1.Application of a pre-intelligent precision dosing and verification system in automatic single-dose packaging
Runzan ZHANG ; Junyu LU ; Lei HONG ; Liucheng LI ; Jie YING
China Pharmacy 2025;36(17):2170-2175
OBJECTIVE To innovatively apply the pre-intelligent precision dosing and verification system (hereinafter referred to as “the system”), and to provide a reference for the high-level “intelligent” transformation of inpatient pharmacy. METHODS The limitations of the triple-serial dispensing mode, which comprised the automatic medicine packaging machine (ATC), intelligent tablet dispensing table (ITDT) and medication detection machine (MDM), were analyzed. The application of the system and the adoption of the barcode scanning verification method optimized the pre-dosing management, whole-tablet drug dispensing process and ATC temporary dosing management. The comparative analysis was conducted to assess dosing time, labor cost and packaging error of the eight-month period, before and after the system application. RESULTS The triple-serial dispensing mode had a weak ability to avoid error risks in the manual dosing stage, and also had errors in the verification stage. Through the innovative application system, the pre-dosing management had been upgraded, the whole-tablet drug dispensing process had been optimized, and the ATC temporary dosing management had been improved. The average time required for each drug for pre-dosing, whole-tablet drug dispensing and ATC temporary dosing was significantly shortened after the application of the system, compared with before the application of the system (P<0.001). The number of pharmacists was reduced from two to one. The error rate of ATC decreased significantly from 0.220‰ to 0.029‰ (P<0.001). Specifically, the rate of pharmacist-related errors (pre-dosing error, ITDT dosing error, and ATC temporary dosing error) decreased from 0.116‰ to 0.001‰ (P<0.001), and machine-related errors decreased from 0.096‰ to 0.023‰ (P<0.001). CONCLUSIONS This innovative integration mode greatly improves the working efficiency and quality of inpatient pharmacy. It enhances refined management of drug expiration and inventory, saves time and labor costs, improves the accuracy of drug dispensing, and ensures patient medication safety.
2.Comprehensive Clinical Evaluation of Duliang Soft Capsules in Treatment of Migraine with Wind-cold Blood Stasis Syndrome
Xiaoxiao ZHAO ; Xuming ZHANG ; Junyu XI ; Zhenkai LU ; Fumei LIU ; Lianxin WANG ; Yuanyuan LI ; Yanming XIE
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(8):223-232
ObjectiveTo comprehensively assess the clinical value of Duliang soft capsules in the treatment of migraine with wind-cold blood stasis syndrome, and to provide guidance for national medical decision-making, clinical drug promotion, and pharmaceutical services. MethodThe evaluation of Duliang soft capsules' clinical value was conducted in accordance with the Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs (Trial Version, 2021) using a combination of qualitative and quantitative methods. Utilizing the CSC v2.0 software, this study conducted a comprehensive clinical evaluation of Duliang soft capsules across the "6+1" dimensions, including safety pre- and post-market launch, effectiveness in treating migraine, economy (cost-effectiveness), and innovation, suitability, accessibility, and traditional Chinese medicine (TCM) characteristics in both its technology and clinical applications. ResultSafety: Duliang soft capsules were found to have good safety based on evidence from known adverse reactions (spontaneous reporting system (SRS) data, literature data, etc.), pre-marketing toxicological research, and post-marketing drug monitoring. Effectiveness: A meta-analysis indicated that the combination of Duliang soft capsules and western medicine was more effective than Western medicine alone in the treatment of migraine. The product's effectiveness was rated as "Best" based on the quality and value of the evidence. Economy: Duliang soft capsules are moderately priced and categorized as a Type B medical insurance product. Economic research indicated that the combination of Western medicine and Duliang soft capsules was more cost-effective than Western medicine alone. The product's economy was rated as "Better". Innovation: Duliang soft capsules, with Angelicae Dahuricae Radix and Chuanxiong Rhizoma as the main components, hold one invention patent and have been awarded the China Patent Excellence Award. The pharmaceutical company has introduced innovative extraction (CO2 supercritical extraction technology) and formulation (soft capsule) processes. The product's innovation was rated as "Better". Suitability: A questionnaire survey on Duliang soft capsules showed that it was well-suited for both patients and healthcare professionals. The product received a comprehensive assessment of suitability through the "Evaluation of Chinese Patent Medicine Information Services". The product's suitability was rated as "Best". Accessibility: Duliang soft capsules are moderately priced, making them accessible and affordable. The product's accessibility was rated as "Good" based on evidence from these three aspects. TCM characteristics: The formulation of Duliang soft capsules can be traced back to WANG Qiu's Selected Formulas from the Praiseworthy Studio (Shi Zhai Bai Yi Xuan Fang) from the Song Dynasty, and it was documented in ZHANG Jiebin's The Complete Works of Zhang Jing-yue (Jing Yue Quan Shu) as "Duliangwan". The product has been extensively studied with over 2000 clinical cases since its market launch, and its TCM characteristics were rated as outstanding with sufficient evidence. ConclusionThe comprehensive clinical value evaluation of Duliang soft capsules demonstrated its high effectiveness, suitability, and accessibility, and outstanding TCM characteristics. The product's safety, economy, and innovation received good ratings. In summary, Duliang soft capsules exhibited significant clinical value and outstanding TCM characteristics, the evidence was sufficient, and the result was confirmed, providing crucial references for clinical decision-making and pharmaceutical management.
3.Recurrence outcomes of robotic-versus laparoscopic-assisted gastrectomy for gastric cancer: a multi-center propensity score-matched cohort study
Jun LU ; Taiyuan LI ; Li ZHANG ; Junjun SHE ; Junyu CHEN ; Qing ZHONG ; Zukai WANG ; Changming HUANG ; Chaohui ZHENG
Chinese Journal of Gastrointestinal Surgery 2024;27(8):799-807
Objective:To compare and evaluate recurrence patterns after robotic-assisted gastrectomy (RAG) versus laparoscopic-assisted gastrectomy (LAG).Methods:This was a retrospective cohort study of 2915 consecutive patients with gastric adenocarcinoma confirmed by postoperative histology as T1-4aN0-3M0, who had undergone minimally invasive radical gastrectomy at four large gastric cancer treatment centers (Fujian Medical University Union Hospital: 1426 patients; the First Affiliated Hospital, Nanchang University: 1108; Tianjin Medical University Cancer Institute and Hospital: 196; and First Affiliated Hospital of Xi'an Jiaotong University: 185 cases) between 1 January 2015 and 30 June 2019. 930 patients had undergone RAG (RAG group) and 1985 had undergone LAG (LAG group). We assessed the following characteristics: age, sex, body mass index, American Society of Anesthesiologists score, comorbidities, tumor size, extent of surgery, extent of lymph node dissection, pT, pN, year of surgery, and adjuvant chemotherapy, after propensity score matching (1:1). There were no significant differences in baseline clinical characteristics between the two groups formed by propensity score matching (837 in each group) (all P>0.05). The 3-year recurrence-free survival (RFS), recurrence pattern, and conditional RFS were compared. Results:We detected no significant differences in the overall recurrence rate at 3 years (128/837 [15.3%] vs. 141/837 [16.8%], P=0.387) or time to recurrence (15.7±8.1 months vs. 16.4±8.4 months, P=0.449) between the RAG and LAG groups. Peritoneal recurrence was the most common type of recurrence in both groups (55 [6.6%] vs. 69 [8.2%], P=0.524). The difference in 3-year RFS between the RAG and LAG groups was not statistically significant (83.2% vs. 82.5%, P=0.781). We found that age > 60 years, total gastrectomy, and worse pT stage and pN stage were independent risk factors for recurrence in the study patients (all P<0.05), whereas the surgical procedure (RAG or LAG) was not an independent risk factor for RFS ( P=0.242). The 3-year conditional RFS at various time points was comparable between the two groups (1 year postoperatively: 84.6% vs. 84.7%, P=0.793; 3 years postoperatively: 91.5% vs. 94.9%, P=0.647). Conclusions:In this multicenter study of patients with locally resectable gastric cancer, we demonstrated that RAG performed by surgeons at large gastric cancer centers is not inferior to LAG in 3-year recurrence rate or recurrence patterns.
4.Recurrence outcomes of robotic-versus laparoscopic-assisted gastrectomy for gastric cancer: a multi-center propensity score-matched cohort study
Jun LU ; Taiyuan LI ; Li ZHANG ; Junjun SHE ; Junyu CHEN ; Qing ZHONG ; Zukai WANG ; Changming HUANG ; Chaohui ZHENG
Chinese Journal of Gastrointestinal Surgery 2024;27(8):799-807
Objective:To compare and evaluate recurrence patterns after robotic-assisted gastrectomy (RAG) versus laparoscopic-assisted gastrectomy (LAG).Methods:This was a retrospective cohort study of 2915 consecutive patients with gastric adenocarcinoma confirmed by postoperative histology as T1-4aN0-3M0, who had undergone minimally invasive radical gastrectomy at four large gastric cancer treatment centers (Fujian Medical University Union Hospital: 1426 patients; the First Affiliated Hospital, Nanchang University: 1108; Tianjin Medical University Cancer Institute and Hospital: 196; and First Affiliated Hospital of Xi'an Jiaotong University: 185 cases) between 1 January 2015 and 30 June 2019. 930 patients had undergone RAG (RAG group) and 1985 had undergone LAG (LAG group). We assessed the following characteristics: age, sex, body mass index, American Society of Anesthesiologists score, comorbidities, tumor size, extent of surgery, extent of lymph node dissection, pT, pN, year of surgery, and adjuvant chemotherapy, after propensity score matching (1:1). There were no significant differences in baseline clinical characteristics between the two groups formed by propensity score matching (837 in each group) (all P>0.05). The 3-year recurrence-free survival (RFS), recurrence pattern, and conditional RFS were compared. Results:We detected no significant differences in the overall recurrence rate at 3 years (128/837 [15.3%] vs. 141/837 [16.8%], P=0.387) or time to recurrence (15.7±8.1 months vs. 16.4±8.4 months, P=0.449) between the RAG and LAG groups. Peritoneal recurrence was the most common type of recurrence in both groups (55 [6.6%] vs. 69 [8.2%], P=0.524). The difference in 3-year RFS between the RAG and LAG groups was not statistically significant (83.2% vs. 82.5%, P=0.781). We found that age > 60 years, total gastrectomy, and worse pT stage and pN stage were independent risk factors for recurrence in the study patients (all P<0.05), whereas the surgical procedure (RAG or LAG) was not an independent risk factor for RFS ( P=0.242). The 3-year conditional RFS at various time points was comparable between the two groups (1 year postoperatively: 84.6% vs. 84.7%, P=0.793; 3 years postoperatively: 91.5% vs. 94.9%, P=0.647). Conclusions:In this multicenter study of patients with locally resectable gastric cancer, we demonstrated that RAG performed by surgeons at large gastric cancer centers is not inferior to LAG in 3-year recurrence rate or recurrence patterns.
5.Predictive value of the differential distribution of peripheral lymphocyte subsets before and after the first 131I treatment on therapeutic response in patients with papillary thyroid cancer
Junyu ZHANG ; Di FAN ; Zhiyong SHI ; Tiane LUO ; Zhifang WU ; Hongliang WANG ; Keyi LU ; Suyun YANG ; Lixiang WU ; Tingting HU ; Yuanyuan MOU ; Sijin LI ; Haiyan LIU
Chinese Journal of Nuclear Medicine and Molecular Imaging 2024;44(12):730-735
Objective:To investigate the predictive value of differential distribution of peripheral lymphocyte subsets before and after the first 131I treatment on the therapeutic response to 131I treatment in patients with papillary thyroid cancer (PTC). Methods:A retrospective study was conducted on 46 PTC patients (16 males, 30 females, age 20-77 years) who underwent total thyroidectomy and received 131I treatment between January 2021 and August 2021 in First Hospital of Shanxi Medical University. Peripheral blood lymphocyte subsets (T, B, CD4 + T, CD8 + T, natural killer (NK), helper T (Th)1, Th2, Th17, and regulatory T (Treg) cells) were measured 1-2 d before and 30 d after 131I treatment. Based on serological and imaging evidence, therapeutic response at 6-12 months post- 131I therapy was categorized as either excellent response (ER) or non-excellent response (NER). Differences of preablative stimulated thyroglobulin (psTg) and clinical baseline characteristics between two groups were assessed by using independent-sample t test, paired t test, or Mann-Whitney U test. Predictive value of lymphocyte subsets before and after 131I treatment for therapeutic response was assessed through logistic regression analysis, ROC curve analysis, and decision curve analysis (DCA). Results:In ER group ( n=33) and NER group ( n=13), most lymphocyte subsets showed different degrees of reduction 30 d after 131I treatment compared to before 131I treatment, such as T, B, CD4 + T and Th1 cells in ER group, as well as T, B, CD4 + T, Th1, Th2, Th17, and Treg cells in NER group ( t values: 2.41-9.57, all P<0.05). Before 131I treatment, NER group had significantly higher levels of psTg, Th2, Th17, and Treg cells compared to the ER group ( t values: from -3.32 to -2.48, U=29.00, all P<0.05). After 131I treatment, most of lymphocyte subsets in NER group (T, B, CD4 + T, CD8 + T, Th1 and Treg cells) showed higher trend than those in ER group but without statistical significances ( t values: from -1.12 to -0.06, all P>0.05). Th2 cells before 131I treatment (odds ratio ( OR)=25.00, 95% CI: 1.36-459.10, P=0.030) was identified as a risk factor for NER. ROC curve analysis indicated that AUCs of psTg and Th2 cells for predicting therapeutic response were 0.932 and 0.790, respectively, which was 0.958 for the combined psTg and Th2 cells. DCA showed that within the threshold probability range of 10%-60%, the curves for psTg, Th2 cells, and the combined psTg and Th2 cells were all higher than the extreme curve, suggesting good effect. Conclusions:Most lymphocyte subsets decrease to varying degrees, and NER group shows a significant decrease 30 d after 131I treatment. Th2 cells may be a risk factor for poor response to 131I treatment, providing a certain value in predicting the therapeutic response to 131I treatment.
6.Research advances in effective constituents of traditional Chinese medicine in intervention of autoimmune hepatitis-related signaling pathways
Junyu HAO ; Guangwei LIU ; Lu XIE ; Wenyan FAN ; Hongxiu CHEN
Journal of Clinical Hepatology 2023;39(3):663-670
As a chronic liver inflammation disease caused by the lack of immune tolerance, autoimmune hepatitis is regulated by various signaling pathways, such as the NF-κB/NLRP3 pathway, the SIRT1/Nrf2/HO-1 pathway, the Hippo-YAP/TAZ pathway, the JAK/STAT pathway, the PI3K/Akt pathway, and the TRAF6/JNK pathway. These pathways can play a role against autoimmune hepatitis by participating in the processes including the proliferation and apoptosis of cytokines, immune response, and oxidative stress. In view of the problems of suboptimal response, obvious adverse reactions, and high recurrence rate in the clinical application of hormones and immune preparations for the treatment of autoimmune hepatitis, this article summarizes the research articles on autoimmune hepatitis-related signaling pathways and the mechanism of effective constituents (glycosides, terpenoids, flavonoids, quinones, and phenols) in traditional Chinese medicine intervening against the disease process of autoimmune hepatitis through the above signaling pathways, in order to provide a theoretical basis for scientific and effective utilization of effective constituents in traditional Chinese medicine to develop anti-autoimmune hepatitis drugs.
7.Pancreatic melatonin enhances anti-tumor immunity in pancreatic adenocarcinoma through regulating tumor-associated neutrophils infiltration and NETosis.
Yau-Tuen CHAN ; Hor-Yue TAN ; Yuanjun LU ; Cheng ZHANG ; Chien-Shan CHENG ; Junyu WU ; Ning WANG ; Yibin FENG
Acta Pharmaceutica Sinica B 2023;13(4):1554-1567
Tumor microenvironment contributes to poor prognosis of pancreatic adenocarcinoma (PAAD) patients. Proper regulation could improve survival. Melatonin is an endogenous hormone that delivers multiple bioactivities. Here we showed that pancreatic melatonin level is associated with patients' survival. In PAAD mice models, melatonin supplementation suppressed tumor growth, while blockade of melatonin pathway exacerbated tumor progression. This anti-tumor effect was independent of cytotoxicity but associated with tumor-associated neutrophils (TANs), and TANs depletion reversed effects of melatonin. Melatonin induced TANs infiltration and activation, therefore induced cell apoptosis of PAAD cells. Cytokine arrays revealed that melatonin had minimal impact on neutrophils but induced secretion of Cxcl2 from tumor cells. Knockdown of Cxcl2 in tumor cells abolished neutrophil migration and activation. Melatonin-induced neutrophils presented an N1-like anti-tumor phenotype, with increased neutrophil extracellular traps (NETs) causing tumor cell apoptosis through cell-to-cell contact. Proteomics analysis revealed that this reactive oxygen species (ROS)-mediated inhibition was fueled by fatty acid oxidation (FAO) in neutrophils, while FAO inhibitor abolished the anti-tumor effect. Analysis of PAAD patient specimens revealed that CXCL2 expression was associated with neutrophil infiltration. CXCL2, or TANs, combined with NET marker, can better predict patients' prognosis. Collectively, we discovered an anti-tumor mechanism of melatonin through recruiting N1-neutrophils and beneficial NET formation.
8.Clinical and endoscopic features of 179 cases of autoimmune gastritis
Zhiji CHEN ; Chao DENG ; Feng XU ; Junyu LU ; Zhihang ZHOU ; Suhua WU ; Song HE
Chinese Journal of Digestion 2023;43(8):531-536
Objective:To explore the clinical and endoscopic features of patients with autoimmune gastritis (AIG) and to improve the accuracy of clinical diagnosis of AIG.Methods:From January 3, 2020 to November 25, 2021, the general information (gender, age), laboratory examination indicators and endoscopic findings of 179 AIG patients diagnosed at the Second Affiliated Hospital of Chongqing Medical University were retrospectively analyzed. The laboratory examination indicators included hemoglobin, gastrin-17, pepsinogen (PG), anemia combination indicators (ferritin, vitamin B 12), thyroid function indicators (thyroid-stimulating hormone, thyroglobulin antibody and thyroid peroxidase antibody), Helicobacter pylori, and anti-parietal cell antibody and anti-intrinsic factor antibody. Descriptive methods were used for statistical analysis. Results:Among the 179 AIG patients, there were 42 males (23.5%) and 137 females (76.5%), with an average age of (55.23±12.04) years old. The gastrin-17 level of AIG patients was 195.31 ng/L (143.64 ng/L, 273.61 ng/L), PG Ⅰ level and PG Ⅰ/PG Ⅱ ratio were 12.40 μg/L (7.65 μg/L, 19.40 μg/L) and 1.03 (0.66, 1.52), respectively. There were 15.3% (18/118) of the AIG patients with iron deficiency anemia, and 16.1% (19/118) with megaloblastic anemia. The positive rate of anti-parietal cell antibody was 71.8% (51/71), and the positive rate of anti-intrinsic factor antibody was 25.4% (18/71). The serum thyroid-stimulating hormone level increased in 27.3% (15/55) of the patients, and the positive rates of thyroglobulin antibody and thyroid peroxidase antibody were 31.6% (12/38) and 47.4% (18/38), respectively. The positive rate of Helicobacter pylori was 29.7% (38/128). The endoscopic appearance of AIG indicated reverse atrophy, characterized by obvious atrophy in gastric fundus and gastric body mucosa, however the atrophy of gastric antrum was not obvious. Under endoscopy yellow-white turbid mucus, which was difficult to be washed, was found in 67.0% (120/179) of the patients, and under endoscopy the residual gastric fundus glands could be seen in 19.6% (35/179) of the patients. Among 179 AIG patients, 7 cases (3.9%) of neuroendocrine tumor (NET), 7 cases (3.9%) of early gastric adenocarcinoma (including 1 case of poorly differentiated adenocarcinoma), 1 case (0.6%) of adenoma, and 14 cases (7.8%) of hyperplastic polyps were found. Except for the case of poorly differentiated adenocarcinoma undergoing surgery, the others were treated with endoscopic resection. Conclusions:When unexplained iron deficiency anemia, megaloblastic anemia, or reverse atrophy is found, AIG should be considered. AIG patients are at high risk for gastric cancer and NET, and should be closely followed up, and active treatment should be given before anemia and neurological symptoms appear.
9.Application of mixed reality technology in reconstruction of soft tissue defect in extremities with anterolateral thigh flap
Kaixuan DONG ; Yungui LI ; Haotian LUO ; Junyu ZHANG ; Zonglin LAN ; Xiaofang ZHAO ; Sheng LU
Chinese Journal of Microsurgery 2023;46(5):534-539
Objective:To investigate the application value of mixed reality (MR) technology in reconstruction of soft tissue defect of extremities with free anterolateral thigh flap(ALTF).Methods:From December 2019 to November 2021, a retrospective analysis was performed on 10 patients who had undergone ALTF reconstruction of soft tissue defects in extremities in Department of Orthopaedics, the First People's Hospital of Yunnan Province. Four patients had the defects in hand and 6 patients in foot and ankle. For the 6 patients in emergency surgery, the time from injury to admission was 4.0-15.0 hours, with an average of 7.3 hours. Four patients with soft tissue defects caused by chronic infection and ulcers were given debridement, and the soft tissue defects were reconstructed by flap transfer at the second stage. The defect area were from 8.0 cm×5.0 cm to 22.0 cm×8.0 cm. Preoperatively, 3D bone-vessel-flap model was established based on the lower extremity CTA scans. Intraoperatively, MR technology was used to project the 3D model on the flap donor site to observe the virtual profile of vessel shape in real time, to locate the perforator and the course of the perforator, and observe the consistency between the virtual image and the actual anatomy of the perforator. The appearance, texture and colour of the flap were recorded at the last follow-up. Hand function was evaluated by the total activity movement (TAM), and foot and ankle function was evaluated by the American Orthopaedic Foot and Ankle Society (AOFAS).Results:The position location and course of perforator vessels were reconstructed successfully in all patients before surgery. The MR technology was used to locate the perforator, and the course of the virtual perforator was consistent with the actual anatomy, and the matching reached 100%. The length of vascular pedicle measured before surgery was at 11.02 cm±1.37 cm. And that measured during surgery was at 11.21 cm±1.23 cm ( P=0.748, t=-0.326). The difference was not statistically significant ( P>0.05). The flap area was at 9.0 cm×6.0 cm to 23.0 cm×9.0 cm. The donor site was sutured directly in one stage. All patients were entered postoperative followed-up for 1 to 24 months, with an average of 13.5 months. All the flaps survived after surgery. The flap with good appearance, colour and texture, and only one linear scar was left in the donor site. According to the TAM of the hand function, 3 cases were excellent and 1 was fair. Foot and ankle function were evaluated according to the AOFAS, 5 cases were in excellent and 1 was good. Conclusion:MR technology applied to the surgery of ALTF can locate the course of the flap vessels in real time, guide the operation, improve the operation efficiency and reduce the risk in surgery.
10.Workflow and error analyses of patient setup based on open-face mask immobilization combined with AlignRT for head tumor radiotherapy
Junyu LI ; Hao WU ; Jingxian YANG ; Shun ZHOU ; Zihong LU ; Songmao YU ; Jixiang CHEN ; Meijiao WANG ; Kaining YAO ; Yi DU
Chinese Journal of Radiological Medicine and Protection 2022;42(8):590-597
Objective:To propose a markless patient setup workflow based on the optical surface monitoring system (AlignRT) and open-face mask immobilization for whole-course head tumor radiotherapy, assess the setup time and repositioning frequency of the proposed workflow, and conduct a comparative analysis of the differences, correlation, and consistency of the setup errors of the AlignRT and cone beam CT (CBCT) systems.Methods:A retrospective analysis was conducted for the data on the errors of 132 fractionated setup based on open-face mask immobilization of 33 head tumor patients. AlignRT-guided markless patient setup workflow was applied throughout the radiotherapy. Meanwhile, the body structures automatically generated by the treatment planning system were used as body references. The 6-degree-of-freedom (6DoF) setup errors (lateral, vertical, longitudinal, rotation, pitch, roll, and yaw directions), setup time, and repositioning frequency of the AlignRT and CBCT systems were recorded and analyzed. The Wilcoxon and Spearman analyses were used to statistically assess the differences and correlation of the setup errors of the two systems. Moreover, the Bland-Altman analysis was employed to evaluate the consistency of the two systems.Results:The 6DoF setup errors of CBCT were within the clinical tolerance (linear motions: -0.30 to 0.30 cm; rotational motions: -2.0° to 2.0°). The setup time and repositioning frequency of CBCT were (98 ± 31) s and 1.51% (2/132), respectively. There was no significant difference in setup errors between the two systems except those in x-axis ( Z = -3.11, P= 0.002), y-axis ( Z = -7.40, P<0.001), and Pitch ( Z= -4.48, P<0.001). There was a significant positive correlation between the setup errors along lateral ( rs = 0.47, P<0.001) and vertical ( rs = 0.29, P = 0.001) directions, rotation (Rtn; rs = 0.47, P<0.001), pitch (Pitch; rs = 0.28, P = 0.001) and roll (Roll; rs = 0.45, P<0.001) of the two systems. The 95% limits of agreement (95% LoA) of 6DoF setup errors were -0.12 to 0.09 cm, -0.07 to 0.17 cm, -0.19 to 0.20 cm, -1.0° to 0.9 °, -1.0° to 1.5°, and -0.9° to 1.0°, respectively. The 95% confidence interval (95% CI) of 95% LoA was -0.14 to 0.11 cm, -0.09 to 0.19 cm, -0.23 to 0.23 cm, -1.2° to 1.1°, -1.2° to 1.7°, and-1.0° to 1.1°, respectively, all of which were within the permissible error ranges. The 6DoF setup error difference of 3.41% (27/792< 5%) was beyond the 95% LoA. The maximum absolute differences of 6DoF setup errors within the 95% LoA were 0.12, 0.16, 0.19 cm, 0.9°, 1.5°, and 1.0°, respectively. Conclusions:The proposed markless setup workflow based on AlignRT combined with open-face mask immobilization for whole-course head tumor radiotherapy exhibits reasonable agreement and consistency with the patient setup using CBCT, with acceptable clinical efficiency. It can be applied to the first radiotherapy and the real-time monitoring of therapy to improve the safety and thus is of value in clinical applications.

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