Aims/Introduction
This study investigated the time trends of the maternal characteristics and perinatal outcomes of Japanese pregnant women with diabetes.
Materials and Methods
This retrospective ...study included 621 deliveries in 429 Japanese women with diabetes between 1982 and 2020. The association of the delivery date with clinical features was analyzed using the generalized estimating equations to adjust for the within‐person correlation.
Results
The mean age of delivery and the mean diabetes duration increased over time (both P < 0.001), while the prevalence of diabetic retinopathy decreased (P = 0.006). The mean HbA1c values during pregnancy decreased significantly over time (all P < 0.001). The decreasing trends were associated with preterm delivery (P = 0.021) but not with other perinatal outcomes. The time trends were significantly different between patients with type 1 diabetes mellitus and with type 2 diabetes mellitus in large for gestational age (LGA) and stillbirth (both P for interaction <0.05). The rate of LGA decreased among patients with type 2 diabetes (P = 0.003) but not those with type 1 diabetes (P = 0.413). In contrast, the prevalence of stillbirth was decreased among those with type 1 diabetes (P < 0.001) but not those with type 2 diabetes (P = 0.768). The proportion of major congenital anomalies did not change in the overall population (P = 0.259) and among patients with type 2 diabetes (P = 0.229), but it increased among those with type 1 diabetes (P = 0.044), although the difference between those with type 1 diabetes and type 2 diabetes was not statistically significant (P for interaction = 0.166).
Conclusions
Maternal glycemic control has improved over the decades, whereas the improvement of perinatal outcomes has been limited. Perinatal outcomes still need to be improved in Japanese women with diabetes.
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FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
ABSTRACT
Aims/Introduction
In 2021, the guidelines on gestational weight gain (GWG) were revised and increased by 2–3 kg in Japan. This study aimed to investigate whether the revised guidelines would ...increase the incidence of babies with excessive birth weight in mothers with diabetes.
Materials and Methods
This retrospective study included 369 deliveries of women with diabetes whose pre‐pregnancy body mass index was below 30 kg/m2 between 1982 and 2021. The primary outcome measure was large for gestational age (LGA). We compared the incidence of LGA between women who gained weight within the previous guidelines and women who gained weight within the revised guidelines. We also compared the incidence of macrosomia, preeclampsia, small for gestational age (SGA), and low birth weight.
Results
The incidence of LGA was not significantly different between women who gained weight within the revised guidelines and those within the previous guidelines (34.6% 95% confidence interval 25.6–44.6% for the revised guidelines vs 28.9% 21.6–37.1% for the previous guidelines; P = 0.246). Neither was the incidence of macrosomia or preeclampsia significantly different (8.7% 4.0–15.8% vs 5.6% 2.5–10.8% and 5.8% 2.1–12.1% vs 6.3% 2.9–11.7%; P = 0.264 and 0.824, respectively), while women who gained weight within the revised guidelines had a lower incidence of SGA (1.9% 0.2–6.8% vs 10.6% 6.0–16.8%; P = 0.001) and low birth weight (1.0% 0.02–5.2% vs 7.0% 3.4–12.6%; P = 0.023).
Conclusions
The revised GWG guidelines could be beneficial in women with diabetes in terms of delivering babies with appropriate birth weight.
Compared with women with diabetes who gained weight within the previous guidelines, women with diabetes who gained weight within the revised guidelines had a lower incidence of small for gestational age (SGA) and low birth weight. On the other hand, the incidence of large for gestational age (LGA), macrosomia, or preeclampsia was not significantly different.
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FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Aim
To investigate the incidence of major congenital malformations in Japanese women with pregestational diabetes, and to determine the cutoff value of hemoglobin A1c (HbA1c) in the first trimester ...associated with congenital malformations.
Methods
This retrospective cohort study included singleton pregnancies in Japanese women with pregestational diabetes, including type 1 and type 2 diabetes, and specific types of diabetes due to other causes. The primary outcome was the incidence of major congenital malformations. The secondary outcome was the incidence of all congenital malformations. The cutoff value of HbA1c for congenital malformations was calculated using receiver operating characteristic curve analysis. The adjusted odds ratios (aOR) of major congenital malformations were calculated using multiple logistic regression analyses.
Results
This study enrolled 292 patients, including 132 (45.2%) with type 1 diabetes, 156 (53.4%) with type 2 diabetes, and 4 (1.4%) with other specific types. The incidence rates of major congenital malformations and all congenital malformations were 7.2% (21/292) and 12.7% (37/292), respectively. The cutoff value of HbA1c in the first trimester for major malformations and for all congenital malformations was 6.5%. HbA1c ≥ 6.5% was significantly associated with major malformations (aOR 3.5; 95% confidence interval: 1.2–12.6; p = 0.018).
Conclusion
The incidence of major congenital malformations significantly increased in pregnant Japanese women with HbA1c values of 6.5% or higher. The recommended HbA1c value during the first trimester used in other countries can be applied to pregnant Japanese women.
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FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Background: Thromboangiitis obliterans (TAO) can lead to the development of critical limb-threatening ischemia (CLTI). Despite conventional treatments, such as smoking cessation or revascularization, ...young patients (<50 years) still require limb amputation. Therapeutic angiogenesis using bone marrow-derived mononuclear cell (BM-MNC) implantation has been tested and shown to have reasonable efficacy in CLTI. In this multicenter prospective clinical trial, we evaluated the safety and efficacy of BM-MNC implantation in CLTI patients with TAO.Methods and Results: We enrolled 22 CLTI patients with skin perfusion pressure (SPP) <30 mmHg. The primary endpoint of this trial is the recovery of SPP in the treated limb after a 180-day follow-up period. Secondary endpoints include the pain scale score and transcutaneous oxygen pressure (TcPO2). One patient dropped out during follow-up, leaving 21 patients (mean age 48 years, 90.5% male, Fontaine Class IV) for analysis. BM-MNC implantation caused no serious adverse events and increased SPP by 1.5-fold compared with baseline. Surprisingly, this effect was sustained over the longer term at 180 days. Secondary endpoints also supported the efficacy of this novel therapy in relieving pain and increasing TcPO2. Major amputation-free and overall survival probabilities at 3 years among all enrolled patients were high (95.5% and 89.5%, respectively).Conclusions: BM-MNC implantation showed safety and significant efficacy in CLTI patients with TAO.
In patients with cancer-associated hypercoagulability (CAH)-related stroke, D-dimer trends after anticoagulant therapy may offer a biomarker of treatment efficacy. The purpose of this study was to ...clarify the association between D-dimer trends and recurrent stroke after anticoagulant therapy in patients with CAH-related stroke.
We performed retrospective cohort study of consecutive patients with CAH-related stroke at two stroke centers from 2011 to 2020. The ratio of posttreatment to pretreatment D-dimer levels (post/pre ratio) was used as an indicator of D-dimer trends after anticoagulant therapy. Fine-Gray models were used to evaluate the association between post/pre ratio and recurrent stroke.
Among 360 acute ischemic stroke patients with active cancer, 73 patients with CAH-related stroke were included in this study. Recurrent stroke occurred in 13 patients (18%) during a median follow-up time of 28 days (interquartile range, 11-65 days). Multivariate analysis revealed that high post/pre ratio was independently associated with recurrent stroke (per 0.1 increase: hazard ratio 2.20, 95% confidence interval 1.61-3.01, p = 0.012).
D-dimer levels after anticoagulant therapy were associated with recurrent stroke in CAH-related stroke patients. Patients with neutral trends in high D-dimer levels after anticoagulant therapy were at high risk of recurrent stroke.
Background and objective
. Osimertinib as first-line treatment for patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor (EGFR) mutations remains controversial. ...Sequential EGFR-tyrosine kinase inhibitor (TKI) might be superior to the first line osimertinib in patients at risk of developing acquired T790M mutations.
Methods
. We enrolled consecutive patients with
EGFR
-mutated (deletion 19 or L858R) advanced NSCLC treated with first-line drugs and evaluated predictive markers using classification and regression tree (CART) for the detection of T790M mutations based on patient backgrounds prior to initial treatment.
Results
. Patients without acquired T790M mutations had worse outcomes than those with T790M mutations (median OS: 798 days vs. not reached; HR: 2.70; P < 0.001). CART identified three distinct groups based on variables associated with acquired T790M mutations (age, CYF, WBC, liver metastasis, and LDH; AUROC: 0.77). Based on certain variables, CART identified three distinct groups in deletion 19 (albumin, LDH, bone metastasis, pleural effusion, and WBC; AUROC: 0.81) and two distinct groups in L858R (age, CEA, and ALP; AUROC: 0.80). The T790M detection frequencies after TKI resistance of afatinib and first-generation EGFR-TKIs were similar (35.3% vs. 37.4%, P = 0.933). Afatinib demonstrated longer PFS (398 vs. 279 days; HR: 0.67; P = 0.004) and OS (1053 vs. 956 days; HR: 0.68; P = 0.051) than first-generation EGFR-TKIs.
Conclusion
. Identification of patients at risk of acquiring T790M mutations after EGFR-TKI failure may aid in choice of first-line EGFR-TKI. Furthermore, afatinib may be the more effective 1st-line EGFR-TKI treatment for patients at risk of developing T790M as initial EGFR-TKI resistance.
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CEKLJ, EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
Objectives
To analyze predictors associated with viable cells in pulmonary residual lesions after chemotherapy for metastatic testicular nonseminomatous germ cell tumors and to develop models to ...prioritize pulmonary resection.
Methods
Between 2008 and 2017, 40 patients underwent pulmonary metastasectomy after chemotherapy for nonseminomatous germ cell tumors. We evaluated these patients, and 326 pulmonary residual lesions were confirmed using computed tomography and pathological evaluations. Relationships with outcomes were analyzed using logistic regression analyses. Risk prediction models were developed, and predictive probabilities for the risk of viable cells were estimated.
Results
Histological examinations showed that 73 (22%) pulmonary residual lesions contained viable cells: teratomas, 46 (14%); and cancer cells, 37 (11%). Multivariate analyses showed that the predictors associated with cancer cells in the residual lesions were elevated tumor marker levels, multiregimen chemotherapy, increased tumor size 6 months before surgery and the histological composition of the primary lesion, including yolk sac tumors. Additional predictors associated with teratomas were aspect ratio and histological composition of the primary lesion, including teratomas.
Conclusions
Intratumoral heterogeneity contributes to nonseminomatous germ cell tumor chemoresistance, and primary lesion site yolk sac tumors and teratomas are associated with greater risks of viable cells. Increased residual lesion size during chemotherapy could also be a predictor. Our simple model can predict the presence of viable cells in residual lesions after chemotherapy, and it might assist in decision‐making and prioritizing pulmonary residual lesion resection.
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BFBNIB, DOBA, FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, SIK, UILJ, UKNU, UL, UM, UPUK
Obese pregnant women are known to experience poorer pregnancy outcomes and are at higher risk of postnatal arteriosclerosis. Hence, weight control during and after pregnancy is important for reducing ...these risks. The objective of our planned randomized controlled trial is to evaluate whether the rate of change in body weight in obese women before pregnancy to 12 months postpartum would be lower with the use of an intervention consisting of Internet of Things (IoT) devices and mobile applications during pregnancy to 1 year postpartum compared to a non-intervention group.
Women will be recruited during outpatient maternity checkups at four perinatal care institutions in Japan. We will recruit women at less than 30 weeks of gestation with a pre-pregnancy body mass index ≥ 25 kg/m
. The women will be randomly assigned to an intervention or non-intervention group. The intervention will involve using data (weight, body composition, activity, sleep) measured with IoT devices (weight and body composition monitor, activity, and sleep tracker), meal records, and photographs acquired using a mobile application to automatically generate advice, alongside the use of a mobile application to provide articles and videos related to obesity and pregnancy. The primary outcome will be the ratio of change in body weight (%) from pre-pregnancy to 12 months postpartum compared to before pregnancy.
This study will examine whether behavioral changes occurring during pregnancy, a period that provides a good opportunity to reexamine one's habits, lead to lifestyle improvements during the busy postpartum period. We aim to determine whether a lifestyle intervention that is initiated during pregnancy can suppress weight gain during pregnancy and encourage weight loss after delivery.
UMIN: UMIN (University hospital Medical Information Network) 000,041,460. Resisted on 18
August 2020. https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047278.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
Background
Nab‐paclitaxel (nab‐PTX) has better transfer to tumor tissue than cremophor‐based paclitaxel. It suggests that the optimum dose of nab‐PTX might be lower than the dose and schedule that is ...widely used. We designed a randomized phase II trial to examine the clinical utility and safety of nab‐PTX in patients with previously treated advanced non‐small cell lung cancer (NSCLC).
Methods
Patients were randomly allocated (1:1) to receive nab‐PTX monotherapy at 100 mg/m2 (group A) or 70 mg/m2 (group B). The primary endpoint was progression‐free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR), and adverse events (AEs).
Results
Finally, 81 patients were randomized. Similar results were observed in both groups for PFS (3.75 vs. 3.71 months), OS (13.50 vs. 16.13 months), or ORR (20.5% vs. 23.1%). The incidences of grade 3 or worse AEs were 57.5% in group A and 41.5% in group B. The proportion of serious side effects was 10.0% in group A and 4.9% in group B.
Conclusion
Both standard dose and low dose of nab‐PTX monotherapy are active for previously treated NSCLC patients with better safety profile. Therefore, nab‐PTX 70 mg/m2 dose and schedule in the trial would be a reasonable option.
In this phase 2 randomized clinical trial to examine activity and safety, and to determine optimum dose of nab‐PTX in patients with previously treated stage IIIB/IV or postoperative relapsed NSCLC, both 100 and 70 mg/m2 of nab‐PTX monotherapy were active in patients with previously treated advanced NSCLC. Since the 70 mg/m2 dose has a better safety profile and numerically favored median overall survival, 70 mg/m2 on days 1, 8, and 15 every 4 weeks would be the optimal dose and schedule for nab‐PTX during treatment of NSCLC.
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FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Typical diabetic nephropathy develops with the appearance of microalbuminuria, followed by the appearance of overt proteinuria, resulting in a decreased renal function. In clinical practice, however, ...since there are cases in which the renal function declines without the appearance of overt proteinuria, the present state and contributing factors at this center were examined. The eGFR slope was calculated for 1326 patients with type 2 diabetes mellitus in whom the eGFR had been measured more than 8 times in the 2 years until June 2017, and cases with less than -5 mL/min/1.73 m2/year were classified as Rapid decliners. Overall, 174 cases (13.1 %) were Rapid decliners. Even if limited to 1106 cases with stage 1 or 2 nephropathy, 119 cases (10.8 %) were Rapid decliners. A logistic regression analysis showed that low hemoglobin at baseline was a significant independent risk factor for a Rapid decline in the eGFR in all cases and in stage 1, 2, and 3 nephropathy.
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