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Objective:To explore the efficacy and safety of different anti-platelet regimens in the treatment of high-risk non-disabling ischemic cerebrovascular events (HR-NICE) guided by point-of-care testing of CYP2C19 gene. Methods:A single-centre, prospective, randomised, open-label, and blinded endpoint design was uesd in the study. From July 2020 to January 2022, HR-NICE patients were enrolled in the Stroke Green Channel and Department of Neurology of Xuzhou Central Hospital, and all patients were scraped the buccal mucosa for screening for CYP2C19 loss-of-function allele carriers by point-of-care testing . Patients with intermediate metabolism were defined as those who carried 1 loss-of-function allele and patients with poor metabolism were those who carried 2 loss-of-function alleles. This study reduced the test turnaround time to 1 hour by using a fully automated medical polymerase chain reaction analyzer for a point-of-care test of CYP2C19 genotype. CYP2C19 loss-of-function allele carriers were divided according to the random number table method into the conventional treatment group (clopidogrel 75 mg, once a day), the ticagrelor group (ticagrelor 90 mg, twice a day) and the intensive dose group (clopidogrel 150 mg, once a day) separately combined with aspirin (100 mg, once a day) dual antiplatelet for 21 days. Baseline information, Acute Stroke Org 10172 Treatment Trial staging, 90-day modified Rankin Scale score, occurrence of adverse events and severe adverse events were collected for all the 3 groups. The primary efficacy outcome was new stroke within 90 days, and the primary safety outcome was severe or moderate bleeding within 90 days. Results:A total of 716 patients were included: 240 in the conventional treatment group, 240 in the ticagrelor group and 236 in the intensive dose group. There was no statistically significant difference between the 3 groups at baseline (all P>0.05). There were 26 cases (10.8%) with new stroke events in the conventional treatment group, 11 cases (4.6%) in the ticagrelor group and 4 cases (1.7%) in the intensive dose group, with statistically significant differences among the 3 groups (χ 2=19.28, P<0.05), and the differences between the conventional treatment group and the ticagrelor group (χ 2=6.59, P=0.010) and between the conventional treatment group and the intensive dose group (χ 2=16.83, P<0.001) were statistically significant, whereas the difference between the ticagrelor group and the intensive dose group was not statistically significant ( P>0.05). In the 3 groups, there was 1 case (0.4%) of severe bleeding in the conventional treatment group, 6 cases (2.5%) in the ticagrelor group and none in the intensive dose group, which showed statistically significant differences (χ 2=7.23, P<0.05), and there was statistically significant difference between the ticagrelor group and the intensive dose group ( P=0.030). Among the patients with intermediate CYP2C19 metabolism, there were 13 cases (13/158, 8.2%) with 90-day recurrent stroke in the conventional treatment group, 4 cases (4/153, 2.6%) in the ticagrelor group, and 0 case (0/159) in the intensive dose group, with statistically significant difference (χ 2=16.04, P<0.001), and the differences between the intensive dose group and the conventional treatment group were statistically significant (χ 2=13.64, P<0.001), whereas there was no statistically significant difference between the intensive dose group and the ticagrelor group ( P>0.05). In the patients with 90-day recurrent stroke in the intensive dose group, there was 0 case (0/159) with intermediate metabolism and 4 cases (4/77,5.2%) with poor metabolism, with statistically significant differences ( P=0.011), whereas there were no statistically significant differences in the conventional treatment group and the ticagrelor group ( P>0.05). Conclusions:Screening carriers of CYP2C19 loss-of-function alleles by point-of-care testing can quickly and precisely guide the treatment of patients with non-cardiogenic HR-NICE. An intensive clopidogrel dose of 150 mg, once a day combined with aspirin was effective in reducing stroke recurrence with less occurrence of any bleeding and adverse events, and patients with intermediate CYP2C19 metabolism may be the best population to benefit.
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Objective:To investigate the clinical efficacy of butylphthalide combined with hyperbaric oxygen therapy on post-stroke cognitive impairment in patients with acute ischemic stroke.Methods:A total of 90 patients with post-stroke cognitive impairment who were hospitalized within 72 hours of onset in Suining County People's Hospital from December 2019 to November 2020 were included in this study. They were randomly divided into a control group and an observation group ( n = 45/group). The control group was given conventional treatment and the observation group was given butylphthalide combined with hyperbaric oxygen therapy in addition to conventional treatment. The National Institutes of Health Stroke Scale score, Montreal Cognitive Assessment score, and Activities of Daily Living score were compared between the two groups before and after treatment. Results:Before treatment, there were no significant differences in the National Institutes of Health Stroke Scale score, Montreal Cognitive Assessment score, and Activities of Daily Living score between the two groups (all P > 0.05). At 14 days and 1 month after surgery, the National Institutes of Health Stroke Scale scores in the observation group were (4.02 ± 2.18) points and (3.21 ± 2.03) points, which were significantly lower than (5.21 ± 2.24) points and (4.62 ± 2.68) points in the control group ( t =2.55, 2.81, both P < 0.05). At 1 and 3 months after treatment, the Montreal Cognitive Assessment score in the observation group were (19.79 ± 5.67) points and (23.69 ± 2.67) points, which were significantly higher than (16.88 ± 5.12) points and (19.74 ± 2.29) points in the control group ( t = 2.56, 7.53, both P < 0.05). At 1 and 3 months after treatment, Activities of Daily Living scores in the observation group were (54.85 ± 5.69) points and (74.38 ± 4.98) points, which were significantly higher than (46.78 ± 6.24) points and (63.21 ± 5.24) points in the control group ( t = 6.41, 9.76, both P < 0.05). Conclusion:Butylphthalide combined with hyperbaric oxygen therapy for the treatment of post-stroke cognitive impairment in patients with acute ischemic stroke can alleviate neurologic deficits, and improve cognitive function and the ability of daily life.
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Objective:To confirm the efficacy and safety of cinepazide maleate injection in acute ischemic stroke patients with obvious motor function deficit.Methods:This study is a subgroup analysis of multi-center, randomized, double-blind, placebo-controlled phase Ⅳ clinical trial. A total 812 patients of acute ischemic stroke with obvious limb motor deficit [motor function of limbs score in National Institutes of Health Stroke Scale (NIHSS) ≥4] were enrolled in this subgroup analysis. Patients received either cinepazide maleate injection or placebo. The treatment period was 14 days and follow-up was 90 days. The efficacy endpoints included the proportions of patients with a modified Rankin Scale (mRS) score ≤2, mRS score ≤1 and Barthel Index <95 on day 90. Safety was evaluated by recording all adverse events, monitoring vital signs, laboratory parameters and electrocardiogram.Results:A total of 732 patients were involved in the final efficacy analysis (361 in cinepazide maleate group and 371 in control group). The baseline limb motor function score of NIHSS was 5.23±1.43 in the cinepazide maleate group whereas 5.20±1.36 in the control group. Logistic regression analysis showed that following treatment for 90 days, the proportion of patients with a mRS score ≤2 was significantly higher in the cinepazide maleate group than in the control group [56.0% (202/361) vs 44.2% (164/371), OR=0.60, 95% CI 0.44-0.82, P=0.002]. The proportion of patients with a mRS score ≤1 was higher in the cinepazide maleate group than in the control group [43.3% (139/361) vs 35.2% (118/371), OR=0.69, 95% CI 0.50-0.97, P=0.031]. The proportion of patients with a Barthel Index <95 on day 90 was significantly lower in the cinepazide maleate group than in the control group [45.2% (145/361) vs 55.2% (185/371), OR=0.64, 95% CI 0.46-0.88, P=0.007]. During the treatment and follow-up period, the incidence of the most common adverse events in the cinepazide maleate group was 50.4% (199/395). Constipation and abnormal liver function were more common, but there were no statistically significant differences between the two groups. Conclusion:Cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery and safe in patients with acute ischemic stroke with obvious limb motor deficit.
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Objective:To establish and evaluate a predictive model for recurrence risk of Graves′ disease after antithyroid drugs(ATD) withdrawal.Methods:Among 308 patients with newly onset Graves′ disease taking ATD from 2012 to 2019, 170 patients who completed follow-up were enrolled and divided into relapse and remission groups according to whether hyperthyroidism reoccurred within 2 years after ATD withdrawal to establish the discovery cohort. An internal validation cohort was constructed by repeating the sampling with bootstrap. Cox regression analysis was used to screen risk factors and establish a predictive model, named Graves′ Recurrence Evaluation System(GRES). The differentiation and accuracy of GRES model were evaluated and compared with the GREAT score.Results:Of 170 patients, 90 Graves′ disease cases relapsed within 2 years after ATD withdrawal. According to Cox regression analysis, family history of Graves′ disease, younger age(<30 years), grade Ⅱ-Ⅲ goiter, high level of TRAb(≥13 IU/L), large thyroid volume(≥26.4 cm 3) and low 25(OH) D(<14.7 ng/mL) were included in the predictive model: PI=0.672×family history+ 0.405×age+ 0.491×severity of goiter+ 0.808×TRAb+ 1.423×thyroid volume+ 0.579×25(OH) D. PI≥1.449 was associated with a higher risk of recurrence after drug withdrawal. The GRES model has good prediction in assessing Graves′ disease relapse within 2 years after ATD withdrawal and better than GREAT score. Conclusion:GRES model can be used to evaluate the recurrence risk within 2 years for patients with newly onset Graves′ disease after ATD withdrawal, and facilitate clinicians to reasonably select treatment modalities in order to improve the remission rate.
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Late-onset hypogonadism (LOH) is an age-related testosterone deficiency syndrome. With the increasing aging of society, LOH results in impaired quality of life of middle-aged and elderly men. Although domestic and international guidelines have been issued in recent years, and the management of LOH became more standardized, numerous controversies still remained in the diagnosis of LOH, the benefits of testosterone replacement therapy (TRT) and therapeutic targets. Based on comparison of different guidelines, this review focuses on age cut-off , specific signs and symptoms of LOH, diagnostic cut-off level of testosterone, the advantages and disadvantages of TRT treatment, and non-testosterone therapy.
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Although traditional treatment for Graves′ disease(GD) displays some effects, it is imperative to explore new treatment methods. Based on the pathogenesis of GD, biologic agents developed by consumption of B lymphocytes and acting on thyroid stimulating hormone receptor(TSHR), such as monoclonal antibodies, TSHR antagonists and epitopes, can provide more options for patients with GD, and some new drugs are expected to be put into clinical practice. By restoring the damaged immune system and maintaining normal thyroid function continuously, it can avoid the disadvantages of conventional therapies such as long-term treatment, induction or aggravation of Graves ophthalmopathy, permanent hypothyroidism, and other complications. Preliminary experience suggests that thermotherapy is effective and safe for patients with refractory GD. In addition, the traditional Chinese medicine improves the symptoms and thyroid function of GD patients.The emergence of new therapeutic modalities and techniques will provide new approaches for the future treatment of GD and help clinicians to make the best decision.
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Objective:To evaluate the effects of ketogenic diet(KD) on pancreatic β-cell dedifferentiation in db/db mice.Methods:In animal study, 8-week-old db/db male mice with type 2 diabetes mellitus(T2DM) were randomly divided into 3 groups: T2DM model group(ND), KD group, 75% caloric restriction(CR) group, and male C57BL/6 mice of the same age as normal control group(C) fed with standard diet. Both C and ND groups were on ad lititum feeding of chow, the KD group was free to eat the ketogenic diet, and the CR group was the positive control group, consuming 75% of the calories of the ND group every day. Four weeks after different diet intervention, body weight, fasting blood glucose, fasting insulin, glucose tolerance and blood β-hydroxybutyric acid(BHB) were measured. Morphology and structure of pancreatic islet was observed by hematoxylin-eosin staining(HE). Immunofluorescence co-staining was used to observe the expression of mouse pancreatic β-cell specific transcription factors.Results:After 4 weeks diet intervention, the fasting blood glucose, insulin and the area under the curve of blood glucose in KD group was significantly decreased( P<0.05); When compared with ND group, the morphology and structure of the islets in the KD group were more regular, and the number of islet cells increased as revealed with HE staining. Pancreatic immunofluorescence co-assay showed that KD not only restored the number and arrangement of β-cells and the ratio of β/α-cell in the pancreatic islets, but also reversed the expression of specific β-cell transcription factors such as pancreatic duodenal homeobox factor-1(PDX1). Conclusion:KD can reduce fasting blood glucose, fasting insulin and improve glucose tolerance in db/db mice, which may be related to its ability to restore the expression of specific β-cell transcription factors and reverse the dedifferentiation of pancreatic β-cells.
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Objective:To evaluate the effect of short-term very low-calorie restriction(VLCR) on glycemic control in overweight/obese patients with type 2 diabetes, and to explore mechanisms through identifying markers of gut microbiota.Methods:This trial was conducted in 14 adult overweight/obese patients with type 2 diabetes. They received VLCR for 9 days in the hospital(calorie intake 300-600 kcal/d). Before and after VLCR, body weight(BW), waist circumference(WC), blood pressure(BP), and heart rate(HR) were measured, and body mass index(BMI) was calculated according to their height and weight. Fasting blood glucose(FBG), 2 h postprandial blood glucose(2hPBG), fasting insulin(FINS), triglycerides(TG), total cholesterol(TC), high-density lipoprotein-cholesterol(HDL-C), and low-density lipoprotein-cholesterol(LDL-C) were determined, and yielded the homeostasis model assessment for insulin resistance(HOMA-IR). Additional lab tests such as liver and kidney function and electrolytes were performed. The estimated glomerular filtration rate(eGFR) was calculated to evaluate renal function. All data were analyzed using the SPSS Sample Power software. Feces samples were collected before and after VLCR. Fecal samples were tested for microbial diversity using 16S rDNA technology. Professional software was used to analyze the differences of gut microbiota in feces before and after VLCR.Results:After 9 days of VLCR, BW, BMI, WC, BP, HR, FBG, 2hPBG, FINS, HOMA-IR, alkaline phosphatase, TG, and blood urea nitrogen of 14 overweight/obese patients with type 2 diabetes were significantly reduced( P<0.05). No effect was seen on serum alanine aminotransferase, aspartate amino transferase, gamma glutamyl transferase, TC, HDL-C, LDL-C, creatinine, eGFR, uric acid, albumin, calcium, and phosphorus( P>0.05). The gut microbiota diversity did not differ before and after VLCR. The abundance of Bacteroidetes increased significantly, and the Firmicutes/Bacteroidetes ratio decreased from 11.79 to 4.20. Between groups analysis showed the abundance of Parabacteroides distasonis increased significantly after VLCR. Conclusion:VLCR can improve body weight and glucose and lipid metabolism in overweight/obese patients with type 2 diabetes, with no serious adverse events. Parabacteroides distasonis may be a marker of VLCR.
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Objective:To investigate the blood pressure change in patients with acute ischemic stroke (AIS) and hypertension treated with cinepazide maleate injection.Methods:This was a subgroup analysis of post-marketing clinical confirmation study of cinepazide maleate injection for acute ischemic stroke: a randomized, double-blinded, multicenter, placebo-parallel controlled trial, which conducted in China from August 2016 to February 2019. Eligible patients fulfilled the inclusive criteria of acute anterior circulation ischemic stroke with National Institutes of Health Stroke Scale (NIHSS) scores of 7-25. The primary endpoints were mean blood pressure of AIS patients treated with cinepazide maleate or control, which were assessed during the treatment period (14 days), and the proportion of the patients with normal blood pressure was analyzed after the treatment period. Furthermore, a subgroup analysis was performed to investigate a possible effect of the history of hypertension on outcomes.Results:This analysis included 809 patients with hypertension. There was no significant difference in patients blood pressure and the proportion of patients with normal blood pressure (60.5% vs. 59.0%, P>0.05) between cinepazide maleate group and control group. Conclusion:Administration of cinepazide maleate injection does not affect the management of clinical blood pressure in patients with AIS.
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Objective:To compare the efficacy and safety of glucocorticoids (GCs), rituximab (RTX), and GCs combined with RTX in the treatment of active moderate-to-severe Graves′ ophthalmopathy (GO).Methods:A total of 42 patients with GO who were hospitalized in the Endocrinology Department of Jiangsu Integrated Traditional Chinese and Western Medicine Hospital from August 2017 to July 2019 were included and divided into GCs group (18 cases), RTX group (7 cases), GCs combined with RTX group (17 cases). Patients in the GCs group were received 500 mg intravenous methylprednisolone once a week for 6 weeks, followed by 250 mg intravenous methylprednisolone once a week for 6 weeks. In RTX group, patients were given intravenous RTX 100 mg every 2 weeks for 2 times. GCs combined with RTX group, i. e. RTX combined with methylprednisolone pulse therapy. At 12 and 24 weeks after treatment, CAS and NOSPECS classes were evaluated in each group. The altered course of thyroid stimulating receptor antibody were compared among the three groups. All adverse events were recorded.Results:The proportion of CAS decreased≥2 or total scores<3 points in the GCs, RTX and combined groups were 88.9%, 85.7% and 100%, with no statistical difference among the three groups ( P=0.321). At 24 weeks, CAS and NOSPECS classes decreased significantly in all three groups compared with those before treatment ( P<0.05). The reduction of CAS in the combined group was greater than in the GCs group (-3.12±1.02 vs -2.39±1.02, P=0.036) and RTX group (-3.12±1.02 vs -2.14±0.90, P=0.034). One patient in the combined group developed optic neuropathy at 24 weeks after treatment, all other patients had no severe adverse events. Conclusion:Low-dose RTX alone is not inferior to intravenous GCs in the treatment of active moderate to severe GO. GCs combined with RTX is more effective in improving patients′ CAS than either drugs alone.
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To investigate the effectiveness and safety of ultrasound-guided microwave ablation (MWA) in treatment of primary hyperparathyroidism (PHPT). A total of 12 PHPT patients with parathyroid adenoma were treated with MWA in Nanjing University of Chinese Medicine Affiliated Hospital of Integrated Traditional Chinese and Western Medicine from May 2019 to February 2021. The patients were followed up once every 3 months for 3-12 months. Levels of serum parathyroid hormone (PTH), calcium and phosphorus were detected before and 20 min, 4h and 1day after ablation, and during follow-up period. The volume and volume reduction rate of parathyroid lesion were compared before the treatment and at the end of follow-up. The technical and clinical success of MWA were assessed as well. At the end of follow-up, median serum PTH [66.60 (42.21,80.03) ng/L vs.169.90 (89.01,396.50) ng/L] and calcium [2.39 (2.32,2.49) mmol/L vs. 2.75 (2.57,2.96) mmol/L] levels in 12 patients decreased significantly (all P<0.05). A complete response in terms of PTH and calcium levels was achieved in 6 of the 12 patients, while 4 of the patients had slightly elevated PTH levels just above the upper limit of normal reference range, and 2 of the patients remained abnormal PTH and calcium levels. The clinical cure rate was 50%. The volumes of all lesion after ablation were significantly decreased ( P<0.05), with the technical success rate reaching 92.3%. No serious complications were observed. Ultrasound-guided MWA, thus, is safe and effective in the treatment of PHPT.
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Objective:To investigate the risk factors for recurrence of Graves′ disease after withdrawal of antithyroid drugs (ATD).Methods:This prospective study recruited 285 patients with newly onset Graves′ disease taking ATD from 2012 to 2018 at Department of Endocrinology, Affiliated Hospital of Integrated Traditional Chinese and Western Medicine. A total of 121 patients who completed follow-up were enrolled and were divided into relapse and remission group according to whether hyperthyroidism reoccurred within 2 years after ATD with drawal. Demographics, clinical manifestations, thyroid serological characteristics, and thyroid color doppler ultrasound at baseline and withdrawal were compared between the two groups. Cox regression analysis was used to analyze the correlation between above factors and recurrence of Graves′ disease.Results:Sixty-five patients relapsed within 2 years after drug withdrawal. Patients with early recurrence were characterized by Graves′ disease genetic history and high baseline thyrotrophin receptor antibody (TRAb) levels. Family history, higher serum FT 3(≥18.1 pmol/L), FT 4(≥49.8 pmol/L), and TRAb(≥16.1 mIU/mL) levels, larger goiter(Ⅱ-Ⅲ) and thyroid volume(≥28.6 cm 3), higher peak velocity of superior thyroid artery (STA-PV; ≥0.6 m/s) before treatment, and higher TRAb(≥0.8 mIU/mL) level after ATD withdraw were risk factors for Graves′ disease recurrence. Higher 25-hydroxy vitamin D(≥14.7 ng/mL) level at baseline, as well as high level of TSH(1.4 μIU/mL) at withdrawal may reduce the risk of relapse. Conclusions:Family history of Graves′ disease, clinical manifestations, thyroid serological indicators and imaging characteristics of severe Graves′ disease before treatment all increased the risk of Graves′ disease recurrence. Patients with aforementioned factors should be actively evaluated in order to choose treatment modalities reasonably. We recommended to maintain lower TRAb titer within normal reference range and TSH level between 1.4 μIU/mL and upper limits of normal reference range at ATD withdrawal to reduce the recurrence rate of Graves′ disease.
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Based on the clinical data of a case of fibrocalculous pancreatic diabetes (FCPD) and literature review, we analyze the etiology, clinical manifestations, diagnostic criteria, treatment, and prognosis of the disease. FCPD is a unique form of diabetes mellitus secondary to pancreatic exocrine disease. The disease is restricted to adolescent or young adult of either sex with poor nutrition in tropical regions of the world. FCPD is characterized by simultaneous involvement of pancreatic endocrine and exocrine functions with clinical manifestations as pancreatic duct stones, pancreatic calcification, and diabetes mellitus. Treatment includes improved nutrition, blood glucose control, and pancreatic duct lithotomy. It could be easy to be misdiagnosed and mistreated, which deserves more attention from clinicians.
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Objective:To investigate the effect of white matter hyperintensities (WMHs) location on the clinical outcomes in patients with anterior circulation acute ischemic stroke (AIS) after intravenous thrombolysis.Methods:Patients with anterior circulation AIS treated with alteplase intravenous thrombolysis in Xuzhou Central Hospital from February 2015 to February 2020 were enrolled retrospectively. The severity of periventricular WMHs (PWMHs) and deep WMHs (DWMHs) was assessed by Fazekas scale. According to the score of the modified Rankin Scale at 90 d after onset, the patients were divided into good outcome group (0-2) and poor outcome group (3-6). The demographic and clinical data were compared between the two groups. Multivariate logistic regression analysis was used to investigate the effect of WMHs location on the clinical outcome in AIS patients treated with intravenous thrombolysis. Results:A total of 408 patients with anterior circulation AIS were enrolled in the study, including 272 males (66.7%) and 136 females (33.3%). Their age was 64.1±12.1 years (range, 40-92years). The baseline median National Institutes of Health Stroke Scale (NIHSS) score was 6 (interquartile range, 4-16). Three hundred and fourteen patients (77.0%) were in the good outcome group and 94 (23.0%) were in the poor outcome group. There were significant differences in age, atrial fibrillation, diabetes mellitus, baseline NIHSS score, blood glucose level before thrombolysis, etiological classification of stroke, PWMHs, DWMHs, hemorrhagic transformation, early neurological deterioration and stroke recurrence between the two groups (all P<0.05). Multivariate logistic regression analysis showed that moderate to severe PWMHs were significantly and independently associated with the poor outcomes in patients with anterior circulation AIS treated with intravenous thrombolysis at 90 d after onset (odds ratio 2.357, 95% confidence interval 1.086-5.115; P=0.030). Other independent related factors included age, baseline NIHSS score, etiological classification of stroke (large artery atherosclerosis and cardiogenic embolism), early neurological deterioration, hemorrhagic transformation, and stroke recurrence. Conclusion:Moderate to severe PWMHs is an independent risk factor for poor outcomes at 90 d after onset in patients with anterior circulation AIS treated with intravenous thrombolysis.
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Ketogenic diet(KD) has been used for centuries in the treatment of epilepsy, which can restrict calorie and liquid intake, with significant therapeutic effects. In recent years, KD has been proved to have therapeutic effects in other fields, such as obesity, diabetes, hypertension, cancer, Alzheimer′s disease and other chronic diseases. KD has a positive effect on the treatment of many diseases, but the high proportion of fat intake in KD process, as well as too little intake of carbohydrates, proteins and trace elements will lead to a very uneven absorption of nutrients. Therefore, the use of KD to treat disease may cause a variety of adverse reactions, and its long-term results are the subjects of controversy. The purpose of this review is to summarize the literature of KD adverse effects and their prevention and treatment methods, in order to provide guidance and assistance to clinical administration.
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Objective@#To investigate the clinical features of Hashimoto′s thyroiditis(HT) with elevated serum IgG4 levels and to guide the clinical practice.@*Methods@#Serum IgG4 concentrations were detected in patients with HT by nephelometric immunoassay. These patients were classified into two groups according to the IgG4 levels: positive group(IgG4≥1.35 g/L), and negative group(IgG4<1.35 g/L). The clinical characteristics of these two groups, including age, gender, medical history, serological features, and ultrasound were compared.@*Results@#Nine out of 111 patients with HT were positive with IgG4(8.11%), all of them were women. There was no significant difference in gender, age, BMI, dose of levothyroxine administration, FT3, FT4, and TSH levels between the two groups. The volume of thyroid in positive group was larger than that in negative group [57.81(38.36, 74.93) ml vs 25.07(18.48, 42.14) ml, P=0.015], and the level of thyroglobulin antibodies(TgAb; P=0.011) and thyroid peroxidase antibodies(TPOAb; P=0.025) in positive group were also significantly higher than those in negative group. Moreover, the positive group had a slightly higher risk of PTC than that of negative group(11.1% vs 2.94%, P=0.290), though the difference was not significant. Correlation analysis showed that IgG4 was positively associated with TgAb, TPOAb, and thyroid volume.@*Conclusions@#The levels of TgAb and TPOAb are higher, the volume of thyroid gland is greater, and the risk of PTC with lymph node metastasis is more frequent in HT patients with elevated serum IgG4. For HT patient with elevated serum IgG4, their thyroid function and morphology should be more closely monitored.
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Objective:To assess the efficacy and safety of cinepazide maleate injection in the treatment of patients with acute ischemic stroke.Methods:A multicenter, randomized, double-blind, placebo-controlled phase Ⅳ clinical trial, led by Peking Union Medical College Hospital, was conducted in 65 Hospitals in China. The efficacy of cinepazide maleate injection in patients with acute anterior circulation cerebral infarction with onset time of ≤48 hours, 7≤National Institute of Health stroke scale (NIHSS) score ≤25 was assessed from August 2016 to February 2019, using the proportion of modified Rankin scale (mRS) score≤1 and Barthel index (BI) score≤95 on day 14 as efficacy endpoint. The patients were divided into treatment group who were treated with cinepazide maleate injection and control group who were treated with placebo.Results:A total 937 patients were involved in the final efficacy analysis (466 in treatment group and 471 in control group). The proportion of subjects with mRS score≤1 on day 14 after treatment were higher in the treatment group than that in the control group (102/466(21.89%) vs76/471(16.14%)). Logistic regression analysis showed that patients treated with cinepazide maleate were significantly more likely to have a favorable outcome (mRS score≤1) than patients treated with placebo on day 14 ( OR=0.677, 95% CI 0.484-0.948 , P=0.023), and patients treated with cinepazide maleate were more likely to reach independence in activities of daily living (Barthel Index ≥95) than those treated with placebo on day 14 (125/466(26.82%) vs 91/471(19.32%); OR=0.632, 95% CI0.459-0.869, P=0.005). The rate of adverse events was similar between the treatment and control groups. Conclusion:The 14-day treatment with cinepazide maleate injection could reduce the degree of disability whereas did not increase the risk of adverse events.
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Metabolic syndrome(MS)is a kind of metabolic disorder, including abdominal obesity, hyperglycemia, dyslipidemia, hypertension, etc. It reflects susceptibility to diabetes, cardiovascular disease, and other pathological conditions. In recent years, ketogenic diet(KD), as one of the natural therapies, has been proved to be effective in reducing weight, lowering blood glucose, regulating lipid metabolism, and improving insulin resistance. Therefore, its application in metabolic diseases has attracted more attention. There is growing evidence demonstrating directly or indirectly that KD may be an effective treatment for MS. How to safely and effectively implement KD and explore the biochemical mechanism of KD in the treatment of MS will be the focus of clinical research in the future.
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Objective:To investigate the serum level of 25-hydroxy vitamin D[25(OH)D] in hospitalized type 2 diabetes men and determine the association between 25(OH)D and sex hormones.Methods:We performed a study among 371 male adults with type 2 diabetes in hospital. The fasting blood was collected for the measurements of 25(OH)D, glucose and lipid metabolism indexes, bone metabolism indexes and sex hormones. Patients were divided into four groups according to the quartiles of 25(OH)D. The differences of glycolipid metabolism and sex hormone indexes between groups were compared. Multivariate linear regression method was used to analyze the correlations between 25(OH)D, glucose and sex hormones.Results:Patients with vitamin D deficiency or insufficiency accounted for 96.5% of the hospitalized type 2 diabetes men. Patients with higher 25(OH)D were with higher HDL-C and lower BMI, HOMA-IR, and TG ( P<0.05). In the linear regression model, 25(OH)D had a significant correlation with TT ( β=0.116, P=0.006), and 25(OH)D had no statistically significant association with TT( β=0.061, P=0.053) after adjusting for BMI. Conclusion:In hospitalized male patients with type 2 diabetes, vitamin D is generally deficient or insufficient, and there is a positive linear correlation between 25(OH)D and testosterone, however, it is affected by BMI.
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Objective:To investigate the clinical features of Hashimoto′s thyroiditis(HT) with elevated serum IgG4 levels and to guide the clinical practice.Methods:Serum IgG4 concentrations were detected in patients with HT by nephelometric immunoassay. These patients were classified into two groups according to the IgG4 levels: positive group(IgG4≥1.35 g/L), and negative group(IgG4<1.35 g/L). The clinical characteristics of these two groups, including age, gender, medical history, serological features, and ultrasound were compared.Results:Nine out of 111 patients with HT were positive with IgG4(8.11%), all of them were women. There was no significant difference in gender, age, BMI, dose of levothyroxine administration, FT 3, FT 4, and TSH levels between the two groups. The volume of thyroid in positive group was larger than that in negative group [57.81(38.36, 74.93) ml vs 25.07(18.48, 42.14) ml, P=0.015], and the level of thyroglobulin antibodies(TgAb; P=0.011) and thyroid peroxidase antibodies(TPOAb; P=0.025) in positive group were also significantly higher than those in negative group. Moreover, the positive group had a slightly higher risk of PTC than that of negative group(11.1% vs 2.94%, P=0.290), though the difference was not significant. Correlation analysis showed that IgG4 was positively associated with TgAb, TPOAb, and thyroid volume. Conclusions:The levels of TgAb and TPOAb are higher, the volume of thyroid gland is greater, and the risk of PTC with lymph node metastasis is more frequent in HT patients with elevated serum IgG4. For HT patient with elevated serum IgG4, their thyroid function and morphology should be more closely monitored.