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1.
ABSTRACTIn clinical trials, selection of appropriate study endpoints is critical for an accurate and reliable evaluation of safety and effectiveness of a test treatment under investigation. In practice, however, there are usually multiple endpoints available for measurement of disease status and/or therapeutic effect of the test treatment under study. For example, in cancer clinical trials, overall survival, response rate, and/or time to disease progression are usually considered as primary clinical endpoints for evaluation of safety and effectiveness of the test treatment under investigation. Once the study endpoints have been selected, sample size required for achieving a desired power is then determined. It, however, should be noted that different study endpoints may result in different sample sizes. In practice, it is usually not clear which study endpoint can best inform the disease status and measure the treatment effect. Moreover, different study endpoints may not translate one another although they may be highly correlated one another. In this article, we intend to develop an innovative endpoint namely therapeutic index based on a utility function to combine and utilize information collected from all study endpoints. Statistical properties and performances of the proposed therapeutic index are evaluated theoretically. A numerical example concerning a cancer clinical trial is given to illustrate the use of the proposed therapeutic index. 相似文献
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Ngai-Yin Chan Chi-Chung Choy Ho-Chuen Yuen Hoi-Fan Chow Ho-Fai Fong 《The Canadian journal of cardiology》2019,35(4):396-404
Background
Persistent iatrogenic atrial septal defect (iASD) is a common but poorly characterized complication after cryoballoon (CB) pulmonary vein isolation (PVI) procedures. We therefore investigate its prevalence, evolution, risk factors, and clinical outcomes in a prospective longitudinal study.Methods
A total of 108 patients (41 women, mean age 57 ± 11.3) underwent CB PVI for AF. Serial transesophageal echocardiography (TEE) was performed 9 months and then annually until 6 years after the procedure to study the characteristics of persistent iASD.Results
Persistent iASD occurred in 33 (30.6%) patients 9 months after CB PVI. Spontaneous closure of iASD was found in 6 (22.2%) and 3 (15.8%) patients 2 and 3 years after the procedures, respectively. No spontaneous closure was observed on 4, 5, and 6-year TEE follow-up. The projected long-term persistence rate of iASD after CB PVI was therefore 20% (30.6% × 0.778 × 0.842). Using multivariate logistic regression, a higher number of cryoapplications (≥ 2 minutes) was the only independent predictor of persistent iASD 9 months after CB PVI (odds ratio [OR] 1.207; 95% confidence interval [CI], 1.033-1.411, P = 0.018). Two (1.9%) patients with significantly larger iASD size than the others (long diameter 12.6 ± 0.8 vs 3.7 ± 1.5 mm, P < 0.001; short diameter 10.9 ± 0.2 vs 3 ± 1.1 mm, P < 0.001) required percutaneous closure because of exertional dyspnea and right ventricular enlargement. Over 129.7 patient-years follow-up, during which iASD persisted, there was no occurrence of neurologic events.Conclusions
Approximately one fifth of patients undergoing CB PVI will have permanently persistent iASD. Patients with defect sizes of greater than 10 mm may need percutaneous closure due to significant left-to-right shunting. 相似文献4.
The effect of zinc deficiency on intestinal absorption of cholesterol was investigated in adult male rats fed 3.6 ppm of dietary zinc (ZD) and compared with pair-fed (PF) and ad-libitum (CT) controls fed 30.6 ppm of zinc for 10 to 12 wk. The intestinal absorption of cholesterol was measured by collecting the mesenteric lymph at hourly intervals for 8 h after infusing a dose of [14C]cholesterol in a lipid emulsion through an indwelling duodenal catheter. Data on the hourly lymphatic output of [14C]cholesterol showed that the absorption of [14C]cholesterol plateaued at 4 h postdosing in all groups. The rate of the appearance of [14C]cholesterol in the mesenteric lymph significantly decreased in ZD rats at 5 h and thereafter. The cumulative absorption of [14C]cholesterol by ZD rats for the 8-h period was 4.4 +/- 1.0% of the dose, compared with 11.8 +/- 1.1% by PF and 10.7 +/- 1.4% by CT rats. There were no differences in percent distribution of esterified [14C]cholesterol among the three groups. Also, no significant change in mucosal cholesterol esterase activity was observed due to zinc deficiency. The present data and previous findings taken together suggest that the primary mechanism responsible for the impaired absorption of cholesterol may be associated with defective formation of chylomicrons in the intestinal mucosa. 相似文献
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Eric Y. T. Chan Daniel K. Ng Chung-hong Chan Ka-li Kwok Pok-yu Chow Josephine M. Cheung Suk-yu Leung 《Sleep & breathing》2009,13(1):59-63
Background and objective The purpose of this study is to assess whether Chinese children with high apnea–hypopnea index (AHI) are sleepier by a modified Epworth Sleepiness Scale (ESS).
Materials and methods Records were retrospectively reviewed. We included children who were between 3 and 12 years old, admitted for overnight polysomnogram
because of suspected obstructive sleep apnea syndrome (OSAS). A modified ESS was used to assess excessive daytime sleepiness
(EDS) of the children.
Results One hundred ninety-two Chinese children were included. Children with high AHI, defined as AHI > 5.0, were sleepier than children with AHI less than or equal
to 5. After adjustment by age, gender, and obesity, children with high AHI remained significantly sleepier. Modified ESS was
significantly correlated with AHI (rho = 0.124, 95% CI = 0.004–0.281). Modified ESS score of >8 was the best cutoff point
with the sensitivity and specificity of 0.29 and 0.91, respectively. The odds ratio of children with modified ESS > 10 having
high AHI was 4.231 (95%CI = 1.248 to 14.338) and children with modified ESS > 8 had the highest odds ratio, 4.295(95%CI = 1.66
to 11.1), of having high AHI.
Conclusion
Chinese children with high AHI appear to be sleepier than children with low AHI. Children with suspected OSAS and high modified ESS,
i.e., ESS > 8, had significantly higher odds ratio of having high AHI. Increased sleepiness is a specific but not a sensitive
symptom in snoring children with high AHI. Screening for EDS in snoring children may help us identify those with high AHI
and prioritize the management of those children.
All authors worked and the study was carried out in Kwong Wah Hospital in Hong Kong. There was no conflict of interest and
no specific source of funding for the study. 相似文献
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Transabdominal sacrocolpopexy has been shown, in multiple long-term studies of its success and durability, to be the definitive
treatment option for post-hysterectomy vaginal vault prolapse. It is, however, associated with greater morbidity than vaginal
repair. We describe a minimally invasive technique for vaginal vault prolapse repair and present our experience with a minimum
of one-year follow-up. The surgical technique involves five laparoscopic ports—three for the da Vinci robot and two for the
assistant. After appropriate dissection a polypropylene mesh is attached to the sacral promontory and to the vaginal apex
by use of Gore-Tex sutures. The mesh material is then covered by the peritoneum. Patient analysis focused on complications,
urinary continence, patient satisfaction, and morbidity, with a minimum of 12 months follow-up. Forty-two patients with post-hysterectomy
vaginal vault prolapse underwent robot-assisted laparoscopic sacrocolpopexy at our institute and 35 have a minimum of 12 months
follow-up, with a mean follow-up of 36 months (range 12–48) in the group. Mean age was 67 (47–83) years and mean operating
time was 3.1 (2.15–4.75) h for the entire cohort. All but one patient were discharged home on postoperative day one; one patient
left on postoperative day two. One developed recurrent grade three rectocele, one had recurrent vault prolapse, and two suffered
from vaginal extrusion of mesh. All patients were satisfied with their outcome. The robot-assisted laparoscopic sacrocolpopexy
is a minimally invasive technique for vaginal vault prolapse repair, combining the advantages of open sacrocolpopexy with
the reduced morbidity of laparoscopy. We observed reduced hospital stay, low occurrence of complications, and high patient
satisfaction, with a minimum of 1-year follow-up. Most importantly, the long-term results of the robotic repair are similar
to those of open repair, but with significantly less morbidity. 相似文献
10.
Lok-Hi Chow Eagle Y. -K. Huang Shung-Tai Ho Tak-Yu Lee Pao-Luh Tao 《Journal canadien d'anesthésie》2004,51(9):905-910
PURPOSE: Morphine is an effective analgesic, but adverse effects limit its clinical use in higher doses. The non-opioid antitussive, dextromethorphan (DM), can potentiate the analgesic effect of morphine and decrease the dose of morphine in acute postoperative pain, but the underlying mechanism remains unclear. We previously observed that DM increases the serum concentration of morphine in rats. Therefore, we investigated the effects of drugs administered at the spinal level to exclude possible pharmacokinetic interactions. As DM has widespread binding sites in the central nervous system [such as N-methyl-D-aspartate (NMDA) receptors, sigma receptors and alpha(3)ss(4) nicotinic receptors], we investigated whether the potentiation of morphine antinociception by DM at the spinal level is related to NMDA receptors. METHODS: We used MK-801 as a tool to block the NMDA channel first, and then studied the interaction between intrathecal (i.t.) morphine and DM. The tail-flick test was used to examine the antinociceptive effects of different combinations of morphine and other drugs in rats. RESULTS: DM (2-20 microg) or MK-801 (5-15 microg) showed no significant antinociceptive effect by themselves. The antinociceptive effect of morphine (0.5 microg, i.t.) was significantly enhanced by DM and reached the maximal potentiation (43.7%-50.4%) at doses of 2 to 10 microg. Pretreatment with MK-801 (5 or 10 microg, i.t.) significantly potentiated morphine antinociception by 49.9% or 38.7%, respectively. When rats were pretreated with MK-801, DM could not further enhance morphine antinociception (45.7% vs 50.5% and 43.3%). CONCLUSION: Our results suggest that spinal NMDA receptors play an important role in the effect of DM to potentiate morphine antinociception. 相似文献