1.A double-blind randomised controlled clinical trial of Shenling Baizhu Granules in treating low anterior resection syndrome in rectal cancer
Shuo FENG ; Hui YE ; Yingchao WU ; Guowei CHEN ; Tao WU ; Yong JIANG ; Tao LIU ; Shuai ZUO ; Xuezhi ZHANG ; Junling ZHANG ; Xin WANG
Journal of Beijing University of Traditional Chinese Medicine 2024;47(7):953-960
Objective This study aimed to assess the clinical efficacy of Shenling Baizhu Granules in treating low anterior resection syndrome(LARS)in rectal cancer.Methods The study employed a randomized,double-blind,placebo-parallel controlled,single-center,validity-tested clinical trial design.December 2019 to June 2022,the Department of Gastrointestinal Surgery and Integrated Traditional Chinese and Western Medicine of Peking University First Hospital recruited 110 patients who had undergone low anterior resection(LAR)for rectal cancer and subsequently developed LARS.These patients,meeting the enrollment criteria,were randomly assigned into the treatment group(55)and the control group(55)using the double-blind method principle.The randomization table was generated by SAS 9.2 software employing the double-blind method.The treatment group received oral Shenling Baizhu Granules,while the control group received oral placebo granules.Both groups commenced treatment on the 10th day after-surgery for 30 consecutive days.Patients were evaluated using LARS score,traditional Chinese medicine(TCM)symptom grading,and XU Zhongfa score before treatment,on the 15th day of treatment,and on the 1st day after treatment cessation.Results Out of 110 patients,107 were included in the full analysis set for efficacy analysis:55 patients in the treatment group and 55 patients in the control group.One case in the treatment group was excluded(against protocol),and two cases in the control group were excluded(one lost to follow-up,one against protocol).Baseline data between the two groups were consistent,with no statistically significant difference.Before treatment,LARS scores for the treatment and control groups were 33.0(31.0,36.0)and 34.0(32.0,37.0)respectively.Patients with TCM symptom scores of grades 2 to 3 accounted for 92.73%and 90.57%in the treatment and control groups,respectively,with no statistically significant difference.After 30 days of treatment,LARS scores for the treatment and control groups were 21.0(19.8,23.0)and 26.0(22.0,28.0)respectively.The percentage of patients with TCM symptom scores of grades 2 to 3 decreased to 33.33%in the treatment group and 66.04%in the control group,with a statistically significant difference.Shenling Baizhu Granules showed rapid improvement in watery or loose stools in post-operative rectal cancer patients.After 30 days of treatment,Shenling Baizhu Granules significantly improved appetite,stool consistency,abdominal distension,abdominal pain,and eructation symptoms in postoperative rectal cancer patients.Before treatment,the XU Zhongfa scores for the treatment and control groups were 3.0(2.0,4.3)and 4.0(2.0,4.0)respectively,with no statistically significant difference.After 30 days of treatment,the XU Zhongfa scores for the treatment and control groups were 7.0(6.0,8.0)and 6.0(5.0,7.0)respectively,with the treatment group significantly higher than the control group(P<0.01).Conclusion Shenling Baizhu Granules can effectively improve LARS symptoms in patients following LAR of rectal cancer within a short period of time.
2.Consistency Evaluation of Dissolution Curves of Cefixime Capsules
Weiwen YE ; Lin GAO ; Guowei CAI ; Yecai LAI ; Fei QIN
Herald of Medicine 2024;43(3):424-430
Objective To develop a method for rapid determination of the dissolution of cefixime capsules,to explore the consistency of the dissolution curves of the generic and reference preparations in different media,and to assess the reliability of the in vitro dissolution evaluation method according to the results of bioequivalence studies.Methods The dissolution test was performed by the paddle method at 50 r·min-1,using pH1.2 hydrochloric acid solution,pH6.8 phosphate buffer solution,pH7.5 phosphate buffer solution,and water as the dissolution media.And a high-performance liquid chromatography(HPLC)method with a core-shell column was established to determine the dissolution curves of the generic and reference preparations respectively.The bioequivalence of the generic and reference preparations was evaluated through the bioequivalence(BE)test.Results The similarity factors(f2)of the three batches of the generic and reference preparations in the four media were greater than 60.The fasting and postprandial pharmacokinetic parameters(Cmax,AUC0-t,AUC0-∞)of the generic and reference preparations in hu-mans were all in line with the bioequivalence standard.Conclusion The in vitro dissolution behavior of the generic and refer-ence preparations was consistent,and the two preparations were bioequivalent.The method is simple and quick,and it can be em-ployed to measure the dissolution of cefixime capsules,which can provide references for the consistency evaluation of cefixime capsules.
3.Multiplex PCR identification of Zaocys dhumnades formula granules and three common counterfeit products
Ye SONG ; Yuqin LUO ; Guowei LI ; Leyao XIAN ; Siyin TAN ; Yaoyao FAN ; Yijing LUO ; Xiangdong CHEN ; Dongmei SUN
Drug Standards of China 2024;25(4):321-329
Objective:To establish a polymerase chain reaction(PCR)method to accurately discriminate the crude materials and aqueous extract of Zaocys dhumnades,Elaphe carinata,Elaphe meollendorff and Ptyas korros.Methods:Specific primers were designed using mitochondrial Cytb gene(CO1)as a target gene,and annealing temperature,number of cycles and the type of DNA polymerases were optimized.The mixed samples were detected by this method.Results:By this multiplex allele-specific PCR identification method,135,182,246 and 197 bp of specific fragments were amplified from DNA templates of Zaocys dhumnades,Elaphe carinata,Elaphe meollendorffi and Ptyas korros,respectively,following the conditions:cycle number of 35,annealing temperature of 62 ℃.The adulterants and the blank control showed no bands.The method could simultaneously and accurately identify the snake-derived components in the mixed samples.Conclusion:The method can be used to identify the samples of Zaocys dhumnades,Elaphe carinata,Elaphe meollendorffi and Ptyas korros simultaneously,accurately and rapidly,and is suitable for the identification of standard decoctiond and formula granules samples.
4.SBC (Sanhuang Xiexin Tang combined with Baihu Tang plus Cangzhu) alleviates NAFLD by enhancing mitochondrial biogenesis and ameliorating inflammation in obese patients and mice.
Zhitao REN ; Gemin XIAO ; Yixin CHEN ; Linli WANG ; Xiaoxin XIANG ; Yi YANG ; Siying WEN ; Zhiyong XIE ; Wenhui LUO ; Guowei LI ; Wenhua ZHENG ; Xiaoxian QIAN ; Rihan HAI ; Liansheng YANG ; Yanhua ZHU ; Mengyin CAI ; Yinong YE ; Guojun SHI ; Yanming CHEN
Chinese Journal of Natural Medicines (English Ed.) 2023;21(11):830-841
In the context of non-alcoholic fatty liver disease (NAFLD), characterized by dysregulated lipid metabolism in hepatocytes, the quest for safe and effective therapeutics targeting lipid metabolism has gained paramount importance. Sanhuang Xiexin Tang (SXT) and Baihu Tang (BHT) have emerged as prominent candidates for treating metabolic disorders. SXT combined with BHT plus Cangzhu (SBC) has been used clinically for Weihuochisheng obese patients. This retrospective analysis focused on assessing the anti-obesity effects of SBC in Weihuochisheng obese patients. We observed significant reductions in body weight and hepatic lipid content among obese patients following SBC treatment. To gain further insights, we investigated the effects and underlying mechanisms of SBC in HFD-fed mice. The results demonstrated that SBC treatment mitigated body weight gain and hepatic lipid accumulation in HFD-fed mice. Pharmacological network analysis suggested that SBC may affect lipid metabolism, mitochondria, inflammation, and apoptosis-a hypothesis supported by the hepatic transcriptomic analysis in HFD-fed mice treated with SBC. Notably, SBC treatment was associated with enhanced hepatic mitochondrial biogenesis and the inhibition of the c-Jun N-terminal kinase (JNK)/nuclear factor-kappa B (NF-κB) and extracellular signal-regulated kinase (ERK)/NF-κB pathways. In conclusion, SBC treatment alleviates NAFLD in both obese patients and mouse models by improving lipid metabolism, potentially through enhancing mitochondrial biogenesis. These effects, in turn, ameliorate inflammation in hepatocytes.
Humans
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Mice
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Animals
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Non-alcoholic Fatty Liver Disease/metabolism*
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NF-kappa B/metabolism*
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Organelle Biogenesis
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Retrospective Studies
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Mice, Inbred C57BL
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Obesity/metabolism*
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Liver
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Inflammation/metabolism*
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Body Weight
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Lipid Metabolism
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Lipids
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Diet, High-Fat/adverse effects*
5.Changes of X-ray examination mode for ophthalmic inpatients and impact on radiation dose level from 2019 to 2020
Ying WANG ; Guowei YE ; Cong CHEN ; Mengxi XU ; Jinying WU ; Weiming ZHANG ; Xinhong WANG
Chinese Journal of Radiological Medicine and Protection 2022;42(6):470-474
Objective:To analyze and compare the X-ray procedures and radiation dose composition of ophthalmic inpatients, and to explore the changes of the X-ray examination mode in recent years and the effect of optimization in imaging technology on the radiation dose level of the patients.Methods:The simple random sampling method was used to retrospectively select the imaging data of the ophthalmic inpatients in the Second Affiliated Hospital of Zhejiang University School of Medicine from July 1st to November 31st in 2019 and from July 1st to November 31st in 2020. A total of 516 cases were selected according to the imaging time, including 258 cases in 2019 and 258 cases in 2020. Based on our previous research and the related documents of low-dose CT screening, a series of optimizations on CT scanning parameters and process were carried out in 2020, including the frequency of DR and CT scanning, the number of examinations per capita, the composition ratio of CT and DR, and X-ray dose per capita.Results:In 2020, the average effective doses of chest CT and orbital CT for ophthalmic inpatients were (2.587±1.586) mSv and (0.877±0.733) mSv, significantly lower than those in 2019 ( F=0.52, 0.72, P<0.05), and decreased by 34.82% and 37.13%, respectively. There was no significant difference in the average effective dose of chest DR and head CT between 2020 and 2019 ( F=6.01, 1.81, P>0.05). The number of X-ray examination per capita increased by 0.15 times, and the effective dose increased by 1.44 times (1.589 mSv). Chest DR was the main type of X-ray examination, accounting for 68.79% of all examinations in 2019, while chest CT was the main type, accounting for 71.05% in 2020. The composition of chest CT in 2020 increased by 63.17% compared with 2019, and the compositions of chest DR, orbital CT and cranial CT were decreased by 53.88%, 5.79% and 2.89%, respectively. Conclusions:With dose optimization measures, the single CT dose of ophthalmic inpatients in 2020 was lower than that in 2019. Chest CT increased significantly in frequency, and became main X-ray examination instead of chest DR which made the effective dose of ophthalmic inpatients increasing significantly.
6.Efficacy and safety study of Chinese botulinum toxin A 100U in patients with overactive bladder: a prospective, multicenter, double-blind and randomized controlled trial
Limin LIAO ; Huiling CONG ; Zhihui XU ; Enhui LI ; Zhiliang WENG ; Haihong JIANG ; Ben LIU ; Xiao HUANG ; Shujie XIA ; Wei WEN ; Juan WU ; Guowei SHI ; Yang WANG ; Peijun LI ; Yang YU ; Zujun FANG ; Jie ZHENG ; Ye TIAN ; Haodong SHANG ; Hanzhong LI ; Zhongming HUANG ; Liqun ZHOU ; Yunxiang XIAO ; Yaoguang ZHANG ; Jianlong WANG ; Xiaodong ZHANG ; Peng ZHANG ; Dongwen WANG ; Xuhui ZHANG ; Keji XIE ; Bin WANG ; Lulin MA ; Xiaojun TIAN ; Lijun CHEN ; Jinkai DONG
Chinese Journal of Urology 2021;42(6):414-422
Objective:To assess the efficacy and safety of 100 units of botulinum toxin A (BTX-A) intradetrusor injection in patients with overactive bladder.Methods:From April 2016 to December 2018, 17 tertiary hospitals were selected to participate in this prospective, multicenter, randomized, double-blind, placebo-controlled study. Two phases of study were conducted: the primary phase and the extended phase. This study enrolled patients aged 18 to 75 years who had been inadequately managed by anticholinergic therapy (insufficient efficacy or intolerable side effects) and had spontaneous voiding with overactive bladder. Exclusion criteria included patients with severe cardiac, renal and hepatic disorders, patients with previous botulinum toxin treatment for 6 months or allergic to BTX-A, patients with urinary tract infections, patients with urinary stones, urinary tract tumors, diabetes mellitus, and bleeding tendency. Eligible patients were randomly assigned to BTX-A group and placebo control group in a ratio of 2∶1. Two groups of patients received 20 intradetrusor injections of BTX-A 100U or placebo at the depth of the submucosal muscle layer respectively under cystoscope, including 5 injections at the base of the bladder, 3 injections to the bladder triangle, 5 injections each to the left and right walls and 2 injections to the top, sparing the bladder neck. As a placebo control group, patients received same volume of placebo containing no BTX-A and only adjuvant freeze-dried preparations for injection with the same method. A combination of gelatin, sucrose, and dextran served as adjuvants. Average micturition times per 24 hours, urinary incontinence (UI) episodes per day, average micturition volume per day, OAB symptom score(OABSS), and quality of life (QOL) score were recorded at baseline and the 2nd, 6th and 12th week after treatment. The primary efficacy endpoint was the change from baseline in the average micturition times per 24 hours at the 6th week after treatment. The secondary efficacy endpoints included the change from baseline in the average micturition times per 24 hours at 2nd and 12th week, as well as the change from baseline in the OABSS, QOL score, average frequency of urgency and UI episodes per day, urgency score, average micturition volume per day at 2nd, 6th and 12th week after treatment. Patients were followed for 12 weeks to assess adverse events (AEs). After assessed at week 12, if the micturition times has decreased less than 50% compared to baseline and the patient is willing to receive retreatment, then patients could enter the extended trial phase. In that phase, patients in both groups were injected with 100 units BTX-A from 12th week onwards and then followed up the same indicators for 12 weeks.Results:216 patients were enrolled in this trial (144 cases in the BTX-A group and 72 cases in the placebo control group). Baseline characteristics such as age (47.75±14.20 in the BTX-A group and 46.39±15.55 in the control group), sex (25 male/117 female in the BTX-A group and 10/61 in the control group), and disease duration (0.51 years in the BTX-A group and 0.60 years in the control group) were balanced between the two groups( P>0.05). A marked reduction from baseline in average micturition times per 24 hours was observed in all treatment groups at the 6th week and the reduction of the two groups was statistically different ( P<0.001 and P=0.008 respectively). Compared with the baseline, the average micturition times per 24 hours at the 6th week decreased from baseline by 2.40(0.70, 4.60)times for the BTX-A group and 0.70(-1.00, 3.30) times for the placebo control group respectively, and the difference between the two groups was considered to be statistically significant ( P=0.003). The change rates of average micturition times per 24 hours from baseline at the 6th week of the two groups were (16±22)% and (8±25)% respectively, and the difference between the two groups was statistically significant ( P=0.014). Compared with the baseline, the average micturition times per 24 hours at 2nd and 12th week decreased by 2.00(0.00, 4.00)and 3.30(0.60, 5.03)for the BTX-A group, 1.00(-1.00, 3.00)and 1.70(-1.45, 3.85)for the placebo control group respectively. The difference between two groups was considered to be statistically significant ( P=0.038 and P=0.012); the changes of average urgency times per day for the BTX-A group and the control group at the 2nd, 6th and 12th week were 2.00(0.00, 4.30)and 2.40(0.30, 5.00), 3.00(0.30, 5.70)and 0.70(-1.30, 2.70), 0.70(-1.30, 3.00) and 1.35(-1.15, 3.50), respectively. There were significant differences between two groups at the 2nd, 6th and 12th week, ( P=0.010, P=0.003 and P=0.025, respectively). The OABSS of the BTX-A group and the control group at the 6th week decreased by 1.00(0.00, 4.00)and 0.50(-1.00, 2.00) compared with the baseline, and the difference between the two groups was statistically significant ( P=0.003). 47 cases of BTX-A group and 34 cases of placebo control group entered the extended trial phase, and 40 and 28 cases completed the extended trial phase, respectively. The average micturition volume per 24 hours changed by -16.60(-41.60, -0.60)ml and -6.40(-22.40, 13.30)ml, (-35.67±54.41)ml and(-1.76±48.69)ml, (-36.14±41.51)ml and (-9.28±44.59)ml, (-35.85±43.35)ml and(-10.41±40.29)ml for two groups at the 12th, 14th, 18th and 24th week, and the difference between two groups was statistically significant at each follow-up time ( P=0.01, 0.006, 0.012 and 0.016, respectively). There was no significant difference in other parameters( P>0.05). However, adverse reactions after intradetrusor injection included increased residual urine volume (27 in the BTX-A group and 3 in the control group), dysuria (21 in the BTX-A group and 6 in the control group), urinary infection (19 in the BTX-A group and 6 in the control group), bladder neck obstruction (3 in the BTX-A group and 0 in the control group), hematuria (3 in the BTX-A group and 1 in the control group), elevated alanine aminotransferase (3 in the BTX-A group and 0 in the control group), etc. During the follow-up period, there was no significant difference in the other adverse events between two groups except the increase of residual urine volume( P<0.05). In the primary trial phase, among the 27 cases with increased residual urine volume in BTA group, only 1 case (3.70%) with PVR more than 300 ml; the PVR of 3 patients in the placebo group was less than 100 ml. The increase of residual urine volume caused by the injection could be improved or disappeared with the passage of time. Conclusions:Intradetrusor injection of Chinese BTX-A improved the average micturition times per 24 hours, the average daily urgent micturition times, OABSS, and average micturition volume per time, and reduced the adverse effects in patients with overactive bladder.Chinese BTX-A at dose of 100U demonstrated durable efficacy and safety in the management of overactive bladder.
7. Reversibility of ischemic core defined by CT perfusion imaging in acute stroke patients receiving thrombolysis within different time windows
Genlong ZHONG ; Lin XIANG ; Weikang CHEN ; Guowei YE ; Ying WANG ; Yanan TANG ; Likang LAN ; Weiwen QIU
Chinese Journal of Neurology 2020;53(1):31-37
Objective:
To investigate the reversibility of ischemic core defined by CT perfusion imaging in acute ischemic stroke (AIS) patients receiving intravenous thrombolysis within different time windows and influencing factors.
Methods:
The data of AIS patients who received intravenous thrombolysis in the Department of Neurology of Lishui People′s Hospital from May 2016 to December 2018 were retrospectively reviewed. All patients had finished multi-model CT imaging before thrombolysis and multi-model MRI examination 24-48 hours after thrombolysis. The baseline ischemic core volume (hypoperfusion area with relative cerebral blood flow (rCBF)<30%) was quantitatively assessed based on CT perfusion images using MIStar software, and the final ischemic core volume was assessed based on diffusion weighted imaging acquired 24-48 hours after thrombolysis. The reversibility of ischemic core was defined as baseline ischemic core volume-the final infarct volume ≥5 ml. Then the clinical and imaging features of the patients between reversible group and irreversible group were compared, and the predictors of ischemic core reversibility were analyzed by binary Logistic regression analysis.
Results:
Finally, 97 patients were enrolled in the present study, of which 64 (66%) patients achieved successful recanalization, 51 (53%) patients with reversible baseline ischemic core. For patients with recanalization, the incidence of reversibility was 76% (26/34), 71% (17/24), 2/5 and 0 (0/1) in patients with time window from onset to thrombolysis (ONT) <3.0 h, 3.0-4.5 h, 4.6-6.0 h, and >6.0 h, respectively. In the non-recanalization group, six patients were also showed with ischemic core reversibility, including 4 (4/12) in the ONT<3.0 h group and 2 (2/12) in the ONT 3.0-4.5 h group. It was found that the reversible volume was positively correlated with baseline ischemic core volume (
8.Analysis of baseline characteristics and treatment status of hepatitis C in sentinel hospitals from 2017 to 2019
Guowei DING ; Lin PANG ; Xiaochun WANG ; Shaodong YE ; Faxin HEI
Chinese Journal of Hepatology 2020;28(10):844-849
Objective:To understand the hepatitis C diagnosis type, progression and treatment in medical institutions.Methods:Monitoring posts were set up in the secondary and tertiary-level hospitals in some parts of the country. Reported infectious diseases cases of hepatitis C in sentinel hospitals during the three consecutive years from 2017 to 2019 were investigated to understand their general demographic characteristics, diagnosis, liver fibrosis degree, and treatment. The diagnosis, treatment and related factors were analyzed by chi square test and trend.Results:A total of 16 241 cases of hepatitis C were investigated in three years. Among them, 7 538 cases were clinically diagnosed (46.41%) and 8703 cases (53.59%) were confirmed as hepatitis C. Among the confirmed cases, 60 cases (0.69%) were acute and 8643 cases (99.31%) were chronic. In the past three years, the proportion of cases diagnosed by liver diseases related departments decreased from 62.23% to 40.01%, while the proportion of medical and surgical cases of non-liver diseases increased from less than 30% to nearly 60%. The proportion of confirmed cases in secondary hospitals (26.27%) was significantly lower than that in tertiary hospitals (62.48%), and the difference was statistically significant ( χ2 = 1594.833, P < 0.001). There were also differences in the proportion of confirmed cases in different regions ( P < 0.001). The cases with FIB-4 > 3.25 accounted for 35.78%, and the proportion was increased significantly with age ( χ2 trend = 1159.624, P < 0.001). The average proportion of antiviral treatment was less than 10%, and the proportion of antiviral treatment in secondary hospitals was very low (2.13%); however, the proportion of liver-protective monotherapy treatment was decreased from 30.40% in 2017 to 11.14% in 2019, and the difference was statistically significant ( P < 0.001). Conclusion:The large-scale screening of hepatitis C by medical institutions is increasing year by year, but only about half of the cases can be diagnosed, and the diagnostic capacity of secondary hospitals is particularly unsatisfactory. Most of the confirmed cases are chronic hepatitis C, and more than one third of them have abnormal liver fibrosis indicators, and the proportion increases with age. The proportion of antiviral treatment for hepatitis C is lower in secondary than tertiary-level hospitals. Therefore, there is an urgent need to raise the attention of both parties (doctors and patients) to enhance diagnostic capabilities and expand the coverage of antiviral treatment for hepatitis C.
9.Executive opinion survey and analysis of diagnosis and treatment schemes of traditional Chinese medicine in diabetes mellitus complicated by sepsis
Guowei LI ; Xianshi ZHOU ; Jingfen CAI ; Guanghua TANG ; Xiaotu XI ; Yuntao LIU ; Changhai ZHAO ; Moming GUZAINUER ; Liuhua DUAN ; Simeng WU ; Ye YE
International Journal of Traditional Chinese Medicine 2019;41(5):502-505
Objective To prospectively survey the well-known experts of critical care and endocrine secretion to summarize their experience in treating diabetes mellitus complicated by sepsis for the purpose of providing guidance of theory and practice in making treatment schemes of traditional Chinese medicine for such disease.Methods The questionnaires were designed and submitted to the experts.The statistic analysis was undertook to investigate the rules.Results A total of 30 questionnaires were released and 28 were retrieved.The experts generally believed that eight-principle syndrome differentiation was the most useful method in the syndrome differentiation and treatment of this disease.The heat,stasis and toxin were usually acted as the main pathogenic factors while damp and phlegm commonly act as secondary pathogenic factors.They thought that weak body resistance under the invading of evil was the key mechanisms in the deterioration of the disease and they chose clearing heat,activating blood and detoxication as 3 core treatment principles.Conclusions The summarized opinions from the experts should be act as important reference in treating this disease,but its effectiveness and possibility for further generalization need to be validated in the clinical practice.
10.Influence of body shape on the short-term therapeutic effects of laparoscopic distal gastrectomy: a multicentre retrospective study (A report of 506 cases)
Hexin LIN ; Su YAN ; Zhijian YE ; Jian ZHANG ; Lisheng CAI ; Jinping CHEN ; Guoqiang SU ; Guowei ZHANG ; Jinbo FU ; Chuanhui LU ; Liang WANG ; Weiping JI ; Wencheng KONG ; Jiang GONG ; Ping CHEN ; Rongjie HUANG ; Hailin KE ; Xian SHEN ; Jun YOU
Chinese Journal of Digestive Surgery 2019;18(1):65-73
Objective To investigate the risk factors of perioperative complications of laparoscopic radical distal gastrectomy and influence of body shape on the short-term therapeutic effects.Methods The retrospective case-control study was conducted.The clinicopathological data of 506 patients (328 males and 178 females,average age 60 years with the range of 24-85 years) who underwent laparoscopic radical distal gastrectomy+D2 lymph nodes dissection in the 8 clinical centers between March 2016 and November 2018 were collected,including 143 in the First Affiliated Hospital of Xiamen University,66 in the Affiliated Hospital of Qinghai University,66 in the Second Affiliated Hospital of Wenzhou Medical University,64 in the Zhongshan Hospital of Xiamen University,54 in the Affiliated Hangzhou First people's Hospital of Zhejiang University School of Medicine,48 in the Zhangzhou Affiliated Hospital of Fujian Medical University,35 in the Affiliated Quanzhou First Hospital of Fujian Medical University,30 in the Second Affiliated Hospital of Xiamen Medical College.The maximum thickness of subcutaneous fat at the level of umbilicus (USCF),the maximum vertical distance between the anterior abdominal skin and the back skin at the level of the umbilicus (UAPD),the maximum horizontal distance between the anterior abdominal skin and the back skin at the level of the umbilicus (UTD),the maximum verticaldistance between the anterior abdominal skin and the back skin at the level of the xiphoid bone (XAPD),the maximum horizontal distance between the.anterior abdominal skin and the back skin at the level of the xiphoid bone (XTD),the distance between the anterior abdominal skin and the root of celiac artery (CAD) and the maximum horizontal distance at a right angle to CAD (CATD) were measured using preoperative imaging examinations.Observation indicators:(1) intraoperative and postoperative situations;(2) follow-up situations;(3) risk factors analysis of perioperative complications;(4) influence of body shape related indexes on intraoperative situations and postoperative recovery:① Pearson univariate correlation analysis,② liner regression model analysis.Followup using outpatient examination and telephone interview was performed to detect the postoperative survival and tumor recurrence or metastasis up to December 2018.Measurement data with normal distribution were represented as Mean±SD.Measurement data with skewed distribution were described as M (range).Comparisons of count data were analyzed using the chi-square test.Comparisons of ordinal data were analyzed by Mann-Whitney U nonparametric test.Risk factors of perioperative complications of laparoscopic distal gastrectomy were analyzed by Logistic regression model.Influence of body shape related indexes on intraoperative situations and postoperative recovery was analyzed by Pearson univariate correlation analysis and liner regression model.Results (1) Intraoperative and postoperative situations:all the 506 patients underwent successful laparoscopic distal gastrectomy,including 103 with Billroth Ⅰ anastomosis,140 with Billroth Ⅱ anastomosis,201 with Billroth Ⅱ + Braun anastomosis,62 with Roux-en-Y anastomosis.The operation time,volume of intraoperative blood loss,number of lymph nodes dissected,time to postoperative anal exsufflation,time for initial fluid diet intake,time for initial semi-fluid diet intake and duration of postoperative hospital stay were (233±44)minutes,(102±86)mL,34±13,(3.6±1.5)days,(5.8±3.3)days,(8.3±3.8)days,(12.2±5.7)days respectively in the 506 patients.Of 506 patients,196 were defined as pathological stage Ⅰ,122 were defined as pathological stage Ⅱ and 188 were defined as pathological stage Ⅲ postoperatively.Of 506 patients,93 had 106 times of perioperative complications,including 33 times of pulmonary and upper respiratory infection,12 times of incisional infection,11 times of anastomotic leakage,11 times of abdominal infection,8 times of intestinal obstruction,8 times of gastroplegia,6 times of abdominal hemorrhage,5 times of bacteremia,3 times of anastomotic hemorrhage,3 times of lymph fluid leakage,2 times of pancreatic leakage,1 time of urinary infection,1 time of anatomotic stenosis,1 time of deep venous thrombosis and 1 time of pulmonary embolism;the same patient can merge multiple complications.Eleven patients were in the Clavien-Dindo classification ≥ Ⅲ.(2) Follow-up situations:465 of 506 patients were followed up for 1-32 months with a median time of 12 months.During the follow-up,451 had postoperative survival and 38 had tumor recurrence or metastasis.(3) Risk factors analysis of perioperative complications.① Results of univariate analysis showed that age,body mass index (BMI),preoperative hemoglobin,preoperative serum albumin and XAPD were related factors affecting perioperative complications of laparoscopic distal gastrectomy (x2 =10.289,7.427,5.269,5.481,4.285,P< 0.05).② Results of multivariate analysis showed that age,BMI,preoperative serum albumin were independent related factors affecting perioperative complications of laparoscopic distal gastrectomy (odds ratio =1.033,1.118,0.937,95% interval confidence:1.011-1.057,1.025-1.219,0.887-0.990,P<0.05).(4) Influence of body shape related indexes on intraoperative situations and postoperative recovery.① Results of Pearson univariate correlation analysis showed correlations between UAPD,XAPD,CAD,CATD and volume of intraoperative blood loss (r=0.107,0.169,0.179,0.106,P<0.05),between UAPD,XAPD,CAD and the number of lymph nodes dissected (r=-0.137,-0.143,-0.173,P<0.05),between USCF,XAPD and time to postoperative anal exsufflation (r =0.122,0.109,P<0.05),between USCF,XAPD,CAD and time for initial fluid diet intake (r=0.132,0.108,0.132,P<0.05),between USCF,XAPD and duration of postoperative hospital stay (r=0.116,0.100,P<0.05).② Results of liner regression model analysis showed a positive correlation between CAD and volume of intraoperative blood loss (r =6.776),a negative correlation between CAD and the number of lymph nodes dissected (r =-0.841),with statistically significant differences (t =2.410,-1.992,P< 0.05);a positive correlation between USCF and time to postoperative anal exsufflation (r=0.170),between USCF and time for initial fluid diet intake (r=0.365),between USCF and duration of postoperative hospital stay (r=0.636) respectively,with statisticallysignificant differences (t =2.188,1.981,2.107,P< 0.05).Conclusions Abdominal shape can influence intraoperative situations and postoperative recovery of laparoscopic distal gastrectomy,but cannot increase risks ofperioperative complications.Age,BMI and preoperative serum albumin are independent related factors affecting perioperative complications of laparoscopic distal gastrectomy.

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