1.Clinical trial of brexpiprazole in the treatment of adults with acute schizophrenia
Shu-Zhe ZHOU ; Liang LI ; Dong YANG ; Jin-Guo ZHAI ; Tao JIANG ; Yu-Zhong SHI ; Bin WU ; Xiang-Ping WU ; Ke-Qing LI ; Tie-Bang LIU ; Jie LI ; Shi-You TANG ; Li-Li WANG ; Xue-Yi WANG ; Yun-Long TAN ; Qi LIU ; Uki MOTOMICHI ; Ming-Ji XIAN ; Hong-Yan ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(5):654-658
Objective To evaluate the efficacy and safety of brexpiprazole in treating acute schizophrenia.Methods Patients with schizophrenia were randomly divided into treatment group and control group.The treatment group was given brexpiprozole 2-4 mg·d-1 orally and the control group was given aripiprazole 10-20 mg·d-1orally,both were treated for 6 weeks.Clinical efficacy of the two groups,the response rate at endpoint,the changes from baseline to endpoint of Positive and Negative Syndrome Scale(PANSS),Clinical Global Impression-Improvement(CGI-S),Personal and Social Performance scale(PSP),PANSS Positive syndrome subscale,PANSS negative syndrome subscale were compared.The incidence of treatment-related adverse events in two groups were compared.Results There were 184 patients in treatment group and 186 patients in control group.After treatment,the response rates of treatment group and control group were 79.50%(140 cases/184 cases)and 82.40%(150 cases/186 cases),the scores of CGI-I of treatment group and control group were(2.00±1.20)and(1.90±1.01),with no significant difference(all P>0.05).From baseline to Week 6,the mean change of PANSS total score wese(-30.70±16.96)points in treatment group and(-32.20±17.00)points in control group,with no significant difference(P>0.05).The changes of CGI-S scores in treatment group and control group were(-2.00±1.27)and(-1.90±1.22)points,PSP scores were(18.80±14.77)and(19.20±14.55)points,PANSS positive syndrome scores were(-10.30±5.93)and(-10.80±5.81)points,PANSS negative syndrome scores were(-6.80±5.98)and(-7.30±5.15)points,with no significant difference(P>0.05).There was no significant difference in the incidence of treatment-related adverse events between the two group(69.00%vs.64.50%,P>0.05).Conclusion The non-inferiority of Brexpiprazole to aripiprazole was established,with comparable efficacy and acceptability.
2.Expert consensus on ethical requirements for artificial intelligence (AI) processing medical data.
Cong LI ; Xiao-Yan ZHANG ; Yun-Hong WU ; Xiao-Lei YANG ; Hua-Rong YU ; Hong-Bo JIN ; Ying-Bo LI ; Zhao-Hui ZHU ; Rui LIU ; Na LIU ; Yi XIE ; Lin-Li LYU ; Xin-Hong ZHU ; Hong TANG ; Hong-Fang LI ; Hong-Li LI ; Xiang-Jun ZENG ; Zai-Xing CHEN ; Xiao-Fang FAN ; Yan WANG ; Zhi-Juan WU ; Zun-Qiu WU ; Ya-Qun GUAN ; Ming-Ming XUE ; Bin LUO ; Ai-Mei WANG ; Xin-Wang YANG ; Ying YING ; Xiu-Hong YANG ; Xin-Zhong HUANG ; Ming-Fei LANG ; Shi-Min CHEN ; Huan-Huan ZHANG ; Zhong ZHANG ; Wu HUANG ; Guo-Biao XU ; Jia-Qi LIU ; Tao SONG ; Jing XIAO ; Yun-Long XIA ; You-Fei GUAN ; Liang ZHU
Acta Physiologica Sinica 2024;76(6):937-942
As artificial intelligence technology rapidly advances, its deployment within the medical sector presents substantial ethical challenges. Consequently, it becomes crucial to create a standardized, transparent, and secure framework for processing medical data. This includes setting the ethical boundaries for medical artificial intelligence and safeguarding both patient rights and data integrity. This consensus governs every facet of medical data handling through artificial intelligence, encompassing data gathering, processing, storage, transmission, utilization, and sharing. Its purpose is to ensure the management of medical data adheres to ethical standards and legal requirements, while safeguarding patient privacy and data security. Concurrently, the principles of compliance with the law, patient privacy respect, patient interest protection, and safety and reliability are underscored. Key issues such as informed consent, data usage, intellectual property protection, conflict of interest, and benefit sharing are examined in depth. The enactment of this expert consensus is intended to foster the profound integration and sustainable advancement of artificial intelligence within the medical domain, while simultaneously ensuring that artificial intelligence adheres strictly to the relevant ethical norms and legal frameworks during the processing of medical data.
Artificial Intelligence/legislation & jurisprudence*
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Humans
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Consensus
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Computer Security/standards*
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Confidentiality/ethics*
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Informed Consent/ethics*
3.Chinese Guideline on the Management of Polypoidal Choroidal Vasculopathy (2022).
You-Xin CHEN ; Yu-Qing ZHANG ; Chang-Zheng CHEN ; Hong DAI ; Su-Yan LI ; Xiang MA ; Xiao-Dong SUN ; Shi-Bo TANG ; Yu-Sheng WANG ; Wen-Bin WEI ; Feng WEN ; Ge-Zhi XU ; Wei-Hong YU ; Mei-Xia ZHANG ; Ming-Wei ZHAO ; Yang ZHANG ; Fang QI ; Xun XU ; Xiao-Xin LI
Chinese Medical Sciences Journal 2023;38(2):77-93
Background In mainland China, patients with neovascular age-related macular degeneration (nAMD) have approximately an 40% prevalence of polypoidal choroidal vasculopathy (PCV). This disease leads to recurrent retinal pigment epithelium detachment (PED), extensive subretinal or vitreous hemorrhages, and severe vision loss. China has introduced various treatment modalities in the past years and gained comprehensive experience in treating PCV.Methods A total of 14 retinal specialists nationwide with expertise in PCV were empaneled to prioritize six questions and address their corresponding outcomes, regarding opinions on inactive PCV, choices of anti-vascular endothelial growth factor (anti-VEGF) monotherapy, photodynamic therapy (PDT) monotherapy or combined therapy, patients with persistent subretinal fluid (SRF) or intraretinal fluid (IRF) after loading dose anti-VEGF, and patients with massive subretinal hemorrhage. An evidence synthesis team conducted systematic reviews, which informed the recommendations that address these questions. This guideline used the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach to assess the certainty of evidence and grade the strengths of recommendations. Results The panel proposed the following six conditional recommendations regarding treatment choices. (1) For patients with inactive PCV, we suggest observation over treatment. (2) For treatment-na?ve PCV patients, we suggest either anti-VEGF monotherapy or combined anti-VEGF and PDT rather than PDT monotherapy. (3) For patients with PCV who plan to initiate combined anti-VEGF and PDT treatment, we suggest later/rescue PDT over initiate PDT. (4) For PCV patients who plan to initiate anti-VEGF monotherapy, we suggest the treat and extend (T&E) regimen rather than the pro re nata (PRN) regimen following three monthly loading doses. (5) For patients with persistent SRF or IRF on optical coherence tomography (OCT) after three monthly anti-VEGF treatments, we suggest proceeding with anti-VEGF treatment rather than observation. (6) For PCV patients with massive subretinal hemorrhage (equal to or more than four optic disc areas) involving the central macula, we suggest surgery (vitrectomy in combination with tissue-plasminogen activator (tPA) intraocular injection and gas tamponade) rather than anti-VEGF monotherapy. Conclusions Six evidence-based recommendations support optimal care for PCV patients' management.
4.Identification, biological characteristics, and control of pathogen causing Pinellia ternata soft rot in Hubei province.
Fan-Fan WANG ; Tao TANG ; Ting MAO ; Yuan-Yuan DUAN ; Xiao-Liang GUO ; Guo-Bin FANG ; Hui KUANG ; Guang-Zhong SUN ; Jing-Mao YOU
China Journal of Chinese Materia Medica 2022;47(4):889-896
This study was designed to identify the pathogen causing soft rot of Pinellia ternata in Qianjiang of Hubei province and screen out the effective bactericides, so as to provide a theoretical basis for the control of soft rot of P. ternata. In this study, the pathogen was identified based on molecular biology and physiological biochemistry, followed by the detection of pathogenicity and pathogenicity spectrum via plant tissue inoculation in vitro and the indoor toxicity determination using the inhibition zone method to screen out bactericide with good antibacterial effects. The control effect of the bactericide against P. ternata soft rot was verified by the leave and tuber inoculation in vitro. The phylogenetic tree was constructed based on the 16 S rDNA, dnaX gene, and recA gene sequences, respectively, and the result showed that the pathogen belonged to the same branch as the type strain Dickeya fangzhongdai JS5. The physiological and biochemical tests showed that the pathogen was identical to D. fangzhongdai, which proved that the pathogen was D. fangzhongdai. The pathogenicity test indicated that the pathogen could obviously infect leaves at 24 h and tubers in 3 d. As revealed by the indoor toxicity test, 0.3% tetramycin, 5% allicin, and 80% ethylicin had good antibacterial activities, with EC_(50) values all less than 50 mg·L~(-1). Tests in tissues in vitro showed that 5% allicin exhibited the best control effect, followed by 0.3% tetramycin and 10% zhongshengmycin oligosaccharide, and their preventive effects were better than curative effects. Therefore, 5% allicin can be used as the preferred agent for the control of P. ternata soft rot, and 0.3% tetramycin and 10% zhongshengmycin oligosaccharide as the alternatives. This study has provided a certain theoretical basis for the control of P. ternata soft rot.
Phylogeny
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Pinellia/chemistry*
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Plant Leaves
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Plant Tubers
5.The 496th case:recurrent syncope for 8 years
Weiting TANG ; Yong YOU ; Shuangxing LI ; Bin ZHANG
Chinese Journal of Internal Medicine 2022;61(6):708-710
A 25-year-old women was admitted to the department of Neurology in Affiliated 2nd Hospital of Hainan Medical University due to recurrent syncope for 8 years and return for 2 months. She had multiple episodes of syncope at onset. She presented with the feeling of weakness in both lower limbs, and fatigue in the past year. She experienced pain in the waist and limbs joint in recent three months. Physical examination showed joint hyperactivity in metacarpophalangeal joints of both upper limbs, increased skin elasticity. Active-standing transcranial Doppler (TCD) test showed that the average heart rate (HR) and the average middle cerebral artery (MCA) blood flow velocity in the supine position were 79 beats/min and 62 cm/s, respectively; while the average HR and the average MCA blood flow velocity in the standing position were 126 beats/min, 47 cm/s. Meanwhile,the blood pressure was normal during the test of supine-to-standing TCD. Genetic testing indicated LDB3 transgenation. The patient was diagnosed as postural tachycardia syndrome (joint-hypermobility-related), Ehlers-Danlos syndrome, and relieved by fluid infusion and rehabilitation therapy.
6.YANG Jun's clinical experience of acupuncture for oculomotor paralysis.
Shan WANG ; You-Bin TANG ; Qing-Ping ZHANG ; Ai-Hong YUAN ; Hong-Yu XIE ; Rong JI ; Wan-Lin ZHANG ; Lin HAO ; Jun YANG
Chinese Acupuncture & Moxibustion 2022;42(6):669-672
Professor YANG Jun's clinical experience of acupuncture and moxibustion for oculomotor paralysis is summarized. Professor YANG Jun pays attention to disease differentiation and syndrome differentiation in the treatment of this disease. According to the characteristics of oculomotor paralysis, "early diagnosis and seeking treatment from the source" is advocated. According to the etiology and pathogenesis, professor YANG divides oculomotor paralysis into three types: the syndrome of wind-evil attacking collaterals, the syndrome of spleen-stomach weakness and the syndrome of qi-deficiency and blood-stasis. As such, the acupoints are selected according to syndrome differentiation, and several different acupuncture methods (pricking needling at eyelids, penetrating needling and lifting eyelids and contralateral- balance needling on the healthy side) are adopted to improve the symptoms of oculomotor paralysis. It is also suggested to use the combination of scalp acupuncture and electroacupuncture to achieve the best dose-effect state. Moreover, local stimulation around the eyes is important to achieve the effects of "qi reaching affected area".
Acupuncture
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Acupuncture Points
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Acupuncture Therapy
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Humans
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Moxibustion
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Ophthalmoplegia
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Syndrome
7.Chinese Expert's Perspectives on Andrological Diseases Responding Specifically to Traditional Chinese Medicine
Yue-qing LI ; Hai-song LI ; Yong-zhang SUN ; Sheng LIN ; Bao-xing LIU ; Jia-you ZHAO ; Jian-wu SHEN ; Hong-ming LIU ; Jing-shang WANG ; Yuan TANG ; Shao-ming LIU ; Hai WANG ; Yu-tian ZHU ; Yong ZHU ; Yong YANG ; Xiao-xiao ZHANG ; Bin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2021;27(12):182-188
In recent years, the incidence rate of andrological diseases has shown a significant growth trend. Considering the unavailability of a perfect theoretical system for andrology in traditional Chinese medicine (TCM) and the complex pathogenesis despite of the limited types of andrological diseases, it is necessary to improve the clinical efficacy of andrological diseases so as to satisfy the needs of patients. Therefore, the China Association of Chinese Medicine (CACM) organized the andrologists of TCM and western medicine and the outstanding young clinicians to discuss the andrological diseases responding specifically to TCM or integrated TCM and western medicine, such as chronic prostatitis, male infertility, benign prostatic hyperplasia, erectile dysfunction, and premature ejaculation, determine their diagnostic criteria in western medicine, and standardize the specifications for TCM diagnosis and treatment based on syndrome differentiation, thus formulating recognized and integrated diagnosis and treatment protocols. Apart from proposing suggestions on the treatment of such andrological diseases with TCM and western medicine, the experts have also figured out the andrological diseases responding specifically to TCM, the optimal intervention time of TCM and western medicine, and the suitable measures including surgery. The resulting consensus helps to better guide the formulation of accurate, personalized, and optimized treatment plans in clinical practice and improve the diagnosis and treatment effects of andrological diseases by giving full play to the advantages of TCM, which will in turn contribute to further innovation and development of TCM.
8.Preliminary study of lateral tibia periosteum distraction for the treatment of chronic ischemic diseases of lower limbs
Naxin ZENG ; Zheng CAO ; Yi YOU ; Meng GAN ; Xinyu PENG ; Wei XU ; Wengao WU ; Jinjun XU ; Yinkui TANG ; Dong WANG ; Bin WANG ; Yan LI ; Yonghong ZHANG ; Sihe QIN
Chinese Journal of Orthopaedics 2021;41(22):1607-1613
Objective:To investigate the effect of lateral tibial periosteum distraction on diabetic foot and vasculitis foot.Methods:A retrospective analysis of 13 patients (16 feet) who received lateral tibial periosteal distraction between June 2019 and May 2020 were included in the study. 9 males and 4 females; aged 39-77 years (average 66 years); left foot 7 cases, right foot 9 cases. 5 cases were patients with diabetic foot, 1 case was diabetic foot with arteriosclerosis obliterans, 2 cases were thromboembolic vasculitis, and 5 cases were arteriosclerosis obliterans. The tibial periosteum was dissected and a distraction device was placed. In the 3 patients with foot ulcers, tibial periosteum distraction devices were placed on the severer side. The periosteal distraction began on the third day after surgery, about 0.75 mm/d, the adjustment was done usually in two weeks. Two weeks later, the stretch plate was removed surgically. The followings were evaluated: visual analogue scale (VAS) pain score, foot peripheral oxygen saturation, foot capillary filling test, lower extremity arterial CT angiography (CTA), etc.Results:All 13 patients were followed up for 2-12 weeks, with an average of 3.85 weeks. VAS pain score: the average pain score of 13 patients with preoperative foot pain was 5.31±1.84 (range, 2-9) points, and 2 weeks after surgery, the average value was 2.46±1.39 (range, 1-6) points with statistical significance ( t=6.124, P<0.001) ; peripheral foot oxygen saturation: the average preoperative blood oxygen saturation of 12 patients was 87.83%±14.83% (range, 50%-98%), 1 patient was not detected before surgery, and 2 weeks after operation, the average blood oxygen saturation was 92.33%±7.91% (range, 75%-99%). There was no significant difference between them ( t=1.124, P=0.285). The foot skin temperature of 10 patients was 35.68±0.85 ℃ (range, 34.00-36.60 ℃) before surgery and 36.23±0.46 ℃ (range, 35.50-36.90 ℃) after surgery, and the difference was statistically significant ( t=3.197, P=0.008) . Capillary filling test: 2 weeks after operation, the capillary filling response was significantly improved. All 13 patients had improved CTA of both lower extremity arteries before operation, and 11 patients had CTA taken back after two weeks of operation. Compared with preoperative CTA, new vascular network was found in the operation limb. In addition to 1 patient with thromboangiitis obliterans (mainly suffering from foot pain, no wound symptoms), 2 of 12 patients with heart failure, renal failure and other basic diseases did not heal, and the wounds of the other 10 patients had improved significantly 1 month later. Conclusion:Lateral tibia periosteum distraction can be used to treat chronic ischemic diseases of lower extremities with satisfactory postoperative results.
9. Corrigendum to “Effects of total iridoid glycosides of Picrorhiza scrophulariiflora against non-alcoholic steatohepatitis rats induced by high-fat and high-sugar diet through regulation of lipid metabolism” Chin Herb Med 12 (2019) 67–72 (Chinese Herbal Medicines (2020) 12(1) (67–72), (S167463841930108X), (10.1016/j.chmed.2019.12.005))
Xu XU ; Xin LI ; Wen-bin HOU ; Wei-ting WANG ; Zhuan-you ZHAO ; Wen-gong XI ; Bing YU ; Chun-hua HAO ; Li-da TANG
Chinese Herbal Medicines 2021;13(2):295-295
When this paper was first published the following ethical statement was omitted in error: This study was carried out in strict accordance with the recommendations in the Guide for the Care and Use of Laboratory Animals of Tianjin Institute of Pharmaceutical Research. The authors would like to apologise for any inconvenience caused.
10.A multi-center retrospective study of perioperative chemotherapy for gastric cancer based on real-world data.
Xue Wei DING ; Zhi Chao ZHENG ; Qun ZHAO ; Gang ZHAI ; Han LIANG ; Xin WU ; Zheng Gang ZHU ; Hai Jiang WANG ; Qing Si HE ; Xian Li HE ; Yi An DU ; Lu Chuan CHEN ; Ya Wei HUA ; Chang Ming HUANG ; Ying Wei XUE ; Ye ZHOU ; Yan Bing ZHOU ; Dan WU ; Xue Dong FANG ; You Guo DAI ; Hong Wei ZHANG ; Jia Qing CAO ; Le Ping LI ; Jie CHAI ; Kai Xiong TAO ; Guo Li LI ; Zhi Gang JIE ; Jie GE ; Zhong Fa XU ; Wen Bin ZHANG ; Qi Yun LI ; Ping ZHAO ; Zhi Qiang MA ; Zhi Long YAN ; Guo Liang ZHENG ; Yang YAN ; Xiao Long TANG ; Xiang ZHOU
Chinese Journal of Gastrointestinal Surgery 2021;24(5):403-412
Objective: To explore the effect of perioperative chemotherapy on the prognosis of gastric cancer patients under real-world condition. Methods: A retrospective cohort study was carried out. Real world data of gastric cancer patients receiving perioperative chemotherapy and surgery + adjuvant chemotherapy in 33 domestic hospitals from January 1, 2014 to January 31, 2016 were collected. Inclusion criteria: (1) gastric adenocarcinoma was confirmed by histopathology, and clinical stage was cT2-4aN0-3M0 (AJCC 8th edition); (2) D2 radical gastric cancer surgery was performed; (3) at least one cycle of neoadjuvant chemotherapy (NAC) was completed; (4) at least 4 cycles of adjuvant chemotherapy (AC) [SOX (S-1+oxaliplatin) or CapeOX (capecitabine + oxaliplatin)] were completed. Exclusion criteria: (1) complicated with other malignant tumors; (2) radiotherapy received; (3) patients with incomplete data. The enrolled patients who received neoadjuvant chemotherapy and adjuvant chemotherapy were included in the perioperative chemotherapy group, and those who received only postoperative adjuvant chemotherapy were included in the surgery + adjuvant chemotherapy group. Propensity score matching (PSM) method was used to control selection bias. The primary outcome were overall survival (OS) and progression-free survival (PFS) after PSM. OS was defined as the time from the first neoadjuvant chemotherapy (operation + adjuvant chemotherapy group: from the date of operation) to the last effective follow-up or death. PFS was defined as the time from the first neoadjuvant chemotherapy (operation + adjuvant chemotherapy group: from the date of operation) to the first imaging diagnosis of tumor progression or death. The Kaplan-Meier method was used to estimate the survival rate, and the Cox proportional hazards model was used to evaluate the independent effect of perioperative chemo therapy on OS and PFS. Results: 2 045 cases were included, including 1 293 cases in the surgery+adjuvant chemotherapy group and 752 cases in the perioperative chemotherapy group. After PSM, 492 pairs were included in the analysis. There were no statistically significant differences in gender, age, body mass index, tumor stage before treatment, and tumor location between the two groups (all P>0.05). Compared with the surgery + adjuvant chemotherapy group, patients in the perioperative chemotherapy group had higher proportion of total gastrectomy (χ(2)=40.526, P<0.001), smaller maximum tumor diameter (t=3.969, P<0.001), less number of metastatic lymph nodes (t=1.343, P<0.001), lower ratio of vessel invasion (χ(2)=11.897, P=0.001) and nerve invasion (χ(2)=12.338, P<0.001). In the perioperative chemotherapy group and surgery + adjuvant chemotherapy group, 24 cases (4.9%) and 17 cases (3.4%) developed postoperative complications, respectively, and no significant difference was found between two groups (χ(2)=0.815, P=0.367). The median OS of the perioperative chemotherapy group was longer than that of the surgery + adjuvant chemotherapy group (65 months vs. 45 months, HR: 0.74, 95% CI: 0.62-0.89, P=0.001); the median PFS of the perioperative chemotherapy group was also longer than that of the surgery+adjuvant chemotherapy group (56 months vs. 36 months, HR=0.72, 95% CI:0.61-0.85, P<0.001). The forest plot results of subgroup analysis showed that both men and women could benefit from perioperative chemotherapy (all P<0.05); patients over 45 years of age (P<0.05) and with normal body mass (P<0.01) could benefit significantly; patients with cTNM stage II and III presented a trend of benefit or could benefit significantly (P<0.05); patients with signet ring cell carcinoma benefited little (P>0.05); tumors in the gastric body and gastric antrum benefited more significantly (P<0.05). Conclusion: Perioperative chemotherapy can improve the prognosis of gastric cancer patients.
Chemotherapy, Adjuvant
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Female
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Gastrectomy
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Humans
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Male
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Neoadjuvant Therapy
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Neoplasm Staging
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Prognosis
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Retrospective Studies
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Stomach Neoplasms/surgery*

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