1.Randomized Controlled Trial Design Based on Patient Cohorts: Methods and Applications of Trials Within Cohorts
Yuyi WANG ; Zeyang SHI ; Kecheng LI ; Zhijun BU ; Xuehui WANG ; Bin WANG ; Jianping LIU ; Zhaolan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(5):96-102
Trials within cohorts (TwiCs) are design methods derived from randomized controlled trials (RCTS). They have been widely used in chronic disease areas such as tumors and cardiovascular diseases. The basis of the TwiCs design is a prospective cohort of specific diseases. When RCTS need to be implemented, some patients meeting the inclusion and exclusion criteria are randomly sampled from the cohort to receive "trial interventions", while the remaining patients in the cohort who meet the inclusion and exclusion criteria continue to receive conventional treatment as control groups. By comparing the efficacy differences between the intervention measures of the trial group and the control group, the efficacy of intervention measures was evaluated. Within the cohort, the same process could be repeated to carry out multiple RCTS, so as to evaluate different intervention measures or compare the efficacy of different doses or timing of interventions. Compared with classical RCTS, TwiCs make it easier to recruit patients from the cohort and have higher external validity, providing a new research paradigm for improving the efficiency and applicability of RCTS in clinical practice. However, TwiCs may also face the challenge of poor compliance of patients in the cohort. Researchers need to take effective measures to control these patients in the design and operation of TwiCs. This article focused on the methodological key points during the implementation of TwiCs, including multi-stage informed consent (patients are informed of consent at three stages: entering the cohort, entering the trial group, and after the trial), randomization procedures (only random sampling of patients from the cohort to receive "trial interventions"), sample size calculation, and statistical analysis methods. The article also compared the differences between TwiCs and traditional RCTS and illustrated TwiCs research design and analysis with examples, so as to provide new research ideas and methods for clinical researchers.
2.LI Yueqing's Experience in Treating Prostate Cancer by Stages from the Perspective of Deficiency and Stasis
Jie LI ; Bin WANG ; Kecheng LI ; Xujun YOU ; Mingqiang ZHANG ; Haodong YANG ; Peixuan REN ; Longsheng DENG
Journal of Traditional Chinese Medicine 2024;65(22):2299-2303
This paper summarized Professor LI Yueqing's clinical experience in treating prostate cancer by stages from the perspective of deficiency and stasis. It is believed that the onset of prostate cancer is due to kidney deficiency, while blood stasis is the core pathogenesis, and dampness-heat, phlegm-turbid, and cancer toxins are the key pathological factors in the progression of the disease. The pathogenesis in the early stage of the disease is kidney qi depletion and dampness, heat and phlegm coagulation; in the middle stage, it is spleen and kidney depletion, phlegm coagulation and blood stasis; and in the late stage, the pathogenesis changes into yin deficiency and essence depletion, and stasis-turbid toxin obstruction. For treatment, the basic principle is to supplement and boost kidney qi, enrich and nourish the kidney yin. The main treatment methods are draining dampness, dissolving phlegm, dispelling stasis, clearing heat and resolving toxins, and the method of invigorating blood and dispelling stasis runs through the whole course of treatment. In the early stage, radical treatment is mainly used, and Longshe Yangquan Decoction (龙蛇羊泉汤) with modifications is supplemented to clear and drain dampness and heat. In the middle stage, androgen deprivation therapy is the basic treatment, and Bushen Tongqiao Decoction (补肾通窍汤) with modifications is used in combination to nourish the spleen and kidney, dissolve phlegm and dispel stasis. In the late stage, Dabuyin Pills and Liuwei Dihuang Pills (大补阴丸合六味地黄丸) with modifications is mainly used to enrich yin and supplement essence, resolve toxins and dissolve stasis, and prevent cancer recurrence.
3.Clinical Diseases Responding Specifically to Traditional Chinese Medicine:Chronic Prostatitis
Zhan QIN ; Mei MO ; Chaoba HE ; Liguo GENG ; Bin WANG ; Jisheng WANG ; Kecheng LI ; Nianwen HUANG ; Zhiming HONG ; Shaoying YUAN ; Xiaoxiao ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(24):152-158
Chronic prostatitis is a common and frequently occurring disease in male clinics. Due to the diverse symptoms, complex etiology, unclear mechanisms, and recurrent episodes of chronic prostatitis, Western medicine often faces the challenge of limited treatment options and unsatisfactory outcomes. In order to fully leverage the unique advantages of traditional Chinese medicine (TCM) in the treatment of chronic prostatitis, the China Association of Chinese Medicine organized a discussion among experts from the fields of TCM urology, Western urology, and related pharmacy. The experts focused on the advancements in the understanding of chronic prostatitis in modern medicine, various theories on the etiology, pathogenesis, and treatment of chronic prostatitis in TCM, entry points from interdisciplinary fields, the role and advantages of TCM in the comprehensive management of chronic prostatitis, and research into mechanisms related to chronic prostatitis. After discussions, the experts concluded that chronic prostatitis is one of the diseases where TCM has a distinct advantage. TCM can effectively improve the clinical syndromes of chronic prostatitis, including urinary issues, social psychology, organ specificity, infection, nervous system problems, pain and discomfort, sexual dysfunction, etc., and can enhance the quality of life. For patients with chronic prostatitis who cannot tolerate or may not accept the adverse effects of Western medicine, as well as for those with non-inflammatory chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), those with pain as the primary symptom, those with urinary tract symptoms, those with coexisting anxiety and depression, and those with abnormal semen liquefaction, TCM-based treatment can be the main approach. Currently, the optimal diagnosis and treatment strategy for chronic prostatitis has not yet been established, and further research from perspectives such as clinical epidemiology, evidence-based medicine, and molecular biology is needed. Both TCM and Western medicine should integrate their respective strengths, clarify the role and advantages of TCM interventions based on mutual reference, and improve the diagnosis and treatment standards for chronic prostatitis in China.
4.Comparative analysis of the efficacy of different surgical approaches in sporadic medullary thyroid carcinoma
Mingyu YANG ; Chengqiu SUI ; Kunlin LI ; Hongbo WANG ; Hao CHI ; Dongyuan LAN ; Kecheng BAI ; Daqi ZHANG
Chinese Journal of Endocrine Surgery 2024;18(1):57-62
Objective:To investigate the efficacy and prognosis of different surgical approaches in sporadic medullary thyroid carcinoma.Methods:A retrospective analysis was conducted on 101 patients with sporadic medullary thyroid carcinoma (MTC) who underwent surgical treatment at the Department of Thyroid Surgery, China-Japan Union Hospital of Jilin University, from Feb. 2009 to Nov. 2023. The patients included 36 males and 75 females, with a male-to-female ratio of 1:2.1. The median age of the patients was 47 years old, with an age range of 21 to 72 years old. The study divided participants into two groups based on their surgical methods: an observation group (78 cases) and a control group (23 cases). The observation group received surgical methods in accordance with expert consensus, while the control group did not. The study compared the efficacy and prognosis of the two groups.Results:Statistical differences were found between the two groups in terms of stage II and III in TNM staging, intraoperative frozen pathological findings, number of lymph node resections in the central group, number of lymph node metastases in the central group, number of lymph node resections in the lateral cervical region, postoperative follow-up time, and five-year postoperative serum procalcitonin (Ctn) levels ( P<0.05) .Both groups of patients obtained a significant decrease in Ctn after surgical treatment. In the observation group, Ctn was at the remission level in 57 cases (73.1%), at the stable level in 13 cases (16.7%), and at the progression level in 8 cases (10.2%), while in the control group, Ctn was at the remission level in 20 cases (86.9%), at the progression level in 3 cases (13.1%), and there were no patients at the stable level after the operation.One patient (1.3 per cent) in the observation group had a recurrence after surgery; Two patients (8.7 per cent) in the control group had a recurrence. Conclusions:Standardised and thorough surgery can maximise the clearance of metastatic lymph nodes, effectively reduce the recurrence rate, achieve better efficacy, and improve the long-term prognosis of patients without increasing the risk of surgery and postoperative complications.
5.LI Haisong's Experience in Treating Spermatorrhea based on the View of "Spirit Controlling Essence and Qi"
Runze WANG ; Kecheng LI ; Jisheng WANG ; Liang HAN ; Yexin CHEN ; Sheng HUANG ; Bin WANG
Journal of Traditional Chinese Medicine 2024;65(11):1109-1114
This paper summarized Professor LI Haisong's clinical experience in treating spermatorrhea based on the view of "spirit controlling essence and qi". It is emphasized that the heart spirit has the function of controlling the essence and qi of the human body, believing the frenetic stirring of heart spirit and the insecurity of essence gate are the core pathogenesis of spermatorrhea, LI advocates to regulate the heart spirit first and take into account of the zang-fu organs, essence and qi simultaneously for the treatment. Treatment should be performed according the clinical syndromes differentiatied. For those with heart spirit failing to nourish syndrome, it is recommended to supplement heart qi, nourish spirit and consolidate essence with self-made Yangxin Mijing Formula (养心秘精方). In case of heart fire hyperactivity, the method of clearing heart heat and draining fire, calming spirit and consolidating essence should be used, and self-made Xiexin Gujing Formula (泻心固精方) is recommended. For heart-liver qi constraint, it is advised to soothe the liver and calm heart, calm the mind and regulate essence with self-made Jieyu Anshen Tiaojing Formula (解郁安神调精方) which is a modifcation to Chaihu Shugan Powder (柴胡疏肝散). In terms of deficiency of both heart and liver, the treatment principle is supplementing spleen and nourishing heart, calming the mind and controlling essence, for which self-made Xinpi Tongtiao Shejing Formula (心脾同调摄精方) modified from Guipi Decoction (归脾汤) can be used. For deficiency of both heart and kidney, it is better to nourish the kidney and calm heart, calm the mind and consolidate essence with self-made Xinshen Liangzi Tianjing Formula (心肾两滋填精方) that modified from Shuilu Erxian Elixir (水陆二仙丹) and Wuzi Yanzong Pill (五子衍宗丸). Prescriptions are used to treat the root by harmonizing the zang-fu organs, nourish the spirit by regulating qi and blood, and calm the mind by taking special medi-cinals, and they should be flexibly modified according to the disease.
6.Diagnostics and treatment challenges and research progress in early-onset gastric cancer
Shuo LI ; Kecheng ZHANG ; Lin CHEN
Chinese Journal of Gastrointestinal Surgery 2024;27(5):436-440
The incidence of gastric cancer has decreased, while the occurrence of early-onset gastric cancer has increased. There is no consensus on the definition of early-onset gastric cancer currently. The characteristics of tumor staging and differentiation, coupled with the lack of targeted comprehensive treatment, present a significant clinical challenge in managing early-onset gastric cancer. Relevant studies have analyzed the genetic characteristics of early-onset gastric cancer and have preliminarily revealed its relationship with Helicobacter pylori infection and molecular subtypes. These findings have the potential to contribute to the prevention and personalized treatment of early-onset gastric cancer. In the future, larger-scale evidence-based data are needed to establish diagnostic criteria, elucidate the mechanisms, and develop targeted diagnostic and therapeutic strategies of early-onset gastric cancer.
7.Computer-vision-based artificial intelligence for detection and recognition of instruments and organs during radical laparoscopic gastrectomy for gastric cancer: a multicenter study
Kecheng ZHANG ; Zhi QIAO ; Li YANG ; Tao ZHANG ; Fenglin LIU ; Dachuan SUN ; Tianyu XIE ; Lei GUO ; Canrong LU
Chinese Journal of Gastrointestinal Surgery 2024;27(5):464-470
Objective:To investigate the feasibility and accuracy of computer vision-based artificial intelligence technology in detecting and recognizing instruments and organs in the scenario of radical laparoscopic gastrectomy for gastric cancer.Methods:Eight complete laparoscopic distal radical gastrectomy surgery videos were collected from four large tertiary hospitals in China (First Medical Center of Chinese PLA General Hospital [three cases], Liaoning Cancer Hospital [two cases], Liyang Branch of Jiangsu Province People's Hospital [two cases], and Fudan University Shanghai Cancer Center [one case]). PR software was used to extract frames every 5–10 seconds and convert them into image frames. To ensure quality, deduplication was performed manually to remove obvious duplication and blurred image frames. After conversion and deduplication, there were 3369 frame images with a resolution of 1,920×1,080 PPI. LabelMe was used for instance segmentation of the images into the following 23 categories: veins, arteries, sutures, needle holders, ultrasonic knives, suction devices, bleeding, colon, forceps, gallbladder, small gauze, Hem-o-lok, Hem-o-lok appliers, electrocautery hooks, small intestine, hepatogastric ligaments, liver, omentum, pancreas, spleen, surgical staplers, stomach, and trocars. The frame images were randomly allocated to training and validation sets in a 9:1 ratio. The YOLOv8 deep learning framework was used for model training and validation. Precision, recall, average precision (AP), and mean average precision (mAP) were used to evaluate detection and recognition accuracy.Results:The training set contained 3032 frame images comprising 30 895 instance segmentation counts across 23 categories. The validation set contained 337 frame images comprising 3407 instance segmentation counts. The YOLOv8m model was used for training. The loss curve of the training set showed a smooth gradual decrease in loss value as the number of iteration calculations increased. In the training set, the AP values of all 23 categories were above 0.90, with a mAP of 0.99, whereas in the validation set, the mAP of the 23 categories was 0.82. As to individual categories, the AP values for ultrasonic knives, needle holders, forceps, gallbladders, small pieces of gauze, and surgical staplers were 0.96, 0.94, 0.91, 0.91, 0.91, and 0.91, respectively. The model successfully inferred and applied to a 5-minutes video segment of laparoscopic gastroenterostomy suturing.Conclusion:The primary finding of this multicenter study is that computer vision can efficiently, accurately, and in real-time detect organs and instruments in various scenarios of radical laparoscopic gastrectomy for gastric cancer.
8.Diagnostics and treatment challenges and research progress in early-onset gastric cancer
Shuo LI ; Kecheng ZHANG ; Lin CHEN
Chinese Journal of Gastrointestinal Surgery 2024;27(5):436-440
The incidence of gastric cancer has decreased, while the occurrence of early-onset gastric cancer has increased. There is no consensus on the definition of early-onset gastric cancer currently. The characteristics of tumor staging and differentiation, coupled with the lack of targeted comprehensive treatment, present a significant clinical challenge in managing early-onset gastric cancer. Relevant studies have analyzed the genetic characteristics of early-onset gastric cancer and have preliminarily revealed its relationship with Helicobacter pylori infection and molecular subtypes. These findings have the potential to contribute to the prevention and personalized treatment of early-onset gastric cancer. In the future, larger-scale evidence-based data are needed to establish diagnostic criteria, elucidate the mechanisms, and develop targeted diagnostic and therapeutic strategies of early-onset gastric cancer.
9.Computer-vision-based artificial intelligence for detection and recognition of instruments and organs during radical laparoscopic gastrectomy for gastric cancer: a multicenter study
Kecheng ZHANG ; Zhi QIAO ; Li YANG ; Tao ZHANG ; Fenglin LIU ; Dachuan SUN ; Tianyu XIE ; Lei GUO ; Canrong LU
Chinese Journal of Gastrointestinal Surgery 2024;27(5):464-470
Objective:To investigate the feasibility and accuracy of computer vision-based artificial intelligence technology in detecting and recognizing instruments and organs in the scenario of radical laparoscopic gastrectomy for gastric cancer.Methods:Eight complete laparoscopic distal radical gastrectomy surgery videos were collected from four large tertiary hospitals in China (First Medical Center of Chinese PLA General Hospital [three cases], Liaoning Cancer Hospital [two cases], Liyang Branch of Jiangsu Province People's Hospital [two cases], and Fudan University Shanghai Cancer Center [one case]). PR software was used to extract frames every 5–10 seconds and convert them into image frames. To ensure quality, deduplication was performed manually to remove obvious duplication and blurred image frames. After conversion and deduplication, there were 3369 frame images with a resolution of 1,920×1,080 PPI. LabelMe was used for instance segmentation of the images into the following 23 categories: veins, arteries, sutures, needle holders, ultrasonic knives, suction devices, bleeding, colon, forceps, gallbladder, small gauze, Hem-o-lok, Hem-o-lok appliers, electrocautery hooks, small intestine, hepatogastric ligaments, liver, omentum, pancreas, spleen, surgical staplers, stomach, and trocars. The frame images were randomly allocated to training and validation sets in a 9:1 ratio. The YOLOv8 deep learning framework was used for model training and validation. Precision, recall, average precision (AP), and mean average precision (mAP) were used to evaluate detection and recognition accuracy.Results:The training set contained 3032 frame images comprising 30 895 instance segmentation counts across 23 categories. The validation set contained 337 frame images comprising 3407 instance segmentation counts. The YOLOv8m model was used for training. The loss curve of the training set showed a smooth gradual decrease in loss value as the number of iteration calculations increased. In the training set, the AP values of all 23 categories were above 0.90, with a mAP of 0.99, whereas in the validation set, the mAP of the 23 categories was 0.82. As to individual categories, the AP values for ultrasonic knives, needle holders, forceps, gallbladders, small pieces of gauze, and surgical staplers were 0.96, 0.94, 0.91, 0.91, 0.91, and 0.91, respectively. The model successfully inferred and applied to a 5-minutes video segment of laparoscopic gastroenterostomy suturing.Conclusion:The primary finding of this multicenter study is that computer vision can efficiently, accurately, and in real-time detect organs and instruments in various scenarios of radical laparoscopic gastrectomy for gastric cancer.
10.Correlations of serum sCD40L, CCL3 with postoperative deep vein thrombosis in patients with multiple rib fractures
Kecheng ZHANG ; Wei LI ; Ying LIU ; Kuankuan QIAO ; Na LI ; Jinghui YAN
Journal of Clinical Medicine in Practice 2024;28(11):58-62
Objective To investigate the correlations of postoperative serum levels of soluble CD40 ligand (sCD40L) and CC-chemokine ligand 3 (CCL3) with postoperative deep venous thrombosis (DVT) in patients with multiple rib fractures. Methods A total of 110 patients with multiple rib fractures were selected as the study subjects and divided into non-DVT group (


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