂线距骶中线距离1.51±0.32cm;术后侧凸Cobb's角矫正至26.8°±15.0° (矫正率69%);后凸Cobb's角25.1°±10.5° (矫正率70%);C7铅垂线距骶中线距离0.50±0.16cm.所有手术顺利安全实施,无截瘫等严重并发症发生.所有患者均获得坚固融合,没有断钉断棒及内固定松动等并发症.结论经椎弓根顶椎截骨凸侧悬臂梁压棒技术治疗重度僵硬性先天性脊柱侧后凸畸形是一种安全、可靠的方法,矫形效果满意.     

后路全脊椎截骨矫形治疗成人先天性脊柱后凸畸形

目的 探讨后路全脊椎截骨治疗成人先天性脊柱后凸的疗效和安全性.方法 2004年2月至2008年11月,对11例成人先天性脊柱后凸的患者进行了经顶椎全脊椎截骨联合椎弓根螺钉系统内固定手术治疗.其中男4例,女7例;年龄24～49岁,平均31.9岁.术前脊柱后凸Cobb's角62～102°,平均79.4°.伴神经压迫症状者9例.所有患者均行后路一期经顶椎全脊椎截骨、经椎弓根固定、植骨融合术,截骨平面T9～L2.结果 所有患者安全接受手术,无神经损伤,内固定失败等严重并发症发生.手术时间3.2-4.8h,平均3.6h.术中出血量750～1500ml,平均990ml;围手术期总出血量1450～2200ml,平均1722ml.术后10d左右佩戴支具下地,6例术前神经压迫症状者术后即有不同程度的恢复,2例1年随访有改善,1例无明显变化.术后后凸Cobb's角10～32°,平均21.8°;矫正率72.5%.随访时间12-39个月,平均16.6个月.术后1年随访时所有患者对治疗结果表示满意,矫正丢失率为2.7%.结论 后路一期全脊椎截骨术治疗成人先天性脊柱后凸手术相对安全,矫正效果良好.通过节段椎弓根螺钉系统固定重建脊柱稳定性,配合支具外固定,患者可在术后早期下地活动.     

后路全脊椎截骨治疗重度脊柱角状后凸畸形的围手术期并发症分析

目的：分析经后路全脊椎截骨（posteriorvertebralcolumnresection,PVCR）治疗重度脊柱角状后凸畸形的围手术期并发症。方法2006年1月至2013年12月,我科采取后路顶椎区全脊椎截骨治疗重度脊柱角状后凸畸形患者38例,男21例,女17例,年龄13～61岁,平均27.5岁。术前后凸Cobb’s角平均116°（85～175）°,侧凸Cobb’s角平均16°（0～40）°。对临床结果进行评估,并对围手术期并发症进行分析。结果手术时间平均312（210～470）min,术中出血量平均2089（800～4500）ml,随访时间平均43.5（6～72）个月,术后脊柱后凸Cobb’s角平均43.6°（10～98）°,矫正率为62.4%;术后侧凸Cobb’s角平均5.2°（0～12）°,矫正率为67.5%。16例（42.1%）发生围手术期并发症。其中发生神经系统并发症5例（13.2%）,包括完全性脊髓损伤1例,一过性神经功能障碍4例;非神经系统并发症早期9例（23.7%）,包括胸腔积液2例,硬膜损伤2例,螺钉拔出3例,伤口表浅感染1例,胃肠道功能障碍1例;中期并发症2例（5.3%）,包括内固定棒断裂1例,后凸加重1例。结论 PVCR是治疗重度脊柱角状后凸畸形的有效手术方法,但其潜在的严重并发症不可忽视。     

经椎弓根椎体截骨术治疗强直性脊柱炎后凸畸形术中大量出血的预测

目的探讨经椎弓根椎体截骨术（pediclesubtractionosteotomy,PSO）治疗强直性脊柱炎（ankylosingspondylitis,AS）后凸畸形术中大量出血（massivebloodloss,MBL）的预测因素。方法共收集147例PSO治疗AS后凸畸形的病例数据。其中106例资料完整,分为两组：A组（ n＝69）术中出血量≥估计血容量的30%,B组（ n＝37）术中出血量＜估计血容量的30%。比较两组患者术前数据,应用单因素分析大量出血所有可能的预测因素。应用多因素 Logitic 回归分析大量出血的独立危险因素。应用 Pearson 相关性检验分析全部106例大量出血的发生率与脊柱外科医生PSO手术积累量的关系。结果 A组患者（65%）中, GK角≥70°、固定节段数≥9、双节段截骨的例数比B组（35%）更多。Logistic回归分析显示固定节段数≥9以及双节段截骨是大量出血的独立危险因素。Pearson 相关性分析显示在一定范围内,大量出血的发生率随着脊柱外科医生PSO手术积累量的增加而下降,二者呈线性相关。结论 PSO手术治疗AS后凸畸形的患者中,大量出血的发生率为65%。术前 GK 角≥70°、双节段 PSO 截骨以及固定节段数≥9是大量出血的预测因素,后两者是独立预测因素。在一定范围内,随着脊柱外科医生 PSO手术量的积累,大量出血的发生率下降。     

成人特发性脊柱侧凸的后路截骨术

目的评价后路脊柱截骨术在治疗成人特发性脊柱侧凸的有效性和安全性。方法回顾性随访2000年1月至2004年12月间接受后路截骨矫形固定融合术并随访2年以上的53例成人特发性脊柱侧凸，男13例，女40例，平均年龄31．2岁（20～48岁）。按照弯曲部位分别为单胸弯23例，胸腰弯15例，双胸弯7例，胸腰双弯8例。术前平均胸椎Cobb角58．8°（44～93），腰椎49．5°（35°～79°），平均柔韧度胸椎28．2％，腰椎37．1％。躯干偏移平均38mm（3～79mm）。本组中37例术前合并腰背痛，5例合并椎管或神经根管狭窄所致的下肢症状。所有患者接受一期后路选择性经关节突椎板截骨矫正、经椎弓根固定融合术。通过病例查阅、X线片测量以及问卷随访，评价矫正情况和功能情况。结果所有患者均安全完成手术，无神经损伤等严重并发症发生。平均截骨节段3．1个（2～5个），平均手术时间3．5h（2．8～5．2h），平均出血量892ml（750～l520m1）。所有患者均获得2年以上随访（2～5年）。术后胸椎侧凸平均17．2°（19°～47°），最终随访时平均19．8°（11°～49°）。术后腰椎侧凸平均16．7°（7°～23°），最终随访时平均l8．9°（8°～26°）。术后躯干偏移平均为l1mm（0～2lmm），平均矫正71％。37例术前存在腰背痛者35例最终随访时腰背痛消失，5例术前存在下肢症状者术后完全消失。结论成人特发性脊柱侧凸行后路经关节突和椎板截骨可以获得满意矫正，疼痛症状缓解，是治疗成人特发性脊柱侧凸的安全有效的手术方法。     

全脊椎截骨联合椎板 V 形截骨在治疗强直性脊柱炎后凸畸形中的应用

目的总结全脊椎截骨联合椎板V形截骨治疗重度强直性脊柱炎后凸畸形的疗效,并对矫形效果和手术适应证进行分析。方法手术治疗重度强直性脊柱炎后凸畸形患者22例,全部为男性,平均手术年龄29.3岁。2例患者术前出现神经损伤症状。全部患者行后路弧顶全脊椎楔形截骨、联合多节段椎板关节突V形截骨、节段椎弓根螺钉固定,术中应用SEP和唤醒试验双向监测。影像学测量脊柱后凸角（CA）、骶骨倾斜角（SEA）、大体像测量颏眉角（CBVA）评价矫形效果。结果术后平均后凸角由术前的76.6°（66°～105°）矫正至29.6°,平均矫正率66.2%,骶骨倾斜角由术前平均17.5°（-5.9°～23.1°）矫正至33.4°,颏眉角由术前平均35.6°（28°～47.1°）矫正至7.4°。19例患者术后平均随访29个月（4～54个月）,植骨融合良好,矫正丢失率平均2.3%。术后2例患者出现暂时神经功能障碍,1个月后完全恢复。术前有神经功能障碍的患者术后完全恢复。结论全脊椎截骨联合椎板V形截骨能够有效恢复躯干矢状面平衡,是治疗重度强直性脊柱炎后凸畸形的有效方法。尤其适用于后凸角度大于70°,特别是弧顶合并楔形变或压缩骨折的重度后凸畸形。     

后路脊柱截骨术与牵引辅助后路广泛松解术治疗重度脊柱畸形的比较研究

目的：比较后路脊柱截骨术和牵引辅助后路广泛松解术治疗重度脊柱畸形的围手术期并发症和初步疗效。方法回顾性比较研究我科收治的29例重度脊柱畸形患者资料。2013年8月至2014年6月,行牵引辅助后路广泛松解术矫形患者（牵引组）12例;2012年6月至2013年8月,行后路脊柱截骨手术矫形患者（对照组）17例。牵引组术前主弯Cobb’s角平均为111.8°,对照组平均为115.2°;牵引组术前最大后凸角度平均为113.3°,对照组为118.5°。比较两组间术后90天内的并发症发生率以及临床疗效。结果两组术前平均年龄、性别比、体重指数、主弯角度、主弯柔韧度、最大后凸角差异无统计学意义。手术时间,牵引组和对照组分别为（322.1±102.5）min和（426.3±100.4）min（P＝0.012）;术中出血量,牵引组和对照组分别为（1241.7±999.5）ml和（2300.0±1449.1）ml（P＝0.040）;置钉密度,牵引组和对照组分别为（58.0±16.2）%和（77.4±13.1）%（P＝0.001）;而围手术期并发症,牵引组和对照组分别为16.7%和58.8%（P＝0.049）;两组比较,牵引组显著小于对照组,差异有统计学意义,但两组的畸形矫正率相当。结论重度脊柱畸形患者的后路脊柱截骨术和牵引辅助后路广泛松解术,疗效相当,但牵引辅助后路广泛松解术,可避免侵袭性大的操作、缩短手术时间、减少出血量,并显著减少了围手术期并发症的发生率。     

合并无症状性Chiari—Ⅰ型畸形脊柱侧凸的手术治疗

目的探讨伴有无症状Chiari—Ⅰ型畸形的脊柱侧凸手术矫正的策略和方法。方法伴发脊柱侧凸的无自觉症状的Chiari—Ⅰ型畸形患者18例,男10例,女8例,平均年龄14．5岁。进行侧凸矫形,单纯后路矫形植骨融合固定10例,前路松解后路截骨固定矫形3例,前路松解固定和后路截骨固定3例,后路生长棒固定矫形2例。固定器械均采用中华长城内固定系列。其中17例患者行枕大孔扩大减压成形手术治疗后再行矫形手术。结果术前冠状面的Cobb角平均70．4°,术后Cobb角平均20．8°,术前矢状面后凸的平均46°,术后平均15．8°,术前平均身高148．9cm,术后平均身高154．8cm,平均增高5．9cm,平均随访24个月,侧凸和后凸矫正平均丢失分别为5％和4％,未发现假关节形成,17例对治疗结果表示满意。结论对于合并有Chiari—Ⅰ脊柱侧凸,针对不同年龄和侧凸弯曲和柔韧性,以及小脑扁桃体下移的程度,先行枕骨大孔扩大硬膜切开成形,再行侧凸矫形,可以取得安全满意的矫形效果。     

重度僵硬性脊柱畸形后路三柱截骨矫形67例疗效及并发症分析

目的探讨重度僵硬性脊柱畸形三柱截骨矫形术的疗效、神经并发症及其防治。方法2006年1月至2017年9月采用脊柱后路三柱截骨矫形术治疗重度僵硬性脊柱畸形患者67例,其中男39例,女28例;年龄9~62岁,平均47.6岁。神经肌肉性脊柱侧凸畸形2例,先天性脊柱侧凸和侧后凸畸形5例,特发性脊柱侧凸畸形8例,强直性脊柱炎后凸和侧后凸畸形10例,脊柱结核后凸与侧后凸畸形22例,陈旧性胸腰椎骨折后凸和侧后凸畸形20例。术前脊柱后凸畸形46例,侧凸畸形14例,侧后凸畸形7例;其中主弯侧凸畸形16例,Cobb’s角平均(75.9±13.5)°;主弯后凸畸形51例,Coob’s角平均(118.6±28.8)°。术前已有脊髓功能损害者24例(35.8%);行经后路椎弓根椎体楔形截骨术(pedicle subtraction osteotomy,PSO)17例,经椎弓根椎体椎间盘截骨术(bone-disc-bone osteotomy,BDBO)13例,全脊椎切除术(ertebral column resection,PVCR)22例,多节段椎体截骨术(posterior multilevel vertebral osteotomy,PMVO)15例,联合椎弓根螺钉钉棒系统矫形固定植骨融合,唤醒试验监测截骨术中脊髓神经功能。结果术后随访24~98个月,平均32个月,主弯侧凸畸形Cobb’s角(26.1±10.5)°,矫正率65.2%,冠状位垂直轴距(coronal vertical axis,CVA)由术前平均12.1 cm矫至术后4.8 cm,P<0.01;主弯后凸畸形Cobb’s角(32.8±9.1)°,矫正率67.67%,矢状位垂直轴距(sagittal vertical axis,SVA)由术前平均18.9 cm矫至术后6.4 cm,P<0.01;术后末次随访较术后1年主弯侧凸畸形与后凸畸形矫正Cobb’s角丢失平均值分别为2.1°和1.6°。术后并发症共16例20种,发生率23.9%;神经并发症9例(13.45%),其中2例不全性截瘫行手术探查后大部恢复,余7例非手术治疗神经功能恢复正常。24例术前已有脊髓神经根损害者术后美国脊髓损伤协会(American spinal injury association,ASIA)脊髓功能分级较术前平均提高2个级别。结论后路三柱截骨矫形术是治疗严重僵硬性脊柱畸形最有效的方法,可达显著的脊柱三维矫形效果,但手术难度高、风险大,截骨矫形疗效受多种因素影响,特别是神经系统并发症发生率高是影响疗效最严重的问题。针对这些因素采取严密的术前设计、个体化截骨方式、规范的手术操作和脊髓神经根的保护,维持正常有效循环血容量和早期发现与处理脊髓神经等并发症是保证手术疗效的关键。     

大于90°的重度脊柱侧凸患者的单纯后路椎弓根螺钉内固定治疗

研究设计回顾性比较研究。目的评估单纯后路椎弓根螺钉内固定治疗侧凸角度＞90°的重度脊柱畸形的疗效和安全性。研究背景对于侧凸角度＞90°的重度脊柱畸形的标准手术方式仍存争议,传统术式包括围手术期牵引辅助和分期前后路联合手术。方法回顾性分析由同一术者采取单纯后路椎弓根螺钉内固定治疗的40例侧凸角度＞90°的重度脊柱畸形患者资料,侧凸角度平均为111.4°（91～175）°,平均随访31（6～60）个月。其中特发性脊柱侧凸27例,先天性9例,神经肌肉型3例,症状性1例。40例中,25例行多节段Ponte截骨术联合后路椎弓根螺钉内固定术,另15例则行全脊椎切除联合后路椎弓根螺钉内固定术。分析影像学结果和并发症发生率。结果影像学结果表明,单纯后路椎弓根螺钉矫形术可使主弯平均矫正率术后8周达49%,而末次随访时为47%（P＜0.001）。总畸形角度（主弯Cobb’s角＋最大后凸角）术前平均为160°,而术后8周和末次随访时,平均矫正率分别为50%和48%（P＜0.001）。有7例（18%）术中运动诱发电位（motorevokedpotential,MEP）消失,而4例（10%）术后出现暂时性脊髓神经损伤。1例术后并发伤口感染。另1例术后2年随访时发现内植物断裂,予以观察随访。结论单纯后路椎弓根螺钉内固定可有效治疗角度＞90°的重度脊柱侧凸,其可避免前路手术或围手术期牵引,达到理想的矫形效果,且无严重并发症。     

Comparative study of cefpiramide + amikacin versus piperacillin + amikacin in granulocytopenic patients: a randomized, prospective study]

Cefpiramide + amikacin (CPM + AMK) was compared in a prospective randomized trial with our standard regimen of piperacillin plus amikacin (PIPC + AMK) as an empiric therapy for fever in 252 episodes of 141 patients with granulocytopenia. Initial profound granulocytopenia (fewer than 100/mm3 mature granulocytes) was present in approximately 69% of the patient trials in both treatment groups. Both groups were equally distributed in regard to age, disease, pretreatment WBC count and duration of antibiotic treatment, although septic shock was more frequently seen in CPM + AMK. Responses to PIPC + AMK and CPM + AMK were similar for microbiologically and clinically documented infection, while the response rate for clinically documented infections treated with PIPC + AMK was superior to CPM + AMK (63% vs. 52%). Patients with persistent granulocytopenia of less than 100/mm3 of mature granulocytes without a rise during therapy responded significantly less in both groups (22% vs. 9%) than those in whom the granulocyte count rose (79% vs. 79%). Toxicities of jaundice or disordered hepatic function test were infrequent in both groups. Disordered renal function test occurred in one case in PIPC + AMK groups.     

Liquid-based cytology versus conventional Papanicolaou smear in an organized screening program : a prospective randomized study

BACKGROUND: The objective of this study was to evaluate whether liquid-based cytology (LBC) can improve high-standard cervical cancer screening cytology further. The primary endpoint was histopathologic high-grade lesions in current and subsequent screening rounds. The secondary endpoints were cytologic diagnosis and inadequate samples. METHODS: Women were randomized to smear taking by conventional Papanicolaou (Pap) smear or LBC according to the time of appointment. Eight thousand eight hundred ten conventional Pap smears and 4674 LBC samples were included. Evaluations of atypical cytology and referral to colposcopy and treatment were performed as routine procedures. Histopathologic diagnoses were retrieved from a regional database 8 months after the study was closed. The mean follow-up was 2 years and 9 months. RESULTS: Inadequate samples were observed in 0.3% of LBC samples versus 0.7% of Pap smears (P = .002). The total fraction of nonbenign diagnoses in cytology was 4.5% versus 3.5%, respectively (P < .001). Histopathologic evaluation was made on 570 patients constituting 4.6% of the LBC samples and 4% of the Pap smears. Forty percent more high-grade lesions were identified as a result of LBC sampling (1.20% vs 0.85%; P = .05). The influence of the sampling method was significant for all variables (odds ratio [OR], 1.60; 95% confidence interval [95% CI], 1.12-2.28) for high-grade lesions that were identified by histology when adjusting for age and screening unit in a logistic regression model. At the second follow-up 2 years and 1 month later, the OR was decreased only slightly (1.51; 95% CI, 1.13-2.01). CONCLUSIONS: In the ongoing cervical screening program of western Sweden, liquid cytology produced a significantly higher yield of histologic high-grade lesions compared with conventional Pap smears.     

Chemotherapy versus chemoimmunotherapy in advanced adenocarcinoma of the colon and rectum: a prospective randomized study.

The combination of vincristine, methyl-CCNU, and methotrexate with or without MER-BCG achieved a 2% complete response (CR) and a 11% partial response (PR) with a median duration of 25-29 weeks in 124 evaluable patients with advanced adenocarcinoma of the colon and rectum. Responses were seen in previously untreated patients and in patients refractory to 5-fluorouracil. The median survival of these objective responders (CR + PR) was 57 weeks. The addition of MER-BCG did not appear to influence response rate or duration of survival and was accompanied by significant toxicity. Response was significantly correlated with performance status, sex, and disease free interval and survival with alkaline phosphatase and performance status. Patients with advanced colorectal carcinoma should be stratified according to these variables.     

Adjuvant prophylactic regional radiotherapy versus observation in stage I Merkel cell carcinoma: a multicentric prospective randomized study

BackgroundThe treatment of stage I Merkel cell carcinoma (MCC) usually includes wide local excision (WLE) combined with irradiation of the tumor bed (ITB). No randomized study has ever been conducted in MCC. The purpose of this study was to assess the efficacy and safety of prophylactic adjuvant radiotherapy on the regional nodes.Patients and methodsIn this randomized open controlled study, patients for a stage I MCC treated by WLE and ITB were randomly assigned to regional adjuvant radiotherapy versus observation. Overall survival (OS) and probability of regional recurrence (PRR) were primary end points. Progression-free survival (PFS) and tolerance of irradiation were secondary end points.ResultsEighty-three patients were included before premature interruption of the trial, due to a drop in the recruitment mainly due to the introduction of the sentinel node dissection in the management of MCC. No significant improvement in OS (P = 0.989) or PFS (P = 0.4) could be demonstrated after regional irradiation, which, however, significantly reduced the PRR (P = 0.007) with 16.7% regional recurrence rate in the observation arm versus 0% in the treatment arm. The treatment was well tolerated.ConclusionThe adjuvant regional irradiation significantly decreased the PRR in MCC, but benefit in survival could not be demonstrated.     

Antibiotic prophylaxis in hernia repair and breast surgery: a prospective randomized study comparing piperacillin/tazobactam versus placebo

Although antibiotic prophylaxis is not explicitly indicated for hernia repair and breast surgery, its use for these clean procedures is widely adopted, albeit to a different extent in different countries, often on the personal decision of the individual surgeon. The present study was carried out to compare the efficacy of a single pre-operative dose of piperacillin-tazobactam with placebo in preventing surgical wound infections and to determine the main risk factors associated with infections following two main elective surgical clean procedures such as hernia repair and breast surgery.A total of 501 patients undergoing elective inguinal/femoral hernia repair or breast surgery were enrolled in this prospective randomized clinical study. Patients were randomly assigned to receive preoperative antibiotic prophylaxis or placebo. One dose of piperacillin-tazobactam 2.250 g or placebo was administered i.v. 30 minutes prior to the surgical procedure. Using statistical univariate analysis, the following variables were correlated with a higher infection risk: age >40 years, concomitant disease, WBC <3500, surgical wound size >9cm, use of drainages, non-prophylaxis. Using multivariate analysis, no antibiotic pre-operative prophylaxis, concurrent chronic diseases, especially diabetes (risk 15 times higher), and length of intervention >45 min (risk 6 times higher) were independent predictors of infection. Finally, patients with postoperative infections had a significantly longer hospitalisation. One pre-operative dose of piperacillin-tazobactam 2.250 g is more effective than placebo in preventing postoperative infections in breast surgery and hernia repair.     

Combined Nd-YAG laser/HDR brachytherapy versus Nd-YAG laser only in malignant central airway involvement: a prospective randomized study

BACKGROUND: Laser debulking and prosthetic stents are useful modalities in the palliative treatment of initial inoperable or recurrent lung cancer. Recently, endobrochial brachytherapy was introduced to extend the duration of palliation and reduce the number of endoscopic treatments. This trial compares Nd-YAG laser alone and associated to high dose rated (HDR)-brachytherapy. PATIENTS AND METHODS: From 1995 to 1998, 29 consecutive patients, with non-small cell lung cancer (NSCLC) and central airway involvement, were randomized in two groups: group 1 (15 patients) received Nd-YAG laser only; group 2 (14 patients) underwent a combined Nd-YAG laser/ HDR brachytherapy treatment. RESULTS: There was no mortality or morbidity related to the treatment. The period free from symptoms was 2.8 months for group 1 and increased to 8.5 months in group 2 (P<0.05). The disease's progression free period grew from 2.2 months of group 1 to 7.5 months of group 2 (P<0.05) and the number of further endoscopic treatment reduced from 15 to 3 (P<0.05). CONCLUSION: The results confirm the potential of brachytherapy to prolong relief from symptoms, lessen disease progression and reduce costs of treatment. A detailed analysis is presented of both groups.     

External irradiation versus external irradiation plus endobronchial brachytherapy in inoperable non-small cell lung cancer: a prospective randomized study.

PURPOSE: No randomized studies are available on the additional value of endobronchial brachytherapy (EBB) to external irradiation (XRT) regarding palliation of respiratory symptoms (RS). A prospective randomized study was initiated to test the hypothesis that the addition of EBB to XRT provides higher levels of palliation of dyspnea and other RS and improvement of quality of life (QoL) in patients with non-small cell lung cancer (NSCLC) with endobronchial tumour. MATERIALS AND METHODS: Patients with previously untreated NSCLC, stages I-IIIb, WHO-performance status of 0-3 and with biopsy proven endobronchial tumour in the proximal airways were eligible. EBB consisted of two fractions of 7.5 Gy at 1 cm on day 1 and 8. XRT started at day 2. The XRT dose was 30 Gy (2 weeks) or 60 Gy (6 weeks). The EORTC QLQ-C30 and QLQ-LC13 were assessed before treatment and 2 weeks, 6 weeks, 3, 6 and 12 months after treatment. Re-expansion of collapsed lung was tested by the inspiratory vital capacity (IVC) and CT scan of the chest. RESULTS: Ninety-five patients were randomized between arm 1 (XRT alone) (n=48) or arm 2 (XRT+EBB) (n=47). The arms were well balanced regarding pre-treatment characteristics and QoL scores. The compliance for QoL-assessment was >90% at all times. No significant difference between the trial arms was observed with respect to response of dyspnea. However, a beneficial effect of EBB was noted concerning the mean scores of dyspnea over time (P=0.02), which lasted for 3 months. This benefit was only observed among patients with an obstructing tumour of the main bronchus. A higher rate of re-expansion of collapsed lung was observed in arm 2 (57%) compared to arm 1 (35%) (P=0.01). The inspiratory vital capacity (IVC) assessed 2 weeks after radiotherapy improved with 493 cm(3) in arm 2 and decreased 50 cm(3) in arm 1 (P=0.03). No difference was noted regarding the incidence of massive haemoptysis (13 vs. 15%). CONCLUSION: The addition of EBB to XRT in NSCLC is safe and provides higher rates of re-expansion of collapsed lung resulting in a transient lower levels of dyspnea. This beneficial effect was only observed among patients with obstructing tumours in the main bronchus.     

Evaluation of high-dose versus standard FAC chemotherapy for advanced breast cancer in protected environment units: a prospective randomized study

Fifty-nine evaluable patients under 65 years of age with measurable metastatic breast cancer and without prior chemotherapy were randomly assigned to treatment with fluorouracil, Adriamycin (Adria Laboratories, Columbus, OH), and cyclophosphamide (FAC) at standard or high doses (100% to 260% higher than standard FAC) following a dose escalation schedule. Patients randomized to the high-dose FAC received the first three cycles of therapy within a protected environment. Subsequent cycles for this group were administered at standard doses of FAC in an ambulatory setting, the same as for the control group. After reaching 450 mg/m2 of Adriamycin, patients in both groups continued treatment with cyclophosphamide, methotrexate, and fluorouracil until there was disease progression. Analysis of pretreatment patient characteristics showed an even distribution for most known pretreatment factors, although the control group had slightly (but nonsignificantly) more favorable prognostic characteristics. Fourteen patients (24%) achieved a complete remission (CR) and 32 (54%) achieved a partial remission (PR), for an overall major response rate of 78%. There were no differences in overall, CR, or PR rates between the high-dose FAC and control groups. The median response durations were 11 and 10 months for the protected environment and control groups, respectively, and the median survival was 20 months for both groups. Hematologic, gastrointestinal (GI), and infection-related complications were significantly more frequent and severe in the group treated with high-dose chemotherapy. Stomatitis, diarrhea, and skin toxicity were dose-limiting. However, there were no treatment-related deaths. High-dose induction combination chemotherapy with the agents used in this study failed to increase the response rate or survival duration, and resulted in a substantial increase in toxicity.