Scholastic achievement among children enrolled in the Seychelles Child Development Study

The Seychelles Child Development Study is a longitudinal cohort study following a group of 779 children exposed prenatally to methyl mercury (MeHg) through a maternal diet high in fish. The cohort has been examined six times beginning in infancy with no consistent evidence of adverse effects. In fact, their performance resembles what would be expected from normal children of comparable ages growing up in western cultures. During a neurodevelopment assessment at 66 months, the children were tested for scholastic achievement using the Woodcock Johnson Tests of Achievement. Their reading scores were depressed relative to US norms while arithmetic scores were within normal limits. This disparity was not evident at 107 months; in fact, reading achievement scores far exceeded expected performance relative to US norms, with over 75% of the cohort obtaining scores at or above the 90th percentile. This study reports a secondary analysis of the scholastic achievement data to test the hypothesis that the results obtained in the primary analysis were probably due to the onset of the primary school curriculum between the first and second testing, and not to inherent cognitive deficits among the children at 66 months. The results suggest that a combination of reading instruction and characteristically consistent letter-sound relationships in Creole, the language spoken at home by the majority of Seychellois families, probably accounted for the high achievement scores at 107 months.     

Incidence of temporomandibular joint clicking in adolescents with and without unilateral posterior cross‐bite: a 10‐year follow‐up study

Among different malocclusions, posterior cross‐bite is thought to have a strong impact on the correct functioning of the masticatory system. The association between unilateral posterior cross‐bite (UPCB) and temporomandibular joint (TMJ) clicking, however, remains still controversial. The aim of this study was to investigate whether the presence of UCPB during early adolescence increases the risk of reporting TMJ clicking after a long‐term follow‐up. A longitudinal survey design was carried out in a group of 12‐year‐old young adolescents, who were examined at baseline for TMJ clicking sounds and unilateral posterior cross‐bite. After 10 years, 519 subjects could be reached by a telephone survey. Standardised questions were used to collect self‐reported TMJ sounds and to determine whether participants had received an orthodontic treatment. Logistic regression analysis revealed a significant association between unilateral posterior cross‐bite and subjectively reported TMJ clicking (odds ratio = 6·0; 95% confidence limits = 3·4–10·8; P < 0·0001). The incidence of TMJ clicking was 12%. At a ten‐year follow‐up, self‐reports of TMJ clicking were significantly associated with the presence of UPCB at baseline, but not with the report of having received an orthodontic treatment. Within the limitation of this study, the presence of unilateral posterior cross‐bite in young adolescents may increase the risk of reporting TMJ sounds at a 10‐year follow‐up. The provision of an orthodontic treatment, however, does not appear to reduce the risk of reporting TMJ sounds.     

Modification by food of the calcium absorbability and physicochemical effects of calcium citrate.

The food-calcium (Ca) interaction was examined in 12 healthy women (mean age 38 years) maintained on a constant metabolic diet. They underwent three phases of study, comprised of control (no Ca), Ca citrate (1 g Ca/day) during meals, and Ca citrate separately from meals. Each phase was 7 days in length and two 24-hour urine samples were collected on days 6 and 7. The rise from the control phase in urinary Ca was slightly more prominent when Ca citrate was given with meals than without (68 and 62%, respectively). The fall in urinary phosphorus was equivalent at about 25% between Ca citrate phases. The rise in urinary citrate and pH and the decline in urinary ammonium were more prominent when Ca citrate was given with meals; however, the changes were small or nonsignificant. The urinary saturation of Ca oxalate, brushite or monosodium urate did not differ between the two Ca citrate phases. There was a nonsignificant rise in serum iron during Ca citrate phases. The results suggest that: 1) dissolution and absorption of Ca citrate might be slightly greater when given with food than without; 2) that the ability of Ca citrate to attenuate crystallization of stone-forming Ca salts in urine is not modified by food; and 3) that Ca citrate may not impair iron absorption from food.     

FDA有关仿制药和抗肿瘤药说明书的2个指导原则介绍

美国食品药品管理局（FDA）于2022年1月发布了“参比制剂（RLD）说明书修订后简化新药申请（ANDA）说明书的修订”供企业用的指导原则草案。该指导原则提供了多种获取RLD说明书变更信息的方法，还告知提交修改后的仿制药说明书的具体资料。2020年11月FDA发布了“联合方案中的抗肿瘤药物的交叉说明书”供企业用的指导原则草案。所谓“交叉说明书”是指被批准用于联合方案的抗肿瘤药物的说明书纳入的相关信息。该指导原则指出，其中新药的交叉说明书“应包括有关联合用药安全有效的信息以及仅限于各自药物的信息”；而其中已批准的药物的交叉说明书，“应包括在联合方案中该药物与其他药物合用的安全有效性信息”。该指导原则还对交叉说明书一些具体项目的内容提出了建议。而我国目前尚没有类似的指导原则。详细介绍FDA这2个指导原则，期望对中国RLD说明书修订后的仿制药说明书的修订以及联合用药方案中的抗肿瘤药的“交叉说明”的实施有帮助；对这两种情况的说明书的监管也有所启迪。