ObjectiveTo systematically evaluate the efficacy and safety of omental wrapping technique for pancreaticojejunal anastomosis in preventing complications after pancreaticoduodenectomy. MethodsThis study was conducted according to the PRISMA guideline. English and Chinese databases including CNKI， Wanfang Data， VIP， CBM， the Cochrane Library， PubMed， Embase， and Web of Science were searched for clinical studies on omental wrapping technique for pancreaticojejunal anastomosis in preventing complications after pancreaticoduodenectomy published up to November 2022， and Stata 16 and Review Manager 5.4 were used to perform the meta-analysis. ResultsA total of 15 studies with 1 830 patients were included in this study. The meta-analysis showed that the omental wrapping group had a significantly lower overall incidence rate of postoperative pancreatic fistula （POPF） than the non-omental wrapping group （odds ratio ［OR］=0.30， 95% confidence interval ［CI］： 0.22‍ ‍—‍ ‍0.41， P<0.001）， and the subgroup analysis showed that the omental wrapping group had a significantly lower incidence rate of grade B/C POPF than the non-omental wrapping group （OR=0.29， 95%CI： 0.21‍ ‍—‍ ‍0.39， P<0.001）. Compared with the non-omental wrapping group， the omental wrapping group had significantly lower incidence rates of postoperative bile leakage （OR=0.30， 95%CI： 0.16‍ ‍—‍ ‍0.56， P<0.001）， postoperative hemorrhage （OR=0.35， 95%CI： 0.24‍ ‍—‍ ‍0.53， P<0.001）， delayed gastric emptying （OR=0.45， 95%CI： 0.31‍ ‍—‍ ‍0.64， P<0.001）， abdominal infection （OR=0.55， 95%CI： 0.40‍ ‍—‍ ‍0.75， P<0.001）， reoperation （OR=0.31， 95%CI： 0.18‍ ‍—‍ ‍0.54， P<0.001）， and death within 30 days after surgery （OR=0.42， 95%CI： 0.22‍ ‍—‍ ‍0.80， P=0.009）， a significantly earlier time to diet （mean difference ［MD］=-0.98， 95%CI： -1.84 to -0.11， P=0.03）， and a significantly shorter length of postoperative hospital stay （MD=-2.44， 95%CI： -4.10 to -0.77， P=0.004）. There were no significant differences between the two groups in the time of operation （MD=-13.68， 95%CI： -28.31 to -0.95， P=0.07） and intraoperative blood loss （MD=-17.26， 95%CI： -57.55 to -23.03， P=0.40）. ConclusionOmental wrapping can reduce the incidence rates of postoperative complications such as pancreatic fistula， bile leakage， postoperative hemorrhage， abdominal infection， and delayed gastric emptying， improve the prognosis of patients， and shorten the length of hospital stay， without increasing surgical difficulty or time of operation.

Objective:To determine the correlation of tumor volume and weight with biochemical parameters in patients with parathyroid adenoma (PA) .Methods:A prospective electronic database collected clinical data on 208 patients with PA treated for the first time by surgery at department of general surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College.The relationship between biochemical parameters and tumor volume and weight was analyzed with Spearman’s correlation.Results:Tumor volume and weight were positively correlated with parathyroid hormone (PTH) ( r=0.33, P<0.001; r=0.39, P<0.001), calcium ( r=0.16, P=0.018; r=0.18, P=0.007) and alkaline phosphatase levels ( r=0.24, P<0.001; r=0.27, P<0.001), respectively. Clinical correlates affecting serum PTH were age, serum calcium and tumor weight ( F=30.325, P<0.001) . Conclusions:Tumor burden in patients with PA correlates with some laboratory biochemical parameters. Age and cystic lesions of the tumor may influence the actual serum PTH levels.

Background and purpose:For patients with human epidermal growth factor receptor 2(HER2)-positive metastatic breast cancer,trastuzumab treatment can prolong the overall survival and significantly improve the prognosis of patients.However,the reference original research trastuzumab(Herceptin?)is more expensive.Biosimilars have comparable efficacy and safety profiles while increasing patient access to treatment.This clinical trial aimed to evaluate the efficacy,pharmacokinetics,safety and immunogenicity of the trastuzumab biosimilar AK-HER2 compared to trastuzumab(Herceptin?)in patients with HER2-positive metastatic breast cancer.Methods:This multi-center,randomised,double-blind phase Ⅲ clinical trial was conducted in 43 subcenters in China.This study complied with the research protocol,the ethical principles stated in the Declaration of Helsinki and the quality management standards for drug clinical trials.It was approved by the hospital's medical ethics committee.The clinical trial registration agency is the State Food and Drug Administration(clinical trial approval number:2015L04224;clinical trial registration number:CTR20170516).Written informed consent was obtained from subjects before enrollment.Enrolled patients were randomly assigned to the AK-HER2 group and the control group,respectively receiving AK-HER2 or trastuzumab(initial loading dose 8 mg/kg,maintenance dose 6 mg/kg,every 3 weeks as a treatment cycle,total treatment time is 16 cycles)in combination with docetaxel(75 mg/m2,treatment duration is at least 9 cycles).The primary endpoint of this clinical trial was the objective response rate(ORR9)between the AK-HER2 group and the control group in the 9th cycle.Secondary efficacy endpoints included ORR16,disease control rate(DCR),clinical benefit rate(CBR),progression-free survival(PFS)and 1-year survival rate.In this study,100 subjects(AK-HER2 group to control group=1:1)were randomly selected for blood sample collection after the 6th cycle of medication,The collection time points were 45 minutes after infusion(the end of administration),4,8,24,72,120,168,336,and 504 hours after the end of administration.After collection,blood samples were analyzed by PK parameter set(PKPS).Other evaluation parameters included safety and immunogenicity assessment.Results:A total of 550 patients with HER2-positive metastatic breast cancer were enrolled in this clinical trial between Sep.2017 and Mar.2021.In the AK-HER2 group(n=237),129 subjects in the experimental group achieved complete response(CR)or partial response(PR),and the ORR9 was 54.4%.There were 134 subjects in the control group(n=241)who achieved CR or PR,and the ORR9 was 55.6%.The ORR9 ratio between the AK-HER2 group and the control group was 97.9%[90%confidence interval(CI):85.4%-112.2%,P=0.784],which was not statistically significant.In all secondary efficacy endpoints,no statistically significant differences were observed between the two groups.We conducted a mean ratio analysis of pharmacokinetics(PK)parameters between the AK-HER2 group and the control group,and the results suggested that the pharmacokinetic characteristics of the two drugs are similar.The incidence of treatment emergent adverse event(TEAE)leading to drug reduction or suspension during trastuzumab treatment was 3.6%(10 cases)in the AK-HER2 group and 8.1%(22 cases)in the control group.There was statistically significant difference between the two groups(P=0.027).The incidence rate was significantly lower in the AK-HER2 group than in the control group,and there was no statistically significant difference among the other groups.The differences in the positive rates of anti-drug antibodies(ADA)and neutralizing antibodies(NAB)between groups were of no statistical significance(P=0.385 and P=0.752).Conclusion:In patients with HER2-positive metastatic breast cancer,AK-HER2 was comparable to the trastuzumab(Herceptin?)in terms of drug efficacy,pharmacokinetics,safety and immunogenicity.

ObjectiveTo explore the protective effect and mechanism of Zingiberis Rhizoma Recens alcohol extract on lipopolysaccharide （LPS）-induced acute lung injury in mice. MethodBalb/c mice were randomly divided into normal group， model group， dexamethasone group， and low- and high-dose Zingiberis Rhizoma Recens groups. Mice in the normal group were instilled with normal saline through the nose， and the other groups were instilled with normal saline containing LPS （50 μg）. After 30 minutes of modeling， the dexamethasone group was gavaged with 5 mg·kg^-1 of dexamethasone acetate solution， the low- and high-dose Zingiberis Rhizoma Recens groups were gavaged with different doses of （7， 14 g·kg^-1） of Zingiberis Rhizoma Recens alcohol extract， and the normal group and the model group were gavaged with the same volume of water. After 24 hours of modeling， the total number of white blood cells in bronchoalceolar lavage fluid （BALF） was detected by cell counter， and the levels of the inflammatory factors including tumor necrosis factor （TNF）-α， interleukin （IL）-1β， IL-6， and superoxide dismutase （SOD）， and myeloperoxidase （MPO） was detected by enzyme-linked immunosorbent assay （ELISA）. Haematoxylin-eosin （HE） staining method was used to observe the pathological changes of lung tissue in each group， and the Western blot was used to detect the protein expression of nuclear transcription factor （NF）-κB p65， phosphorylation （p）-NF-κB p65， and Toll-like receptor 4 （TLR4） in lung tissue. ResultCompared with the normal group， the white blood cell count in BALF and the levels of TNF-α， IL-1β， IL-6， and MPO in the model group was increased （P<0.01）， and the level of SOD was decreased （P<0.05）. Pathological damage of lung tissue was obvious， and the protein expression of NF-κB p65， p-NF-κB p65， and TLR4 in lung tissue was increased （P<0.01）. Compared with the model group， the white blood cell count in BALF and the levels of TNF-α， IL-1β， IL-6， and MPO in the treatment group was decreased （P<0.05，P<0.01）， and the level of SOD was increased （P<0.05，P<0.01）. Pathological damage of lung tissue was alleviated， and the protein expression of NF-κB p65， p-NF-κB p65， and TLR4 in lung tissue was decreased （P<0.01）. ConclusionZingiberis Rhizoma Recens alcohol extract may play a protective role in LPS-induced acute lung injury in mice by inhibiting the TLR4/NF-κB signaling pathway.

Objective To explore the safety and effectiveness of transvaginal ischia spinous fascia fixation for pelvic organ prolapse.Methods The retrospective analysis of 124 patients who underwent surgical treatment for stage Ⅲ-Ⅳ pelvic organ prolapse was conducted.Among them, 53 cases of transvaginal ischia spinous fascia fixation (IS-FF) were performed as a study group (ISFF group) while 71 cases of transvaginal sacrospinous ligament fixation (SSLF) were performed as a control group (SSLF group) .The operation time, postoperative hospitalization days, preoperative and postoperative hemoglobin values, indwelling urinary catheter time, postoperative pain scores, and the occurrence of complications were compared between the two groups, and the efficacy of the operation was objec-tively evaluated by using the staging method of pelvic organ prolapse (POP-Q) .Also the scores of the pelvic floor impact questionnaire-7 (PFIQ-7) , the pelvic floor dysfunction questionnaire-20 (PFDI-20) , and the questionnaire of quality of life12 (PISQ-12) were used to evaluate the patients' postoperative quality of life.Results The oper-ation time and postoperative hospitalization days of patients in the ISFF group were less than those in the SSLF group , and the differences were statistically significant (P<0.05) .The preoperative and postoperative hemoglobin values, retention time of urinary catheter, postoperative pain scores, and hospitalization costs of patients in the two groups were compared, and the differences were not statistically significant.At the 3-month postoperative outpatient follow-up, the objective success rate was 100％ in two groups.The median follow-up time of patients in both groups was 24 months (12-41 months) , and there were 2 cases of recurrence in the ISFF group, with a recurrence rate of 3.77％ and a subjective success rate of 96.23％.While there were 3 cases of recurrence in the SSLF group and 2 cases of loss of visit, with a recurrence rate of 4.34％ and a subjective success rate of 95.65％.1 patient in the SSLF group presented with a pelvic hematoma with a diameter of about 5 cm after surgery.The hematoma disap-peared after hemostasis and other symptomatic treatment.There was no organ injury or blood transfusion in both groups.Conclusion Transvaginal ischia spinous fascia fixation is a safe and effective treatment for pelvic organ prolapse, and it has the advantages of short operation time, fast postoperative recovery, fewer complications, and improvement of patients' quality of life.

Objective Meta-analysis was used to summarize the current status of medication adherence in patients with type 2 diabetes mellitus and to clarify the characteristics of people with low medication adherence.Methods Relevant literatures were searched in Pubmed,Cochrane Library,Web of Science,Embase,CINAHL,CBM,China National Knowledge Infrastructure,Wanfang Data,and VIP.Two researchers conducted literature screening,data extraction and quality evaluation.Stata 16.0 software was used for subgroup analysis,sensitivity analysis,offset analysis.Results A total of 42 papers were included,and the overall medication adherence of middle-aged and elderly type 2 diabetes patients ranged from 18.37%-96.53%.The medication adherence was higher among those with high education level(63%),married(61%),not living alone(50%),monthly income>3000 RMB/month(64%),having medical insurance(49%),good psychological status(61%),no chronic co-morbidities(66%),having knowledge about the disease(53%),taking≤3 types of medication(58%),convenient access to medical care(58%),and good doctor-patient relationship(50%).Conclusion The medication adherence of patients with type 2 diabetes mellitus varies greatly among different subgroups.In the future,the specific influencing factors should be further explored to formulate targeted policies and intervention measures to improve patients'medication adherence and improve their health and quality of life.

Objective To systematically evaluate the efficacy and acceptability of non-pharmaceutical intervention(NPI)for depression in patients with mild cognitive impairment(MCI).Methods Randomized controlled trials of NPI in treatment of depression patients with MCI published in PubMed,Embase,Web of Science,CINAHL,Cochrane Library,CNKI,Wanfang Data,VIP and CBM databases were searched from self-built databases to January 6,2024,and performed a network Meta-analysis using Stata 14.0 software.Results A total of 55 literatures were included,involving 10 NPIs.According to the surface under the cumulative ranking curve(SUCRA),the top 3 curative effects were cognitive behavioral therapy(CBT),Chinese traditional sport(CTS)and art therapy,the top 3 acceptability were CBT,CTS,and health education.Conclusion CBT and CTS may be effective and acceptable NPI for improving depression in patients with MCI,and individualized interventions can be tailored to the patient's situation to achieve the best results.

Background::Although overnight fasting is recommended prior to endoscopic retrograde cholangiopancreatography (ERCP), the benefits and safety of high-carbohydrate fluid diet (CFD) intake 2 h before ERCP remain unclear. This study aimed to analyze whether high-CFD intake 2 h before ERCP can be safe and accelerate patients’ recovery.Methods::This prospective, multicenter, randomized controlled trial involved 15 tertiary ERCP centers. A total of 1330 patients were randomized into CFD group ( n = 665) and fasting group ( n = 665). The CFD group received 400 mL of maltodextrin orally 2 h before ERCP, while the control group abstained from food/water overnight (>6 h) before ERCP. All ERCP procedures were performed using deep sedation with intravenous propofol. The investigators were blinded but not the patients. The primary outcomes included postoperative fatigue and abdominal pain score, and the secondary outcomes included complications and changes in metabolic indicators. The outcomes were analyzed according to a modified intention-to-treat principle. Results::The post-ERCP fatigue scores were significantly lower at 4 h (4.1 ± 2.6 vs. 4.8 ± 2.8, t = 4.23, P <0.001) and 20 h (2.4 ± 2.1 vs. 3.4 ± 2.4, t= 7.94, P <0.001) in the CFD group, with least-squares mean differences of 0.48 (95% confidence interval [CI]: 0.26–0.71, P <0.001) and 0.76 (95% CI: 0.57–0.95, P <0.001), respectively. The 4-h pain scores (2.1 ± 1.7 vs. 2.2 ± 1.7, t = 2.60, P = 0.009, with a least-squares mean difference of 0.21 [95% CI: 0.05–0.37]) and positive urine ketone levels (7.7% [39/509] vs. 15.4% [82/533], χ2 = 15.13, P <0.001) were lower in the CFD group. The CFD group had significantly less cholangitis (2.1% [13/634] vs. 4.0% [26/658], χ2 = 3.99, P = 0.046) but not pancreatitis (5.5% [35/634] vs. 6.5% [43/658], χ2 = 0.59, P = 0.444). Subgroup analysis revealed that CFD reduced the incidence of complications in patients with native papilla (odds ratio [OR]: 0.61, 95% CI: 0.39–0.95, P = 0.028) in the multivariable models. Conclusion::Ingesting 400 mL of CFD 2 h before ERCP is safe, with a reduction in post-ERCP fatigue, abdominal pain, and cholangitis during recovery.Trail Registration::ClinicalTrials.gov, No. NCT03075280.

OBJECTIVES: To explore the effects of hypoxic and hypobaric conditions on blood gas and erythrocyte-related indicators in rats. METHODS: SD male rats were exposed to low-pressure hypoxic conditions simulating an altitude of 6500 m in a small or a large experimental cabin. Abdominal aortic blood samples were collected and blood gas indicators, red blood cells (RBCs) count, and hemoglobin (Hb) content were measured. The effects of exposure to different hypoxia times, different hypoxia modes, normal oxygen recovery after hypoxia, and re-hypoxia after hypoxia preconditioning on blood gas indicators, RBCs count and Hb content were investigated. RESULTS: The effect of blood gas indicators was correlated with the length of exposure time of hypoxia and the reoxygenation after leaving the cabin. Hypoxia caused acid-base imbalance and its severity was associated with the duration of hypoxia; hypoxia also led to an increase in RBCs count and Hb content, and the increase was also related to the time exposed to hypoxia. The effects of reoxygenation on acid-base imbalance in rats caged in a small animal cabin were more severe that those in a large experimental cabin. Acetazolamide alleviated the effects of reoxygenation after leaving the cabin. Different hypoxia modes and administration of acetazolamide had little effect on RBCs count and Hb content. Normal oxygen recovery can alleviate the reoxygenation and acid-base imbalance of hypoxic rats after leaving the cabin and improve the increase in red blood cell and hemoglobin content caused by hypoxia. The improvement of hypoxia preconditioning on post hypoxia reoxygenation is not significant, but it can alleviate the acid-base imbalance caused by hypoxia in rats and to some extent improve the increase in red blood cell and hemoglobin content caused by hypoxia. CONCLUSIONS Due to excessive ventilation and elevated RBCs count and Hb content after hypoxia reoxygenation, oxygen partial pressure and other oxygenation indicators in hypoxic rats are prone to become abnormal, while blood gas acid-base balance indicators are relatively stable, which are more suitable for evaluating the degree of hypoxia injury and related pharmacological effects in rats.
Rats ; Animals ; Male ; Acetazolamide ; Hypoxia ; Oxygen ; Erythrocytes ; Hemoglobins ; Acid-Base Imbalance

Objective:The development of traditional Chinese medicine(TCM)in the plateau area is relatively backward.There is a lack of system to analyze the effects of the special environment of plateau low pressure and hypoxia on human meridians qi and blood,as well as the etiology and pathogenesis of plateau hypoxic diseases.To analyze the composition rules of anti-hypoxia TCM formulation with data mining methods. Methods:The experimental literatures related to high altitude hypoxia were searched in China National Knowledge Infrastructure(CNKI),Wanfang Med Online,VIP,China Biology Medicine disc and other databases,a standardized prescription database was established after screening and standardization of prescription data in the literature.The composition rules of these prescription including drug frequency,drug attributes,drug efficacy,drug combination,and core prescription were analyzed and displayed with visual charts. Results:A total of 135 TCM prescriptions were included,and 229 flavored drugs were included.Among these prescriptions,the TCM with high frequency of use were Astragalus,Danshen,Ginseng,and Angelica,etc.Four natures of the TCM were mostly warm and calm.Five flavours of the TCM were mostly sweet,bitter,and pungent.And channel tropism of the TCM mostly entered the heart,lung,and liver meridians.The frequency combination of TCM was Astragalus-Danshen and Astragalus-Angelica.The core medicines of these prescriptions were Astragalus,Danshen,Angelica,Rhodiola,Goji,and Ginseng.TCM could alleviate symptoms such as chest tightness,chest pain,coughing and wheezing,coughing,vomiting,fatigue,and loss of appetite caused by hypoxia at high altitude. Conclusion:Through data mining,it is concluded that the prevention or treatment of plateau hypoxic diseases mostly utilized products can nourish blood,replenish qi and dispel stasis,and help yang and dispel qi,most of them are compatible with qi tonic drugs and blood circulation and stasis dissolving drugs,and pay attention to the combination of virtual and real,yin and yang.