Clinical Characterization and the Caregiver Burden of Dementia in China

AbstractObjectivesThe prevalence of dementia in China is among the highest in the world, but systematic estimates of the rate of dementia subtypes and characterization of associated deficits are lacking. The primary aim of this study was to determine the clinical presentation of dementia and describe the caregiver burden in mainland China.MethodsA 3-month, open-enrollment, multicenter, cross-sectional study was conducted at 48 tier-3 hospitals. Caregivers who qualified for study entry (provided amount and duration of care information), had intimate knowledge of patient status, and accompanied enrolled patients to study sites were asked to participate in an interview about patient care and caregiver burden. Caregiver burden was assessed via the Chinese version of the validated Zarit Burden Interview.ResultsA total of 1425 caregivers completed the survey. Patients had mild to moderate dementia (mean Clinical Dementia Rating score of 1.67±0.79), and the most common dementia subtypes were Alzheimer disease (46.7%) and vascular dementia (28.7%). Among caregivers, 57% were females, 52% were patients’ spouses, and 67.3% had been caring for patients for 1 year or more. Most patients required family help and lived at home or with a family member. Caregiver awareness of dementia was limited. The mean total caregiver Zarit Burden Interview score was 26.6. Observations were similar across age, gender, education, dementia type, Clinical Dementia Rating score, and duration of care.ConclusionsChina faces multiple obstacles in preparing to care for its fast-growing dementia population. Better understanding of patients and caregivers may mitigate these challenges by improving awareness and education

A clinical practice comparison of patients with chronic lymphocytic leukemia with and without deletion 17p receiving first-line treatment with ibrutinib

Among patients with chronic lymphocytic leukemia (CLL) with deletion 17p (del[17p]), evidence from clinical trials for the effectiveness of single-agent ibrutinib as first-line therapy is limited. This retrospective analysis compared real-world clinical outcomes among patients with CLL, with and without del(17p), treated with first-line ibrutinib monotherapy. Overall survival, time to next treatment, time to treatment discontinuation, and reasons for ibrutinib discontinuation were evaluated. Using data from a real-world database, patients included were aged ≥18 years, had been diagnosed with CLL between January 1, 2011 and December 31, 2019, had undergone cytogenetic testing, and had received first-line ibrutinib monotherapy. A total of 1,069 patients were included in the analysis (62.7% male; median age 69 years); 23.8% (n=254) had del(17p). The median overall survival was significantly shorter in patients with del(17p) than in patients without (57.7 months vs. not reached; P=0.0006). Similar results were observed for median time to next treatment (49.4 months vs. not reached, P=0.0330). The median time to treatment discontinuation was non-significantly shorter in the group of patients with del(17p) (32.5 months vs. 42.9 months, P=0.3370). Results of an adjusted Cox proportional hazards model showed that the group with del(17p) was at significantly higher risk of death than was the group without del(17p) (hazard ratio=1.70, P=0.0031). Event rates for switching to new treatment and discontinuation were higher but not statistically significantly so. The most common reason for discontinuing ibrutinib treatment in both groups was toxicity, but discontinuation due to progression was significantly more frequent among patients with del(17p) (20% vs. 6%; P<0.0001). This study identifies an unmet need for more effective first-line therapeutic options in patients with CLL/small lymphocytic lymphoma and del(17p), despite the advent of ibrutinib

Trends in use of and complications from intrauterine contraceptive devices and tubal ligation or occlusion

Abstract Background Long-acting reversible contraceptives such as intrauterine devices (IUDs) are highly effective in preventing pregnancy, cost effective, and increasing in popularity. It is unclear whether changes in IUD use are associated with changes in rates of irreversible tubal sterilization. In this analysis, we evaluate changes in rates of tubal sterilization, insertion of copper or levonorgestrel (LNG) IUDs, and related complications over time. Methods Data were obtained from a retrospective claims database (OptumTM ClinformaticsTM Data Mart) of women aged 15 to 45 years who underwent insertion of copper or LNG IUD or tubal sterilization between 1/1/2006 and 12/31/2011. Outcomes of interest included annual rates of insertion or sterilization and annual rates of potential complications and side effects. Results The number of women included in the analysis each year ranged from 1,870,675 to 2,016,916. Between 2006 and 2011, copper IUD insertion claim rates increased from 0.18 to 0.25% and LNG IUD insertion claim rates increased from 0.63 to 1.15%, while sterilization claims decreased from 0.78 to 0.66% (P < 0.0001 for all comparisons). Increases in IUD insertion were apparent in all age groups; decreases in tubal sterilization occurred in women aged 20 to 34 years. The most common side effects and complications were amenorrhea (7.36–11.59%), heavy menstrual bleeding (4.85–15.69%), and pelvic pain (11.12–14.27%). Significant increases in claims of certain complications associated with IUD insertion or sterilization were also observed. Conclusion Between 2006 and 2011, a decrease in sterilization rates accompanied an increase in IUD insertion rates, suggesting that increasing numbers of women opted for reversible methods of long-term contraception over permanent sterilization

The effects of tislelizumab treatment on the health‐related quality of life of patients with advanced non‐small cell lung cancer

Abstract This study examined the health‐related quality of life (HRQoL) of patients with advanced non‐small cell lung cancer (NSCLC) receiving tislelizumab versus docetaxel in the open‐label, multicenter, Phase 3 trial called RATIONALE‐303 (NCT03358875). HRQoL was assessed with the EORTC QLQ‐C30, EORTC QLQ‐LC13, and the EQ‐5D‐5L instruments. A longitudinal analysis of covariance assessed the change from baseline to Week 12 and from baseline to Week 18. A time to deterioration analysis was also performed using the Kaplan–Meier method. Eight hundred and five patients were randomized to either tislelizumab (n = 535) or docetaxel, respectively (535 and 270 to tislelizumab and docetaxel, respectively). The tislelizumab arm improved while the docetaxel arm worsened in the QLQ‐C30 global health status/QoL scale score (difference LS mean change Week 18: 5.7 [95% CI: 2.38, 9.07, p = 0.0008]), fatigue (Week 12: ‐3.2 [95% CI: −5.95, −0.37, p < 0.0266]; Week 18: −4.9 [95% CI: −8.26, −1.61, p = 0.0037]), and QLQ‐LC13 symptom index score (Week 12: −5.5 [95% CI: −6.93, −4.04, P < 0.0001]; Week 18: −6.6 [95% CI: −8.25, −4.95, p < 0.0001]). The tislelizumab arm had improvements in coughing versus the docetaxel arm (Week 12: −4.7 [95% CI: −8.57, −0.78, p = 0.0188]; Week 18: −8.3 [95% CI: −13.02, −3.51, p = 0.0007]). The patients who received tislelizumab were less at risk for clinically meaningful worsening in the overall lung cancer symptom index scale (hazard ratio (HR): 0.24 [95% CI: 0.162, 0.356], p < 0.0001), dyspnea (HR: 0.74 [95% CI: 0.567, 0.958], p = 0.0109), coughing (HR: 0.74 [95% CI: 0.534, 1.019], p = 0.0309), and peripheral neuropathy (HR: 0.55 [95% CI: 0.370, 0.810] p = 0.0011). In general, tislelizumab versus docetaxel was associated with improved HRQoL and symptoms of lung cancer in patients who previously failed treatment with platinum‐containing chemotherapy

<i>P25</i> Gene Knockout Contributes to Human Epidermal Growth Factor Production in Transgenic Silkworms

Transgenic silkworm expression systems have been applied for producing various recombinant proteins. Knocking out or downregulating an endogenous silk protein is considered a viable strategy for improving the ability of transgenic expression systems to produce exogenous proteins. Here, we report the expression of human epidermal growth factor (hEGF) in a P25 gene knockout silkworm. The hEGF gene regulated by the P25 gene promoter was integrated into a silkworm’s genome. Five transgenic positive silkworm lineages were generated with different insertion sites on silkworm chromosomes and the ability to synthesize and secrete proteins into cocoons. Then, a cross-strategy was used to produce transgenic silkworms with a P25 gene knockout background. The results of the protein analysis showed that the loss of an endogenous P25 protein can increase the hEGF production to about 2.2-fold more than normal silkworms. Compared to those of transgenic silkworms with wild type (non-knockout) background, the morphology and secondary structure of cocoon silks were barely changed in transgenic silkworms with a P25 gene knockout background, indicating their similar physical properties of cocoon silks. In conclusion, P25 gene knockout silkworms may become an efficient bioreactor for the production of exogenous proteins and a promising tool for producing various protein-containing silk biomaterials