1.Randomized, double-blind, parallel-controlled, multicenter, equivalence clinical trial of Jiuwei Xifeng Granules(Os Draconis replaced by Ostreae Concha) for treating tic disorder in children.
Qiu-Han CAI ; Cheng-Liang ZHONG ; Si-Yuan HU ; Xin-Min LI ; Zhi-Chun XU ; Hui CHEN ; Ying HUA ; Jun-Hong WANG ; Ji-Hong TANG ; Bing-Xiang MA ; Xiu-Xia WANG ; Ai-Zhen WANG ; Meng-Qing WANG ; Wei ZHANG ; Chun WANG ; Yi-Qun TENG ; Yi-Hui SHAN ; Sheng-Xuan GUO
China Journal of Chinese Materia Medica 2025;50(6):1699-1705
Jiuwei Xifeng Granules have become a Chinese patent medicine in the market. Because the formula contains Os Draconis, a top-level protected fossil of ancient organisms, the formula was to be improved by replacing Os Draconis with Ostreae Concha. To evaluate whether the improved formula has the same effectiveness and safety as the original formula, a randomized, double-blind, parallel-controlled, equivalence clinical trial was conducted. This study enrolled 288 tic disorder(TD) of children and assigned them into two groups in 1∶1. The treatment group and control group took the modified formula and original formula, respectively. The treatment lasted for 6 weeks, and follow-up visits were conducted at weeks 2, 4, and 6. The primary efficacy endpoint was the difference in Yale global tic severity scale(YGTSS)-total tic severity(TTS) score from baseline after 6 weeks of treatment. The results showed that after 6 weeks of treatment, the declines in YGTSS-TSS score showed no statistically significant difference between the two groups. The difference in YGTSS-TSS score(treatment group-control group) and the 95%CI of the full analysis set(FAS) were-0.17[-1.42, 1.08] and those of per-protocol set(PPS) were 0.29[-0.97, 1.56], which were within the equivalence boundary [-3, 3]. The equivalence test was therefore concluded. The two groups showed no significant differences in the secondary efficacy endpoints of effective rate for TD, total score and factor scores of YGTSS, clinical global impressions-severity(CGI-S) score, traditional Chinese medicine(TCM) response rate, or symptom disappearance rate, and thus a complete evidence chain with the primary outcome was formed. A total of 6 adverse reactions were reported, including 4(2.82%) cases in the treatment group and 2(1.41%) cases in the control group, which showed no statistically significant difference between the two groups. No serious suspected unexpected adverse reactions were reported, and no laboratory test results indicated serious clinically significant abnormalities. The results support the replacement of Os Draconis by Ostreae Concha in the original formula, and the efficacy and safety of the modified formula are consistent with those of the original formula.
Adolescent
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Child
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Child, Preschool
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Female
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Humans
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Male
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Double-Blind Method
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Drugs, Chinese Herbal/therapeutic use*
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Tic Disorders/drug therapy*
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Treatment Outcome
2.Effect and mechanism of Moringa oleifera leaves, seeds, and velamen in improving learning and memory impairments in mice based on transcriptomic and metabolomic.
Zhi-Hao WANG ; Shu-Yi FENG ; Tao LI ; Wan-Ping ZHOU ; Jin-Yu WANG ; Yang LIU ; Lin ZHANG ; Yuan-Yuan XIE ; Xiu-Lan HUANG ; Zhi-Yong LI ; Lu-Qi HUANG
China Journal of Chinese Materia Medica 2025;50(13):3793-3812
Moringa oleifera, widely utilized in Ayurvedic medicine, is recognized for its leaves, seeds, and velamen possessing traditional effects such as vātahara(wind alleviation), sirovirecaka(brain clearing), and hridya(mental nourishment). This study aims to identify the medicinal part of ■ in the Sārasvata ghee formulation as described in the Bower Manuscript, while investigating the ameliorative effects of different medicinal parts of M. oleifera on learning and memory deficits in mice and elucidating the underlying molecular mechanisms. A total of 144 male ICR mice were randomly assigned to the following groups: control, model(scopolamine hydrobromide, Sco, 2 mg·kg~(-1)), donepezil(donepezil hydrochloride, Don, 3 mg·kg~(-1)), M. oleifera leaf low-, medium-, and high-dose groups(0.5, 1, 2 g·kg~(-1)), M. oleifera seeds low-, medium-, and high-dose groups(0.25, 0.5, 1 g·kg~(-1)), and M. oleifera velamen low-, medium-, and high-dose groups(0.31, 0.62, 1.24 g·kg~(-1)). Learning and memory abilities were assessed using the passive avoidance test and Morris water maze. Nissl and HE staining were employed to examine histopathological changes in the hippocampus. Transcriptomics and targeted metabolomics were used to screen differential genes and metabolites, with MetaboAnalyst 6.0 and O2PLS methods applied to identify key disease-related targets and pathways. RESULTS:: demonstrated that M. oleifera leaf(1 g·kg~(-1)) significantly ameliorated Sco-induced learning and memory deficits, outperforming M. oleifera seeds(0.25 g·kg~(-1)) and M. oleifera velamen(1.24 g·kg~(-1)). This was evidenced by improved behavioral performance, reversal of neuronal damage, and reduced acetylcholinesterase(AChE) activity. Multi-omics analysis revealed that M. oleifera leaf upregulated Tuba1c gene expression through the synaptic vesicle cycle, enhancing glutamate(Glu), dopamine(DA), and acetylcholine(ACh) release via Tuba1c-Glu associations for neuroprotection. M. oleifera seeds targeted the dopaminergic synapse pathway, promoting memory consolidation through Drd2-ACh associations. M. oleifera velamen was associated with the cocaine addiction pathway, modulating dopamine metabolism via Adora2a-DOPAC, with limited relevance to learning and memory. In conclusion, M. oleifera leaf exhibits superior efficacy and mechanistic advantages over M. oleifera seeds and velamen, suggesting that the ■ in the Sārasvata ghee formulation is likely M. oleifera leaf, providing scientific evidence for its identification in ancient texts.
Animals
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Moringa oleifera/chemistry*
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Male
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Mice
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Seeds/chemistry*
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Plant Leaves/chemistry*
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Mice, Inbred ICR
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Memory Disorders/psychology*
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Transcriptome/drug effects*
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Memory/drug effects*
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Learning/drug effects*
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Metabolomics
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Humans
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Drugs, Chinese Herbal/administration & dosage*
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Maze Learning/drug effects*
3.Clinical Characteristics and Prognosis of Primary Pulmonary Lymphoma.
You-Fan FENG ; Yuan-Yuan ZHANG ; Xiao Fang WEI ; Qi-Ke ZHANG ; Li ZHAO ; Xiao-Qin LIANG ; Yuan FU ; Fei LIU ; Yang-Yang ZHAO ; Xiu-Juan HUANG ; Qing-Fen LI
Journal of Experimental Hematology 2025;33(2):387-392
OBJECTIVE:
To investigate the clinical characteristics and prognosis of primary pulmonary lymphoma (PPL).
METHODS:
The clinical data of 17 patients with PPL admitted to Gansu Provincial Hospital from January 2013 to June 2023 were collected, and their clinical characteristics and prognosis were retrospectively analyzed and summarized.
RESULTS:
The median age of the 17 patients was 56 (29-73) years old. There were 8 males and 9 females. According to Ann Arbor staging system, there were 9 patients with stage I-II and 8 patients with stage III-IV. There were 14 patients with IPI score of 0-2 and 3 patients with IPI score of 3-4. All 17 patients had symptoms at the initial diagnosis, most of the first symptoms were cough, and 6 patients had B symptoms.Among the 17 patients, there were 8 cases of diffuse large B-cell lymphoma (DLBCL), 5 cases of mucosa-associated lymphoid tissue (MALT) lymphoma, 1 case of gray zone lymphoma (GZL), and 3 cases of Hodgkin's lymphoma (HL). 15 patients received chemotherapy, of which 3 cases received autologous hematopoietic stem cell transplantation(ASCT) and 3 cases received radiotherapy; 2 patients did not receive treatment. The median number of chemotherapy courses was 6(2-8). The short-term efficacy was evaluated, 12 patients achieved complete remission (CR) and 3 patients achieved partial remission (PR). The age, pathological subtype, sex, Ann Arbor stage, β2-microglobulin(β2-MG) level, lactate dehydrogenase(LDH) level were not correlated with CR rate (P >0.05), while IPI score was correlated with recent CR rate (P < 0.05 ). The median follow-up time was 31(2-102) months. One of the 12 CR patients died of COVID-19, and the rest survived. Among the 3 patients who did not reach CR, 1 died after disease progression, while the other 2 survived. One of the 2 untreated patients died one year after diagnosis. Both the median progression-free survival (PFS) time and overall survival (OS) time of the 17 patients were both 31 (2-102) months.
CONCLUSION
The incidence of PPL is low, and the disease has no specific clinical manifestations, which is easily missed and misdiagnosed. The pathological subtypes are mainly MALT lymphoma and DLBCL, and the treatment is mainly combined chemotherapy. The IPI score is related to the treatment efficacy.
Humans
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Middle Aged
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Male
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Female
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Adult
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Prognosis
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Aged
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Lung Neoplasms/therapy*
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Retrospective Studies
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Neoplasm Staging
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Lymphoma/therapy*
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Lymphoma, Large B-Cell, Diffuse
4.Clinical Characteristics and Prognosis of B-cell Acute Lymphoblastic Leukemia Patients with IKZF1 Deletion.
Li-Hua WANG ; Yan GUO ; Yuan ZHANG ; Xiu-Feng WANG ; Xian-Kai LIU ; Yan HUANG
Journal of Experimental Hematology 2025;33(4):966-971
OBJECTIVE:
To analyze clinical characteristics and prognosis of B-cell acute lymphoblastic leukemia (B-ALL) patients with IKZF1 deletion.
METHODS:
72 patients with B-ALL admitted to our hospital from April 2020 to January 2023 were selected, IKZF1 deletion were detected, and clinical characteristics and prognosis were analyzed.
RESULTS:
Among the 72 patients, a total of 32 patients (44.4%) were identified with IKZF1 deletions (IKZF1 + ). There was no statistically significant difference in basic clinical data between patients with normal IKZF1 (IKZF1 -) and those with IKZF1 + (P >0.05). The proportion of patients with IKZF1 + in Ph+ group was significantly higher than that in Ph- group (P < 0.05). The main types of IKZF1 + were exon 1-8 deletion (34.4%) and exon 4-7 deletion (31.2%). The median OS and PFS of IKZF1 - patients were significantly longer than those of IKZF1 + patients (OS: 26.0 months vs 16.0 months, χ 2=23.094, P < 0.05; PFS: 26.0 months vs 16.0 months, χ 2=11.150, P < 0.05). Among IKZF1 + patients, the median OS of patients who received allogeneic hematopoietic stem cell transplantation (allo-HSCT) was significantly longer than that of patients who did not receive allo-HSCT (no reached vs 15.0 months, χ 2=5.685, P < 0.05).
CONCLUSION
IKZF1 deletion is a risk factor affecting the prognosis of B-ALL patients.
Humans
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Ikaros Transcription Factor/genetics*
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Prognosis
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Gene Deletion
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Female
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Male
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Precursor Cell Lymphoblastic Leukemia-Lymphoma/genetics*
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Adult
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Precursor B-Cell Lymphoblastic Leukemia-Lymphoma/genetics*
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Adolescent
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Young Adult
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Middle Aged
5.Effects of continued use of targeted therapy on patients with pulmonary arterial hypertension and complicated by hemoptysis.
Zhong-Chao WANG ; Xiu-Min HAN ; Yao ZUO ; Na DONG ; Jian-Ming WANG ; Li-Li MENG ; Jia-Wang XIAO ; Ming ZHAO ; Yuan MI ; Qi-Guang WANG
Journal of Geriatric Cardiology 2025;22(3):404-410
7.Clinical Observation on the Joint Needling Method Combined with Ultrasound in the Treatment of Patellofemoral Pain Syndrome of Qi Stagnation and Blood Stasis Type
Xiu-Lan LI ; Hui-Kang YUAN ; Shu-Xiong LUO ; Long-An CHEN ; Ai-Guo XUE ; Yu-Bing LIU
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(1):141-146
Objective To observe the clinical efficacy of joint needling method combined with ultrasound in the treatment of qi stagnation and blood stasis type of patellofemoral pain syndrome(PFPS).Methods Eighty-six patients with qi stagnation and blood stasis type of PFPS were randomly divided into observation group and control group,with 43 cases in each group.The control group was given western medicine conventional treatment combined with functional exercise,and the observation group was given joint needling method combined with ultrasound treatment on the basis of the control group.Both groups were treated for 2 consecutive weeks.After 2 weeks of treatment,the clinical efficacy of the two groups was evaluated,and the changes in the Visual Analogue Scale(VAS)scores of knee pain and the Kujala scale scores of the two groups were observed before and after treatment.The changes in active range of motion(AROM)of the affected knee joint were compared before and after treatment between the two groups.Results(1)After treatment,the VAS scores of the two groups of patients were significantly improved(P<0.05),and the observation group was significantly superior to the control group in improving the level of VAS scores,and the difference was statistically significant(P<0.05).(2)After treatment,the Kujala scores of patients in the two groups were significantly improved(P<0.05),and the observation group was significantly superior to the control group in improving the level of Kujala scores,and the difference was statistically significant(P<0.05).(3)After treatment,the AROM of patients in the two groups were significantly improved(P<0.05),and the observation group was significantly superior to the control group in improving the level of AROM,and the difference was statistically significant(P<0.05).(4)The total effective rate was 95.35%(41/43)in the observation group and 81.40%(35/43)in the control group.The efficacy of the observation group was superior to that of the control group,and the difference was statistically significant(P<0.05).Conclusion The joint needling method combined with ultrasound can significantly relieve the pain symptoms of patients with PFPS and promote the recovery of knee joint function,and the clinical efficacy is remarkable.
8.A Retrospective Study on the Qianyang Fengsui Dan Combined with Flying Needle Therapy in the Treatment of Kidney-Yang Deficiency Type of Insomnia
Hong-Yan YANG ; Bao-Ting XU ; Ling-Ling DONG ; Xiu-Hong LIU ; Yuan-Min LI ; Qing-Bo MIAO ; Chao-Peng LIU
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(3):664-670
Objective To analyze the clinical efficacy of the Qianyang Fengsui Dan(combined with flying needle therapy)in the treatment of kidney-yang deficiency type of insomnia.Methods A retrospective study was conducted to select 82 patients with insomnia admitted to the Department of Traditional Chinese Medicine of Dezhou Hospital of Traditional Chinese Medicine from November 2020 to November 2021,and they were divided into an observation group and a control group according to whether or not they were treated with Qianyang Fengsui Dan combined with flying needle therapy,with 41 cases in each group.The control group was treated with Estazolam,while the observation group was treated with Qianyang Fengsui Dan combined with flying needle therapy on the basis of the treatment of the control group,and the course of treatment was 1 month.The changes of Pittsburgh Sleep Quality Index(PSQI)scores and Epworth Sleepiness Scale(ESS)scores,as well as polysomnographic parameters were observed before and after treatment in the two groups.The changes of γ-aminobutyric acid(GABA),glutamate(GA),substance P(SP),and neuropeptide Y(NPY)levels were compared before and after treatment between the two groups.And followed up for 1 year to compare the incidence of relapce of the two groups of patients.Results(1)The total effective rate was 95.12%(39/41)in the observation group and 63.41%(26/41)in the control group,and the efficacy of the observation group was superior to that of the control group,and the difference was statistically significant(P<0.05).(2)After treatment,PSQI scores and ESS scores of patients in the two groups were significantly improved(P<0.05),and the observation group was significantly superior to the control group in improving PSQI scores and ESS scores,and the differences were statistically significant(P<0.05).(3)After treatment,sleep efficiency,awakening time,sleep latency,REM,and total sleep time were significantly improved in the two groups(P<0.05),and the observation group was significantly superior to the control group in improving sleep efficiency,awakening time,sleep latency,REM,and total sleep time,and the differences were statistically significant(P<0.05).(4)After treatment,the serum GABA,GA,SP,and NPY levels of patients in the two groups were significantly improved(P<0.05),and the observation group was significantly superior to the control group in improving the serum GABA,GA,SP,and NPY levels,and the differences were all statistically significant(P<0.05).(5)After treatment,follow-up for 1 year,the recurrence rate of the observation group was 0,and there were 7 cases of recurrence in the control group,and the recurrence rate of the control group was 17.07%(7/41),and the recurrence rate of the observation group was lower than that of the control group,and the difference was statistically significant(P<0.05).Conclusion The combination of flying needle therapy and Qianyang Fengsui Dan can effectively relieve insomnia and fatigue in patients with insomnia,reduce daytime drowsiness,regulate the release of blood monoamine neurotransmitters,and reduce the relapse rate,and its efficacy is superior to that of simple western medicine treatment.
9.Protective effect and mechanism of acellular nerve allografts combined with electroacupuncture on spinal ganglia in rats with sciatic nerve injury
Ze-Yu ZHOU ; Yun-Han MA ; Jia-Rui LI ; Yu-Meng HU ; Bo YUAN ; Yin-Juan ZHANG ; Xiao-Min YU ; Xiu-Mei FU
Acta Anatomica Sinica 2024;55(2):143-149
Objective To investigate the protective effect and mechanism of acellular nerve allografts(ANA)combined with electroacupuncture on spinal ganglia in rats with sciatic nerve injury(SNI).Methods Totally 50 male adult SD rats were randomly selected for this experiment.Ten rats were prepared for the ANA.Forty male SD rats were randomly divided into normal group,model group,ANA group and combinational group,with 10 rats in each group.The SNI model was established by cutting off the nerves 10 mm at the 5 mm on the inferior border of piriformis after separating the right sciatic nerves.The rats in the ANA group were bridged with ANA to the two broken ends of injured nerves.The rats in the combinational group were treated with electroacupuncture 2 days after ANA bridging,Huantiao(GB30)and Yanglingquan(GB34)were performed as the acupuncture points,each electroacupuncture lasted 15 minutes and 7 days as a course of treatment,4 courses in all.Sciatic nerve conduction velocity was measured by electrophysiology to evaluate the regeneration of damaged axons.Morphology of spinal ganglia was observed by Nissl staining.The expression of nerve growth factor(NGF)and brain-derived neurotrophic factor(BDNF)were detected by Western blotting and immunofluorescent staining.Results Compared with the normal group,the sciatic nerve conduction velocity in model group decreased significantly(P<0.01),Nissl bodies in neurons of spinal ganglia were swollen and dissolved,with incomplete structure and the number decreased dramatically(P<0.01),while the level of NGF and BDNF also decreased significantly(P<0.01).Compared with the model group,the sciatic nerve conduction velocity in ANA and combinational groups strongly increased(P<0.01),the damage of Nissl bodies in neurons of spinal ganglia reduced and the number obviously increased(P<0.01),the level of NGF and BDNF increased considerably(P<0.01).Compared with the ANA group,the sciatic nerve conduction velocity in combinational group increased significantly(P<0.01),the morphology of Nissl bodies in neurons of spinal ganglia were more regular and the number increased(P<0.01),moreover,the level of NGF also increased significantly(P<0.01).Conclusion ANA combined with electroacupuncture can enhance the sciatic nerve conduction velocity,improve the morphology of neurons in spinal ganglia and play a protective effect on spinal ganglia.The mechanism can be related to the higher expression of NGF and BDNF proteins,especially the expression of NGF protein.
10.Preliminary Study on Prognostic Factors of New-onset Diabetes Mellitus After Distal Pancreatectomy for Pancreatic Cystic Tumor
Yuan LI ; Li ZHANG ; Jinglin LI ; Dianrong XIU ; Hangyan WANG
Chinese Journal of Minimally Invasive Surgery 2024;24(3):184-189
Objective To explore the prognostic factors of new-onset diabetes mellitus(NODM)in patients with pancreatic cystic tumor after distal pancreatectomy(DP).Methods Between January 2010 and December 2019,92 patients with cystic pancreatic tumors in our hospital underwent laparoscopic DP.According to the inclusion and exclusion criteria,a total of 74 cases were included and divided into NODM group or normal glucose metabolism group based on whether postoperative NODM occurred.A univariate analysis was used to evaluate the prognostic factors of laparoscopic DP for pancreatic cystic tumors.P<0.05 was considered statistically significant,OR>4 was considered as a potential prognostic factor of clinical significance for NODM.Results NODM was diagnosed in26 cases(35.1%),with a median diagnosis time of 9 months(range,3-56 months)after surgery.Univariate analysis showed that transecting pancreas in the neck(OR = 11.000,P = 0.000),BMI≥25.0(OR = 4.333,P = 0.007),and family history of diabetes mellitus(OR =5.000,P =0.004)were prognostic factors of postoperative NODM.Conclusions When performing DP for pancreatic cystic tumors,it is advisable to preserve as much pancreatic tissue as possible and avoid cutting off the pancreas in the neck.Precise postoperative strategy of glucose metabolism surveillance for patients with BMI≥25.0 and family history of diabetes mellitus should be promoted.

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