OBJECTIVES: The objective of this study was to evaluate the effects of allergen sensitization and family history of atopy on asthma and allergic disease in Chinese schoolchildren from three southeast Asian populations.
METHODS: Written questionnaires on respiratory and allergic symptoms were completed by parents of children of secondary-school age (age range 12 to 18 years) in Hong Kong (n = 1062), Kota Kinabalu in eastern Malaysia (n = 409), and San Bu in southern China (n = 737). A subsample of school-children underwent skin prick testing to common inhalant allergens (Hong Kong 471 children, Kota Kinabalu 321, San Bu 647).
RESULTS: The prevalence of asthma and allergic disease in schoolchildren was highest in Hong Kong, intermediate in Kota Kinabalu, and lowest in San Bu. However, the overall rate of atopic sensitization was similar in the three populations (49% to 63%). House dust mite and cockroach were the two most common allergens causing sensitization and these gave rise to more than 95% of the positive skin test results in all three populations. By regression analysis, mite allergy was associated with rhinitis and asthma in all three populations, and a family history of asthma, rhinitis, or eczema was strongly associated with respective symptoms in the subjects. After adjusting for age, sex, atopic status, and family history of allergic disease, the place of residence remained a significant independent factor for asthma (odds ratio [OR] = 1.0 for Hong Kong, 0.57 for Kota Kinabalu, 0.15 for San Bu, p < 0.001), rhinitis (OR = 1.0 for Hong Kong, 0.59 for Kota Kinabalu, 0.15 for San Bu, p < 0.001), or eczema (OR = 1.0 for Hong Kong, 0.35 for Kota Kinabalu, 1.01 for San Bu, p < 0.001).
CONCLUSION: Sensitization to indoor allergens was a significant risk factor for asthma and allergic disease, and familial clustering of disease was common in the region. However, the marked difference in disease prevalence in the three southeast Asian populations of Chinese schoolchildren cannot be explained by atopic sensitization and family history alone, and the place of residence was an independent risk factor for asthma and allergies, which suggests an important environmental role in disease pathogenesis.
OBJECTIVES: The objectives of this paper were (1) to review the literature for information about post-traumatic stress disorder among Chinese women survivors of intimate partner violence; (2) to provide a synthesis of the literature on post-traumatic stress disorder among abused Chinese women; and (3) to identify implications for practice and to suggest directions for research relating to post-traumatic stress disorder among abused Chinese women.
DESIGN: A systematic review of the literature.
DATA SOURCES: Following a systematic search for relevant literature in computerized databases and manual searches of English and Chinese language publications, five papers reporting on four studies conducted in China, Taiwan, Malaysia, and the United States were included in the review.
REVIEW METHODS: Abstracts meeting the inclusion criteria were reviewed independently by two of the authors and any discrepancies were resolved by discussion. Full papers for selected abstracts were then retrieved and assessed independently by the same reviewers.
RESULTS: The present literature review revealed a paucity of information relating to post-traumatic stress disorder symptoms or diagnoses in abused Chinese women. Nevertheless, a link between post-traumatic stress disorder and intimate partner violence was demonstrated by the reviewed papers.
CONCLUSIONS: Caution should be exercised when making comparison of the findings across the four studies because of the inherent methodological differences. Also, as the assessment tools have not been validated for culture-bound interpretation of trauma and symptom manifestation, comparisons of findings for Chinese women to women in Western literature should be undertaken with due consideration. Implications for practice and recommendations for future research are discussed.
METHODS: BELIEVE was a phase 3, randomised, double-blind, placebo-controlled study performed at 65 sites in 15 countries. The trial included adults with transfusion-dependent β-thalassaemia or haemoglobin E/β-thalassaemia and Eastern Cooperative Oncology Group score of 0-1. Patients were randomly assigned (2:1) using integrated response technology stratified by region to luspatercept (1·0-1·25 mg/kg) or placebo administered subcutaneously once every 21 days. After study unblinding, patients could receive luspatercept in the open-label extension phase (crossover allowed). The primary endpoint results (proportion of patients with reduction in transfusion burden of ≥33% and ≥2 RBC units during weeks 13-24) are described elsewhere; herein we present an update to the primary endpoint analysis consequent to late-reported transfusion events. We also report long-term efficacy (intention-to-treat population) and safety data (safety population) for patients followed up for approximately 3 years. This trial is registered on ClinicalTrials.gov (NCT02604433) and is completed.
FINDINGS: Between May 2, 2016, and May 16, 2017, 336 patients were randomly assigned to luspatercept (n=224) or placebo (n=112). The median age of patients was 30 years (IQR 23-40); 195 (58%) were female and 141 (42%) male. As of Jan 5, 2021, the median duration of treatment in the luspatercept group was 153·6 weeks (IQR 81·0-171·0) and median study follow-up was 163·1 weeks (140·5-176·2). Due to the difference in treatment duration between the luspatercept and placebo groups, no comparative analyses between the two groups were performed after week 96. Patients in the luspatercept group showed a sustained reduction in RBC transfusion burden from baseline through week 192, with mean decreases of 6·2 RBC units (SD 5·7) during weeks 97-144 and 6·4 RBC units (4·3) during weeks 145-192. In the luspatercept group, a 33% or greater reduction in transfusion burden from baseline was observed in 173 (77%) patients over any 12-week interval and in 116 (52%) patients over any 24-week interval. The median total duration of 33% or greater transfusion burden reduction response during any period of at least 12 weeks was 586·0 days (IQR 264·0-1010·0). The most common grade 3 or worse treatment-emergent adverse events (TEAEs) among all patients who received luspatercept (n=315, including 92 patients who crossed over after study unblinding) were anaemia (nine [3%]), increased liver iron concentration (seven [2%]), and bone pain (seven [2%]); serious TEAEs occurred in 71 (23%) patients. No treatment-related deaths occurred in any group during the study.
INTERPRETATION: These long-term results affirm luspatercept's efficacy in addressing key unmet needs of patients with transfusion-dependent β-thalassaemia with a manageable safety profile.
FUNDING: Celgene and Acceleron Pharma.
METHODS: In this randomized, double-blind, phase 3 trial, we assigned, in a 2:1 ratio, adults with transfusion-dependent β-thalassemia to receive best supportive care plus luspatercept (at a dose of 1.00 to 1.25 mg per kilogram of body weight) or placebo for at least 48 weeks. The primary end point was the percentage of patients who had a reduction in the transfusion burden of at least 33% from baseline during weeks 13 through 24 plus a reduction of at least 2 red-cell units over this 12-week interval. Other efficacy end points included reductions in the transfusion burden during any 12-week interval and results of iron studies.
RESULTS: A total of 224 patients were assigned to the luspatercept group and 112 to the placebo group. Luspatercept or placebo was administered for a median of approximately 64 weeks in both groups. The percentage of patients who had a reduction in the transfusion burden of at least 33% from baseline during weeks 13 through 24 plus a reduction of at least 2 red-cell units over this 12-week interval was significantly greater in the luspatercept group than in the placebo group (21.4% vs. 4.5%, P<0.001). During any 12-week interval, the percentage of patients who had a reduction in transfusion burden of at least 33% was greater in the luspatercept group than in the placebo group (70.5% vs. 29.5%), as was the percentage of those who had a reduction of at least 50% (40.2% vs. 6.3%). The least-squares mean difference between the groups in serum ferritin levels at week 48 was -348 μg per liter (95% confidence interval, -517 to -179) in favor of luspatercept. Adverse events of transient bone pain, arthralgia, dizziness, hypertension, and hyperuricemia were more common with luspatercept than placebo.
CONCLUSIONS: The percentage of patients with transfusion-dependent β-thalassemia who had a reduction in transfusion burden was significantly greater in the luspatercept group than in the placebo group, and few adverse events led to the discontinuation of treatment. (Funded by Celgene and Acceleron Pharma; BELIEVE ClinicalTrials.gov number, NCT02604433; EudraCT number, 2015-003224-31.).