RationaleStroke presents a serious health problem in China. Despite progresses made in recent years, there is still a lack of effective treatments for acute ischemic stroke (AIS) in clinical practices.AimsThe Chinese Acute Ischemic Stroke Treatment Outcome Registry (CASTOR) is designed to evaluate the patterns and cost-effectiveness of current treatments for AIS in real-world settings in China.DesignCASTOR is a prospective, multi-center study registered with ClinicalTrials.gov (NCT02470624) with a target sample size of 10,000 patients who are experiencing AIS. The patients are treated for AIS following the Chinese stroke guideline and local practice. Real-world data on treatment regimens, outcomes and costs are collected at baseline (Visit 1) and during subsequent visits (Visit 2 to Visit 5) after medication treatments.OutcomeThe primary objective of the present study is to analyze the current treatment status of AIS in real world settings. The secondary objectives include: 1) to compare the effectiveness of common treatment regimens, 2) to analyze the cost-effectiveness of different treatment regimens for AIS, 3) to analyze the incidence of adverse events and complications in enrolled patients with AIS, 4) to analyze the effect of Trial of Org 10,172 in Acute Stroke Treatment (TOAST) classification on the specific therapies during acute phase treatment period.DiscussionIn face of changing treatment patterns and increasing demand from medical insurers for cost-effectiveness data in China, a large-scale registry study examining the real-world patterns of AIS in hospitals is needed. The CASTOR study will help to find favorable cost-utility treatment regimens for AIS and improve the overall treatment outcome of Chinese patients with AIS.Electronic supplementary materialThe online version of this article (doi:10.1186/s12906-017-1863-4) contains supplementary material, which is available to authorized users.
Many definitions have been used to evaluate remission in patients with attention-deficit/hyperactivity disorder (ADHD) in different studies resulting with varied remission rates. This open-label, multicenter study investigated the remission rate in Chinese children (n = 239; aged 6-16 years) with a diagnosis of ADHD (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition), treated with osmotic-release oral-system methylphenidate at doses of 18, 36, and 54 mg, once daily. Two definitions of remission were used: (1) (primary end point): average scores of SNAP-IV (Swanson, Nolan, and Pelham, Fourth Edition) items of 1 or less (0-3 rating scale for each item) according to the subtype of ADHD (inattentive [1-9], hyperactive-impulsive [10-18], and combined type [1-18]), and (2) total score of SNAP-IV items 1 to 18 of 18 or less, at week 8. The study consisted of screening/baseline, titration/open-label treatment (8 weeks), and extended observation (up to 24 weeks) phases. Secondary efficacy assessments were Clinical Global Impression-Improvement (clinical efficacy), Behavior Rating Inventory of Executive Function Scale (BRIEF; executive function behaviors), and Weiss Functional Impairment Rating Scale (social function). Validity of remission was assessed by comparing the function measures (BRIEF and Weiss's) between patients who achieved remission and those who did not. At week 8, 69.3% (151/218) of patients achieved remission by definition 1, and 73.2% (161/220) by definition 2. At weeks 8 and 24, the remission group had significantly lower BRIEF, Weiss's, and Clinical Global Impression-Improvement scores (P < 0.001 for all) compared with the nonremission group. Overall, treatment with osmotic-release oral-system methylphenidate was well tolerated, with increased remission rates in children with ADHD.
Hyaluronic acid injectable gels are commonly used to treat nasolabial folds (NLFs). We evaluated the safety and effectiveness of VYC-17.5L for correcting NLFs in Chinese subjects. Patients and Methods: This prospective, multicenter, double-blind, within-subject-controlled study randomized adults with moderate-to-severe NLFs to VYC-17.5L treatment (initial and touch-up) in 1 NLF and control (without lidocaine) in the contralateral NLF. Effectiveness endpoints at 6 months included noninferiority of VYC-17.5L to control in NLF Severity Scale response rate (primary endpoint), subject-reported procedural pain (11-point scale), and investigator and subject assessments using the Global Aesthetic Improvement Scale (GAIS). Results: A total of 175 subjects were included. The primary endpoint was met, with response rates of 84.2% for VYC-17.5L and 82.5% for control. Mean pain scores after initial and touch-up treatments were 2.4 for VYC-17.5L versus 5.2 for control (P < 0.001) and 2.0 versus 3.3 (P < 0.001), respectively. Investigator-rated GAIS scores were 86.5% for VYC-17.5L versus 86.0% for control. There were no between-group differences in subject-rated GAIS scores. Safety profiles were comparable for VYC-17.5L and control. Conclusion: VYC-17.5L was noninferior to control without lidocaine for correcting moderate-to-severe NLFs in Chinese subjects and was superior to control in reducing procedural pain.
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