Objective:To analyze early improvements in clinical indicators among patients with pre-diabetes (pre-DM), type 2 diabetes mellitus (T2DM), and hypertension (HT) participating in the Chronic Disease Co-Care (CDCC) Pilot Scheme in the Hong Kong Special Administrative Region of the People′s Republic of China (HKSAR). Methods:This longitudinal study enrolled participants with pre-DM, T2DM, and HT who participated in the CDCC Pilot Scheme between November 2023 and May 2024. Baseline clinical data was collected. All participants were managed followed standardized protocols: family doctors issued prescriptions in accordance with the Hong Kong Reference Framework by the Health Bureau of the Government of the HKSAR, District Health Centre (DHC) and DHC Express provided health education, and personalized counseling by allied health professionals (nurses, optometrists, and dietitians). During the screening phase, screening costs, including consultations and related laboratory investigations, were fully covered by the Government of the HKSAR, while partial subsidies were available during the treatment phase. Participants were followed for 6 months. Primary outcomes were glycated hemoglobin A1c (HbA1c) for pre-DM and T2DM, and blood pressure for HT. Secondary outcomes included body mass index (BMI), triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and the Framingham model-based 10-year cardiovascular risk score. Changes in clinical indicators from baseline to 6 months were analyzed using a linear mixed model, with subgroup analyses by age, sex, and baseline Framingham 10-year cardiovascular disease risk score. Results:A total of 3 910 participants were included in the study, comprising 903 (23.1%) with pre-DM, 478 (12.2%) with T2DM, and 2 529 (64.7%) with HT. Pre-DM participants had an age of (61.4±7.0) years with 641 (71.0%) females; T2DM participants had an age of (60.4±7.4) years with 247 (51.7%) females; HT participants had an age of (60.8±7.9) years with 1 237 (48.9%) females. At 6 months, HbA1c levels declined in the pre-DM and T2DM groups by -0.09% (95% CI:-0.10%--0.07%) and -1.06% (95% CI:-1.21%--0.91%), respectively. In the HT group, systolic blood pressure decreased by 15.3 mmHg (1 mmHg=0.133 kPa) (95% CI:-16.0--14.6 mmHg) and diastolic blood pressure by 8.6 mmHg (95% CI:-9.0--8.1 mmHg). BMI decreased in the three groups, with the largest reduction in the T2DM group (-1.04 kg/m 2, 95% CI:-1.22--0.86 kg/m 2). TC, TG, and LDL-C levels decreased in the three groups (all P<0.05). Subgroup analysis revealed that among HT participants, individuals with a baseline Framingham 10-year cardiovascular disease risk of ≥20% experienced greater reductions in blood pressure compared to those with a risk <20% ( P<0.05). Additionally, male participants demonstrated significantly lower diastolic blood pressure than female participants ( P<0.05). Among participants with T2DM, males exhibited greater reductions in HbA1c levels than females, and participants aged 45-64 years showed significantly lower HbA1c levels compared to those aged 65 years and older (both P<0.05). Conclusions:In the early phase of the CDCC Pilot Scheme, glycemic, blood pressure, lipid, and BMI indicators improved among patients with pre-DM, T2DM, and HT. These effects were particularly pronounced in males and in individuals younger than 65 years of age.

Objective:To analyze early improvements in clinical indicators among patients with pre-diabetes (pre-DM), type 2 diabetes mellitus (T2DM), and hypertension (HT) participating in the Chronic Disease Co-Care (CDCC) Pilot Scheme in the Hong Kong Special Administrative Region of the People′s Republic of China (HKSAR). Methods:This longitudinal study enrolled participants with pre-DM, T2DM, and HT who participated in the CDCC Pilot Scheme between November 2023 and May 2024. Baseline clinical data was collected. All participants were managed followed standardized protocols: family doctors issued prescriptions in accordance with the Hong Kong Reference Framework by the Health Bureau of the Government of the HKSAR, District Health Centre (DHC) and DHC Express provided health education, and personalized counseling by allied health professionals (nurses, optometrists, and dietitians). During the screening phase, screening costs, including consultations and related laboratory investigations, were fully covered by the Government of the HKSAR, while partial subsidies were available during the treatment phase. Participants were followed for 6 months. Primary outcomes were glycated hemoglobin A1c (HbA1c) for pre-DM and T2DM, and blood pressure for HT. Secondary outcomes included body mass index (BMI), triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and the Framingham model-based 10-year cardiovascular risk score. Changes in clinical indicators from baseline to 6 months were analyzed using a linear mixed model, with subgroup analyses by age, sex, and baseline Framingham 10-year cardiovascular disease risk score. Results:A total of 3 910 participants were included in the study, comprising 903 (23.1%) with pre-DM, 478 (12.2%) with T2DM, and 2 529 (64.7%) with HT. Pre-DM participants had an age of (61.4±7.0) years with 641 (71.0%) females; T2DM participants had an age of (60.4±7.4) years with 247 (51.7%) females; HT participants had an age of (60.8±7.9) years with 1 237 (48.9%) females. At 6 months, HbA1c levels declined in the pre-DM and T2DM groups by -0.09% (95% CI:-0.10%--0.07%) and -1.06% (95% CI:-1.21%--0.91%), respectively. In the HT group, systolic blood pressure decreased by 15.3 mmHg (1 mmHg=0.133 kPa) (95% CI:-16.0--14.6 mmHg) and diastolic blood pressure by 8.6 mmHg (95% CI:-9.0--8.1 mmHg). BMI decreased in the three groups, with the largest reduction in the T2DM group (-1.04 kg/m 2, 95% CI:-1.22--0.86 kg/m 2). TC, TG, and LDL-C levels decreased in the three groups (all P<0.05). Subgroup analysis revealed that among HT participants, individuals with a baseline Framingham 10-year cardiovascular disease risk of ≥20% experienced greater reductions in blood pressure compared to those with a risk <20% ( P<0.05). Additionally, male participants demonstrated significantly lower diastolic blood pressure than female participants ( P<0.05). Among participants with T2DM, males exhibited greater reductions in HbA1c levels than females, and participants aged 45-64 years showed significantly lower HbA1c levels compared to those aged 65 years and older (both P<0.05). Conclusions:In the early phase of the CDCC Pilot Scheme, glycemic, blood pressure, lipid, and BMI indicators improved among patients with pre-DM, T2DM, and HT. These effects were particularly pronounced in males and in individuals younger than 65 years of age.

Objective: To compare the efficacy of using “distal acupoints only” vs. “local acupoints mainly combined with distal acupoints” in cases of acute low back pain (ALBP). Methods: A total of 102 eligible patients aged 18–65 years with ALBP lasting less than 6 weeks will be randomized in a 1:1 ratio to the distal acupoints only group (DPOG) and the local acupoints mainly combined with the distal acupoints group (LPMG). During a 4-week treatment period, patients in the DPOG will receive acupuncture at distal acupoints only (Houxi [SI 3] and Yaotongxue [EX-UE 7]) twice a week, while those in the LPMG group will receive acupuncture at local acupoints (mainly Shenshu [BL 23] and Dachangshu [BL 25]) combined with distal points (Weizhong [BL 40]). The patients in both groups will be evaluated at every session of treatment, and the follow-up will be performed for 3 months. The primary outcome measure will be the change in ALBP intensity, assessed using visual analogue scale scores before and after treatment. The secondary outcome measure will be the evaluation of functional disability using the Oswestry Disability Index. Discussion This study compares the DPOG and LPMG to explore the feasibility of the DPOG in the treatment of ALBP.

Background: and Purpose Recent studies suggested an increased incidence of cerebral venous thrombosis (CVT) during the coronavirus disease 2019 (COVID-19) pandemic. We evaluated the volume of CVT hospitalization and in-hospital mortality during the 1st year of the COVID-19 pandemic compared to the preceding year. Methods: We conducted a cross-sectional retrospective study of 171 stroke centers from 49 countries. We recorded COVID-19 admission volumes, CVT hospitalization, and CVT in-hospital mortality from January 1, 2019, to May 31, 2021. CVT diagnoses were identified by International Classification of Disease-10 (ICD-10) codes or stroke databases. We additionally sought to compare the same metrics in the first 5 months of 2021 compared to the corresponding months in 2019 and 2020 (ClinicalTrials.gov Identifier: NCT04934020). Results: There were 2,313 CVT admissions across the 1-year pre-pandemic (2019) and pandemic year (2020); no differences in CVT volume or CVT mortality were observed. During the first 5 months of 2021, there was an increase in CVT volumes compared to 2019 (27.5%; 95% confidence interval [CI], 24.2 to 32.0; P<0.0001) and 2020 (41.4%; 95% CI, 37.0 to 46.0; P<0.0001). A COVID-19 diagnosis was present in 7.6% (132/1,738) of CVT hospitalizations. CVT was present in 0.04% (103/292,080) of COVID-19 hospitalizations. During the first pandemic year, CVT mortality was higher in patients who were COVID positive compared to COVID negative patients (8/53 [15.0%] vs. 41/910 [4.5%], P=0.004). There was an increase in CVT mortality during the first 5 months of pandemic years 2020 and 2021 compared to the first 5 months of the pre-pandemic year 2019 (2019 vs. 2020: 2.26% vs. 4.74%, P=0.05; 2019 vs. 2021: 2.26% vs. 4.99%, P=0.03). In the first 5 months of 2021, there were 26 cases of vaccine-induced immune thrombotic thrombocytopenia (VITT), resulting in six deaths. Conclusions During the 1st year of the COVID-19 pandemic, CVT hospitalization volume and CVT in-hospital mortality did not change compared to the prior year. COVID-19 diagnosis was associated with higher CVT in-hospital mortality. During the first 5 months of 2021, there was an increase in CVT hospitalization volume and increase in CVT-related mortality, partially attributable to VITT.

BACKGROUND: Zhibai Dihuang pill (ZBDH), a Chinese herbal formula, has been widely used as an adjunctive therapy to help reduce the patient's steroid dose and maintain low disease activity in systemic lupus erythematosus (SLE). OBJECTIVE: This systematic review evaluates the therapeutic effect of modified ZBDH in reducing steroid use in patients with SLE. SEARCH STRATEGY: A systematic literature search was carried out using seven databases, including PubMed, Embase, Cochrane Central Register of Controlled Trials, Chinese Biomedical Literature Database, Chinese National Knowledge Infrastructure, Chinese VIP Information and Wanfang Database, from their inception to June 1st, 2019. The search terms included "systemic lupus erythematosus," "Chinese medicine" and "clinical trial," and their synonyms. Subject headings matching the above terms were also used. INCLUSION CRITERIA: This meta-analysis included randomized controlled trials that evaluated the reduction of steroid dose in patients with SLE. Traditional Chinese medicine (TCM) formulas in experimental group should be prescribed based on ZBDH and used as adjunctive therapy and the comparator should contain steroids. DATA EXTRACTION AND ANALYSIS: Two authors independently conducted database search, study selection, data extraction and quality assessment. The extracted information contained study design, sample size, recruitment mode, diagnostic criteria, inclusion and exclusion criteria, participant characteristics, TCM patterns, TCM formulas and treatment outcomes. The primary outcome was the change of steroid dose. Secondary outcomes included SLE Disease Activity Index (SLEDAI), biomarkers of disease activity and clinical response rate. STATA 15.0 was used to analyze the pooled effects reported as weighted mean difference (WMD) or odds ratio, with a 95% confidence interval (CI). RESULTS: In total, 20 trials involving 1470 SLE patients were included. The pooled result showed that modified ZBDH taken in combination with standard care led to a larger reduction in steroid dose, compared to standard care alone (WMD: 3.79; 95% CI: 2.58-5.01; P < 0.001). Favorable outcomes were also seen in secondary outcome criteria, such as SLEDAI and complement 3. The modified ZBDH treatments were well tolerated without increasing adverse effects. CONCLUSION The systematic review provided preliminary evidence supporting the use of ZBDH as a co-therapy to aid steroid dose reduction in patients with SLE. However, more rigorous studies should be conducted to validate these findings, and explore the mechanisms of ZBDH's relevant bioactive constituents.

BACKGROUND/AIMS: Inflammation-based scores, such as the neutrophil-to-lymphocyte ratio (NLR), have been associated with prognosis in hepatocellular carcinoma (HCC); but variable cut-off values and potential lack of specificity have limited the utility of NLR. This study evaluates NLR in a large cohort of HCC patients. METHODS: We retrospectively reviewed 789 HCC cases (1993–2017) for demographics, tumor characteristics, treatment, and survival. NLR was stratified into NLR ≥1.5 and NLR ≥3 and analyzed for correlation with American Joint Committee on Cancer (AJCC) and Barcelona Clinic Liver Cancer (BCLC) stages. In 235 patients who underwent liver resection, survival and recurrence were evaluated by NLR. RESULTS: In 789 HCC cases, mean NLR was increased with advanced AJCC and BCLC stages. Hepatitis C patients were less likely to have NLR ≥1.5 and ≥3. Non-alcoholic steatohepatitis patients were more likely to have NLR ≥3. Patients with tumor size >5 cm, rupture, or macrovascular invasion were more likely to have NLR ≥3. In patients treated with resection, NLR ≥3 predicted early recurrence (odds ratio [OR] 4.14, P<0.01) and overall recurrence (OR 4.05, P<0.01). Mean NLR was 4.30 in those with recurrence and 2.75 in those without recurrence. Patients with NLR ≥3 showed significantly worse survival compared to those with NLR <3 (P<0.01 by log-rank test). CONCLUSIONS: Elevated NLR is associated with advanced cancer stage and aggressive tumor characteristics, such as large size, rupture, and invasion. NLR ≥3 was associated with early and overall recurrence after resection but varied with etiology. NLR may be a useful biomarker in predicting recurrence for HCC patients undergoing curative resection, but further studies are required to elucidate the effect of disease etiology.
Carcinoma, Hepatocellular ; Cohort Studies ; Demography ; Fatty Liver ; Hepatitis C ; Humans ; Joints ; Liver Diseases ; Liver Neoplasms ; Liver ; Prognosis ; Recurrence ; Retrospective Studies ; Rupture ; Sensitivity and Specificity

Traditional Chinese Medicine (TCM) is one of the oldest systems of medicine. More and more attention has been paid to TCM application, but the variable quality of clinical trials with TCM impedes its widespread acceptance. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement has established guidelines for designing clinical trials to ensure that the trial results are accurate and reliable. However, there are difficulties when applying SPIRIT 2013 Statement to trials with TCM, due to the unique theory and the characteristic of TCM intervention. An Extension to the original SPIRIT was developed to ensure the quality of trial design with TCM. As Chinese herbal formulae, acupuncture and moxibustion are common and representative interventions in TCM practice, the executive working group determined that the SPIRIT-TCM Extension focus on these three interventions. Extension was developed through initiation, 3 rounds of Delphi consensus survey, and finalizing expert meeting. Seven items from the SPIRIT 2013 Statement were modified, namely, "title", "background and rationale", "objectives", "eligibility criteria", "interventions", "outcomes", and "data collection methods". The Extension includes the introduction of the concept of TCM pattern and 3 major TCM interventions, with examples and explanations. The SPIRIT-TCM Extension 2018 provides suggestion for investigators in designing high quality TCM clinical trials. It is expected that wide dissemination and application of this extension ensure continuous improvement of TCM trial quality throughout the world.
Clinical Protocols ; Clinical Trials as Topic ; Humans ; Medicine, Chinese Traditional ; Research Design

Many biologic products have improved the outcomes of cancer patients, but the costs can substantially burden healthcare systems. Biosimilar products can potentially reduce drug costs and increase patient access to beneifcial treatments. Approval of a biosimilar product relies on the demonstration of “comparability” or “no clinically meaningful differences” as compared to its reference biologic product. Biosimilar products for erythropoietin, granulocyte colony-stimulating factor, trastuzumab, and rituximab are already available, and the regulatory processes in various countries are constantly evolving. It is important that oncologists be familiar with the potential issues surrounding the clinical use of biosimilar products. In this review article, we provide background information about biosimilar products and their regulatory approval processes, followed by a discussion of individual biosimilar drugs.

Approximately 5% of breast cancer patients develop leptomeningeal metastases over the course of their disease. Though several treatments options are available for these patients, their prognosis is typically considered to be poor. We report a case of leptomeningeal failure after a patient underwent prior radiotherapy, radiosurgery, surgery, chemotherapy, and biologic therapy. This patient experienced a prolonged response after receiving bevacizumab and capecitabine. The literature currently contains several reports regarding the use of systemic therapy to manage leptomeningeal metastases from breast cancer, which we summarize. Finally, we review the relevant effects of the patient's treatment modalities and provide a rationale for the mechanism that led to her prolonged response.
Antibodies, Monoclonal, Humanized ; Biological Therapy ; Breast ; Breast Neoplasms ; Deoxycytidine ; Fluorouracil ; Humans ; Meningeal Neoplasms ; Neoplasm Metastasis ; Prognosis ; Radiosurgery ; Bevacizumab ; Capecitabine

Stroke is a major cause of death and disability in Singapore and many parts of the world. Chronic disease management programmes allow seamless care provision across a spectrum of healthcare facilities and allow appropriate services to be brought to the stroke patient and the family. Randomised controlled trials have provided evidence for efficacious interventions. After the management of acute stroke in a stroke unit, most stable stroke patients can be sent to their family physician for continued treatment and rehabilitation supervision. Disabled stroke survivors may need added home-based services. Suitable community resources will need to be harnessed. Clinic-based stroke nurses may enhance service provision and coordination. Close collaboration between the specialist and family physician would be needed to right-site patients and also allow referrals in either direction where necessary. Barriers to integration can be surmounted by trust and improved communication. Audits would allow monitoring of care provision and quality care enhancement. The Wagner model of chronic care delivery involves self-management support, shared clinical information systems, delivery system redesign, decision support, healthcare organisation and community resources. The key and critical feature is the need for an informed, activated (or motivated) patient, working in collaboration with the specialist and family physician, and a team of nursing and allied healthcare professionals across the continuum of care. The 3-year Integrating Services and Interventions for Stroke (ISIS) project funded by the Ministry of Health will test such an integrative system.
Delivery of Health Care, Integrated ; organization & administration ; Evidence-Based Medicine ; Humans ; Ischemic Attack, Transient ; Medicine ; Middle Aged ; Models, Organizational ; Neurology ; Primary Health Care ; Rehabilitation Nursing ; Singapore ; Specialization ; Stroke ; nursing ; Stroke Rehabilitation