1.Diagnostic value of procalcitonin in infections in patients with malignant hematologic diseases
Mei LIU ; Yishu TANG ; Yulian XIAO ; Lingyan YAN ; Linzhi XIE ; Xinyi LONG ; Yan YU ; Xin LI
Journal of Central South University(Medical Sciences) 2024;49(5):721-729
Objective:The incidence of infections in patients with malignant hematologic diseases is extremely high and significantly affects their prognosis.Identifying early and precise biomarkers for infection is crucial for guiding the treatment of infections in these patients.Previous studies have shown that procalcitonin(PCT)can serve as an early diagnostic marker for bloodstream infections in patients with malignant hematologic diseases.This study aims to compare serum PCT levels in these patients with different pathogens,disease types,infection sites,and severity levels. Methods:Clinical data and laboratory results of infected patients with malignant hematologic diseases treated at the Department of Hematology,the Third Xiangya Hospital of Central South University from January 2018 to August 2023 were collected.General patient information was retrospectively analyzed.Serum PCT levels were compared among patients with different pathogens,types of malignant hematologic diseases,infection sites,and infection severity;Receiver operator characteristic(ROC)curves were used to determine the cut-off values and diagnostic value of serum PCT levels in diagnosing bloodstream infections versus local infections and severe infections versus non-severe infections.Mortality rates after 4-7 days of anti-infective treatment were compared among groups with rising,falling,and unchanged PCT levels. Results:A total of 526 patients with malignant hematologic diseases were included.The main pathogens were Gram-negative bacteria(272 cases,51.7%),followed by Gram-positive bacteria(120 cases,22.8%),fungi(65 cases,12.4%),viruses(23 cases,4.4%),and mixed pathogens(46 cases,8.7%).The main types of malignant hematologic diseases were acute myeloid leukemia(216 cases,41.1%),acute lymphoblastic leukemia(107 cases,20.3%),and lymphoma(93 cases,17.7%).Granulocyte deficiency was present in 68.3%(359 cases)of the patients during infection,with severe infection in 24.1%(127 cases).Significant differences in serum PCT levels were found among patients with different types of pathogens(P<0.001),with the highest levels in Gram-negative bacterial infections.Significant differences in serum PCT levels were also found among patients with different types of malignant hematologic diseases(P<0.05),with the highest levels in lymphoma patients.Serum PCT levels were significantly higher in systemic infections and severe infections compared to local infections and non-severe infections(both P<0.001).ROC curve analysis showed that the cut-off values for diagnosing bloodstream infections and severe infections were 0.22 and 0.28 ng/mL,with areas under the curve of 0.670 and 0.673,respectively.After 4-7 days of anti-infective treatment,the mortality rates of the PCT declining,PCT unchanged,and PCT rising groups were 11.9%,21.2%,and 35.7%,respectively,and pairwise comparisons were statistically significant(all P<0.05). Conclusion:PCT can be used as an auxiliary indicator for early identification of different pathogens,infection sites,and severity levels in patients with malignant hematologic diseases combined with infections.Dynamic monitoring of PCT levels after empirical antibiotic treatment provides important guidance for assessing patient's prognosis.
2.An evidence-based predictive model for early recurrence risk after hepatocellular carcinoma surgery and external validation study
Wenkao ZHOU ; Fangli ZHAO ; Jiajia CHEN ; Lei CHEN ; Lingyan HUANG ; Yue WANG ; Huimin TANG
Cancer Research and Clinic 2024;36(11):835-842
Objective:To construct an evidence-based prediction model for early recurrence after surgery of hepatocellular carcinoma (HCC) based on Meta-analysis and to do external validation study.Methods:The literatures in Chinese National Knowledge Infrastructure, Wanfang, VIP, Chinese Science Citation Database (CSCD), Chinese Social Science Citation System (CCSCI), PubMed, Web of Science and IEEE databases between January 2019 and December 2023 were searched based on the subject words. According to the inclusion and exclusion criteria, 9 literatures were included to screen the risk factors affecting the early recurrence of HCC. When the same risk factor was found in ≥5 included literatures, Meta-analysis was performed by using Review Manager 5.4.1 software. External validation data were collected from 401 patients with primary HCC who underwent surgery in Liaoning Cancer Hospital between March 2014 and March 2017. The patients were divided into early recurrence group (176 cases) and early non-recurrence group (225 cases) according to whether they relapsed 2 years after surgery. The OR values of all risk factors obtained in the Meta-analysis were converted into modeling, and postoperative early recurrence rate of HCC in the Meta-analysis was used to calculate β 0, and finally the logistic model was obtained. The OR value was incorporated into the logit (P) model, and the morbidity (P) of the external validation data was calculated. Taking the recurrence 2 years after surgery or not as the dependent variable and P as the independent variable, the receiver operating characteristic (ROC) curve was drawn to calculate the area under the curve (AUC). Results:A total of 8 risk factors for early HCC recurrence were screened out from 9 literatures (x 1: alpha-fetoprotein ≥ 400 ng/ml; x 2: tumor number ≥ 2; x 3: the longest tumor diameter ≥ 5 cm; x 4: Barcelona staging B-C; x 5: microvascular invasion; x 6: moderate to low differentiation; x 7: incomplete capsule; x 8: nonanatomic hepatectomy). The Meta-analysis included 1 757 HCC cases, with 960 postoperative early recurrences and an early recurrence rate of 45.36%, finally the β 0 value was -0.201. The predictive model for 2-year recurrence of HCC was constructed and calculated as logit (P) = -0.201+0.835x 1+0.905x 2+0.783x 3+1.008x 4+0.765x 5+0.831x 6+1.533x 7+0.940x 8. Analysis of variance by external validation data showed that the differences in ascites, alpha-fetoprotein, tumor number, tumor diameter, Barcelona staging, microvascular invasion, tumor differentiation degree, capsule invasion, resection type, and systemic inflammation index were statistically significant between early recurrence group and early non-recurrence group (all P < 0.05). ROC curve analysis showed that AUC of postoperative early recurrence of HCC predicted by the model was 0.718, (95% CI: 0.689-0.753), the optimal cut-off value was 3.11, the Yoden index was 0.288, the sensitivity was 69.32%, and the specificity was 69.56%. Conclusions:The evidence-based prediction model constructed based on Meta-analysis for postoperative early recurrence of HCC has a high predictive value. However, further verification and optimization with big data is still needed.
3.QL1604 plus paclitaxel-cisplatin/ carboplatin in patients with recurrent or metastatic cervical cancer:an open-label, single-arm, phase II trial
Cheng FANG ; Yun ZHOU ; Yanling FENG ; Liping HE ; Jinjin YU ; Yuzhi LI ; Mei FENG ; Mei PAN ; Lina ZHAO ; Dihong TANG ; Xiumin LI ; Buzhen TAN ; Ruifang AN ; Xiaohui ZHENG ; Meimei SI ; Baihui ZHANG ; Lingyan LI ; Xiaoyan KANG ; Qi ZHOU ; Jihong LIU
Journal of Gynecologic Oncology 2024;35(6):e77-
Objective:
QL1604 is a highly selective, humanized monoclonal antibody against programmed death protein 1. We assessed the efficacy and safety of QL1604 plus chemotherapy as first-line treatment in patients with advanced cervical cancer.
Methods:
This was a multicenter, open-label, single-arm, phase II study. Patients with advanced cervical cancer and not previously treated with systemic chemotherapy were enrolled to receive QL1604 plus paclitaxel and cisplatin/carboplatin on day 1 of each 21-day cycle for up to 6 cycles, followed by QL1604 maintenance treatment.
Results:
Forty-six patients were enrolled and the median follow-up duration was 16.5 months. An 84.8% of patients had recurrent disease and 13.0% had stage IVB disease. The objective response rate (ORR) per Response Evaluation Criteria in Advanced Solid Tumors (RECIST) v1.1 was 58.7% (27/46). The immune ORR per immune RECIST was 60.9% (28/46).The median duration of response was 9.6 months (95% confidence interval [CI]=5.5–not estimable). The median progression-free survival was 8.1 months (95% CI=5.7–14.0). Fortyfive (97.8%) patients experienced treatment-related adverse events (TRAEs). The most common grade≥3 TRAEs (>30%) were neutrophil count decrease (50.0%), anemia (32.6%), and white blood cell count decrease (30.4%).
Conclusion
QL1604 plus paclitaxel-cisplatin/carboplatin showed promising antitumor activity and manageable safety profile as first-line treatment in patients with advanced cervical cancer. Programmed cell death protein 1 inhibitor plus chemotherapy may be a potential treatment option for the patient population who have contraindications or can’t tolerate bevacizumab, which needs to be further verified in phase III confirmatory study.
4.QL1604 plus paclitaxel-cisplatin/ carboplatin in patients with recurrent or metastatic cervical cancer:an open-label, single-arm, phase II trial
Cheng FANG ; Yun ZHOU ; Yanling FENG ; Liping HE ; Jinjin YU ; Yuzhi LI ; Mei FENG ; Mei PAN ; Lina ZHAO ; Dihong TANG ; Xiumin LI ; Buzhen TAN ; Ruifang AN ; Xiaohui ZHENG ; Meimei SI ; Baihui ZHANG ; Lingyan LI ; Xiaoyan KANG ; Qi ZHOU ; Jihong LIU
Journal of Gynecologic Oncology 2024;35(6):e77-
Objective:
QL1604 is a highly selective, humanized monoclonal antibody against programmed death protein 1. We assessed the efficacy and safety of QL1604 plus chemotherapy as first-line treatment in patients with advanced cervical cancer.
Methods:
This was a multicenter, open-label, single-arm, phase II study. Patients with advanced cervical cancer and not previously treated with systemic chemotherapy were enrolled to receive QL1604 plus paclitaxel and cisplatin/carboplatin on day 1 of each 21-day cycle for up to 6 cycles, followed by QL1604 maintenance treatment.
Results:
Forty-six patients were enrolled and the median follow-up duration was 16.5 months. An 84.8% of patients had recurrent disease and 13.0% had stage IVB disease. The objective response rate (ORR) per Response Evaluation Criteria in Advanced Solid Tumors (RECIST) v1.1 was 58.7% (27/46). The immune ORR per immune RECIST was 60.9% (28/46).The median duration of response was 9.6 months (95% confidence interval [CI]=5.5–not estimable). The median progression-free survival was 8.1 months (95% CI=5.7–14.0). Fortyfive (97.8%) patients experienced treatment-related adverse events (TRAEs). The most common grade≥3 TRAEs (>30%) were neutrophil count decrease (50.0%), anemia (32.6%), and white blood cell count decrease (30.4%).
Conclusion
QL1604 plus paclitaxel-cisplatin/carboplatin showed promising antitumor activity and manageable safety profile as first-line treatment in patients with advanced cervical cancer. Programmed cell death protein 1 inhibitor plus chemotherapy may be a potential treatment option for the patient population who have contraindications or can’t tolerate bevacizumab, which needs to be further verified in phase III confirmatory study.
5.QL1604 plus paclitaxel-cisplatin/ carboplatin in patients with recurrent or metastatic cervical cancer:an open-label, single-arm, phase II trial
Cheng FANG ; Yun ZHOU ; Yanling FENG ; Liping HE ; Jinjin YU ; Yuzhi LI ; Mei FENG ; Mei PAN ; Lina ZHAO ; Dihong TANG ; Xiumin LI ; Buzhen TAN ; Ruifang AN ; Xiaohui ZHENG ; Meimei SI ; Baihui ZHANG ; Lingyan LI ; Xiaoyan KANG ; Qi ZHOU ; Jihong LIU
Journal of Gynecologic Oncology 2024;35(6):e77-
Objective:
QL1604 is a highly selective, humanized monoclonal antibody against programmed death protein 1. We assessed the efficacy and safety of QL1604 plus chemotherapy as first-line treatment in patients with advanced cervical cancer.
Methods:
This was a multicenter, open-label, single-arm, phase II study. Patients with advanced cervical cancer and not previously treated with systemic chemotherapy were enrolled to receive QL1604 plus paclitaxel and cisplatin/carboplatin on day 1 of each 21-day cycle for up to 6 cycles, followed by QL1604 maintenance treatment.
Results:
Forty-six patients were enrolled and the median follow-up duration was 16.5 months. An 84.8% of patients had recurrent disease and 13.0% had stage IVB disease. The objective response rate (ORR) per Response Evaluation Criteria in Advanced Solid Tumors (RECIST) v1.1 was 58.7% (27/46). The immune ORR per immune RECIST was 60.9% (28/46).The median duration of response was 9.6 months (95% confidence interval [CI]=5.5–not estimable). The median progression-free survival was 8.1 months (95% CI=5.7–14.0). Fortyfive (97.8%) patients experienced treatment-related adverse events (TRAEs). The most common grade≥3 TRAEs (>30%) were neutrophil count decrease (50.0%), anemia (32.6%), and white blood cell count decrease (30.4%).
Conclusion
QL1604 plus paclitaxel-cisplatin/carboplatin showed promising antitumor activity and manageable safety profile as first-line treatment in patients with advanced cervical cancer. Programmed cell death protein 1 inhibitor plus chemotherapy may be a potential treatment option for the patient population who have contraindications or can’t tolerate bevacizumab, which needs to be further verified in phase III confirmatory study.
6.Consensus on prescription review of commonly used H 1-antihistamines in pediatrics
Lihua HU ; Lu LIU ; Huiying CHEN ; Heping CAI ; Wentong GE ; Zhiying HAN ; Huijie HUANG ; Xing JI ; Yuntao JIA ; Lingyan JIAN ; Nannan JIANG ; Zhong LI ; Li LI ; Hua LIANG ; Chuanhe LIU ; Qinghong LU ; Xu LU ; Jun′e MA ; Jing MIAO ; Yanli REN ; Yunxiao SHANG ; Kunling SHEN ; Huajun SUN ; Jinqiao SUN ; Yanyan SUN ; Jianping TANG ; Hong WANG ; Lianglu WANG ; Xiaochuan WANG ; Lei XI ; Hua XU ; Zigang XU ; Meixing YAN ; Yong YIN ; Shengnan ZHANG ; Zhongping ZHANG ; Xin ZHAO ; Deyu ZHAO ; Wei ZHOU ; Li XIANG ; Xiaoling WANG
Chinese Journal of Applied Clinical Pediatrics 2023;38(10):733-739
H 1-antihistamines are widely used in the treatment of various allergic diseases, but there are still many challenges in the safe and rational use of H 1-antihistamines in pediatrics, and there is a lack of guidance on the prescription review of H 1-antihistamines for children.In this paper, suggestions are put forward from the indications, dosage, route of administration, pathophysiological characteristics of children with individual difference and drug interactions, so as to provide reference for clinicians and pharmacists.
7.Exploration on training model of general practitioners in county medical community with the outreaching of medical consortium
Yuling TONG ; Weihua WANG ; Lingyan WU ; Yongfu TANG ; Liang WANG ; Xue SUN ; Bohan LI ; Zhenya SONG
Chinese Journal of General Practitioners 2023;22(5):540-544
In recent years, a number of policies have been implemented to strengthen the cultivation of general practitioners in China. However, the development of community-level health professionals is still lagging behind, the development is uneven among regions, the overall number of general practitioners is insufficient, and the quality of medical services needs to be improved. Based on the Shanhai (Mountain and Sea) promotion project, with the close cooperation between the Second Affiliated Hospital and the medical consortium unit Suichang County People′s Hospital, a " Joint Cultivation by Dual-Teachers " model has been applied in training general practitioners for Suichang county community since March 2021. In this article we discuss the optimization and integration of medical and health resources through the outreaching assistance of high-quality personnel, management and system of medical service, to comprehensively upgrade the primary care and the quality of grass-roots general practitioners in remote mountainous areas.
8.Application of white noise therapy on the alleviation of hospital procedural pain of colostomy newborns
Hui YANG ; Lingyan TANG ; Penghui YANG ; Yingying HE ; Xiaojuan YAN ; Shengjuan LONG ; Luxing JIANG
Chinese Journal of Practical Nursing 2022;38(17):1319-1324
Objective:To investigate the application value of white noise therapy on the alleviation of procedural pain of colostomy newborns.Methods:By a prospective, randomized and controlled trial, a total of 88 colostomy newborns in Hunan Children′s Hospital from January 2018 to January 2020 divided into experimental group (44 cases) and control group (44 cases) according to the random number table method. The control group received routine nursing; based on thesis, the experimental group played white noise intervention therapy on the basis of routine nursing. The intervention effect was assessed byNeonatal Infant Acute Pain Assessment Scale (NIAPAS), the first crying time and the duration of first crying, the first painful face and the duration of first painful face as well as heart rate and blood oxygen saturation.Results:The first crying time and the duration of first crying, the first painful face and the duration of first painful face were (28.05 ± 7.39) s, (46.18 ± 13.29) s, (32.89 ± 6.79) s, (52.75 ± 10.71) s in the experimental group, significantly shorter than in the control group (35.79 ± 5.81) s, (35.79 ± 5.81) s, (38.64 ± 10.53) s, (59.79 ± 13.52) s, the difference was statistically significant ( t values were 2.71-5.47, all P<0.05). During and after the procedure, the scores of NIAPAS were (6.32 ± 1.62) points, (4.18 ± 1.06) points in the experimental group, significantly lower than that in the control group (7.43 ± 1.78) points, (4.79 ± 1.34) points ( t=3.06, 2.38, both P<0.05); the heart rate were (152.82 ± 13.25) times/min and (147.84 ± 12.37) times/min in the experimental group, significantly lower than in the control group (166.11 ± 13.79) times/min and (155.77 ± 12.84) times/min ( t=4.61, 2.95, both P<0.05); the blood oxygen saturation were 0.979 8 ± 0.009 5 and 0.980 9 ± 0.012 4 in the experimental group, significantly higher than in the control group 0.969 1 ± 0.014 9, 0.972 3 ± 0.017 8, the difference was statistically significant ( t=4.01, 2.65, both P<0.05). Conclusions:White noise therapy can effectively alleviate procedural pain and stabilizing vital signs of colostomy newborns.
9.Scan time and accuracy of full-arch scans with intraoral scanners: a comparative study on conditions of the intraoral head-simulator and the hand-held model
Mingtong WU ; Suxia TANG ; Lingyan PENG ; Yuting HAN ; Yucheng SU ; Xia WANG
Chinese Journal of Stomatology 2021;56(6):570-575
Objective:To comparatively evaluate the scan time and the accuracy of maxillary full-arch scans using four intraoral scanners (IOS) on conditions of the intraoral head-simulator and the hand-held model, and to evaluate the influence of different scanning conditions on digital scan.Methods:A upper dental arch model with melamine-formaldehyde resin teeth and silica gel gingiva that could be fixed on a head simulator was scanned with an optical scanner (ATOS Core) in order to obtain the standard tessellation language dataset as reference. Intraoral scans were performed on the model fixed on the head simulator by three researchers with four IOS [A: TRIOS 3; B: CS 3600; C: CEREC Omnicam; D: iTero]. For each scanner and each researcher, six scans were performed, to obtain the datasets as the head simulator group. And another six scans with each of the four intraoral scanners were performed by each researcher on the hand-held model to obtain the STL datasets as the hand-held group. The scan time were recorded for each scan. In the Geomagic Wrap software, the digital models were trimmed with only the teeth information retained and supreimposed by best fit alignment function and compared to obtain the root mean square (RMS) values of the discrepancies by three-dimensional compare function. The test datasets of each group were compared with the reference dataset for trueness. The six test scanning datasets with the same scanner of the same researcher were cross compared for precision. Mann Whitney U test was used to statistically analyze the difference values of the scan time, trueness and precision of the same intraoral scanner between head simulator group and hand-held group. Results:Compared to the hand-held group, the scan time of A [142(82) s] and D [119(52) s], which two IOS both with handle, were longer in head simulator group [A: 98(28) s; D: 85(22) s] ( P<0.01). However there were no significant differences between the two groups for scan time of IOS B and C ( P>0.05). For full-arch scan accuracy (trueness and precision), there were no significant differences between the two groups of IOS A and B ( P>0.05), while the trueness of C ( P<0.05) and the precision of D ( P<0.01) were better in head simulator group [C: 112(38) μm; D: 43(13) μm] compared to hand-held group [C: 135(47) μm; D: 53(18) μm]. However, there were no significant differences for the precision of C ( P>0.05) and the trueness of D ( P>0.05). Conclusions:The scan time and the accuracy of full-arch digital scans with different IOS may be effected by the scan conditions. For in vitro study of intraoral scanning, head-simulator can simulate the intraoral environment of the real patient to some extent. Meanwhile, the position of the dentist and the patient, and also the limited intraoral space during intraoral scanning are also simulated.
10.Effect of digital intraoral full-arch scan strategies on scan time and accuracy on conditions of intraoral head-simulator
Mingtong WU ; Suxia TANG ; Lingyan PENG ; Deping CHEN ; Yucheng SU ; Xia WANG
Chinese Journal of Stomatology 2021;56(11):1092-1097
Objective:To comparatively evaluate the accuracy and the scan time of three full-arch scan strategies on the head-simulator, to explore a full-arch scan strategy with better clinical operability and high accuracy.Methods:A cross-controlled study design was used. A model with melamine-formaldehyde resin teeth and silica gel gingiva of an upper dental arch which can be fixed on a head simulator was scanned with an optical scanner (ATOS Core) in order to obtain the standard tessellation language (STL) dataset as reference. Intraoral scans were performed on the model fixed on the head simulator with four intraoral scanners (IOS) [A (TRIOS 3), B (CS 3600), C (CEREC Omnicam), D (iTero)]. The STL datasets were obtained from each of the four different IOS systems by using three scan strategies (scan strategies 1, 2 and 3 were composed of 10, 5 and 7 paths respectively) all by one attending doctor with 3 years of intraoral scanning experience. For each scanner and each scan strategy, nine scans were acquired. And the scan time was recorded for each scan. Following the scan strategy, the scan path was completed to obtain a full-arch digital model, and the scan time was recorded as full-arch scan time. Complementary scans were performed to fill the missing image, and this scan time was recorded as complementary scan time. The total scan time was obtained by adding full-arch scan time and complementary scan time. Through the Geomagic Wrap software, the three-dimensional (3D) models were overlaid by best fit alignment function and compared to obtain the root mean square values of the discrepancies by 3D compare function. The intraoral scanning datasets were compared with the reference for trueness. The nine intraoral scanning datasets were cross compared with same scan strategy and same intraoral scanner for precision.Results:There were no significant differences among the three scan strategies for trueness ( P>0.05), while the differences among the three scan strategies for precision were affected by difference IOSs ( P<0.05), and only scan strategy 3 showed the highest precision with all the four IOS. The full-arch scan time of scan strategies 1, 2 and 3 were (130±24), (72±17) and (90±19) s respectively ( P<0.05). For complementary scan time, scan strategy 2 [(50±24) s] took longer time than scan strategy 1 [(26±18) s] and scan strategy [(25±21) s] ( P<0.05), while no significant differences between the latter two ( P>0.05). For total scan time, scan strategy 1 [(156±31) s] took longer time than scan strategy 2 [(122±30) s ] and scan strategy 3 [(115±29) s ] ( P<0.05), while no significant differences between the latter two ( P>0.05). Conclusions:Full-arch scanning on the head-simulator with scan strategy 3 which can obtain scanning datasets with high accuracy, was more convenient to operate and took shorter scan time, and is generally suitable for intraoral scanners commonly used in clinic.

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