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Fludarabine and mitoxantrone followed by yttrium-9 ibritumomab tiuxetan in previously untreated patients with follicular non-Hodgkin lymphoma trial: a phase II non-randomised trial (FLUMIZ)

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LANCET ONCOLOGY 2008年第4期9卷 352-358页

作者： Zinzani, Pier Luigi Tani, Monica Pulsoni, Alessandro Gobbi, Marco Perotti, Alessio De Luca, Stefano Fabbri, Alberto Zaccaria, Alfonso Voso, Maria Teresa Fattori, Pierpaolo Guardigni, Luciano Ronconi, Sonia Cabras, Maria Giuseppina Rigacci, Luigi De Renzo, Arnalia Marchi, Enrica Stefoni, Vittorio Fina, Mariapaola Pellegrini, Cinzia Musuraca, Gerardo Derenzini, Enrico Pileri, Stefano Fanti, Stefano Piccaluga, Pier Paolo Baccarani, Michele Univ Bologna Inst Haematol & Med Oncol L&A Seragnoli I-40138 Bologna Italy Univ Roma La Sapienza Dept Haematol Rome Italy Univ Roma La Sapienza Dept Cellular Biotechnol Rome Italy Univ Genoa Dept Haematol Genoa Italy Univ Roma Tor Vergata Dept Haematol S Eugenio Hosp Rome Italy Univ Udine Dept Haematol I-33100 Udine Italy Le Scotte Hosp Dept Internal Med & Haematol Siena Italy S Maria Croci Hosp Div Haematol Ravenna Italy La Cattol Univ Dept Haematol Rome Italy Rimini Hosp Div Oncol Rimini Italy Cesena Hosp Div Internal Med Casena Italy Forli Hosp Div Oncol Forli Italy Cagliari Hosp Div Haematol Cagliari Italy Careggi Hosp Div Haematol Florence Italy Univ Naples Federico 2 Dept Haematol Naples Italy Sant Orsola Malpighi Hosp Dept Nucl Med Bologna Italy

Background Follicular lymphoma is the most common form of lymphoma in Europe and the USA. In this prospective, single-arm, open-labelled, multicentre non-randomised phase II trial (FLUMIZ [FLUdarabine, MItoxantrone, Zevalin] teal) we aimed to assess the efficacy and safety of fludarabine and mitoxantrone plus radioimmunotherapy in untreated patients with follicular non-Hodgkin lymphoma (NHL). Methods Patients with stage III or IV untreated indolent follicular NHL were enrolled between June 1, 2004, and April 15, 2006, at 13 Italian institutions, and were treated with oral fludarabine (40 mg/m(2) on days 1 to 3) and intravenous mitoxantrone (10 mg/m2 on day 1) every 28 days for six cycles. Patients who had at least a partial response (PR) with normal platelet counts (>100x10(9)/L) and granulocyte counts (1.5x10(9)/L), and bone-marrow infiltration less than 25% 4-6 weeks after completion of the sixth cycle of chemotherapy were deemed eligible for consolidation treatment 6-10 weeks after the sixth cycle with one course of yttrium-90 (Y-90)-labelled ibritumomab tiuxetan (Zevalin), which consisted of an initial infusion of intravenous rituximab (250 mg/m2) on day 1 followed by a second 250 mg/m2 infusion on day 7, 8, or 9. The second infusion was followed by a weight-based dose of Y-90-ibritumomab tiuxetan, administered as a slow intravenous push over 10 min. Primary endpoints were complete response (CR) and haematological toxic effects and secondary endpoints were overall survival and progression-free survival. Responses were classified according to the International Workshop for Response Criteria for non-Hodgkin's lymphomas. Analysis was per protocol. This trial is registered as a European Standard Controlled Trial on the EudraCT website http://***, number 2004-002211-92. Findings 61 patients were enrolled in the trial and received six cycles of fludarabine and mitoxantrone, after which an overall response was noted in 98% (60 of 61) of pati

关键词： Adult Aged Antibodies Monoclonal Antineoplastic Combined Chemotherapy Protocols 成年人老年人抗体单克隆综合疗法无病生存剂量效应关系药物用药计划表 fludarabine Mitoxantrone Antineoplastic Combined Chemotherapy Protocols Patients Follicular Lymphoma Trials chromium yttrium-90-ibritumomab tiuxetan Monoclonal Antibodies ibritumomab tiuxetan

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Implementation of evidence-based practices for surgical site infection prophylaxis: Results of a pre- and postintervention study

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JOURNAL OF THE AMERICAN COLLEGE OF SURGEONS 2008年第3期207卷 336-341页

作者： Forbes, Shawn S. Stephen, Wesley J. Harper, William L. Loeb, Mark Smith, Rhonda Christoffersen, Emily P. McLean, Richard F. Hamilton Hlth Sci Hamilton ON L8L 2X2 Canada McMaster Univ Dept Surg Div Gen Surg Hamilton ON L8S 4L8 Canada McMaster Univ Dept Med Div Endocrinol Hamilton ON L8S 4L8 Canada McMaster Univ Dept Pathol Hamilton ON L8S 4L8 Canada McMaster Univ Dept Mol Med Hamilton ON L8S 4L8 Canada McMaster Univ Dept Clin Epidemiol & Biostat Hamilton ON L8S 4L8 Canada McMaster Univ Dept Anesthesiol Hamilton ON L8S 4L8 Canada

BACKGROUND: Although evidence-based guidelines for best practices pertaining to surgical site infection (SSI) prophylaxis exist, the feasibility of implementing such practices remains to be demonstrated outside of a controlled clinical trial. This study was designed to assess the safety and feasibility of implementing evidence-based care practices to prevent SSIs. STUDY DESIGN: A prospective, double-cohort (pre- and postintervention) trial in elective, general surgery patients was conducted. All patients undergoing elective, major colorectal or hepatobiliary operations were enrolled. Postintervention cohort patients were exposed to new strategies to improve antibiotic administration times, perioperative normothermia rates, and perioperative glucose control. They were compared with the preintervention cohort, which received standard practice at the time. Outcomes evaluated include timing of antibiotic administration, perioperative temperatures, and postoperative glucose levels. SSI rates between cohorts were also compared. RESULTS: A total of 208 patients were enrolled. The proportion of patients receiving their preoperative antibiotics within 60 minutes improved from 5.9% to 92.6% (p < 0.001);perioperative normothermia rates improved from 60.5% to 97.6% (p < 0.001) between cohorts. There was no improvement in rates of hyperglycernia. SSI rates improved but did not reach statistical significance (14.3% versus 8.7%;p = 0.21). CONCLUSIONS: Implementation of evidence-based care practices to prevent SSI is both safe and practical outside the setting of a randomized, controlled trial. Sustained compliance remains to be dernonstrated, although practice audits at our institution suggest ongoing success is possible.

关键词： Adult Aged Algorithms Antibiotic Prophylaxis Blood Glucose Body Temperature 成年人老年人算法抗生素预防血糖体温队列研究结肠切除术用药计划表 Body temperature Antibiotic Prophylaxis Evidence-Based Practice algorithms Sector Scan Indicator Surgical Wound Infection Surgical site infection Adults Blood Glucose

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Tissue factor pathway inhibitor dose-dependently inhibits coagulation activation without influencing the fibrinolytic and cytokine response during human endotoxemia

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BLOOD 2000年第4期95卷 1124-1129页

作者： de Jonge, E Dekkers, PEP Creasey, AA Hack, CE Paulson, SK Karim, A Kesecioglu, J Levi, M van Deventer, SJH van der Poll, T Univ Amsterdam Dept Intens Care Acad Med CtrLab Expt Internal Med Cent LabRed Cross Blood Transfus Serv NL-1100 DD Amsterdam Netherlands Univ Amsterdam Dept Vasc Med Acad Med Ctr Cent LabRed Cross Blood Transfus Serv NL-1100 DD Amsterdam Netherlands

Inhibition of the tissue factor pathway has been shown to attenuate the activation of coagulation and to prevent death In a gram-negative bacteremia primate model of sepsis, It has been suggested that tissue factor influences inflammatory cascades other than the coagulation system. The authors sought to determine the effects of 2 different doses of recombinant tissue factor pathway inhibitor (TFPI) on endotoxin-induced coagulant, fibrinolytic, and cytokine responses in healthy humans. Two groups, each consisting of 8 healthy men, were studied in a double-blind, randomized, placebo-controlled crossover study. Subjects were studied on 2 different occasions. They received a bolus intravenous injection of 4 ng/kg endotoxin, which was followed by a 6-hour continuous infusion of TFPI or placebo. Eight subjects received 0.05 mg/kg per hour TFPI after a bolus of 0.0125 mg/kg (tow-dose group), and 8 subjects received 0.2 mg/kg per hour after a bolus of 0.05 mg/kg (high-dose group). Endotoxin injection induced the activation of coagulation, the activation and subsequent inhibition of fibrinolysis, and the release of proinflammatory and antiinflammatory cytokines. TFPI infusion induced a dose-dependent attenuation of thrombin generation, as measured by plasma F1 + 2 and thrombin-antithrombin complexes, with a complete blockade of coagulation activation after high-dose TFPI. Endotoxin-induced changes in the fibrinolytic system and cytokine levels were not altered by either low-dose or high-dose TFPI, The authors concluded that TFPI effectively and dose-dependently attenuates the endotoxin-induced coagulation activation in humans without influencing the fibrinolytic and cytokine response.

关键词：抗凝药/投药和剂量抗凝药/药理学抗凝血酶Ⅲ/代谢血液凝固/药物作用血压/药物作用体温/药物作用交叉研究细胞因子类/血液双盲法用药计划表内毒素血症/血液内毒素血症/药物疗法内毒素血症/免疫学大肠杆菌感染/血液大肠杆菌感染/药物疗法大肠杆菌感染/免疫学纤维蛋白溶解/药物作用心率/药物作用输注静脉内注射静脉内脂多糖类/投药和剂量脂蛋白类/投药和剂量脂蛋白类/药理学肽水解酶类/代谢纤溶酶原激活物抑制物1/血液成年人人类男(雄)性

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Randomized trial of candesartan cilexetil in the treatment of patients with congestive heart failure and a history of intolerance to angiotensin-converting enzyme inhibitors

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AMERICAN HEART JOURNAL 2000年第4期139卷 609-617页

作者： Granger, CB Ertl, G Kuch, J Maggioni, AP McMurray, J Rouleau, JL Stevenson, LW Swedberg, K Young, J Yusuf, S Califf, RM Bart, BA Held, P Michelson, EL Sellers, MA Ohlin, G Sparapani, R Pfeffer, MA Duke Clin Res Inst Durham NC USA Med Univ Klin Mannheim Heidelberg Germany Warsaw Univ Sch Med Warsaw Poland Mario Negri Inst Pharmacol Res I-20157 Milan Italy Univ Glasgow Glasgow G12 8QQ Lanark Scotland Montreal Heart Inst Montreal PQ H1T 1C8 Canada Brigham & Womens Hosp Boston MA 02115 USA Univ Gothenburg Gothenburg Sweden Cleveland Clin Fdn Cleveland OH 44195 USA McMaster Univ Hamilton ON Canada Astra Hassle AB Molndal Sweden Astra Merck Pharmaceut Inc Wayne PA USA

Background Many patients with congestive heart failure do not receive the benefits of angiotensin-converting enzyme (ACE) inhibitors because of intolerance. We sought to determine the tolerability of an angiotensin II receptor blocker, candesartan cilexetil, among patients considered intolerant of ACE inhibitors. Methods patients with CHF, left ventricular ejection Fraction less than 35%, and history of discontinuing an ACE inhibitor because of intolerance underwent double-blind randomization in a 2:1 ratio to receive candesartan (n = 179) or a placebo (n = 91). The initial dosage of candesartan was 4 mg/d;the dosage was increased to 16 mg/d if the drug was tolerated. A history of intolerance of ACE inhibitor was attributed to cough (67% of patients), hypotension (15%), or renal dysfunction (11%). Results The study drug was continued for 12 weeks by 82.7% of patients who received candesartan versus 86.8% of patients who received the placebo. This 4.1% greater discontinuation rate with active therapy was not significant;the 95% confidence interval ranged from 4.8% more discontinuation with placebo to 13% more with candesartan. Titration to the 16 mg target dose was possible for 69% of patients who received candesartan versus 84% of those who received the placebo. Frequencies of death and morbidity were not significantly different between the candesartan and placebo groups (death 3.4% and 3.3%, worsening heart failure 8.4% and 13.2%, myocardial infarction 2.8% and 5.5%, all-cause hospitalization 12.8% and 18.7%, and death or hospitalization for heart failure 11.7% and 14.3%). Conclusions Candesartan was well tolerated by this population. The effect of candesartan on major clinical end points, including death, remains to be determined.

关键词：血管紧张素转换酶抑制药/治疗应用抗高血压药/治疗应用苯咪唑类/治疗应用联苯化合物/治疗应用死亡原因剂量效应关系药物双盲法用药计划表心力衰竭/诊断心力衰竭/药物疗法心力衰竭/死亡率血流动力学/药物作用试点项目存活率四唑类心室功能障碍左/诊断心室功能障碍左/药物疗法心室功能左/药物作用老年人女(雌)性人类男(雄)性中年人

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REAPPRAISAL OF KANAMYCIN USAGE IN NEONATES

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JOURNAL OF PEDIATRICS 1975年第6期86卷 949-956页

作者： HOWARD, JB MCCRACKEN, GH UNIV TEXAS HLTH SCI CTRSW MED SCHDEPT PEDIAT 5323 HARRY HINES BLVD DALLAS TX 75235 USA

This study documents an important change in the kanamycin susceptibilities of Escherichia coli strains cultivated from neonates. Whereas some nurseries have in the past experienced resistance rates as high as 70%, recent surveillance of seven North American nurseries demonstrated that 90% or more of E. coli strains are currently susceptible to kanamycin. Pharmacokinetic studies of 65 babies treated with either 7.5 or 10 mg/kg kanamycin doses revealed that peak serum values varied with dosage, birthweight, and chronologic age. Peak serum levels were below the desired therapeutic range in many babies treated with 7.5 mg/kg doses of kanamycin every 12 hours. Concentrations in cerebrospinal fluid specimens from 21 infants were 0.5 to 12 μg/ml after 7.5 mg/kg kanamycin doses. Calculated distribution volumes, plasma clearances, and serum halflife values were used in formulating a revised kanamycin dosage and frequency of administration schedule.

关键词：年龄因素抗菌药/脑脊髓液出生体重培养基剂量效应关系药物用药计划表抗药性微生物大肠杆菌/分离和提纯大肠杆菌感染/药物疗法孕龄半衰期婴儿新生疾病/药物疗法卡那霉素/血液卡那霉素/药理学卡那霉素/治疗应用脑膜炎/脑脊髓液微生物敏感性试验时间因素人类婴儿新生

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AlloDerm tympanoplasty of tympanic membrane perforations

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AMERICAN JOURNAL OF OTOLARYNGOLOGY 2003年第1期24卷 6-13页

作者： Downey, TJ Champeaux, AL Silva, AB Madigan Army Med Ctr Dept Otolaryngol Head & Neck Surg Ft Lewis WA 98431 USA Madigan Army Med Ctr Dept Pathol Tacoma WA 98431 USA

Purpose: To study the effectiveness of AlloDerm (LifeCell Corporation, Branchburg, NJ) as a graft material in underlay tympanoplasty by comparison to autologous fascia in a chronic tympanic membrane perforation animal model. Materials and Methods: Seventeen chinchillas underwent creation of bilateral chronic tympanic membrane perforations over a 6-week period. Twenty-two stable perforations were divided equally between the experimental AlloDerm and control fascia graft groups. The grafts were surgically placed through a postauricular tympanomeatal flap. The tympanic membranes were examined at 4 and 10 weeks and then harvested for histopathological analysis. Tympanoplasty operative times, perforation closure rates, and gross and histological analyses were compared between the AlloDerm and fascia grafts. Results: A statistically significant difference in mean surgical time was recorded between the AlloDerm (47 minutes) and fascia (68 minutes) grafting procedures (t test, P =.001). Perforation closure was achieved in 90% of the AlloDerm and 100% of the fascia treated tympanic membranes. Gross and histopathologic inspections revealed no significant differences. Microscopically, AlloDerm and fascia grafts had similar inflammatory responses, but AlloDerm showed increased fibroblast infiltration and neovascularization. Conclusion: The avoidance of donor site morbidity, reduction of surgical time, and excellent gross and histologic outcomes in this animal model reveal that AlloDerm could be a safe, cost-effective alternative to autologous fascia. Further study would be necessary in human clinical trials.

关键词：抗感染药泌尿系/治疗应用毛丝鼠属胶原用药计划表复方合剂筋膜/移植磺胺嘧啶/治疗应用时间因素甲氧苄啶/治疗应用鼓膜穿孔/药物疗法鼓膜穿孔/外科学鼓室成形术/方法动物女(雌)性

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Joint HOVON-50/GMMG-HD3 randomized trial on the effect of thalidomide as part of a high-dose therapy regimen and as maintenance treatment for newly diagnosed myeloma patients

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ANNALS OF HEMATOLOGY 2003年第10期82卷 654-659页

作者： Goldschmidt, H Sonneveld, P Cremer, FW van der Holt, B Westveer, P Breitkreutz, I Benner, A Glasmacher, A Schmidt-Wolf, IGD Martin, H Hoelzer, D Ho, AD Lokhorst, HM Univ Heidelberg Med Klin & Poliklin 5 D-69115 Heidelberg Germany Univ Rotterdam Hosp Dept Hematol NL-3015 GD Rotterdam Netherlands Univ Rotterdam Hosp HOVON Data Ctr NL-3015 GD Rotterdam Netherlands Deutsch Krebsforschungszentrum Zent Einheit Biostat D-69120 Heidelberg Germany Univ Bonn Med Klin & Poliklin 1 D-53105 Bonn Germany Univ Klin Frankfurt Med Klin 3 D-60596 Frankfurt Germany Univ Utrecht Hosp Dept Hematol NL-3584 CX Utrecht Netherlands

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LANCET ONCOLOGY 2005年第5期6卷 287-294页

作者： Bottomley, A Therasse, P Piccart, M Efficace, F Coens, C Gotay, C Welnicka-Jaskiewicz, M Mauriac, L Dyczka, J Cufer, T Lichinitser, MR Schornagel, JH Bonnefoi, H Shepherd, L European Org Res Treatment Canc EORTC Ctr Data Qual Life Unit Brussels Belgium Inst Jules Bordet B-1000 Brussels Belgium Univ Hawaii Canc Res Ctr Honolulu HI 96822 USA Med Univ Gdansk Gdansk Poland Inst Bergonie Bordeaux France Med Acad Lodz Lodz Poland Inst Oncol Ljubljana Slovenia Canc Res Ctr Moscow Russia Univ Hosp Geneva Geneva Switzerland Swiss Grp Clin Canc Res SAKK Bern Switzerland NCIC Clin Trials Grp Kingston ON Canada

Background Dose-intensive chemotherapy has generated much interest in the treatment of patients with locally advanced breast cancer because it might offer a survival benefit. We aimed to compare the effects of such an approach with those of standard chemotherapy on health-related quality of life (HRQOL). Methods 224 patients with locally advanced breast cancer were randomly assigned to 75 mg/m(2) cyclophosphamide given orally on days 1-14, and 60 mg/m(2) epirubicin and 500 mg/m(2) fluorouracil both given intravenously on days 1 and 8, for six cycles every 28 days (6 months' treatment;standard treatment) and 224 patients to 830 mg/m(2) cyclophosphamide and 120 mg/m(2) epirubicin both given intravenously on day 1, and 5 mu g/kg filgrastim per day given subcutaneously on days 2-13, for six cycles every 14 days (3 months' treatment;dose-intensive treatment). HRQOL was assessed by use of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Baseline assessments were done before randomisation;then once a month for the first 3 months;and at months 6, 9, 12, 18, 26, 34, 42, 48, and 54. The primary endpoint was progression-free survival;secondary endpoints were HRQOL, response, safety, overall response, and health economics. Analyses were by intention to treat. Findings Previously reported data showed that groups did not differ in progression-free survival. Patients assigned shorter, intensified treatment had a significantly lower overall HRQOL score during the first 3 months than did those assigned standard treatment (mean score at 3 months 41.8 [SD 1.78] vs 49.6 [1.64], p=0.0015). However, scores returned to near baseline, with no difference between groups, at 12 months (62.6 [1.97] vs 65.6 [2.04], p=0.3007). Over the remaining 2 years, the groups showed few significant differences in HRQOL. Interpretation Dose-intensive treatment only has a temporary effect on HRQOL, thus enabling more research on intensive t

关键词： Breast Neoplasms Drug Administration Schedule Quality of Life 乳腺肿瘤用药计划表生活质量 Locally Advanced Malignant Neoplasm Breast Neoplasms Clinical Trials, Phase III as Topic Health-Related Quality Of Life European organisation Breast Cancer patient treatment Survivors Randomisation Drug Administration Schedule Epirubicin

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Simplification of protease inhibitor-containing regimens with efavirenz, nevirapine or abacavir: safety and efficacy outcomes

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ANTIVIRAL THERAPY 2003年第1期8卷 27-35页

作者： Chiesa, E Bini, T Adorni, F Capetti, A Rizzardini, G Faggion, I Mussini, C Sollima, S Melzi, S Bongiovanni, M Tordato, F Cicconi, P Castelnuovo, B Rusconi, S Monforte, AD Univ Milan Inst Infect Dis & Trop Med Milan Italy CNR ITBA Milan Italy L Sacco Hosp Vialba Div Infect Dis 1 Milan Italy Univ Modena Clin Infect Dis I-41100 Modena Italy

Objective: To describe the immunological and virological outcome, and the factors associated to discontinuation in patients switching to a regimen containing efavirenz (EFV), nevirapine (NVP) or abacavir (ABC) after long-term viral suppression under protease inhibitor-including HAART. Design: Observational study at three outpatient clinics for HIV care in Italy. Methods: Patients with HIV RNA <80 copies/ml and CD4 >200 cells/ml for at least 6 months on a protease inhibitor-containing treatment who switched to NVP, EFV or ABC were included in the study. End-points were immunological failure, virological failure and discontinuation due to toxicity. Survival analyses were performed to find out any independent variables predictive of reaching the end-points. Results: 177 patients were enrolled;85 started EFV, 54 NVP and 38 ABC as part of the simplification regimen. 16/159 patients experienced immunological failure: the variables associated to CD4 count decrease were HIV RNA set point value (HR 2.32 for each log(10) copies more, P=0.040) and intolerance/toxicity as reason for simplification (HR 3.96, P=0.05). 13/151 subjects showed virological failure;an AIDS diagnosis (HR 6.04, P=0.021) and the use of NVP (HR 7.98, P=0.027) were associated to a worse virological outcome, while patients naive before HAART showed a lower risk of failure (HR 0.008, P=0.007). 16/177 patients discontinued simplification regimen due to toxicity;longer HAART duration before switch was associated to risk reduction (HR 0.92, P=0.004). Conclusions: Simplification is safe and effective, but it should be offered to patients with shorter treatment duration, and in good clinical and immunovirological conditions.

关键词：抗逆转录病毒治疗高效苯并恶嗪类 CD4淋巴细胞计数双脱氧核苷类/副作用用药计划表药物疗法联合 HIV感染/药物疗法 HIV感染/病毒学 HIV蛋白酶抑制药/副作用 HIV-1/生理学奈韦拉平/副作用恶嗪类/副作用 RNA 病毒/血液回顾性研究逆转录酶抑制剂/副作用治疗结果人类

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Malignant neoplasms subsequent to treatment of inflammatory bowel disease with 6-mercaptopurine

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AMERICAN JOURNAL OF GASTROENTEROLOGY 1999年第11期94卷 3248-3253页

作者： Korelitz, BI Mirsky, FJ Fleisher, MR Warman, JI Wisch, N Gleim, GW Lenox Hill Hosp Gastroenterol Sect Dept Med New York NY 10021 USA Lenox Hill Hosp Sect Oncol Dept Med New York NY 10003 USA Lenox Hill Hosp Biostat Sect Dept Med New York NY 10003 USA NYU Sch Med New York NY USA

OBJECTIVE: Most complications of 6-mercaptopurine (6MP) used in the treatment of inflammatory bowel disease (IBD) occur early, whereas neoplasms occur late in the course. Concern persists that the risk is increased when 6MP is used. We report our experience with malignant tumors developing over 27 yr of treating IBD patients with 6MP. METHODS: A total of 591 patients with LED treated with 6MP;between 1969 and 1997 were followed or traced until present to identify all malignant tumors and blood dyscrasias that had developed to determine the type, distribution, and duration of the LED, the dose and duration of 6MP therapy, the concurrent versus previous use of 6MP, the incidence and probable relationship of 6MP to specific neoplasms, and whether the 6MP had been effective in treatment. RESULTS: A total of 550 patients (93%) fulfilled the criteria for follow-up;these included 380 with Crohn's disease (CD) and 170 with ulcerative colitis (UC). Twenty-five patients had developed neoplasms (16 of 380 CD and nine of 170 UC) (p = 0.66). In half of the cases, the goal of therapy had been achieved with 6MP. In 10 patients, the neoplasm was diagnosed while the patients were taking 6MP (40%) and in 15, many years after the 6MP had been terminated (60%). The incidence of neoplasms (25 of 550) was 2.7/1000 patient-years of follow-up. The most common neoplasms were found in the bowel (eight of 550, 1.6%?;five CD, and three UC), and breast (three, 0.5%;two CD, and one UC). Non-Hodegkins lymphomas occurred in tu po patients with CD;one was cerebral and the other abdominal. One patient with CD developed Leukemia. The duration of 6MP therapy ranged from 5 months to 22 yr, with a mean of 5 yr. The dose of 6MP ranged from a quarter of a tablet/day (12.5 mg) to 100 mg/day, with the majority in a range from 50 to 75 mg/day. CONCLUSION: In no instance could a neoplasm be attributed to the use of 6MP. The incidence of colon cancer is not greater than that with long standing colitis. Suspici

关键词： 6-巯嘌呤/投药和剂量腹部肿瘤脑肿瘤/化学诱导乳腺肿瘤/化学诱导结肠炎溃疡性/药物疗法 Crohn病/药物疗法用药计划表随访研究血液病/化学诱导免疫抑制剂/投药和剂量发病率炎性肠疾病/药物疗法肠肿瘤/化学诱导白血病/化学诱导淋巴瘤非霍奇金/化学诱导肿瘤/化学诱导危险因素时间因素成年人老年人老年人 80以上女(雌)性人类男(雄)性中年人

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