药物临床研究

规范的质量过程管理在药物临床研究中的重要作用

Important role of normative quality process management in drug clinical trial research

50年来我国抗肿瘤药物临床研究的进展

Clinical studies on new anticancer drugs during the past 5 decades in China

但是他们想迅速地启动药物临床研究，他们推测是错误的。

But they wanted to get the study started quickly , and they guessed wrong .

方法：按卫生部颁发的《抗菌药物临床研究指导原则》进行临床观察。

METHODS : According to Clinical Research Guideline of Antibacterial Agents issued by Ministry of Health .

他汀类调脂药物临床研究新进展

Progress in clinical research of statins

药物临床研究必须经国家药品监督管理局批准后实施，必须执行《药物临床试验质量管理规范》。

Clinical study of drugs must be approved by the SDA before it is carried out , and must follow the Criterions for the Quality Control of Clinical Trial of Drugs .

2疗程治疗完毕后统一按1998年卫生部制定的心血管系统药物临床研究指导原则进行疗效评定。

To evaluate the curative effect according to the clinical research guideline of medicine for cardiovascular system that Ministry of Public Health makes in 1998 in unison after 2 courses of treatment .

拉莫三嗪（LTG）作为一种新型抗癫癎药物，临床研究表明可以改善癫癎患者的认知功能。

Recent studies indicated that Lamotrigine ( LTG ), as a new anti-epileptic drug , can improve cognition function of patients with epilepsy .

对新药安全性实验实施质量监督检查是药物非临床研究质量管理规范（GLP）赋予质量保证部门（QAU）的重要职责。

Study inspection of preclinical safety evaluation of drug is an important responsibility for quality assurance unit ( QAU ) with good laboratory practice ( GLP ) .

深层型单疱病毒性角膜炎药物治疗临床研究

Clinical study of medication for the treat-ment of deep-layer-type herpes simplex keratitis

开胸肺叶切除术后硬膜外镇痛药物临床应用研究

The clinical application of epidural analgesic in lung excision

阑尾炎性疾病腔内菌群分类及药物敏感性临床研究

Clinical study of microbial pathogens and drug susceptibility in appendical intracavity with appendicitis

抗炎免疫药物的临床研究进展

Clinical development of antiinflammatory - immunity drugs

纤维肌痛综合征药物治疗临床研究

Clinical study on medication for fibromyalgia syndrome

肝硬化食道静脉曲张再出血的药物预防临床研究

The Clinical Study of Drug Therapy in Cirrhotic Patients for the Prevention of Esophageal Variceal Rebleeding

阿立哌唑替换传统和其他非典型抗精神病药物的临床研究

Clinical study on the replacement of traditional antipsychotics and other atypical antipsychotics with aripiprazole in schizophrenics

第二，各国政府及其卫生机构进行比较两种药物的临床研究。

Second , governments and health agencies should consider planning research trials that compare the two drugs .

高龄老年冠心病患者应用不同种类抗血小板药物的临床研究

A Clinical Study in the Very Old Patients with Coronary Heart Disease Treated with Different Anti-platelet Agents

伊曲康唑间歇冲击治疗趾甲真菌病疗效和血清及甲中药物水平临床研究

Clinical study of efficacy and levels of itraconazole in serum and nail samples of toenail onychomycosis treatment with itraconazole intermittent pulse therapy

本实验应用克炎健骨冲剂和对照药物进行临床研究，以判断克炎健骨冲剂的临床疗效，验证其治疗骨折延迟愈合的作用机制。

This study used Granula of Anti-inflammation and Bone-strong to have a clinical study with the control group to evaluate the effect of Granula of Anti-inflammation and Bone-strong on Delay Fracture Healing and discuss its mechanism .

老年高血压病与高血压病合并糖尿病心率变异性和动态血压变化分析高龄老年冠心病患者应用不同种类抗血小板药物的临床研究

Analysis of heart rate variability and ambulatory blood pressure of elderly patients with hypertension and concurrent hypertension and diabetes A Clinical Study in the Very Old Patients with Coronary Heart Disease Treated with Different Anti-platelet Agents

于1999年11月开始由北京、上海、广州等地的5个国家抗肿瘤药物临床试验研究中心进行注册临床试验，并以商品名希罗达在中国上市。

It was began the registration of clinical trials in Beijing , Shanghai , Guangzhou and other places of the five national anticancer drug ′ s clinical trial research centers in November 1999 . Then it was listed in China as the trade name " Xeloda " .

我国GCP与药物临床试验监管研究

Studies on GCP and Supervision for Drug Clinical Trials in China

提出II期临床研究合理的剂量及方案。方法：按抗癌药物I期临床研究要求，选择经病理组织学或细胞学证实的晚期恶性肿瘤患者，签署书面知情同意书。

Methods : Patients with advanced cancer diagnosed by pathology or cytology were selected according to the principle of phase I clinical trial of antitumor drug , and signed informed consent .

YB-ZG肝病治疗仪联合药物治疗肝硬化临床研究

Combination Therapy of Ordinary Therapy and YB-ZG Liver Disease Therapy Instrument in Patients with liver cirrhosis

结论：YS2H是一种有选择性抑制白血病细胞生长的脂类抗白血病药物，具有临床研究应用价值。

Conclusion : Heplipin can be expected as a good anti leukemia lipid remedy in the aspect of the very mild side effect and strengthening normal bone marrow cells , there is clinical value of investigation and use .

支架内再狭窄与药物支架的临床研究现状

The Overview of Clinical Trials of Drug-eluting Stents and In-stent Restenosis

急性有机磷中毒患者并发急性药物性肝病临床研究

Clinical Study of Acute Organophosphorus Poisoning Complicated by Acute Drug Induced Hepatopathy

外伤性前房出血药物治疗的临床研究

Clinical study of medication for the treatment of traumatic hyphema

抗肿瘤药物Ⅰ期临床研究设计的考虑要点

Consideration on phase ⅰ clinical trial design for anticancer drugs