Exploration of screening criteria for healthy volunteers in human bioequivalence clinical trials / 中国临床药理学与治疗学

Human bioequivalence testing is an important part of evaluating the quality of a formulation. Although these drugs have a large amount of safety data and clinical application data, they may still have ethical risks in healthy subjects. The definition of healthy volunteers, the general inclusion and exclusion criteria, auxiliary inclusion and exclusion criteria, and inclusion and exclusion criteria considering drug specificity are summarized. The basis for determining whether abnormal test values are clinically significant when screening healthy subjects and the considerations for improving the screening pass rate are discussed. It is expected to provide useful reference for the smooth implementation of human bioequivalence testing.

The Incidence of Potential Candidates for Total Disc Replacement among Lumbar and Cervical Fusion Patient Populations

STUDY DESIGN: Retrospective chart review. PURPOSE: To evaluate the incidence of potential total disc replacement (TDR) candidates among cervical and lumbar fusion patient populations using strict Food and Drug Administration (FDA) criteria and with relative exclusion criteria removed. OVERVIEW OF LITERATURE: Recent studies suggest that the potential percentage of patients that are candidates for TDR ranges from 0-5% in lumbar fusions and 43% in cervical fusions. METHODS: We performed a retrospective chart review of 280 consecutive patients who had lumbar (n = 174) and cervical (n = 106) fusion or TDR performed by one of four independent adult orthopaedic spine surgeons. Charts were screened for investigational device exemption (IDE) inclusion/exclusion criteria and later reanalyzed excluding relative exclusion criteria, such as history of chronic medical illness, twolevel disease (cervical cases), and history of prior fusion surgery in the anatomic region. RESULTS: Of the 174 lumbar surgeries, 10 were TDR with Prodisc-L and 164 were lumbar fusions. The most common TDR exclusion criteria were lytic spondylolisthesis or spinal stenosis (47.7% of patients) and more than 2 level degenerative disc disease (37.9%). 14.9% had no IDE exclusion criteria and would be considered candidates for TDR. After excluding the relative lumbar exclusion criteria, this percentage increased to 25.8%. Of the 106 cervical cases, 3 had a TDR with Prodisc-C and 103 had a cervical fusion. Twenty eight percent had no IDE exclusion criteria and would be considered candidates for cervical TDR. CONCLUSIONS: A larger percentage of cervical fusion candidates are potential candidates for TDR (28%) than lumbar fusion candidates (14.9%) based on the strict IDE criteria.

A Clinical Outcome of Automated Percutaneous Lumbar Discectomy: more than 4 years follow up / 대한정형외과학회잡지

An automated percutaneous lumbar discectomy(APLD) have been apphed for contained lumbar disc herniation. But suggested that more exclusion criteria than disc containment was needed to improve success rate. The purposes of this study are to evaluate cIinical outcome of more than 4 years follow up of APLD, to analysis the cause of failure for longer follow up period, and to define prognostic factor of APLD. The l04 patients with contained lumbar disc herniation were treated with APLD from March 1990 to November 1992 in National Medical Center. The surgical candidates were contained focal disc herniation in MRI, sciatica than back pain, failure to conservative management at least 6 weeks and clinical and radiological correlation. And patient were excluded from this data if they had history of previous lumbar surgery and compensation claims. Among them 74 cases were followed up for over 4 years (Mean: 5.3 years). The results were accessed by questionnaire using telephone or OPD follow up. The overall success rate was 84% on 3 months follow up, but 68.9% on more than 4 years follow up by four subjective criterias (Onik, 1987). Causes of decreasing success rate were reoperation, recurrence without specific cause or after sprain and heavy work. 76% of failed cases occurred within 1 year and 40% of them underwent open discectomy. The patient sex, treated level, duration of symptom were not influenced on success rate, but age was factor related to success rate. In this study we can assess the effectiveness of APLD within 3 months in most cases and then change treatment option according to patients status, and it seems that we need more exclusion criteria than disc containment in MRI and refined patient selection in order to decrease the failures.