Validation of a Chin Retrusion Scale for Chinese Subjects.

ABSTRACT: Chin augmentation procedures are gaining in popularity. The purpose of this study was to validate the China (Allergan) Chin Retrusion Scale (CACRS) and to evaluate the reliability of the scale. A team of 10 physicians based in Beijing, China, consisting of 1 principal investigator and 9 independent raters, assessed a pool of subject images. Using standardized equipment to capture 2-dimensional images, 100 subjects were photographed from a left, lateral, 90° view. Two measures were used to assess the validity of the scale: rater evaluations of clinically significant differences in 52 pairs of images and rater assessment of chin retrusion using the CACRS to grade the 100 images. The CACRS demonstrated almost perfect inter-rater agreement during 2 validation sessions, with intraclass correlation coefficients of 0.89 and 0.90 at sessions 1 and 2, respectively. Overall inter-rater agreement for all 9 raters was almost perfect, with a weighted kappa of 0.82. Based on inter- and intra-rater agreement, the CACRS was validated for physician ratings of chin retrusion in Chinese subjects. Results from clinical significance evaluations indicated that a 1-grade difference between image pairs was considered clinically meaningful for the CACRS. The CACRS is a validated and reliable photonumeric scale for the assessment of chin retrusion in Chinese men and women. The scale is a clinically significant reference tool for evaluating the effect of chin augmentation.

Chinese acute ischemic stroke treatment outcome registry (CASTOR): protocol for a prospective registry study on patterns of real-world treatment of acute ischemic stroke in China.

RATIONALE: Stroke 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. AIMS: The 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. DESIGN: CASTOR 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. OUTCOME: The 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. DISCUSSION: In 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.

Remission Rate and Functional Outcomes During a 6-Month Treatment With Osmotic-Release Oral-System Methylphenidate in Children With Attention-Deficit/Hyperactivity Disorder.

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.

Juvéderm Volift (VYC-17.5L), a Hyaluronic Acid Filler with Lidocaine, is Safe and Effective for Correcting Nasolabial Folds in Chinese Subjects.

PURPOSE: 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.

Human urinary kallidinogenase in treating acute ischemic stroke patients: analyses of pooled data from a randomized double-blind placebo-controlled phase IIb and phase III clinical trial.

Objectives: Intravenous thrombolysis and thrombectomy are recommended for patients whose stroke onsets are within first 6 h, and very few options are available for patients whose stroke onset is more than 6 h, which includes most ischemic stroke patients. Human urinary kallidinogenase (HUK) showed potential clinical benefits in acute ischemic stroke patients. This study aims to investigate the safety and clinical benefits of HUK in ischemic stroke patients.Patients and methods: Patients were recruited for a multicenter double-blind, placebo-controlled phase II b and phase III trial. Neurophysiological outcomes were assessed by the European Stroke Scale (ESS) and the functional outcomes were assessed by the activity of daily living scale (ADL). Safety was monitored by recording adverse events.Results: The improvements in ESS scores and ADL scores in the HUK group were significantly greater than that in patients receiving placebo. Furthermore, HUK treatment was also associated with a lower rate of disable, according to ADL. HUK-related adverse events occurred at a low rate, in 1.73% of HUK-treated patients.Conclusion: HUK is safe and provides potential clinical benefits as a treatment for acute ischemic stroke. Further large post-marketing observational studies are needed.

Re-evaluate the Efficacy and Safety of Human Urinary Kallidinogenase (RESK): Protocol for an Open-Label, Single-Arm, Multicenter Phase IV Trial for the Treatment of Acute Ischemic Stroke in Chinese Patients.

Acute ischemic stroke (AIS) is a major medical challenge in China. Thrombolytic drugs recommended for the treatment of AIS usually have a narrow time window. Human urinary kallidinogenase (HUK) was approved by the China Food and Drug Administration (CFDA) in 2005 for the treatment of mild to moderate AIS, and it is thus widely used in China. However, large-scale clinical study data for a more complete understanding of various aspects of its safety and efficacy characteristics are still unavailable. The ongoing Reevaluate the Efficacy and Safety of Human Urinary Kallidinogenase (RESK) trial is designed to reevaluate the safety and efficacy of HUK in Chinese patients with AIS. RESK is an open-label, single-arm, multicenter phase IV trial. A total of 2186 Chinese patients with AIS will be enrolled. All patients receive HUK by intravenous drip once daily for 21 consecutive days. The study has registered on ClinicalTrials.gov (NCT02562183). On 8 September 2016, 202 patients have been enrolled. Primary outcome includes the frequency and severity of adverse events. Secondary outcomes include functional improvement measured by the National Institutes of Health Stroke Scale, Barthel index, and modified Rankin Scale, and recurrence rate of ischemic stroke. Data from large-scale clinical studies are still unavailable concerning the post-marketing use of HUK. The RESK study is designed to provide a comprehensive reevaluation of the safety and efficacy of HUK in Chinese patients with AIS. TRIAL REGISTRATION: The study has registered on ClinicalTrials.gov (NCT02562183).