Improving clinical trial design for hepatocellular carcinoma treatments

Despite its place as the third leading cause of cancer deaths worldwide, there are currently no approved chemotherapeutic agents, devices or techniques to treat hepatocellular carcinoma. Importantly, there have been no phase III studies demonstrating survival benefit, nor any randomized studies of treatment except for transarterial chemoembolization and most recently sorafenib. The importance of well-designed clinical trials of agents to treat HCC has never been greater. However, general clinical study design issues, combined with HCC-specific issues pose significant challenges in structuring such studies. HCC-related challenges include the heterogeneity of this cancer and the fact that it is frequently accompanied by significant comorbidities at diagnosis, such as active hepatitis B or C virus replication, substantial past or on-going alcohol use, and cirrhosis, itself often a fatal disease. The recently published comparison of a newer treatment, nolatrexed to doxorubicin, and comments about this study’s initial HCC diagnostic criteria, staging system, comparator therapy and choice of endpoints have provided a platform to discuss the challenges unique to the design of HCC clinical trials. The difficulty in accurately framing study results obtained from the constantly changing HCC clinical landscape and approaches to meet these challenges will be reviewed.     

国产长效皮下埋植避孕剂的临床应用

1992年我院用国产长效皮下埋植避孕剂(左旋18-甲基炔诺酮),对600例育龄妇女进行皮下埋植,经1年随访,结果显示:国产长效皮下埋植剂的避孕效果达100％。600例中10例因出现月经异常而终止使用,其持续使用率为98.33％,获得了与进口长效皮下埋植避孕剂相同的效果。     

麦考酚酸酯及其临床应用进展

目的:麦考酚酸酯(MMF)是一种新型的免疫抑制剂.在临床应用中,MMF的使用也越来越广泛,已不仅仅局限于器官移植,还涉及到系统性红斑狼疮(SLE)、自体免疫风湿性疾病的治疗,以及在糖尿病,肺部血管高压的辅助治疗等诸多方面.肠包衣麦考酚酸钠,是一种新的可抵抗胃溶作用的麦考酚酸肠包衣剂型,药物在肠内释放,可以降低胃肠道(GI)不良反应的发生.     

卡维地洛配伍螺内酯治疗老年难治性高血压的临床观察

目的：评价卡维地洛联合螺内酯对老年难治性高血压的临床疗效及安全性，以指导临床工作。方法：老年难治性高血压患者200例分成两组，观察组（120例）经安慰剂洗脱2周后口服卡维地洛配伍螺内酯治疗，对照组（80例）在原有用药基础上加用螺内酯，治疗后共观察8周，探讨疗效。结果：观察组不良反应发生少，且观察组总有效率明显高于对照组，观察组对改善左心室射血分数和左心室舒张末期内径效果明显。结论：卡维地洛联合螺内酯对老年难治性高血压控制较好，并能改善心室结构，临床应用效果好。     

亚低温治疗高温高湿环境下重型颅脑损伤的临床护理

目的 探讨亚低温治疗高温高湿环境下重型颅脑损伤的护理方法。方法 高温高湿环境下的重型颅脑损伤患者60例，随机分为亚低温治疗组和对照组。规范护理程序，严密观察病人生命体征变化，采取积极护理措施，减少并发症。结果 亚低温治疗24h后颅内压逐渐下降，脑组织PO2逐渐上升，伤后3个月亚低温治疗组的良好率明显高于对照组（P〈0.05），而死亡率明显低于对照组（P〈0．01）。结论 精心护理有助于改善亚低温治疗的高温高湿环境下重型颅脑损伤病人的预后。     

Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial.

BACKGROUND: We tested whether transcranial magnetic stimulation (TMS) over the left dorsolateral prefrontal cortex (DLPFC) is effective and safe in the acute treatment of major depression. METHODS: In a double-blind, multisite study, 301 medication-free patients with major depression who had not benefited from prior treatment were randomized to active (n = 155) or sham TMS (n = 146) conditions. Sessions were conducted five times per week with TMS at 10 pulses/sec, 120% of motor threshold, 3000 pulses/session, for 4-6 weeks. Primary outcome was the symptom score change as assessed at week 4 with the Montgomery-Asberg Depression Rating Scale (MADRS). Secondary outcomes included changes on the 17- and 24-item Hamilton Depression Rating Scale (HAMD) and response and remission rates with the MADRS and HAMD. RESULTS: Active TMS was significantly superior to sham TMS on the MADRS at week 4 (with a post hoc correction for inequality in symptom severity between groups at baseline), as well as on the HAMD17 and HAMD24 scales at weeks 4 and 6. Response rates were significantly higher with active TMS on all three scales at weeks 4 and 6. Remission rates were approximately twofold higher with active TMS at week 6 and significant on the MADRS and HAMD24 scales (but not the HAMD17 scale). Active TMS was well tolerated with a low dropout rate for adverse events (4.5%) that were generally mild and limited to transient scalp discomfort or pain. CONCLUSIONS: Transcranial magnetic stimulation was effective in treating major depression with minimal side effects reported. It offers clinicians a novel alternative for the treatment of this disorder.     

善宁治疗急性胰腺炎临床疗效观察

目的:观察人工合成的生长抑素类似物(善宁)治疗急性胰腺炎(AP)的临床疗效.方法:对我院1999～2008年收治的156例AP患者分为治疗组与对照组各78例,对照组采用一般常规治疗方法,治疗组在一般常规治疗的基础上加用善宁0.1 mg,缓慢静脉推注后,继以25μg/h的速度持续静脉滴注,连用7～14天.观察两组腹痛缓解时间;实验室检查:白细胞计数、血淀粉酶、血钙与血糖恢复正常时间,多器官功能障碍(MODS)发生情况,恢复进食的时间.结果:善宁治疗组比对照组明显降低血淀粉酶,减少腹痛缓解时间,降低MODS的发生.结论:善宁能有效改善AP的临床症状,减少并发症.     

文拉法辛与三环类抗抑郁药治疗抑郁症痊愈率的循证医学研究

目的　比较文拉法辛与三环抗抑郁药治疗抑郁症临床痊愈率的差异。方法　应用循证医学的Me-ta分析,采用固定效应模型(fixed effects model,FEM)法对符合标准的16项对照研究文献进行评价。结果　文拉法辛与三环抗抑郁药治疗抑郁症的临床痊愈率不同,差异有显著性(χ2=4.773,df=1,P<0.05);综合的ORs=1.36,95%CI为1.04~1.78。提示文拉法辛治疗抑郁症的临床痊愈率是三环抗抑郁药的 1.36倍。结论　治疗抑郁症,文拉法辛比三环抗抑郁药有更可靠的临床痊愈率。     

Atlas钛缆固定上颈椎的解剖与临床

目的: 观察寰椎后弓和枢椎椎板的形态学特征, 以更为安全、方便地开展颈后路寰枢椎Atlas钛缆固定术。方法: 观察 100套寰椎后弓和枢椎椎板的形态学特点并进行解剖学测量, 设计引导钛缆穿绕的特殊的器械, 并应用于 17例上颈椎损伤患者的手术操作。结果:(1) 寰椎后弓较纤弱, 横截面呈扇形, 内侧面从后上方向内下方倾斜; 枢椎椎板较粗大, 上窄下宽, 内侧面基本垂直, 内侧面下缘多形成一骨嵴; (2) 寰椎后弓的引导器要求头端折弯, 枢椎椎板引导器要求头端圆钝; (3) 17例患者手术操作均安全、顺利完成, 无脊髓损伤等并发症发生。结论: 根据寰椎后弓和枢椎椎板的形态学特征, 穿绕钛缆时宜自上向下操作; 采用专用的引导器使得颈后路寰枢椎Atlas钛缆固定术的操作更为安全、方便。     

努力提高严重多发伤的基础研究和临床救治水平

目的:探讨提高严重多发伤的基础研究和临床救治水平。方法:结合我们的有关研究和参加抢救的临床救治体会,并引用国内外公开发表的相关论文及著作进行分析研究。结果:善于应用现有的先进科技手段,提高严重多发伤的基础研究和临床救治水平。降低伤残率和死亡率。结论:严重多发伤具有脏器损伤率高、出血性休克率高、感染率高、MODS发生率高、死亡率高等“五高”特点,所以其诊治的复杂性、紧迫性远远超过其他许多疾病。因此努力提高我国严重多发伤的基础研究及诊断和救治水平已是当务之急。