1.The efficacy and safety of linagliptin in elderly patients with type 2 diabetes: a pooled analysis of eight placebo-controlled clinical trials
Xiaohui GUO ; Zhikai FENG ; Linhua XU
Chinese Journal of Internal Medicine 2017;56(8):588-594
Objective To evaluate the efficacy and safety of dipeptidyl peptidase-4 inhibitor,linagliptin,in subjects aged 60 years or older with type 2 diabetes mellitus (T2DM).Methods Data from eight 24-week,multinational,multicenter,randomized,double-blind,placebo-controlled,parallel-group studies were analyzed.Patients aged 60 years or older with T2DM were received oral linagliptin (5 mg/d) or placebo in combination with mefformin,or metformin plus sulfonylurea.Efficacy was assessed by the changes in glycosylated hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) from baseline to 24 weeks of treatment.Safety endpoint included the frequency and intensity of adverse events.Results A total of 1 421 patients (placebo 429,linagliptin 992) were included in the full analysis set (FAS).Mean ages of the subjects were (67.4 ± 5.6) years in the linagliptin group and (66.7-± 5.6) years in the placebo group.Baseline HbA1c was (8.0 ±0.8) % in the linagliptin group and (8.1 ±0.9) % in the placebo group.At the end of 24-week,placebo-adjusted reduction in HbAlc in subjects with linagliptin was (0.7 ±0.1)% (95% CI 0.6-0.8,P <0.000 1),and placebo-adjusted reduction in FPG in subjects with linagliptin was (0.88 ±0.12) mmol/L(95% CI 0.65-1.11,P <0.000 1).Overall safety and tolerability in the two groups were similar.Adverse events occurred in 57.1% of patients in the placebo group and 61.1% of patients in the linagliptin group,and the incidence of adverse events leading to discontinuation was 3.2% in the placebo group and 3.8% in the linagliptin group.Serious adverse events occurred in 1.6% of patients in the placebo group and 2.8% of patients in the linagliptin group.Investigator-defined hypoglycaemia occurred in 7.3% of patients in the placebo group and 11.9% of patients in the linagliptin group.Among them,most were mild or moderate hypoglycaemia,and severe hypoglycaemia only occurred in 0.2% of patients in the placebo and 0.5% in the linagliptin groups.Overall incidence of hypoglycaemia in linagliptin group was slightly higher than that in placebo group,which might be due to the fact that more patients were taking sulfonylureas in linagliptin group than in placebo group (26.8% linagliptin;18.4% placebo).No difference could be viewed in hypoglycaemia between the two groups in patients without sulfonylureas (1.2% linagliptin,1.1% placebo)Moreover,no severe hypoglycaemia was reported in subjects without sulfonylureas.The incidences of other adverse events were similar in both groups.Conclusion Linagliptin was efficacious in lowering glucose with a safety profile similar to placebo in type 2 diabetic patients aged 60 years or older.
2.Diagnosis and treatment of 112 patients with solid pseudopapillary neoplasm of the pancreas
Zhikai JIAO ; Ningning FENG ; Yan DING ; Jionghui FU ; Yueshan ZHANG ; Baoming YANG ; Xi KANG ; Shunxiang WANG
Chinese Journal of General Surgery 2021;36(11):831-834
Objective:To study the clinicopathological features, diagnosis, treatment and prognosis of patients with solid pseudopapillary neoplasm of the pancreas (SPN).Methods:From Jan 2008 to Dec 2017, 112 pathology confirmed SPN patients who underwent surgical treatment at the Fourth Hospital of Hebei Medical University were followed up. The clinicopathological characteristics and diagnosis were analyzed.Results:Most SPN patients were young women, the ratio of male to female is 1∶7. SPN patients have no typical clinical symptoms. The preoperative diagnostic accuracy of SPN was 57.14% with imaging examination. Pathological diagnosis depends mainly on immunohistochemical staining. All patients underwent surgical resection. Follow-up ranged from 4 to 123 months. The mean follow-up time was 49 months. All patients were doing well and no recurrence or metastasis was found.Conclusions:SPN is a rare tumor with low malignant potential. Surgical resection is effective.
3.Clinical efficacy of laparoscopic surgery for infected pancreatic necrosis in subgastric approach
Feng FENG ; Chen XU ; Zhikai YANG ; Weihong ZHAO ; Ang LI ; Jingpo ZHANG ; Wei WANG ; Yueyao SUN ; Yong LI ; Fengshan LI ; Jianhua LIU
Chinese Journal of Pancreatology 2022;22(6):426-431
Objective:To investigate the technical key points and clinical effects of laparoscopic surgery using the subgastric approach for infected pancreatic necrosis (IPN).Methods:From October 2020 to October 2021, The clinical data of 6 patients with IPN after severe acute pancreatitis (SAP) undergoing laparoscopic surgery using the subgastric approach at First Hospital and Second Hospital of Hebei Medical University was retrospectively analyzed. Parameters in this report included the operation time, estimated blood loss, and the patient's vital signs, inflammatory marker CRP, and WBC before operation and postoperative 24 h, 3 d, and 1 w, and postoperative complications including pancreatic leakage, organ failure, bleeding, and abdominal infection and incision infection. Follow-up after surgery was completed in outpatient checkups and long-term complications were recorded.Results:There were 4 male and 2 female patients. The median age of the 6 patients was 50 (43.5, 56.5) years. Laparoscopic debridement surgery using the subgastric approach was successfully completed in all the patients and no reoperation was needed. The median operation time was 65 (52.5, 85) min; the median estimated blood loss was 20 (25, 37.5) ml. Median APACHEⅡ score one day before surgery was 11.5 (10.25, 12.75) and the median MCTSI score at initial admission was 8 (7, 8). The inflammatory parameters including CRP, WBC, and neutrophil count on postoperative day 3 and 1w were significantly lower than those before surgery, and all the differences were statistically significant (all P value <0.05). One patient had a postoperative pancreatic fistula and was alleviated after ERCP with pancreatic stent implantation. Another patient had a incision infection after surgery and recovered after complete surgical drainage of the abdominal wall incision. No patients had complications such as heart, lung, and kidney failure, abdominal hemorrhage and infection. During the follow-up, 5 of 6 patients had no newly-occurred diabetes, except one patient who had diabetes before the operation. None of the 6 patients had recurrent IPN. Conclusions:Laparoscopic surgery using the subgastric approach for infected IPN in lesser omental sac is safe and feasible.
4.Association between perfluoroalkyl and polyfluoroalkyl substances and maternal thyroid-related hormones in pregnant women
Xin WANG ; Lan YANG ; Zhikai WANG ; Xing FENG ; Honglei JI ; Hong LIANG ; Xiuxia SONG ; Maohua MIAO
Journal of Environmental and Occupational Medicine 2023;40(6):661-666
Background Exposure to perfluoroalkyl and polyfluoroalkyl substances (PFAS) during pregnancy might affect thyroid-related hormone levels in pregnant women. However, most previous studies focused on the effects of PFAS containing 8-10 carbon atoms, and few studies have estimated the associations between PFAS with longer carbon chain and thyroid-related hormone levels. Objective To examine the associations between PFAS exposure and thyroid-related hormones in pregnant women. Methods The present study was based on the Jiashan Birth Cohort from September 2016 to April 2018. We analyzed 13 PFAS in maternal blood samples (n=781) by high-performance liquid chromatography-tandem mass spectrometry, as well as total triiodothyronine (T3), total thyroxine (T4), free T3 (FT3), free T4 (FT4), thyroid stimulating hormone (TSH), thyroglobulin antibody (TG-Ab), and thyroid peroxidase antibody (TPOAb) by electrochemiluminescence immunoassay. PFAS were divided into three groups:low concentration, medium concentration and high concentration according to the tertile of their concentrations. We estimated the associations between PFAS concentrations and thyroid-related hormones in pregnant women by multiple linear regression. Results In the multiple linear regression models, a change in perfluorododecanoic acid (PFDoA) concentrations from the low concentration group to the high concentration group was associated with a −0.10 (95%CI: −0.20, 0) nmol·L−1 change in T3, −0.15 (95%CI: −0.28, −0.02) pmol·L−1 change in FT3, and −3.02 (95%CI: −5.66, −0.39) pmol·L−1 change in FT4, respectively. A change in perfluorotridecanoic acid (PFTrDA) concentrations from the low concentration group to the high concentration group was associated with a −0.10 (95%CI: −0.20, 0) nmol·L−1 change in T3. Compared with the low concentration group, the concentration of T4 in the medium concentration group of perfluorohexane sulfonate (PFHxS) increased by 6.10 (95%CI: 0.44, 11.75) nmol·L−1. No statistically significant associations were found between PFAS and TSH concentration. The negative associations of PFAS with thyroid-related hormones were more pronounced in pregnant women with positive TG-Ab and/or TPOAb. Conclusion Exposure to PFAS during pregnancy may affect thyroid-related hormone homeostasis in pregnant women, and the effect is stronger in TG-Ab and/or TPOAb-positive pregnant women.