重组人血管内皮抑制素治疗恶性胸腔积液的临床观察

目的观察重组人血管内皮抑制素(恩度)治疗恶性胸腔积液的近期疗效,评价恩度局部应用的疗效、安全性及耐受性。方法将病例随机分为两组:A组(治疗组)18例,B组(对照组)14例。治疗组胸腔注入恩度30 mg+0.9%氯化钠注射液40 m l;对照组胸腔注入顺铂40 mg+0.9%氯化钠注射液60 m l,每周2次,共2~4次。结果 A组(治疗组)中CR 5例,PR 9例,ND 4例,有效率77.8%。B组(对照组)CR2例,PR5例,ND7例,有效率50%。A组副反应较轻。结论顺铂和恩度胸腔灌注治疗恶性胸腔积液,均能有效控制恶性胸腔积液,但恩度有效率高于顺铂组,而且副反应较轻。     

胸腔灌注顺铂联合吉西他滨治疗老年非小细胞肺癌合并胸腔积液

目的：观察吉西他滨全身化疗联合胸腔灌注顺铂治疗老年非小细胞肺癌合并恶性胸腔积液的疗效及安全性。方法对35例老年非小细胞肺癌合并恶性胸腔积液患者留置胸腔内中心静脉导管闭式引流,排尽胸腔内积液后予胸腔灌注顺铂30mg／m2,每周1次,并给予吉西他滨静脉化疗（ D18）,3周为1个疗程,2疗程后评估近期疗效及毒性情况。结果近期总有效率为88.5％,完全缓解率为57.1％,主要毒性为白细胞、血小板减少及胃肠道反应,多为Ⅰ、Ⅱ度,无治疗相关死亡,无肝肾功能损害。结论老年非小细胞肺癌合并恶性胸腔积液患者局部灌注联合全身化疗具有较好的疗效,不良反应轻可耐受。     

不同药物胸腔灌注治疗恶性胸腔积液临床不良反应的观察

目的:观察免疫制剂与化疗药物两种不同药物经胸腔灌注治疗胸腔积液的疗效和不良反应,探讨不良反应较小的治疗胸腔积液的方法。方法:将57例恶性胸腔积液患者随机分为A组(29例)和B组(28例)。A组29例患者胸腔置管排尽胸腔积液后胸腔灌注0.9%氯化钠+香菇多糖+白介素Ⅱ+干扰素γ进行治疗;B组28例患者胸腔置管排尽胸腔积液后胸腔灌注0.9%氯化钠+顺铂进行治疗。结果:A组有效率为79.31%,B组有效率为71.43%,有效率比较差异无统计学意义(P>0.05)。但在生存质量方面,A组优于B组;不良反应方面,A组小于B组。结论:免疫制剂经胸腔灌注治疗恶性胸腔积液疗效确切,不良反应小,可减少对患者的伤害,提高患者的生活质量。     

重组人血管内皮抑制素联合顺铂和博来霉素治疗肺癌恶性胸腔积液的效果比较

目的：观察重组人血管内皮抑制素联合顺铂和博来霉素治疗肺癌恶性胸腔积液的近期效果及安全性。方法2011年10月~2013年10月,将73例肺癌伴恶性胸腔积液的患者经胸腔内置中心静脉导管排尽积液后随机分为A、B组。 A组37例给予胸腔内灌注重组人血管内皮抑制素30 mg+顺铂40 mg;B组36例给予胸腔内灌注重组人血管内皮抑制素30 mg+博来霉素粉针60 mg,两组均每周给药1次,连续给药3周。评价两组患者胸腔积液减少量的近期疗效、Karnofsky体力状况评分、不良反应发生率及生存率。结果胸腔积液减少量的近期疗效：A组的总有效率为72.97%,B组为88.89%,两组比较,差异无统计学意义(χ2=2.98,P>0.05)。A组的KPS体力状况评分改善率为37.84%,B组为61.11%,两组比较,差异有统计学意义(χ2=3.87,P<0.05)。两组的不良反应发生率均较低,差异无统计学意义(P>0.05)。两组的6个月生存率(A组为86.49豫,B组为94.44豫)差异无统计学意义(χ2=0.57,P>0.05),1年生存率(A组为54.05豫,B组为77.78豫)差异有统计学意义(χ2=4.56,P<0.05)。结论重组人血管内皮抑制素联合顺铂和博来霉素治疗肺癌恶性胸腔积液均具有较好的效果,且不良反应少。     

恩度胸腔内灌注治疗恶性胸腔积液疗效观察

目的观察恩度联合顺铂胸腔内灌注治疗晚期非小细胞肺癌合并恶性胸腔积液的疗效和毒副反应。方法 42例晚期非小细胞肺癌合并胸腔积液患者分成顺铂组(对照组)和恩度联合顺铂组,每组21例,分别注入顺铂及顺铂、恩度联用,每周1次,连用3周后评价疗效及生活质量。结果顺铂、恩度联用组治疗胸水有效率及生活质量改善率比顺铂单用组有明显提高(P<0.05)。结论恩度联合顺铂治疗晚期非小细胞肺癌合并恶性胸腔积液疗效显著,不良反应小,值得临床推广应用。     

化疗联合恩度胸腔灌注治疗非小细胞肺癌恶性胸腔积液的疗效观察

目的在非小细胞肺癌合并恶性胸腔积液患者治疗过程中,应用化疗联合恩度(重组人血管内皮抑制素注射液)胸腔灌注的治疗手段,并对其临床疗效进行观察和探究。方法从我院2015年4月至2016年4月期间所收治的非小细胞肺癌恶性胸腔积液患者中选取48例,将其按照随机数字表法均分为观察组与对照组,每组患者例数为24例。在对照组患者的治疗过程中应用含铂双药方案化疗疗法,在观察组患者的治疗过程中应用含铂方案化疗联合恩度胸腔灌注治疗疗法,对比两组患者经对应性治疗后,评估患者胸腔积液的控制疗效以及不良反应情况。结果非小细胞肺癌合并恶性胸腔积液的患者经对应性治疗后,观察组患者的总有效率为75.0%,对照组患者的总有效率为58.3%,观察组患者的胸腔积液改善情况显著性优于对照组,差异具有显著优势,存在统计学意义(P<0.05);观察组患者的不良反应发生情况与对照组无明显差异,无明显统计学意义(P>0.05)。结论在治疗非小细胞肺癌患者的恶性胸腔积液过程中,应用化疗联合恩度胸腔灌注治疗的患者获得的临床疗效比较显著,患者的胸腔积液得以显著控制,患者的生活质量得以提高,该治疗方案值得在临床上推广应用。     

重组人血管内皮抑制素胸腔灌注治疗对非小细胞肺癌恶性胸腔积液患者的效果

目的 分析不同剂量重组人血管内皮抑制素（恩度）胸腔灌注治疗对非小细胞肺癌（non-small cell lung cancer,NSCLC）恶性胸腔积液患者的疗效与安全性。方法 选取150例NSCLC恶性胸腔积液患者作为研究对象,分为3组,各50例。3组均给予恩度胸腔灌注治疗：低剂量组30 mg,中剂量组60 mg,高剂量组90 mg。对比3组的疗效、肿瘤标志物[细胞角蛋白片段21-1(cytokeratin fragment 21-1,CYFRA21-1)、癌胚抗原（carcinoembryonic antige,CEA）、癌抗原125(cancer antigen 125,CA125)、癌抗原19-9(cancer antigen 19-9,CA19-9)]变化以及安全性。结果 治疗后,中、高剂量组的总有效率高于低剂量组（P<0.05）,中、高剂量组总有效率比较差异无统计学意义（P>0.05）;3组CYFRA21-1、CEA、CA19-9水平均降低（P<0.05）,低剂量组CEA、CA125、CA19-9水平高于中、高剂量组（P<0.05）;3组并发症总发生...     

高聚金葡素联合顺铂局部治疗肺癌恶性胸腔积液的疗效观察

目的:观察胸腔内中心静脉导管留置引流后高聚金葡素(HAS)与顺铂治疗肺癌恶性胸腔积液的临床疗效。方法:将90例肺癌合并胸腔积液患者随机分为A、B、C3组,应用中心静脉导管胸腔穿刺置管引流,A组胸腔内注入HAS5000U,B组胸腔内注入顺铂40mg·m-2,C组胸腔内注入HAS5000U+顺铂40mg·m-2,每周1次,连用3周后进行疗效评价,并记录不良反应。结果:3组总有效率分别为43.0%、46.7%、80.0%,C组与A、B组比较差异均有统计学意义,而A、B组比较差异无统计学意义。3组不良反应比较差异无统计学意义。结论:HAS与顺铂联用局部治疗肺癌胸腔积液疗效好、毒副作用小。     

斑蝥酸钠维生素B_6联合奈达铂治疗恶性胸腔积液的临床研究

目的观察斑蝥酸钠维生素B6联合奈达铂与单用奈达铂胸腔灌注治疗恶性胸腔积液的临床疗效与毒副反应。方法将73例恶性胸腔积液患者随机分为A组(38例)和B组(35例),A组用斑蝥酸钠维生素B6注射液联合奈达铂治疗,B组单用奈达铂治疗。用一次性中心静脉引流专用导管胸腔置管闭式引流胸腔积液。A组胸腔用药:斑蝥酸钠维生素B6注射液50mL+生理盐水20mL+奈达铂100mg;B组胸腔用药:奈达铂100mg+生理盐水70mL。结果 A组患者临床总有效率和生活质量改善率均优于B组(P<0.05),两组毒副反应相近。结论胸腔置管闭式引流后,斑蝥酸钠维生素B6注射液联合奈达铂胸腔灌注治疗恶性胸腔积液的疗效优于单用奈达铂,安全性较好,不增加化疗药物的不良反应能改善患者的生存质量。     

腔内应用恩度和顺铂治疗恶性胸腔积液疗效及安全性临床研究

目的研究重组人血管内皮抑制素(恩度)联合顺铂(DDP)腔内注射治疗恶性胸腔积液的临床疗效和不良反应。方法随机对照观察46例恶性胸腔积液患者的腔入治疗情况,其中恩度联和顺铂组(A组)21例,单纯顺铂组(B组)25例;3次为1个疗程。1个疗程结束后进行疗效评价,非PD的患者再进行1个疗程,腔内应用2个疗程后再次评效,进行对照观察。结果 A组总有效率为61.90%,B组总有效率为44.00%,两组比较,差异有统计学意义(P0.05);A组总的不良反应率为38.10%,B组总的不良反应率为32.00%,两组比较差异无统计学意义(P0.05)。结论恩度联合顺铂腔内注射治疗恶性胸腔积液的临床疗效较单药顺铂略有提高,而不良反应未见明显增加,值得临床进一步推广研究。     

Safety and efficacy of rotigotine transdermal patch in patients with restless legs syndrome: a post-hoc analysis of patients taking 1 – 3 mg/24 h for up to 5 years

Objective: This post-hoc analysis of a prospective open-label study investigated patients with restless legs syndrome (RLS) taking approved dosages (1, 2 or 3 mg/24 h) of rotigotine transdermal patch for up to 5 years.

Research design and methods: Following 6 weeks' double-blind treatment, patients with moderate-to-severe RLS received open-label rotigotine titrated to optimal dosage.

Main outcome measures: Safety was assessed by adverse events (AEs) and efficacy was assessed by the International Restless Legs Syndrome Study Group Rating Scale (IRLS).

Results: Of 295 patients who entered the open-label study, 198 (67%) began the maintenance period taking rotigotine dosages of 1 – 3 mg/24 h, or increased their dosage from 0.5 mg in the first 3 months of the maintenance period. Of the 198 patients, 45 patients (23%) completed 5 years of follow-up within this dosage range, 79 patients (40%) had their dosage adjusted outside this range during follow-up and 74 patients (37%) withdrew (including 49 [25%] due to AEs and 6 [3%)] for lack of efficacy). Application site reactions were the most common AEs (102 of 198 patients [52%]), with an incidence of 35% (69 of 198) in year 1, 19% (19 of 102) in year 2, and 4 – 6% during each of years 3 – 5. Mean IRLS total score decreased from 27.1 ± 6.0 at double-blind baseline to 6.5 ± 6.5 at the beginning of maintenance, and to 7.4 ± 8.4 after 5 years' treatment on 1 – 3 mg/24 h (n = 45); 21 patients (47%) were classified as symptom-free (IRLS = 0).

Conclusions: Consistent with the results for the overall population, rotigotine transdermal patch at approved dosages of 1 – 3 mg/24 h was generally well tolerated after the first year, with sustained efficacy in patients who completed 5 years of treatment at dosages of 1 – 3 mg/24 h.     

聚乙二醇重组人血管内皮抑制素注射液联合TC方案治疗晚期非小细胞肺癌的单中心、开放性Ⅰ期临床安全性研究

目的 评价聚乙二醇重组人血管内皮抑制素注射液(PEGylated recombinant human endostatin solution for injection,M2ES)在非小细胞肺癌患者中联合紫杉醇、卡铂化疗(TC方案)多剂量给药的耐受性和安全性.方法 23例经病理确诊的晚期非小细胞肺癌患者按入组标准进入本研究.M2ES共包括4个剂量组:7.5、10、12.5、15 mg/m2,每个剂量组至少含3例非小细胞肺癌患者;第1天按175(±20％) mg/m2给予紫杉醇,第2天按AUC=(5±0.5) mg/(mL·min)给予卡铂,M2ES按给药剂量组设定的剂量于第3、10、17天给药,21d为1个周期,共2个周期.观察治疗期间患者的耐受性和安全性,治疗结束计算客观有效率和疾病控制率.结果 M2ES联合TC方案最常见的不良反应是白细胞下降82.6％、心电图异常34.8％、恶心21.7％.剂量限制性毒性见于15 mg/m2剂量组,表现为1例Ⅳ度皮疹、1例Ⅲ度黄疸和Ⅳ度转氨酶异常.M2ES最大耐受剂量(MTD)为15 mg/m2,推荐Ⅱ期临床试验剂量为12.5 mg/m2.根据RECIST标准评价肿瘤缓解程度,治疗结束时13例患者病情稳定,2例患者部分缓解,临床有效率为13.3％,临床受益率为100％.结论 M2ES与TC联合并不明显增加化疗的不良反应,M2ES的MTD为15 mg/m2,推荐Ⅱ期临床试验剂量为12.5 mg/m2.     

托吡酯单药治疗癫痫有效性和安全性的长期临床研究

目的评价托吡酯(topiram ate)单药治疗成人及儿童癫痫患者的长期疗效和安全性。方法58例癫痫患者(成人32例,儿童26例)为新诊断癫痫(45例),或原服用1种抗癫痫药仍发作(13例)。采取托吡酯小剂量开始逐渐添加的开放性自身对照研究,第8周达最大耐受量。以后13例逐渐减原服抗癫痫药。托吡酯维持最大耐受量观察1～3年或以上。评定托吡酯的长期疗效和安全性及其与剂量的关系。结果托吡酯治疗6个月时成人组与儿童组有效率比较差异无统计学意义。治疗第8周、6个月、1年、2年和3年的有效率分别为54%、69%、74%、80%、77%,发作控制率分别为30%、39%、37%、46%、47%。部分性发作有效率(70%)与全面性发作的有效率(43%)比较差异无统计学意义(P>0.05)。连续发作控制2年以上者12例(34%)。有效组维持剂量成人为(124±55)m g/d,儿童为(2.8±1.3)m g.kg-1.d-1。第1、2、3年坚持托吡酯单药治疗者分别占73%、60%和57%。18例(31%)出现不良反应,大部分出现在添加期,最常见的不良反应为胃纳差、体重减轻和反应迟钝。观察满3年因不良反应退出2例(7%),因疗效不佳退出6例(20%)。结论托吡酯单药治疗癫痫长期有效和安全,采取个体化治疗可减轻不良反应。     

A comparison of adverse renovascular experiences among osteoarthritis patients treated with rofecoxib and comparator non-selective non-steroidal anti-inflammatory agents

BACKGROUND: Non-selective non-steroidal anti-inflammatory drugs (NSAIDs) inhibit both cyclo-oxygenase (COX) isoenzymes, i.e. COX-1 and COX-2. Rofecoxib, an agent that selectively inhibits COX-2, has been shown to provide equivalent anti-inflammatory and analgesic efficacy to comparator non-selective NSAIDs in osteoarthritis (OA) and other pain models with a significant improvement in gastrointestinal (GI) safety and tolerability. Based on renal physiology studies, it was predicted that rofecoxib would have renovascular effects similar to those observed with non-selective NSAIDs--specifically edema, blood pressure elevation, attenuation of the effects of ACE inhibitors, and (in rare circumstances), acute renal failure might be manifest in a small percentage of patients. OBJECTIVE: To assess the renovascular safety profile of rofecoxib in OA patients compared to that of non-selective NSAID comparators. METHODS: Renovascular adverse experiences (AEs) in over 5,000 participants in Phase IIb/III OA clinical trials were reviewed and compared between rofecoxib and non-selective NSAID comparators (ibuprofen 800mg tid, diclofenac 50 mg tid, nabumetone 1,500 mg qd). RESULTS:The incidence of lower extremity edema (LEE) AEs was generally similar between rofecoxib 12.5 mg/day, rofecoxib 25 mg/day, and non-selective comparator NSAIDs. Treatment discontinuations due to LEE AEs and clinically significant weight gain (> or = 2 kg) associated with LEE AEs were infrequent and generally similar in all active treatment groups. Congestive heart failure (CHF) was rare in all treatment groups. The incidence of hypertension AEs was low in all active treatment groups. Discontinuations due to hypertension AEs and hypertension AEs requiring a change or adjustment in blood pressure medications were similar and uncommon in all treatment groups. There was only a single report of acute renal failure (in the ibuprofen treatment group). CONCLUSIONS: In the rofecoxib phase IIb/III OA database, the renal safety profile for rofecoxib, a selective inhibitor of COX-2, was generally similar to that of the comparator, non-selective NSAIDs which were studied.     

Atomoxetine: the first nonstimulant for the management of attention-deficit/hyperactivity disorder.

PURPOSE: The pharmacology, pharmacokinetics, clinical efficacy, safety, drug interactions, dosage and administration, and place in therapy of atomoxetine in the treatment of attention-deficit/hyperactivity disorder (ADHD) are reviewed. SUMMARY: Atomoxetine is a methylphenoxy-benzenepropanamine derivative with antidepressant activity and is thought to enhance noradrenergic function via selective inhibition of the presynaptic norepinephrine transporter. Atomoxetine is rapidly absorbed from the gastrointestinal tract, reaching peak levels in 1.83 hours in pediatric patients and 1-1.5 hours in adults. The clinical efficacy of atomoxetine in the treatment of ADHD has been evaluated in six published clinical trials of children and adolescents and two studies enrolling only adults. Clinical trial data indicate that atomoxetine is safe and well tolerated for the treatment of ADHD; however, safety data about long-term use (greater than one year) are unavailable. Adverse events reported in clinical trials were mainly mild to moderate and transient in nature. Recommended dosing of atomoxetine is weight based, and dosages should be adjusted to a target dosage of 1.2 mg/kg/day in children and adolescents weighing 70 kg or less and to 80 mg/day in children and adolescents weighing over 70 kg and adults. While current guidelines from the American Academy of Pediatrics recommend stimulants and behavior modification as first-line therapy for the management of ADHD, atomoxetine offers those patients who do not respond to or cannot tolerate one or more stimulants an alternative treatment option. CONCLUSION: Atomoxetine, the first non-stimulant approved for the management of ADHD in children, adolescents, and adults, provides patients who have not responded to or cannot tolerate one or more stimulants an alternative treatment option.     

Safety of 25- and 50-mg capsules in the initiation of zonisamide therapy in patients with epilepsy: an uncontrolled, open-label study

OBJECTIVE: This study was designed to assess the safety of 25- and 50-mg dosage strengths of zonisamide for initial titration in patients with epilepsy. Research design and methods: This phase 3, multicenter, open-label, uncontrolled study conducted at 26 study sites in the United States included male and female patients with epilepsy >or= 12 years of age. After a screening visit, subjects began zonisamide therapy at a dosage depending on their body weight. Zonisamide was titrated to 100 mg/day. MAIN OUTCOME MEASURES: At the study's conclusion, information regarding adverse events (AEs) and body weight was recorded. RESULTS: One hundred forty-three subjects enrolled and received at least one zonisamide dose. Of these subjects, 125 reached at least the 100-mg dosage before terminating the study. Eighty-two subjects (57.3%) experienced at least one AE. Most commonly reported AEs included headache, somnolence, asthenia, rhinitis, nausea, and rash. No significant change in patient body weight was noted during the study (95% confidence interval: -0.1, 0.6). CONCLUSIONS: Study limitations include the open-label design and the lack of direct comparison between lower (25- and 50-mg) and higher (100-mg) starting dosages. Despite these limitations, the 25- and 50-mg zonisamide dosage formulations were well tolerated in this study.     

Efficacy of etoricoxib 60 mg/day and diclofenac 150 mg/day in reduction of pain and disability in patients with chronic low back pain: results of a 4-week, multinational, randomized, double-blind study

BACKGROUND AND METHODS: The efficacy and safety of etoricoxib 60 mg/day in patients with established chronic low back pain (CLBP) were compared with those of diclofenac 150 mg/day in a 4-week, multicentre, randomized, double-blind, parallel-group trial. Four hundred and forty-six adult patients with CLBP (Quebec Task Force on Spinal Disorders Class 1 or 2) and with worsening pain upon discontinuation of pre-study analgesic medication were enrolled in the study.The study primary efficacy endpoint was change from baseline in Low Back Pain Intensity Scale (LBP-IS) score over the 4-week treatment period. Secondary and other efficacy endpoints included: changes in Roland and Morris Disability Questionnaire (RMDQ), Patient Global Assessment of Response to Therapy (PGART) and Low Back Pain Bothersomeness Scale (LBP-BS) scores. Early efficacy was assessed using PGART and LBP-IS scores 4 h after the first dose on the mornings of Days 1, 2 and 3. The overall safety and tolerability of etoricoxib 60 mg/day during 4 weeks of treatment were also assessed. RESULTS: The least-squares mean time-weighted change from baseline LBP-IS score over 4 weeks was -32.94 mm (95% CI -36.25, -29.63) for etoricoxib, indicating substantial efficacy in relief of pain. The treatment difference for the primary outcome was 2.51 mm (95% CI -1.50, 6.51), fulfilling the prespecified equivalence criterion of 95% confidence interval wholly within +/- 10 mm. Etoricoxib improved all secondary and other efficacy outcomes.There were no statistically significant between-group differences in the proportion of patients with one or more clinical adverse events (AEs) (etoricoxib 35%, diclofenac 39%), or the proportion of patients who discontinued due to AEs (etoricoxib 7%, diclofenac 5%). CONCLUSIONS: The results of this study confirm that, for adult patients with CLBP, etoricoxib 60 mg once daily over 4 weeks is effective for relief of pain and improvement of physical function and comparable to high-dose diclofenac 150 mg daily.     

Clinical study of intramuscular imipenem/cilastatin sodium in the field of obstetrics and gynecology]

We evaluated the clinical efficacy and safety of intramuscular (as a new route of administration) imipenem/cilastatin sodium (IPM/CS) in patients with intrauterine infections which are typical in the field of obstetrics and gynecology. The obtained results are summarized as follows. 1. Twenty-seven patients were treated with IPM/CS, 250 mg/250 mg b.i.d. (3 patients), 500 mg/500 mg b.i.d. (22) and other dosages (a change in dosing regimen, 2). The duration of treatment ranged from 3 to 11 days and the total dosage during an entire course of treatment varied from 1.5 to 9.0 g. The drug was suspended in a lidocaine solution and administered in the gluteal muscle of the patients. 2. Clinical efficacies were excellent in 7 patients (26%), good in 19 (70%) and poor in 1 (4%) and the overall efficacy rate was 96.3%. All of the 8 patients who had not previously showed improvements with treatment by other antibiotics responded well to this drug. 3. Bacteriologically, the clinical efficacy rate was 95.8% (23/24) and the eradication rate was 76.2% (16/21). 4. No adverse effects due to the drug were observed. As abnormal laboratory test results, transient elevations of GOT and GPT were noted in one patient.