更新于：2024-11-04
R&G Pharma Studies Co., Ltd.
更新于：2024-11-04
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Safety and Efficacy of Buagafuran Capsules in the Treatment of Generalized Anxiety Disorder: a Multi-center, Randomized, Double-blind, Double-dummy, Placebo-controlled, Positive-controlled, Fixed-dose Phase Ⅲ Clinical Trial
Safety and Efficacy of Buagafuran Capsules in the Treatment of Generalized Anxiety Disorder: a Multi-center, Randomized, Double-blind, Double-dummy, Placebo-controlled, Positive-controlled, Flexible-dose Phase Ⅲ Clinical Trial
A Phase I/IIa, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Anti-tumor Activity of H002 in Patients With EGFR Mutation Locally Advanced or Metastatic NSCLC
100 项与 诺思格（北京）医药科技股份有限公司 相关的临床结果
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2023-04-29Journal of gastrointestinal oncology
A systematic review and meta-analysis of nursing effect of fast-track recovery surgery on patients undergoing total endoscopic resection of esophageal cancer: fast-track recovery surgery vs. nursing care as usual.
Article
作者: Li, Yue ; Xing, Jiahui ; Jia, Yujie ; Li, Linfeng ; Du, Jing
Background:
Esophageal cancer (EC) is the 6th leading cause of cancer-related deaths worldwide, and the morbidity and mortality of EC have continued to increase in recent years. The results of the clinical application of the Fast-track recovery surgery (FTS) concept in nursing interventions for EC patients after total endoscopic esophagectomy are unconvincing. This study sought to evaluate the nursing effect of the fast-track recovery surgical nursing model on patients with EC after total cavity endoscopic esophagectomy.
Methods:
We searched for articles on case-control trials about nursing interventions after total endoscopic esophagectomy. The search time was set from January 2010 to May 2022. The data were independently extracted by 2 researchers. RevMan5.3 statistical software (Cochrane) was used to analyze the extracted data. All the articles included in the review were assessed for risk of bias using the Cochrane Handbook 5.3 (https://training.cochrane.org/).
Results:
Ultimately, 8 clinical controlled trials, comprising 613 cases, were identified. A meta-analysis was conducted of the extubation times, and the results showed that the study group's extubation times were remarkably shorter. In relation to the exhaust times, the study group had significantly shorter exhaust times than control group (P<0.05). In relation to the time, it took patients to leave bed, patients in the study group left bed in a considerably shorter time compared with controls (P<0.00001). In relation to the hospitalization time, a remarkable reduction in the length of hospital stay was observed in the study group (P<0.00001). The analysis of the funnel plots showed a small number of asymmetries, suggesting that the number of articles included was small due to the heterogeneity of the studies (P<0.00001).
Conclusions:
FTS care is effective at accelerating patients' postoperative recovery. This model of care needs to be further validated in the future by higher-quality and longer follow-up studies.
2020-12-01Health and quality of life outcomes3区 · 医学
Quality of life analysis of patients treated with cetuximab or cisplatin for locoregionally advanced squamous cell carcinoma of head and neck in the United States
3区 · 医学
ArticleOA
作者: Punekar, Rajeshwari S ; Li, Li ; Carter, Gebra Cuyun ; Aggarwal, Himani ; Walker, Mark S
Abstract:
Background:
To compare quality of life of patients treated with cetuximab with or without radiation therapy (±RT) vs. cisplatin±RT for locoregionally advanced squamous cell carcinoma of the head and neck (SCCHN) in the real-world setting.
Methods:
In this retrospective observational study, electronic medical records and Patient Care Monitor (PCM) survey data from the Vector Oncology Data Warehouse were utilized from adult patients in the United States who received initial treatment with cetuximab±RT or cisplatin±RT for locoregionally advanced SCCHN between January 1, 2007 and January 1, 2017. Quality of life was assessed using PCM index scores and individual PCM items. Cetuximab±RT and cisplatin±RT cohorts were balanced using propensity score weighting. Linear mixed models were used to assess the impact of baseline demographic and clinical characteristics on PCM endpoints.
Results:
Of 531 patients with locoregionally advanced SCCHN, 187 received cetuximab±RT, and 344 received cisplatin±RT. Before propensity score weighting, the cetuximab±RT cohort was older (mean [SD] age of 63.9 [9.6] years vs. 57.4 [8.6] years), and more likely to be white (82.4% vs. 72.4%) compared to the cisplatin±RT cohort. After propensity score weighting, the two cohort subsamples (cetuximab±RT, N = 60; cisplatin±RT, N = 177) with PCM data showed no significant differences in General Physical Symptoms, Treatment Side Effects, Impaired Ambulation, or Impaired Performance index scores. Patients in the cetuximab±RT cohort had higher Acute Distress index (p = 0.023), Despair index (p = 0.011), and rash (p = 0.003) scores but lower numbness/tingling scores (p = 0.022) than patients in the cisplatin±RT cohort.
Conclusions:
Significant group differences were observed in this comparative analysis, as the cetuximab±RT cohort had significantly higher Acute Distress index, Despair index, and rash scores compared with the cisplatin±RT cohort but lower numbness/tingling scores. These patterns of symptoms appear consistent with previously reported symptoms associated with the treatment of SCCHN.
2019-12-01BMC cancer2区 · 医学
First-in-class immune-modulating small molecule Icaritin in advanced hepatocellular carcinoma: preliminary results of safety, durable survival and immune biomarkers
2区 · 医学
ArticleOA
作者: Ding, Xiaoyan ; Xu, Binghe ; Zhao, Hong ; Li, Shu ; Liu, Kezhen ; Jiang, Jun ; Fan, Ying ; Ye, Bin ; Zheng, Limin ; Meng, Kun ; Li, Ying ; Wang, Shengdian ; Qiu, Weiliang ; Yue, Jian ; Hao, Rui
BACKGROUND:
With poor prognosis and limited treatment options for advanced hepatocellular carcinoma (HCC), development of novel therapeutic agents is urgently needed. This single-arm phase I study sought to assess the safety and preliminary efficacy of icaritin in human as a potential oral immunotherapy in addition to the immune-checkpoint inhibitors.
METHODS:
Eligible advanced HCC patients with Child-Pugh Class A or B were administered with a fixed oral dose of icaritin at either 600 or 800 mg b.i.d. The primary endpoint was safety, and the secondary endpoints included time-to-progression (TTP), overall survival (OS) and the clinical benefit rate (CBR). Icaritin treatment induced immune biomarkers and immune-modulating activities in myeloid cells were also explored.
RESULTS:
No drug-related adverse events ≥ Grade 3 were observed in all 20 enrolled HCC patients. Among the 15 evaluable patients, 7 (46.7%) achieved clinical benefit, representing one partial response (PR, 6.7%) and 6 stable disease (SD, 40%). The median TTP was 141 days (range: 20-343 days), and the median OS was 192 days (range: 33-1036 days). Durable survival was observed in PR/SD patients with a median OS of 488 days (range: 72-773). TTP was significantly associated with the dynamic changes of peripheral neutrophils (p = 0.0067) and lymphocytes (p = 0.0337). Icaritin treatment induced changes in immune biomarkers-and immune-suppressive myeloid cells were observed.
CONCLUSIONS:
Icaritin demonstrated safety profiles and preliminary durable survival benefits in advanced HCC patients, which were correlated with its immune-modulation activities and immune biomarkers. These results suggested the potential of icaritin as a novel oral immunotherapy for advanced HCC in addition to antibody-based PD-1/PD-L1 blockade therapies.
TRIAL REGISTRATION:
Clinicaltrial.gov identifier. NCT02496949 (retrospectively registered, July 14, 2015).
100 项与 诺思格（北京）医药科技股份有限公司 相关的药物交易
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100 项与 诺思格（北京）医药科技股份有限公司 相关的转化医学
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