CLINICAL THERAPEUTICS临床治疗学
CLINICAL THERAPEUTICS(英文缩写 CLIN THER),ISSN 0149-2918,eISSN 1879-114X,中文译名:临床治疗学 是一本学术期刊。本页汇总该期刊的最新影响因子、分区信息以及最新收录于 PubMed 的文献,帮助您快速了解期刊全貌。
发文量统计区间：2025-11-01 至 2026-10-31，按本站收录文献的发表日期统计。
期刊介绍
历年影响因子趋势
| JCR 数据年份 | 影响因子 | JCR 分区 |
|---|---|---|
| 2021 | 3.637 | Q2 |
| 2022 | 3.200 | Q3 |
| 2023 | 3.200 | Q2 |
| 2024 | 3.600 | Q2 |
| 2025 | 3.700 | Q2 |
CLINICAL THERAPEUTICS 最新收录文献
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1. Remimazolam Versus Propofol During Hysteroscopy: A Systematic Review And Meta-Analysis of Nine Randomized Controlled Trials.
1. 瑞马唑仑与丙泊酚在宫腔镜检查中的比较：九项随机对照试验的系统综述与荟萃分析PMID:日期:2026-10-03To compare the efficacy and safety of remimazolam (RMZ) versus propofol during hysteroscopy. A systematic review and meta-analysis synthesizing evidence from randomized controlled trials (RCTs) obtained from PubMed, Google Scholar, EMBASE, CENTRAL, Scopus, and Web of Science until February 2025. We pooled dichotomous outcomes and continuous outcomes using relative risk (RR) and standardized mean difference, respectively, with a 95% confidence interval (CI). Nine RCTs and 1164 patients were included. RMZ was significantly associated with decreased incidence of injection pain (RR = 0.07; with 95% CI, [0.02, 0.20]; P = 0.001), hypotension (RR = 0.33; with 95% CI, [0.22, 0.50]; P = 0.001), and low SpO₂/respiratory depression (RR = 0.26; with 95% CI, [0.18, 0.38]; P = 0.001). However, RMZ was significantly associated with an increased incidence of hiccough (RR = 10.37; with 95% CI, [2.94, 36.62]; P = 0.001), with no significant difference between both groups regarding bradycardia (RR = 0.32; with 95% CI, [0.08, 1.18]; P = 0.09), and body movement (RR = 1.17; with 95% CI, [0.95, 1.44]; P = 0.15). Additionally, there was no significant difference between the 2 groups regarding sedation success (P = 0.83), recovery duration (P = 0.05), and total procedural duration (P = 0.07). RMZ may provide a safer alternative to propofol during hysteroscopy, with similar procedural outcomes and fewer injection-related and cardiorespiratory adverse events.
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2. Safety Challenges and Emerging Solutions in Regenerative Medicine: Tissue Engineering, Cell Therapy, and Gene Therapy.
2. 再生医学中的安全性挑战与新兴解决方案：组织工程、细胞治疗和基因治疗PMID:日期:2026-09-26Regenerative medicines such as tissue, cell therapy, and gene therapy have revolutionized the treatment paradigm for difficult-to-treat diseases. Despite their therapeutic promise, these therapies pose safety challenges due to risks in manufacturing, contamination, inadvertent biologic behavior, and immune reactivity. This commentary highlights key safety concerns across major regenerative medicine categories and emerging solutions to address these risks. This commentary reviews current literature, manufacturer prescribing information, and regulatory perspectives involving tissue-engineered products, cell, and gene therapies. Key safety challenges common to and unique among these categories are examined, along with technological and regulatory approaches in development to improve product safety and consistency. Major safety concerns include microbial and manufacturing process-related contamination, variability in product quality, off-target biological effects, unintended cell differentiation or persistence, insertional mutagenesis, and immune responses to transplanted cells or gene delivery vectors. Recent advances in manufacturing controls, close system processing, and vector engineering are improving safety profiles across these products. Additionally, new regulatory frameworks are promoting greater standardization and risk management throughout product development and commercialization. As regenerative medicine continues to expand, addressing safety challenges remains essential. Continued innovation in manufacturing, gene editing, and cell activation is critical for maximizing benefits while minimizing safety events. Understanding the safety challenges and emerging solutions will support broader integration of these therapies in clinical practice.
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3. Association of Chronic Vascular Complications of Diabetes With Cardiovascular Autonomic Neuropathy: The Silesia Diabetes-Heart Project.
3. 糖尿病慢性血管并发症与心血管自主神经病变的关联：西里西亚糖尿病-心脏项目PMID:日期:2026-09-22Cardiovascular autonomic neuropathy (CAN) is a serious but frequently underdiagnosed complication of diabetes mellitus (DM). Increasing evidence suggests that CAN may coexist with other diabetes-related complications implicating the need for comprehensive screening and holistic risk assessment in people with DM. This study aimed to evaluate the relationship between selected microvascular and macrovascular complications of DM with CAN. This single-center observational study included 728 adults with DM (median age 56 (IQR 42, 67) years, 53% female) participating in the Silesia Diabetes-Heart Project. Clinical data, biochemical parameters, and the presence of diabetic vascular complications, namely diabetic retinopathy (DR), chronic kidney disease (CKD), and atherosclerotic cardiovascular disease (ASCVD) were collected. CAN was assessed using cardiovascular autonomic reflex tests (CARTs) in accordance with the Toronto Consensus criteria. Participants were classified as having no CAN, early CAN, or definite CAN. Associations between diabetic vascular complications and CAN were evaluated using multivariable logistic regression models. CAN was present in 48.2% of participants (early CAN 32.4%, definite CAN 15.8%). Increasing CAN severity was associated with older age, longer DM duration, higher HbA and triglyceride levels, and impaired renal function (all p < 0.05). In multivariable analyses, CAN was independently associated with DR (2.26, 95% CI 1.25-4.19; p = 0.008), while the association with CKD remained borderline significant (OR 1.57, 95% CI 1.00-2.47; p = 0.049). CAN is common in individuals with DM and is associated with microvascular complications, particularly DR, with a more modest association for CKD. These findings support the concept that CAN reflects systemic vascular injury in DM and highlight the importance of routine autonomic assessment especially in people with DR and CKD to identify those at increased risk of CAN.
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4. Efficacy, Safety, and Economic Evaluation of Originator Versus Generic Moxifloxacin Hydrochloride Injection in the Treatment of Community-Acquired Pneumonia Under China's National Centralized Drug Procurement Policy: A Retrospective Study.
4. 中国国家药品集中采购政策下原研药与仿制药盐酸莫西沙星注射液治疗社区获得性肺炎的疗效、安全性与经济性评价：一项回顾性研究PMID:日期:2026-09-22To investigate the efficacy, safety and economic outcomes of moxifloxacin hydrochloride injection in the treatment of community-acquired pneumonia (CAP) under the centralized volume-based procurement policy, and to provide a basis for its rational clinical application. Inpatients with CAP who received moxifloxacin hydrochloride injection as initial therapy across 4 tertiary hospitals from January 2019 to March 2024 were retrospectively enrolled and divided into the originator group (Group A) and the NCDP-selected generic group (Group B) based on the drug source. Inverse probability of treatment weighting (IPTW) was applied to balance baseline confounding factors. Efficacy was evaluated by comparing primary and secondary outcomes such as the clinical efficacy and microbial clearance rates; for missing data regarding efficacy outcomes, complete-case analysis and baseline observation carried forward (BOCF) were adopted for sensitivity testing. Concurrently, exploratory subgroup analyses based on different treatment regimens and the concurrent-use period were conducted to evaluate the stability of moxifloxacin's efficacy and control for potential temporal confounding. Safety was assessed based on the incidence of total and specific adverse reactions. Economic evaluation utilized a cost-consequences analysis (CCA), and the robustness of the conclusions was assessed through sensitivity analyses (including a generalized linear model and bootstrap resampling). Group A and Group B included 414 and 455 patients, respectively. After balancing via IPTW, there were no statistical differences in baseline characteristics between the 2 groups. In terms of efficacy, there were no statistical differences between the 2 groups in the primary and secondary outcomes (P > 0.05). The sensitivity analysis for missing data supported the robustness of the main analysis results. Furthermore, exploratory subgroup analyses showed no statistical differences in efficacy among the treatment regimen subgroups, suggesting that the effect of moxifloxacin is relatively stable. Additionally, the subgroup analysis based on the concurrent-use period indicated that the comparative effectiveness was not significantly affected by calendar time. In terms of safety, no statistically significant differences were observed in the incidence of total and specific adverse reactions between the 2 groups (P > 0.05). Economically, with no statistically significant difference observed clinically, the base-case CCA and sensitivity analyses showed significantly lower average total medical costs in the NCDP-selected group. Under the centralized procurement policy, the NCDP-selected generic moxifloxacin showed clinical efficacy and safety not significantly different from those of the originator, while being associated with lower total medical costs. These findings require further validation in large‑sample studies.
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5. Medical Device Safety Throughout the Product Lifecycle: Regulatory Frameworks, Digital Transformation, and the Role of Artificial Intelligence in Devices and Monitoring.
5. 医疗器械全生命周期安全：监管框架、数字化转型以及人工智能在器械与监测中的作用PMID:日期:2026-09-16Medical devices are a mainstay in modern healthcare, supporting the diagnosis, monitoring, treatment, and management of acute and chronic conditions. Rapid technological innovation, increasing software dependence, growing connectivity, and the emergence of artificial intelligence (AI)-enabled systems have expanded the traditional boundaries of device safety. This narrative review examines medical device safety across the product lifecycle, from early design and preclinical development through clinical investigation, regulatory review, postmarket surveillance (PMS), software change management, cybersecurity, and AI-enabled device oversight. It examines recent regulatory approaches and implications of modern technological advances. A structured literature search was conducted using PubMed and ScienceDirect for relevant publications from 2016 to 2026, as well as an additional literature search focused on clinical research topics for the date range of 2013 to 2026. Findings were supplemented by regulatory guidance documents, industry white papers, and key sources from the FDA, EMA, and Cochrane Library. Authors screened, reviewed, and summarized the publications collectively to use as a basis for the discussion. The review highlights that although drug and device safety share common principles, including adverse event (AE) monitoring, serious AE reporting, benefit-risk assessment, and signal management, device safety requires a broader socio-technical framework. Device-related harm may arise from product malfunction, device deficiency, use error, operator dependence, procedural factors, environmental conditions, maintenance practices, or workflow failures. Therefore, robust safety oversight requires integration of risk management, biocompatibility, usability engineering, quality systems, clinical investigation standards, complaint handling, and PMS. The findings also emphasize progressive transition from retrospective and passive safety reporting toward more proactive, real-time, and lifecycle-based evidence generation. Real-world data, active surveillance, decentralized trial models, digital health technologies, and AI-assisted signal detection are reshaping how safety risks are identified and managed. At the same time, software updates, cybersecurity vulnerabilities, and AI/ML-enabled device behavior introduce new risks that may not be fully captured during premarket evaluation. These developments require continuous monitoring, disciplined change control, human factors assessment, and stronger international regulatory alignment. Overall, medical device safety should be approached as a dynamic lifecycle discipline rather than a static premarket requirement. Future safety frameworks will depend on harmonized global reporting systems, stronger postmarket evidence generation, integration of cybersecurity into benefit-risk assessment, adoption of Good Machine Learning Practice, and continued attention to human factors in increasingly complex clinical environments.
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6. Effects of Phosphodiesterase-5 Inhibitors on Mortality and Clinical Outcomes in Advanced Interstitial Lung Disease with Severe Impairment in Gas Exchange: A Systematic Review and Meta-Analysis.
6. 磷酸二酯酶-5抑制剂对晚期间质性肺病伴严重气体交换受损患者死亡率和临床结局的影响：一项系统评价和荟萃分析PMID:日期:2026-09-10Given limited treatments for advanced interstitial lung disease (ILD), this updated study focuses strictly on phosphodiesterase 5 inhibitors (PDE5Is) efficacy exclusively in a clinically high-risk ILD subgroup, unlike prior meta-analyses that pooled diverse lung diseases or mixed vasodilator classes. We systematically searched PubMed, Embase, and the Cochrane Library from inception to February 2026 to identify randomized controlled trials (RCTs) and observational cohort studies evaluating PDE5Is in advanced ILD. The primary outcome was all-cause mortality. The secondary outcomes were the St. George's Respiratory Questionnaire (SGRQ) score, forced vital capacity (FVC), B-type natriuretic peptide (BNP) levels, and serious adverse events. Effect sizes were pooled using random-effects models, and between-study heterogeneity was assessed using the I² and τ² statistics. Six studies (including 3 RCTs) with a total of 1,800 patients were analyzed (759 patients in the PDE5Is group and 1,041 patients in the control group; 4 IPF and 2 generalized ILD studies). Overall, PDE5I therapy was not associated with a significant reduction in all-cause mortality, and substantial between-study heterogeneity was observed (HR 0.76, 95% CI 0.31-1.90; p = 0.56; I² = 96%). However, a subgroup analyses suggested a lower mortality point estimate in the clinically suspected or hemodynamically confirmed PH-targeted population (HR 0.51, 95% CI 0.37-0.71; p < 0.01; I² = 23%), whereas no significant mortality benefit was observed in the untargeted advanced ILD population (HR 1.11, 95% CI 0.33-3.72; p = 0.86; I² = 91%), though the subgroup interaction was statistically insignificant (p = 0.23). Additionally, PDE5I therapy significantly improved SGRQ scores (-3.48; 95% CI -5.41 to -1.55; p < 0.001; I² = 0%) without significantly affecting FVC, BNP or serious adverse events (RR= 0.84; 95% CI 0.62-1.14; p = 0.27). Our findings show that PDE5I therapy was not associated with a statistically significant overall survival benefit in advanced ILD, although a favorable survival trend is observed within the clinically suspected or hemodynamically confirmed PH-targeted population. (HR 0.51, 95% CI 0.37-0.71). However, the absence of a statistically significant subgroup interaction indicates that this finding should be interpreted with caution.
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7. Early Hemodynamic Trajectory Phenotypes and Exploratory Albumin Exposure-Mortality Associations in Septic Shock: A Retrospective Cohort Study.
PMID:日期:2026-09-10Identifying clinical phenotypes that may exhibit heterogeneous associations with treatment exposure is an important focus of sepsis research. Sepsis phenotyping mainly relies on static variables, which fail to fully capture early hemodynamic evolution. This study utilized longitudinal mean arterial pressure (MAP)/norepinephrine equivalent dose (NEQ) trajectories to characterize hemodynamic phenotypes in patients with septic shock and to explore phenotype-specific associations between albumin exposure and ICU mortality. Adult patients diagnosed with septic shock within 24 h of ICU admission and with at least four MAP/NEQ measurements during the 72 h following initiation of the first vasopressor after ICU admission were identified from the MIMIC-IV database. The trajectory time origin was defined as initiation of the first vasopressor after ICU admission. Hourly MAP/NEQ values during the subsequent 72 h were used to identify phenotypes by group-based trajectory modeling. Associations between MAP/NEQ-trajectory phenotypes and ICU mortality were analyzed using doubly robust estimation. Subsequently, parametric G-formula was employed to estimate the cumulative mortality risk under hypothetical daily albumin infusion regimens within each phenotype. External validation was performed using the eICU-CRD. A total of 3152 patients with septic shock were included in this study. Four distinct MAP/NEQ trajectory phenotypes were identified: phenotype A (low-level stable, 29.8%), phenotype B (ascending, 26.1%), phenotype C (descending, 24.0%), and phenotype D (high-level stable, 20.1%). Phenotype A was associated with the highest risk of ICU mortality compared with the other phenotypes (B: odds ratio [OR], 0.303; 95% CI, 0.225-0.408; C: OR, 0.606; 95% CI, 0.458-0.801; D: OR, 0.547; 95% CI, 0.391-0.766). G-formula analyses suggested that albumin exposure-mortality associations varied across phenotypes. Higher simulated daily albumin exposure categories were associated with lower model-estimated ICU mortality risk in phenotypes B, C, and D, whereas no significant association was observed in phenotype A (risk ratio [95% CI]: 0.89 [0.72-1.07]). Directionally similar model-estimated association patterns were observed in the external validation cohort. This study identified four MAP/NEQ trajectory phenotypes in patients with septic shock that exhibited differential associations with ICU mortality and albumin exposure. Since this study adopts a retrospective observational design, findings regarding albumin are exploratory and hypothesis-generating rather than proof of treatment benefit. Prospective studies and randomized trials are needed to determine whether MAP/NEQ trajectories have clinical utility for risk stratification or treatment decision-making.
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8. The Impact of Recommended Changes to the Childhood Vaccine Schedule at a State Level: An Interview With the Rhode Island Department of Health.
8. 州级层面推荐的儿童疫苗接种计划变更的影响：罗德岛卫生部访谈PMID:日期:2026-09-09该文献暂无摘要。
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9. Issues in Monitoring Oncology Trials.
9. 肿瘤试验监测中的问题PMID:日期:2026-09-09The role of the medical monitor has become increasingly important as oncology clinical trials have grown in complexity. Issues in medical monitoring and proposed approaches to improve monitoring, make trials less expensive, and possibly shorten timelines are discussed. This commentary reviews the role of the medical monitor in oncology clinical research. The complexity of the malignant process and the multiple immunotherapeutic, hormonal, cytotoxic, and targeted therapies currently available and in development require an understanding of the biology of both cancer and its systemic treatments. In addition, the amount of data collected requires better methods for data collection and for the early identification of trends, especially in Phase I and II trials. An approach to improved data collection and monitoring methodology that would allow the early identification of safety and efficacy signals is proposed.
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10. Benefit-Risk Balance for Medicinal Products: Report Summary from the Council for International Organizations of Medical Sciences (CIOMS) Working Group XII.
10. 医药产品的收益-风险平衡：国际医学科学组织理事会（CIOMS）第十二工作组报告摘要PMID:日期:2026-09-09Benefit-risk assessment (BRA) is a foundation of regulatory decision making and clinical practice for medicinal products. Although historically assessments relied on expert judgment and narrative summaries, over time, expectations have shifted toward approaches that are more structured, transparent, and patient centered. At the same time, therapeutic innovation, new data sources, and evolving stakeholder roles have increased the complexity and uncertainty of benefit-risk decision making. The Council for International Organizations of Medical Sciences (CIOMS) Working Group XII developed updated consensus guidance for BRA through multidisciplinary international collaboration among regulators, industry, and academia. This narrative review summarizes the CIOMS Working Group XII consensus framework, which advances a structured, transparent, and life-cycle based approach to BRA. The framework puts forward patient‑centric approaches by moving benefit-risk evaluation from a post‑hoc exercise to integrated assessments that enable holistic patient-level BRAs. The structured benefit-risk framework harmonizes qualitative and quantitative methods, integrates patient perspectives, and emphasizes transparency in communication. Ultimately, the CIOMS Working Group XII consensus report advances the science and practice of BRAs, ensuring that medicinal products are assessed in a structured and systematic format from early development throughout the lifecycle. By embedding structured, patient-centered BRA into lifecycle management, the CIOMS Working Group XII report provides a roadmap for transparent, evidence-based decisions that safeguard public health and optimize therapeutic outcomes.