Long‐term efficacy and safety of ranibizumab administered pro re nata in Japanese patients with neovascular age‐related macular degeneration in the EXTEND‐I study

Purpose: To evaluate the long‐term efficacy and safety of ranibizumab administered pro re nata (PRN) in Japanese patients with choroidal neovascularization secondary to age‐related macular degeneration during the extension phase of the EXTEND‐I study. Methods: EXTEND‐I, an open‐label, multicenter, Phase I/II study comprised: a single‐injection (Group A); a multiple‐injection (Groups A and B; the latter consisted of patients who did not participate in the single‐injection phase); and an extension phase. In the extension phase, a PRN regimen of ranibizumab (0.3 or 0.5 mg) guided by monthly best‐corrected visual acuity (BCVA) score and other ophthalmic examinations was employed. The efficacy variables included the mean BCVA change from Month 12 to the last visit in Group B. Safety was assessed in all patients. Results: In the extension phase, efficacy was assessed only in Group B patients. The number of ranibizumab injections per year in the 0.3 and 0.5 mg Group B patients was 4.19 and 4.27, respectively. The mean BCVA change (SD) from Month 12 to the last visit was ?3.6 (14.82) letters for 0.3 mg (n = 28) and ?2.2 (7.92) letters for 0.5 mg groups (n = 33) in Group B. Conjunctival haemorrhage and nasopharyngitis were the most commonly reported adverse events. Of the 13 serious adverse events reported, cerebral infarction (two incidences) was suspected to be study‐drug related. Conclusions: Pro re nata regimen of ranibizumab guided by monthly BCVA and other ophthalmic examinations appears effective in sustaining the BCVA gained with 12 monthly injections while reducing the number of injections during the extension phase. Ranibizumab was well tolerated during the extension phase.     

CHOPE方案治疗侵袭性非霍奇金淋巴瘤(NHL)40例

目的：观察CHOPE方案治疗侵袭性NHL的近期疗效。方法：80例侵袭性NHL患者，分成对照组与治疗组，每组各40例，对照组为CHOP方案：CTX 750mg／m^2静脉注射，d1；VCR1．4mg／m^2，静脉注射，d1；ADM 40mg／m^2，静脉注射，d1；强的松100mg／d，d1～5。治疗组为CHOPE方案：CHOP（同对照组）＋VP-16 100mg／d，静脉滴注，d1～3 21天为1个周期，完成2个周期以上者做疗效评价。结果：治疗组40例患者中，CR21例，PR12例．NC4例．PD3例，总有效率（CR＋PR）为82．5％。结论：CHOPE方案治疗侵袭性NHL的近期疗效满意，不良反应可耐受。     

小儿急性上呼吸道感染3种治疗方案的成本-效果分析

目的:评价3种用药方案治疗小儿急性上呼吸道感染的成本-效果。方法:将96例患儿随机分成3组,A组(34例)给予莪术油治疗,B组(32例)给予双黄连治疗、C组(30例)给予银黄清治疗,观察其疗效并进行成本-效果分析。结果:3组成本分别为61.50元、80.40元、18.00元,总有效率分别为73.53%、96.88%、86.67%,成本-效果比分别为0.84、0.83、0.21,A、B组相对于C组的增量成本-效果比分别为-3.31、6.11。结论:C组方案是小儿急性上呼吸道感染的最佳治疗方案。     

DNCE方案治疗复发或难治的侵袭性非霍奇金淋巴瘤

目的 探讨DNCE方案作为二线解救方案治疗复发或难治的侵袭性非霍奇金淋巴瘤(NHL)的有效性和安全性.方法 经病理学或组织学证实的、且一线CHOP方案治疗后进展的侵袭性恶性NHL患者69例,按信封法随机分为DNCE方案组与DICE方案组.其中DICE组37例,采用地塞米松(DXM)20 mg,静脉滴注,d1～d4;异环磷酰胺(IFO)1 S/m2,静脉滴注,d1～d4;Mesna解救400 mg,静脉滴注q8h,d1～d4;顺铂(DDP)25 mg/m2,静脉滴注,d1～d4;依托泊苷(Vp-16)100 ms/m2,静脉滴注,d1～d4.21～28d为1个周期.DNCE组32例,采用DXM、DDP、Vp-16的剂量与DICE方案相同;NVB 25 ms/m2,静脉滴注,d1和d5.21～28d为1个周期.所有患者均完成≥2个周期的化疗.结果 DNCE组中,完全缓解(CR)6例,部分缓解(PR)12例,有效率为56.3%(18/32);DICE组中,CR 4例,PR 13例,有效率为45.9%(17/37).DNCE组的疗效优于DICE组,但两组间差异无统计学意义(P>0.05).DICE组的1、3、5年生存率分别为86.5%、58.3%和42.9%,DNCE组分别为87.5%、63.2%和38.5%,两组间差异无统计学意义(P>0.05).两组主要的不良反应为骨髓抑制和消化道反应,表现为粒细胞、血小板减少及恶心、呕吐等.DNCE组的骨髓毒性轻于DICE组,差异有统计学意义(P<0.05).结论 DNCE方案治疗侵袭性NHL的疗效肯定,骨髓毒性较DICE方案为轻,是侵袭性NHL患者安全有效的解救治疗方案.     

地榆升白片预防含泰素方案化疗患者白细胞减少症的临床观察

目的观察地榆升白片预防含泰素方案化疗患者白细胞减少症的疗效。方法使用含泰素方案化疗的恶性肿瘤患者69例,治疗组32例,化疗同时服用地榆升白片,并与单纯化疗的37例作对照,观察两组的外周血白细胞数的变化、粒细胞集落刺激因子（G-CSF）的用量及继发感染发生情况等。结果治疗组化疗后Ⅲ度以上白细胞减少发生率低于对照组,差异有显著意义。治疗组在化疗第14天、21天的白细胞数均高于对照组,二者差异有显著性。两组集落刺激因子用量、白细胞减少继发感染发生例数之间的差异均有统计学意义。结论地榆升白片能有效预防含泰素方案化疗患者白细胞减少症。     

道家养生对中医命门学说形成的影响

命门学说奠基于《难经》，发展成熟于明代。在命门学说发展成熟的过程中，道家养生发挥了重要作用。命门学说是道家养生理论与医学实践逐步结合的产物。     

Associations with medication adherence among ethnically different pediatric patients with renal transplants

This study examined perceived medication regimen characteristics as factors in levels of medication adherence among 26 African American and 42 European American pediatric renal transplant patients. Among both groups, perceived characteristics of their medication regimen, including pill size, pill taste and medication complexity, were found to have significantly low to moderate associations with medication adherence. These associations were stronger and more consistent across medication adherence measures among the African American patients. This supports the need to separately examine the factors contributing to medication adherence among ethnically different pediatric patients. Suggestions for promoting medication adherence among pediatric patients with renal transplants and implications for future research are discussed. Received: 21 September 2000 / Revised: 14 November 2001 / Accepted: 18 November 2001     

Treatment of advanced gastric cancer with etoposide,folinic acid,and fluorouracil in the clinical setting: efficacy of therapy and value of serum tumor markers

The combination of etoposide, folinic acid, and 5-fluorouracil (5-FU) (ELF regimen) has been proved to be an active chemotherapy in patients with advanced gastric cancer. The aim of this study was to confirm the efficacy in the clinical setting and to correlate response with different parameters like serum tumor markers. We treated 60 patients with advanced gastric cancer with 120 mg/m² etoposide, 300 mg/m² folinic acid, and 500 mg/m² 5-FU, on d 1–3. The cycle was repeated on d 21. Objective response was obtained in 23% of all patients with measurable disease. Stable disease was obtained in 37%. The tumor-growth-control rate in patients with proximal carcinoma was significantly higher than in those with distal carcinoma (85% vs 48%, p=0.04). Median survival for all patients was 8.0 mo (95% confidence interval [CI] 7.0–8.5). In responsive patients, survival was more than two-fold longer than in patients with progressive disease. The administration of ELF could be performed safely on an outpatient basis. Toxicity was rather mild. The most frequently elevated serum tumor marker was CA 72-4 (55% of the patients). An elevated level of carcinoembryonic antigen before treatment was significantly correlated with progressive disease. A more than two-fold elevation of at least one marker under treatment was significantly correlated to progressive disease (p<0.002). A reduction of at least one marker under treatment was significantly correlated to tumor growth control (p<0.00015). The results of the present trial confirm the efficacy and low toxicity of the ELF regimen in advanced gastric carcinoma. Serum tumor markers proved suitable parameters for assessing response to treatment.     

晚期结直肠癌三种化疗方案的成本-效果分析

目的:探讨晚期结直肠癌不同化疗方案临床疗效和经济学效果。方法:92例晚期结直肠癌患者,根据不同治疗方案分为3组。FOLFOX方案:奥沙利铂85 mg·m-2,iv,d1;亚叶酸钙200 mg·m-2,iv,d1～2;氟尿嘧啶400 mg·m-2,iv,d1～2,600 mg·m-2·d-1,44 h持续静脉点滴,d1～2。14 d为一周期。FOLFIRI方案:伊立替康180 mg·m-2,iv,d1;亚叶酸钙200 mg·m-2,iv,d1～2;氟尿嘧啶400 mg·m-2,iv,d1～2,600 mg·m-2·d-1,44 h持续静脉点滴,d1～2。14 d为一周期。XELOX方案:卡培他滨2 000 mg·m-2·d-1,po,d1～14;奥沙利铂130 mg·m-2,iv,d1。21 d为一周期。运用药物经济学成本-效果分析方法,对3组治疗方案进行分析和评价。结果:FOLFOX方案、FOL- FIRI方案、XELOX方案的有效率分别为40．0％,48．6％,11．8％。化疗一个疗程住院费用分别为4 704．60元、11 167．25元、6 387．97元。在FOLFOX方案的基础上,每增加一个单位效果,FOLFIRI方案和XELOX方案所追加的成本分别为751．47元和-59．69元。结论:根据本研究结果表明,FOLFOX方案为晚期结直肠癌化疗的较好方案。     

IP方案治疗35例复发和难治性非霍奇金淋巴瘤疗效分析

目的：观察IP方案治疗复发和难治性非霍奇金淋巴瘤的疗效和毒性反应。方法：对35例复发和难治性非霍奇金淋巴瘤患者采用IFO 1．5g／m^2，静滴，第1～5天；Mesna 0．4g，静注，于IFO静滴后0．4h各1次，第1～5天；DDP30mg／m^2。静滴。第1～3天。以上方案每3～4周重复1次，连用2～3个周期。结果：全组35例。CR5例,PR23例，总有效率80．O％。毒副反应主要是血液学毒性，白细胞和血小板下降发生率分别为77．1％、34．3％，白细胞Ⅲ、Ⅳ度毒性为25．7％、11．4％。结论：IP方案治疗复发和难治性非霍奇金淋巴瘤的疗效比较满意，其毒性能够耐受。经对症处理均能恢复。