Percutaneous electrical nerve field stimulation for adolescents with irritable bowel syndrome: Cost-benefit and cost-minimization analysis.

Abdominal pain drives significant cost for adolescents with irritable bowel syndrome (IBS). We performed an economic analysis to estimate cost-savings for patients' families and healthcare insurance, and health outcomes, based on abdominal pain improvement with percutaneous electrical nerve field stimulation (PENFS) with IB-Stim® (Neuraxis). We constructed a Markov model with a 1-year time horizon comparing outcomes and costs with PENFS versus usual care without PENFS. Clinical outcomes were derived from a sham-controlled double-blind trial of PENFS for adolescents with IBS. Costs/work-productivity impact for parents were derived from appropriate observational cohorts. PENFS was associated with 18 added healthy days over 1 year of follow-up, increased annual parental wages of $5,802 due to fewer missed work days to care for the child, and $4744 in cost-savings to insurance. Percutaneous electrical field nerve stimulation for adolescents with IBS appears to yield significant cost-savings to patients' families and insurance.

Benefits and Harms of Standard Versus Reduced-Dose Direct Oral Anticoagulant Therapy for Older Adults With Multiple Morbidities and Atrial Fibrillation.

Background Dose reduction of direct oral anticoagulant (DOAC) medications is inconsistently applied to older adults with multiple morbidities, potentially due to perceived harms and unknown benefits of standard dosing. Methods and Results Using 2013 to 2017 US Medicare claims linked to Minimum Data Set records, we conducted a retrospective cohort study. We identified DOAC initiators (apixaban, dabigatran, rivaroxaban) aged ≥65 years with nonvalvular atrial fibrillation residing in a nursing home. We estimated inverse-probability of treatment weights for DOAC dose using propensity scores. We examined safety (hospitalization for major bleeding) and effectiveness outcomes (all-cause mortality, thrombosis [myocardial infarction, stroke, systemic embolism, venous thromboembolism]). We estimated hazard ratios (HRs) and 95% CIs using cause-specific hazard-regression models. Of 21 878 DOAC initiators, 48% received reduced dosing. The mean age of residents was 82.0 years, 66% were female, and 31% had moderate/severe cognitive impairment. After estimating inverse-probability of treatment weights, standard dosing was associated with a higher rate of bleeding (HR, 1.18 [95% CI, 1.03-1.37]; 9.4 versus 8.0 events per 100 person-years). Standard-dose therapy was associated with the highest rates of bleeding among those aged >80 years (9.1 versus 6.7 events per 100 person-years) and with a body mass index <30 kg/m2 (9.4 versus 7.4 events per 100 person-years). There was no association of dosing with mortality (HR, 0.99 [95% CI, 0.96-1.06]) or thrombotic events (HR, 1.16 [95% CI, 0.96-1.41]). Conclusions In this nationwide study of nursing home residents with nonvalvular atrial fibrillation, we found a higher rate of bleeding and little difference in effectiveness of standard versus reduced-dose DOAC treatment. Our results support the use of reduced-dose DOACs for many older adults with multiple morbidities.

Efficacy of nonpharmacologic interventions in preoperative anxiety: A systematic review of systematic reviews.

AIMS AND OBJECTIVES: Evidence suggests that preparing patients for surgery using nonpharmacological strategies reduces their anxiety. However, there is no consensus on what the best practices are. This study aims to answer the question: Are interventions using nonpharmacological therapies effective in reducing preoperative anxiety? BACKGROUND: Preoperative anxiety causes physiological and psychological adverse effects, with a negative effect on postoperative recovery. INTRODUCTION: According to the World Health Organization, between 266 and 360 million surgical procedures are performed annually worldwide, and it is estimated that more than 50% of patients will experience some degree of preoperative anxiety. DESIGN: Systematic review of systematic reviews with results of interventions aimed at mitigating preoperative anxiety. METHODS: A search was conducted for systematic reviews with meta-analyses published between 2012 and 2021 in Medline, Scopus, Web of Science and Cochrane Library. Quality was assessed using the AMSTAR-2 scale. The protocol was registered in PROSPERO. RESULTS: A total of 1016 studies were examined, of which 17 systematic reviews were selected, yielding 188 controlled trials with 16,884 participants. In adults, the most common intervention included music, followed by massage, in children virtual reality and clowns. Almost all controlled trials reported a reduction in preoperative anxiety after the intervention, of which almost half had statistically significant results. CONCLUSION: Interventions that include music, massage and virtual reality reduce preoperative anxiety and have shown that they are cost-effective, minimally invasive and with a low risk of adverse effects. Preoperative anxiety can be reduced through a short-term intervention involving nursing professionals as an alternative or complement to drugs. RELEVANCE TO CLINICAL PRACTICE: This review suggests that nursing professionals, in collaboration with other health professionals, should continue to conduct research on the reduction in preoperative anxiety. Further research in this area is needed, to reduce heterogeneity and consolidate the results. NO PATIENT OR PUBLIC CONTRIBUTION: Not applied to our study, as it is a systematic review of systematic reviews.

Dose Intensity in Real-World Patients With Metastatic Renal Cell Carcinoma Taking Vascular Endothelial Growth Factor Receptor Tyrosine Kinase Inhibitors.

BACKGROUND: Tyrosine kinase inhibitors (TKIs) that target the vascular endothelial growth factor receptor (VEGFR) are oral therapies used to treat metastatic renal cell carcinoma (mRCC). VEGFR TKI treatment is often complicated by dose-limiting adverse events (AE). We sought to describe dose intensity and clinical outcomes in a real-world cohort of patients treated with VEGFR TKIs to better characterize dosing patterns and toxicity management compared with previously reported clinical trials. MATERIALS AND METHODS: We conducted a retrospective chart review of sequential patients with mRCC treated with VEGFR TKIs at 1 academic medical center from 2014 to 2021. RESULTS: 139 patients (75% male, 75% white, median age 63 years) were treated with 185 VEGFR TKIs in our real-world cohort. Per International Metastatic RCC Database Consortium criteria, 24% had good risk, 54% intermediate risk, and 22% poor risk mRCC. With their first VEGFR TKI, median relative dose intensity (RDI) was 79%. 52% of patients required a dose reduction, 11% discontinued treatment due to AEs, 15% visited the ED, and 13% were hospitalized for treatment-related adverse events. Cabozantinib had the highest rate of dose reductions (72%) but a low rate of discontinuation (7%). Real-world patients consistently had lower RDI than reported clinical trials with more frequent dose reductions, fewer drug discontinuations, shorter progression-free survival, and shorter overall survival. CONCLUSION: Real-world patients were less able to tolerate VEGFR TKIs compared to patients treated on clinical trials. Low real-world RDI, high dose reductions, and low overall discontinuation rates can inform patient counseling prior to treatment initiation and during therapy.

Comparison of nivolumab and sorafenib for first systemic therapy in patients with hepatocellular carcinoma and Child-Pugh B cirrhosis.

BACKGROUND: Patients with decompensated cirrhosis are excluded or underrepresented in clinical trials of systemic therapies for hepatocellular carcinoma (HCC) and comparisons of available therapies are lacking. We aimed to compare overall survival for patients with HCC and Child-Pugh B cirrhosis treated with nivolumab or sorafenib as first systemic treatment. METHODS: We performed a retrospective cohort study in patients with HCC and Child-Pugh B cirrhosis treated at Veterans Affairs medical centers to compare overall survival, adverse events, and reason for discontinuation of therapy between patients treated with nivolumab or sorafenib as first systemic treatment. All statistical tests were 2-sided. RESULTS: Of those meeting inclusion criteria, 431 patients were treated with sorafenib and 79 with nivolumab. Median OS was 4.0 months (95% CI 3.5-4.8) in the sorafenib cohort and 5.0 months (95% CI 3.3-6.8) in the nivolumab cohort. In the multivariable Cox proportional hazards model, nivolumab was associated with a significantly reduced hazard of death compared to sorafenib (HR 0.69; 95% CI 0.52-0.91; p = 0.008). In a secondary analysis using propensity score methods, results did not reach statistical significance (HR 0.77; 95% CI 0.55-1.06; p = 0.11). Treatment was discontinued due to toxicity in 12% of patients receiving nivolumab compared to 36% receiving sorafenib (p = 0.001). CONCLUSION: In patients with HCC and Child-Pugh B cirrhosis, nivolumab treatment may be associated with improved overall survival and improved tolerability compared to sorafenib and should be considered for the first systemic treatment in this population.

Clinical effect of Huangqi Chifeng Decoction combined with modified Duhuo Jisheng Decoction in the treatment of ischemic stroke during recovery / 国际中医中药杂志

Objective:To evaluate the clinical curative effect of Huangqi Chifeng Decoction combined with modified Duhuo Jisheng Decoction on patients with ischemic stroke (IS) during recovery.Methods:Prospective cohort study. A total of 220 patients with IS during recovery who met inclusion criteria in the First People's Hospital of Dongcheng District in Beijing, were enrolled and divided into control group ( n=110) and observation group ( n=110) by random number table method between January 2015 and July 2020. The control group was given basic treatment, while observation group was given Huangqi Chifeng Decoction combined with modified Duhuo Jisheng Decoction. All were treated for 1 month. Before and after treatment, Traditional Chinese Medicine (TCM) syndromes were scored. The activities of daily living were evaluated by Barthel index. The quality of life was evaluated by stroke specific quality of life scale (SS-QOL). The severity of neurological impairment was evaluated by National Institute of Health Stroke Scale (NIHSS). The functional recovery of stroke was evaluated by modified Rankin scale (mRS). The adverse reactions during treatment were observed and recorded. Results:After treatment, scores of TCM syndromes, mRS and NIHSS in observation group were significantly lower than those in the control group ( t=21.87, 4.66, 12.06, P<0.01), while scores of Barthel index and SS-QOL were significantly higher than those in the control group ( t=14.13, 5.80, P<0.01). During treatment, there were no obvious adverse reactions in either group. Conclusion:Huangqi Chifeng Decoction combined with modified Duhuo Jisheng Decoction can improve clinical symptoms and nerve function in patients with IS during recovery, which is beneficial to improve outcomes and quality of life.

A Randomised Controlled Trial of YOGa and Strengthening Exercise for Knee OsteoArthritis: Protocol for a Comparative Effectiveness Trial (YOGA Trial).

Osteoarthritis (OA) is a common joint disorder for which there is no cure. Current treatments are suboptimal. Exercise is a core treatment for knee OA, with muscle strengthening exercise commonly recommended. Yoga is a mind-body exercise intervention that can improve flexibility, muscle strength, balance, and fitness and potentially reduce symptoms of OA. However, there is a scarcity of robust, high-quality conclusive evidence on the efficacy of yoga in knee OA. We are currently conducting the first randomised comparative effectiveness and cost-effectiveness trial of a yoga program compared with a strengthening exercise program in patients with symptomatic knee OA. This study protocol describes the design and conduct of this trial. The YOGA study is a phase III, single-centre, parallel, superiority, randomised, active-controlled trial which will be conducted in Hobart, Australia. One hundred and twenty-six participants (63 in each arm) aged over 40 years with symptomatic knee OA will be recruited from the community and randomly allocated to receive either a 24-week yoga program (3×/week) or a strengthening exercise program (3×/week). The primary outcome will be change in knee pain over 12 weeks, assessed using a 100 mm visual analogue scale (VAS). The secondary outcomes include change in knee pain, patient global assessment, physical function, quality of life, gait speed, biomarkers, and others over 12 and 24 weeks. We will also assess whether the presence of neuropathic pain moderates the effects of yoga compared to strengthening exercise. Additional data, such as cost and resource utilization, will be collected for the cost-effectiveness analysis. The primary analysis will be conducted using an intention-to-treat approach. Adverse events will be monitored throughout the study. Once completed, this trial will contribute to the knowledge of whether yoga can be used as a simple, effective, low-cost option for the management of knee OA, thus saving economic costs in the healthcare system.

Comparative Safety and Effectiveness of Aldosterone Antagonists Versus Beta-Blockers as Fourth Agents in Patients With Apparent Resistant Hypertension.

BACKGROUND: Limited evidence exists regarding long-term effectiveness and safety of aldosterone antagonists (AAs) versus beta blockers (BBs) as fourth-line antihypertensive agents in patients with resistant hypertension (RH). We evaluated the comparative effectiveness and safety of aldosterone AA versus BB. METHODS: We conducted a real-world retrospective cohort study using IBM MarketScan commercial claims and Medicare Supplemental claims (2007-2019). Patients with RH entered the cohort (ie, index date) when they newly initiated either AA or BB. The effectiveness outcome was major adverse cardiovascular events. Safety outcomes were hyperkalemia, gynecomastia, and kidney function deterioration. Potential confounding was addressed by adjustment for baseline characteristics via stabilized inverse probability of treatment weighting (SIPTW) based on propensity scores. Cox proportional hazards regression with SIPTWs were used to estimate adjusted hazard ratio (aHR) and 95% CI comparing risk for outcomes between AA and BB groups. RESULTS: We identified 80 598 patients with RH (mean age: 61 years, 51% males), of which 6626 initiated AA and 73 972 initiated BB as the fourth antihypertensive agent. Among patients with RH, initiation of AA as a fourth-line antihypertensive agent did not significantly reduce major adverse cardiovascular event risk relative to BB initiation (aHR, 0.77 [95% CI, 0.50-1.19]) but did substantially increase the risk of hyperkalemia (aHR, 3.86 [95% CI, 2.78-5.34]), gynecomastia (aHR, 9.51 [95% CI, 5.69-15.89]), and kidney function deterioration (aHR, 1.63 [95% CI, 1.34-1.99]). CONCLUSIONS: Long-term clinical trials powered to assess major adverse cardiovascular events are necessary to understand the risk-benefit trade-off of AA as fourth-line therapy for RH.

Acupuncture as a tool to reduce nausea in terminally ill patients.

AIM: To investigate if acupuncture reduces nausea and vomiting in terminally ill patients. DESIGN: A comparative effectiveness research design was used to generate evidence-based knowledge close to practice for the use of clinicians. The sample size was calculated to 136 patients randomised into an intervention and a control group, respectively. Nausea and vomiting were measured using the EORTC QLQ-c15-PAL (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire, core 15, Palliation). LOCATION: The trial was conducted among terminally ill patients admitted to three in-bed hospices in Demark. PARTICIPANTS: Terminally ill patients suffering from nausea and/or vomiting; 95% of patients had cancer. INTERVENTION: The intervention group received acupuncture in addition to usual care for three days. We used the acupuncture spots: Pericardium-6, Stomach-36, Liver-3 and Yin Tang. The control group received usual care only. RESULTS: In total, 136 patients were randomised, 24 patients withdrew resulting in a total sample of 112 patients: 52 patients in the intervention group and 60 patients in the control group. In the intervention group, 75% of the patients experienced a reduction of their nausea score after the intervention compared to 55% in the control group. The statistical difference was p = 0.028. In the intervention group, 52% of the patients did not experience nausea at all after the intervention compared to 30% in the control group. In the intervention group, 31% of the patients were still vomiting after the intervention compared to 34% in the control group; no statistically significant difference was found. CONCLUSION: Acupuncture reduced the experience of nausea among terminally ill patients but did not reduce vomiting. Thus, acupuncture is recommended to reduce nausea among terminally ill patients.

Acupuncture therapy combined with rhubarb applied to the umbilicus for constipation in patients with stage IV-V diabetic nephropathy / 中国基层医药

Objective:To investigate the efficacy of acupuncture therapy combined with rhubarb applied to the umbilicus in the treatment of constipation in patients with stage IV-V diabetic nephropathy.Methods:Ninety stage IV-V diabetic nephropathy patients with constipation, who received treatment in Wenzhou Hospital of Traditional Chinese Medicine from December 2019 to December 2020, were included in this study. They were randomly assigned to receive either routine treatment (control group, n = 45) or routine treatment plus acupuncture therapy combined with rhubarb applied to the umbilicus (study group, n = 45). Serum motilin, gastrin, and somatostatin levels and orocecal transit time pre- and post-treatment were compared between the two groups. The constipation severity was evaluated using the Constipation Severity Scale (CSS). Quality of life was evaluated using the Patient Assessment of Constipation Quality of Life Questionnaire. Clinical efficacy was compared between the two groups. Results:The somatostatin level and orocecal transit time post-treatment in the study group were (13.66 ± 4.24) ng/L and (80.58 ± 10.11) minutes, respectively, which were significantly lower than those in the control group [(19.31 ± 6.13) ng/L, (87.16 ± 12.04) minutes, t = 5.08, 2.80, both P < 0.05]. Serum motilin and gastrin levels post-treatment in the study group were (281.07 ± 41.16) ng/L and (181.07 ± 35.16) ng/L, respectively, which were significantly higher than those in the control group [(259.64 ± 39.83) ng/L, (162.65 ± 32.83) ng/L, t = 2.51, 2.56, both P < 0.05]. The scores of the Constipation Severity Scale and the Patient Assessment of Constipation Quality of Life Questionnaire post-treatment in the study group were (10.66 ± 3.14) points and (60.14 ± 13.64) points, respectively, which were significantly lower than those in the control group [ (15.31 ± 4.13) points, (71.61 ± 14.72) points, t = 6.01, 3.83, both P < 0.05). Total response rate was significantly higher in the study group than in the control group (97.78% vs. 80.00%, χ2 = 5.51, P < 0.05). Conclusion:Acupuncture therapy combined with rhubarb applied to the umbilicus can be used to treat constipation in patients with stage IV-V diabetic nephropathy. The combined therapy can adjust the secretion of gastrointestinal tract-related hormones, shorten orocecal transit time, improve clinical symptoms, and improve clinical efficacy and quality of life.

Efficacy of intense pulse light and M22-ResurFx fractional laser on lateral crow＇s feet / 中华医学美学美容杂志

Objective:To evaluate the efficacy and patients＇ satisfaction of the intense pulse light (IPL) and M22-Resur Fx non-ablative fractional laser (NAFL) for the treatment of lateral static crow＇s feet.Methods:A prospective split-face, randomized, controlled study of 60 consecutive patients with lateral static crow＇s feet was performed. The patients aged 30 to 55 years, who were enrolled in the Department of Ophthalmology, Beijing Tongren Hospital, Capital Medical University from January 2018 to January 2020. The two sides of each patient＇s face were randomized to receive different treatment, and according to their treatment, the patients were divided into 3 groups with 20 cases each: Group A, in which 20 patients＇ one side face was treated with IPL, and other side was treated with NAFL; Group B, in which one side face was treated with IPL, and another side was treated with IPL immediately followed by NAFL; Group C, in which one side face was treated with NAFL, and another side was treated with IPL immediately followed by NAFL. The improvements including the water content of stratum corneum of skin and the patients＇ satisfaction, as well as the improvement of the lateral static crow＇s feet were evaluated.Results:The IPL plus NAFL combined treatment group and the NAFL treatment group showed the effective rate of the improvement for lateral static crow＇s feet of patients on days 60 and 90 was statistically significant ( P<0.05) compared with that before the treatment. And the improvement for lateral static crow＇s feet of patients on days 60 and 90 in combined treatment side was significantly different from either NAFL side ( P<0.05). 60 days and 90 days after treatment, the satisfaction of combined treatment side was significantly higher than that of either NAFL side or IPL side ( P<0.05). Conclusions:The treatment with an optimized IPL immediately followed by a NAFL is clinically superior to those with the NAFL or IPL alone for improving the lateral static crow＇s feet of patients. The satisfaction treated by NAFL combined with IPL is higher than using the NAFL or IPL alone.

An emulated target trial analysis based on Medicare data suggested non-inferiority of Dabigatran versus Rivaroxaban.

OBJECTIVES: Rivaroxaban and Dabigatran were the first two non-vitamin K antagonist oral anticoagulants (NOACs) for preventing stroke among non-valvular Atrial Fibrillation patients. This article aimed to evaluate the relative efficacy and safety of Rivaroxaban versus Dabigatran. STUDY DESIGN AND SETTING: An emulated target trial analysis was conducted based on Medicare, in which we constructed three "randomized clinical trials" with well-defined inclusion/exclusion criteria, treatment regimens, and analysis procedures. We analyzed the individual trials, examined temporal variations, and generated unified results via pooled analysis. RESULTS: With a two-year data collection window (2012-2013), 70,129 subjects were enrolled in the three emulated trials, with 36,269 and 34,089 in the Rivaroxaban and Dabigatran arms, respectively. Dabigatran (the reference group for hazard ratio - HR) was superior regarding time to any primary event (including ischemic stroke, other thromboembolic events, major bleeding, and death; HR 1.232, P-value 0.0025), major bleeding (HR 1.187, P-value <0.0001), and mortality (HR 1.488, P-value <0.0001). Differences regarding stroke and other thromboembolic events were not significant. CONCLUSION: Dabigatran was found as superior for the Medicare patients with multiple chronic conditions. Temporal variations, which had been largely neglected in the literature, were observed. This study may provide new insight into treating AF with NOACs.

Design characteristics of comparative effectiveness trials for the relief of symptomatic dyspepsia: A systematic review.

BACKGROUND: Dyspepsia represents a symptom domain rather than a diagnostic condition and covers a wide range of complex, underlying pathophysiologies that are not well understood. The review explores comparative effectiveness interventions for the treatment of symptomatic dyspepsia along a pragmatic-explanatory continuum. The aim is to identify relevant design characteristics applicable to future upper gastrointestinal comparative effectiveness research employing integrative medicine. METHODS: Medline, CINAHL, Scopus, Cochrane Central Register of Controlled Trials (CENTRAL) and WHO Clinical Trials were systematically searched until January 2019. Included articles were original research with two or more comparative intervention arms for the primary outcome; relief of symptomatic dyspepsia. Evaluation of the studies was conducted using the pragmatic-explanatory continuum indicator summary (PRECIS-2) tool. RESULTS: Thirty-six articles were included in the review. A total of 68 Patient Reported Outcome Measurements (PROMs), utilizing 50 different formats were deployed across the studies. The appraisal process revealed eligibility, flexibility in adherence, flexibility in delivery and organization domains further aligned towards an explanatory design. CONCLUSION: This review identified three design characteristics relevant for future comparative effectiveness research for the treatment of upper gastrointestinal disorders in a community setting. Extensive exclusion eligibility criteria limited the generalization of comparative effectiveness study results by removing sub-groups of the target populations more at risk of dyspeptic symptoms. The requirement for entry endoscopy was found to be common and not always pragmatically justifiable. Development of validated PROMs appropriate for a generic application to upper gastrointestinal disorders would be advantageous for future comparative effectiveness research within integrative medicine.

Progress of traditional Chinese medicine in treatment of acute mononuclear leukemia / 白血病·淋巴瘤

Acute mononuclear leukemia is a type of disease with a high incidence in acute myeloid leukemia. With the continuous deepening of traditional Chinese medicine research, some progress has been made in the research on its clinical efficacy and mechanism of action. This article reviews the research progress in the treatment of acute mononuclear leukemia with traditional Chinese medicine in recent years.

Effect of acupuncture combined with medical training therapy for the patients with functional ankle instability / 国际中医中药杂志

Objective:To observe the clinical effect of acupuncture combined with Medical Training Therapy (MTT) for Functional ankle instability (FAI).Methods:A total of 72 patients, who met the inclusion criteria of FAI, from January 2018 to June 2019, were selected and randomly divided them into 4 groups: Combination group (CG), MTT group (MTT), Acupuncture group (ACU) and Control group (Ctrl). Intervention of groups were that MTT and Acupuncture were used in CG, MTT and acupuncture are used separately in MTT and ACU groups. Patients of Ctrl Group were on the waiting list. All four groups were treated for 8 weeks. The Cumberland Ankle Instability Tool (CAIT), Foot And Ankle Ability Measure (FAAM) and American Orthopedic Foot and Ankle Society (AOFAS) were assessed for the ankle function evaluation.Results:After treatment, the CAIT (23.17 ± 5.22, 21.17 ± 6.85, 21.88 ± 4.24 vs. 20.10 ± 6.31, F=34.737), FAAM-ADL (96.52 ± 3.61, 94.39 ± 5.56, 95.04 ± 4.03 vs. 92.66 ± 10.18, F=39.244), FAAM-Sport (72.38 ± 8.10, 70.71 ± 9.57, 71.82 ± 10.0 vs. 57.98 ± 15.27, F=42.187) and AOFAS (89.16 ± 3.02, 85.82 ± 5.33, 86.08 ± 4.00 vs. 77.08 ± 8.90, F=37.629) in CG Group, MTT Group, ACU Group were significantly higher than those in the Ctrl Group ( P<0.01). Conclusion:Acupuncture combined with MTT treatment can increase the stability and improve the ankle function, which is superior to acupuncture alone and MTT alone.

Efficacy of Shenqi Fuzheng Injection combined with nimodipine in the treatment of convalescent-phase cerebral infarction and its effects on neurocognitive function, hemorheology and T cell subsets / 中国基层医药

Objective:To investigate Shenqi Fuzheng Injection combined with nimodipine in the treatment of convalescent-phase cerebral infarction and its effects on neurocognitive function, hemorheology and T cell subsets. Methods:A total of 108 patients with cerebral infarction in the convalescent phase who received treatment in Hangzhou Hospital of Traditional Chinese Medicine, China between April 2016 and December 2019 were included in this study. They were randomly assigned to receive either nimodipine treatment (control group, n = 54) or treatment with Shenqi Fuzheng Injection combined with nimodipine (study group, n = 54). Curative effects and changes in neurocognitive function, hemorheology and T cell subsets after treatment relative to before treatment were compared between the control and study groups. Results:Total effective rate in the study group was significantly higher than that in the control group [90.74% (49/54) vs. 75.93% (41/54), χ2 = 4.267, P = 0.039]. After 2 weeks of treatment, whole blood viscosity at a high shear rate, whole blood viscosity at a low shear rate, plasma viscosity in the study group were (4.17 ± 0.24) mPa/s, (9.27 ± 1.98) mPa/s, (1.07 ± 0.19) mPa/s, respectively, which were significantly lower than those in the control group [(4.52 ± 0.31) mPa/s, (13.69 ± 2.13) mPa/s, (1.34 ± 0.23) mPa/s, t = 6.560, 11.169, 6.651, all P < 0.05]. The proportion of CD 3+ cells, CD 4+ and CD 4+/CD 8+ in the study group was (48.59 ± 4.59) %, (44.24 ± 6.17) % and (1.91 ± 0.17) respectively, which were significantly higher than those in the control group [(44.97 ± 5.31) %, (39.55 ± 5.13) %, (1.47 ± 0.22), t = 3.790, 4.295, 11.629, all P < 0.05]. The proportion of CD 8+ cells in the study group was significantly lower than that in the control group [(23.13 ± 5.62) % vs. (26.97 ± 4.26) %, t = 4.001, P < 0.05]. Mini-Mental State Examination score in the study group was significantly higher than that in the control group [(28.87 ± 0.85) points vs. (27.91 ± 1.45) points, t = 4.197, P < 0.05]. National Institute Health of Stroke Scale score in the study group was significantly lower than that in the control group [(9.63 ± 2.19) points vs. (15.27 ± 1.97) points, t = 14.070, P < 0.05]. Conclusion:Shenqi Fuzheng Injection combined with nimodipine can remarkably improve the neurocognitive function, hemorheology and T cell subsets in patients with cerebral infarction in the convalescent phase. The combined method is safe and reliable, and its curative effect is stable.

Efficacy of Nicorandil in the treatment of unstable angina pectoris in 30 patients / 中国基层医药

Objective:To investigate the efficacy of Nicorandil in the treatment of unstable angina pectoris.Methods:Sixty patients with unstable angina pectoris who received treatment in Department of Cardiovascular Disease, Suixi Hospital of Traditional Chinese Medicine, China during January-July 2020 were included in this study. They were randomly assigned to receive either conventional treatment including antiplatelet, increasing coronal blood flow velocity, lipid-lowering treatment and stabilization of atherosclerotic plaque (control group, n = 30) or Nicorandil treatment and conventional treatment (observation group, n = 30). Clinical efficacy was compared between the two groups. Angina attack, electrocardiogram changes and adverse reactions in each group were analyzed before and after treatment. Results:Total effective rate in the observation group was significantly higher than that in the control group [88.67% (26/30) vs. 53.33% (16/30), χ2 = 7.937, P = 0.005]. The frequency and duration of angina pectoris in the observation group were (1.53 ± 0.62) times/week, (1.93 ± 0.78) minutes, which were significantly lower or shorter than those in the control group [(1.97 ± 0.71) times /week, (2.60 ± 1.00) minutes, t = -2.359, -3.162, P = 0.025, 0.004). The total effective rate of electrocardiogram in the observation group was significantly higher than that in the control group [70.00% (22/30) vs. 43.34% (13/30), χ2 = 5.554, P = 0.018]. There was no significant difference in the incidence of adverse drug reactions such as nausea, dizziness and palpitation between the two groups (all P > 0.05). Conclusion:Based on conventional treatment, Nicorandil treatment for unstable angina pectoris can improve the clinical symptoms and electrocardiogram changes, exhibit remarkable efficacy, and therefore deserve clinical promotion.

Stakeholder impact on the implementation of integrated care: Opportunities to consider for patient-centered outcomes research.

Nearly half of Americans live with chronic disease. Many have multiple chronic conditions that often present as a combination of physical and mental health conditions. Aligning stakeholder-driven, patient-centered outcomes research with population health strategies such as innovative ways to deliver care management can reduce the burden of multiple chronic conditions. In addition, successfully creating meaningful, inclusive research requires actively engaging stakeholders throughout the lifecycle of a study. This study integrates stakeholder engagement, using a large health plan in western Pennsylvania, to conduct a randomized controlled trial. Three care management strategies, High-Touch, High-Tech, and Usual Care, are compared for effectiveness among members with multiple chronic conditions. Care strategies are delivered via the Community Team, a multidisciplinary community-based team, offering in-person (High-Touch) and digital (High-Tech) care management in 14 counties across Pennsylvania. Participants are followed for 12months, with repeated measurements of self-reported health status and activation in care, while tracking administrative measurements of primary and specialty health service utilization. Quality of life, care satisfaction, engagement in care, and service utilization will be compared using generalized mixed models. Additionally, semi-structured interviews are conducted for both participants and care managers over the course of the study to evaluate feasibility. This manuscript presents implementation strategies, while noting that the implementation of patient-centered outcomes research in a real-world setting requires rapid evaluation, redesign of workflow, and tailored approaches for success.

Effectiveness of adjuvant FOLFOX vs 5FU/LV in adults over age 65 with stage II and III colon cancer using a novel hybrid approach.

PURPOSE: Estimates of cancer therapy effects can differ in clinical trials and clinical practice, partly due to underrepresentation of certain patient subgroups in trials. We utilize a hybrid approach, combining clinical trial and real-world data, to estimate the comparative effectiveness of two adjuvant chemotherapy regimens for colon cancer. METHODS: We identified patients aged 66 and older enrolled in the Multicenter International Study of Oxaliplatin/5FU-LV in the Adjuvant Treatment of Colon Cancer. Similar patients were identified in the Surveillance, Epidemiology, and End Results (SEER)-Medicare database, initiating adjuvant chemotherapy with either 5-fluorouracil (5FU) alone or in combination with oxaliplatin (FOLFOX). We used logistic regression to estimate the likelihood of trial enrollment as a function of age, sex, and substage. Using inverse odds of sampling weights (IOSW), we compared 5-year mortality in patients randomized to FOLFOX vs 5FU using weighted Cox proportional hazards regression, the Nelson-Aalen estimator for cumulative hazards, and bootstrapping for 95% confidence intervals (CIs). RESULTS: There were 690 trial participants and 3834 SEER-Medicare patients. The SEER-Medicare population was older and had a higher proportion of stage IIIB and IIIC patients than the trial. After controlling for differences between populations, the IOSW 5-year HR was 1.21 (0.89, 1.65), slightly farther from the null than the trial estimate (HR = 1.14, 95%CI: 0.87, 1.49). CONCLUSIONS: This study supports mounting evidence of little to no incremental reduction in 5-year mortality for FOLFOX vs 5FU in older adults with stage II-III colon cancer, emphasizing the importance of combining clinical trial and real-world data to support such conclusions.

The OPTIMIZE study: protocol of a pragmatic sequential multiple assessment randomized trial of nonpharmacologic treatment for chronic, nonspecific low back pain.

BACKGROUND: Low back pain is a prevalent condition that causes a substantial health burden. Despite intensive and expensive clinical efforts, its prevalence is growing. Nonpharmacologic treatments are effective at improving pain-related outcomes; however, treatment effect sizes are often modest. Physical therapy (PT) and cognitive behavioral therapy (CBT) have the most consistent evidence of effectiveness. Growing evidence also supports mindfulness-based approaches. Discussions with providers and patients highlight the importance of discussing and trying options to find the treatment that works for them and determining what to do when initial treatment is not successful. Herein, we present the protocol for a study that will evaluate evidence-based, protocol-driven treatments using PT, CBT, or mindfulness to examine comparative effectiveness and optimal sequencing for patients with chronic low back pain. METHODS: The Optimized Multidisciplinary Treatment Programs for Nonspecific Chronic Low Back Pain (OPTIMIZE) Study will be a multisite, comparative effectiveness trial using a sequential multiple assessment randomized trial design enrolling 945 individuals with chronic low back pain. The co-primary outcomes will be disability (measured using the Oswestry Disability Index) and pain intensity (measured using the Numerical Pain Rating Scale). After baseline assessment, participants will be randomly assigned to PT or CBT. At week 10, participants who have not experienced at least 50% improvement in disability will be randomized to cross-over phase-1 treatments (e.g., PT to CBT) or to Mindfulness-Oriented Recovery Enhancement (MORE). Treatment will consist of 8 weekly sessions. Long-term outcome assessments will be performed at weeks 26 and 52. DISCUSSION: Results of this study may inform referring providers and patients about the most effective nonoperative treatment and/or sequence of nonoperative treatments to treat chronic low back pain. TRIAL REGISTRATION: This study was prospectively registered on March 1, 2019, with Clinicaltrials.gov under the registration number NCT03859713 (https://clinicaltrials.gov/ct2/show/NCT03859713).