2.Comparison of efficacies of four different intensive insulin therapies with regard to blood-glucose control and vascular endothelial function in patients with newly-diagnosed type 2 diabetes
Huiling SHI ; Yan LI ; Shanying LIU ; Ying LIANG ; Huisheng XIAO
Chinese Journal of Endocrinology and Metabolism 2012;28(6):496-498
To compare the effects of four different intensive insulin therapies on blood glucose control and vascular endothelial function in newly-diagnosed type 2 diabetes.Patients were randomly divided to accept pre-meal insulin aspart 30 or pre-meal insulin aspart and glargine at bedtime or pre-meal Novolin-R and NPH at bedtime or continuous subcutaneous insulin aspart infusion.Capillary blood glucose determination and continuous glucose monitoring system were carried out,therapeutic time and total insulin dosage were recorded.Ultrasound was used to evaluate the vascular endothelial function.Glucose level,incidence of low glucose,potency ratio of the four groups were similar( P>0.05 ) ; FMD and NMD were not significantly improved ( P =0.718,P =0.065 ).The short-term efficacy and safety of the four groups are similar.The short-term intensive insulin therapy has no obvious effect on vascular endothelial function.
3.Clinical significance of serum testosterone levels in young and middle-aged men with type 2 diabetes mellitus accompanied by erectile dysfunction
Xiaoping JIANG ; Fangping LI ; Xujun XUAN ; Huisheng XIAO ; Dan LIU ; Li YAN
Chinese Journal of Endocrinology and Metabolism 2012;28(7):570-571
The relationship of erectile dysfunction (ED) with serum levels of total testosterone (TT) and free testosterone (FT) was investigated in 53 men with type 2 diabetes under 50 years of age.The relevant clinical status was matched and no significant difference was noticed for TT [ ( 14.11 ±5.81 vs 14.97 ±4.93 ) nmol/L] and FT [ (9.31 ± 8.84 vs 8.72 ± 5.33 ) pg/ml ] levels in type 2 diabetic patients with and without ED.This study has demonstrated that testicular androgen may not contribute to ED in young and middle-aged men with type 2 diabetes.
4.Clostridium difficile carriage in infants and the characteristics of isolates
Tianxiang ZHOU ; Zhenhua SHU ; Kelin XIAO ; Zhongxing WANG ; Guangxing MAI ; Yong XIA ; Zhen HUANG ; Huisheng FAN ; Conghui GU
International Journal of Laboratory Medicine 2017;38(13):1735-1737
Objective To investigate the carrying status and characteristics of Clostridium difficile isolated from infants.Methods Two hundred and thirty-eight stool specimens were collected from infant younger than 1 year old,that were hospitalized or outpatient from August to November 2015.Immunochromatography targeted GDH and toxin A&B of C.difficile was used for C.difficile screening,and those positive specimens were inoculated in CDIF and anaerobic culture.C.difficile isolates were genotyped by using slpA sequence typing (slpA ST),and tcdA,tcdB,cdtA and cdtB of C.difficile isolates were detected by PCR.Results Fifty C.difficile strains were isolated from 238 stool samples,and the isolated rates of C.difficile from <3 months,3 months to <6 months,and 6 months to 1 years old groups were 9.3%,17.6% and 27.3%(χ2=6.940,P=0.031<0.05),respectively.52.0%(26/50) of the C.difficile isolates were toxigenic,and 69.2% (18/26) toxigenic isolates harbored tcdA+tcdB+cdtA-cdtB-.Fifty C.difficile isolates were genotyped as 11 slpA STs,slpA ST fr-02 and kr-02 were the commonest genotypes in toxigenic C.difficile isolates;however,that was slpA ST xr-03 in non-toxigenic isolates.Conclusion High C.difficile carriage is found in infants younger than 1 year old,and more than half of C.difficile isolates are toxigenic.Most of toxigenic isolates harbored toxin A and B.The genotype of C.difficile isolates is different between toxigenic isolates and non-toxigenic isolates.
5.Efficacy and safety of lixisenatide in a predominantly Asian population with type 2 diabetes insufficiently controlled with basal insulin: The GetGoal-L-C randomized trial
Chinese Journal of Endocrinology and Metabolism 2018;34(4):344-348
Almost all the type 2 diabetic patients require insulin therapy as disease progresses over time. However, there are still a large number of patients who fail to achieve glycemic target with basal insulin therapy. How to optimize glycemic control in these patients is a problem in clinical practice. Glucagon-like peptide 1 (GLP-1)receptor agonist is a new type of anti-hyperglycemic agent with complementary mechanisms of actions to basal insulin,helpful for improved glycemic control in type 2 diabetic patients with basal insulin treatment. Therefore, clinical evidence in Chinese population is valuable for clinical diabetes management in China. This paper is the translation of "Efficacy and safety of lixisenatide in a predominantly Asian population with type 2 diabetes insufficiently controlled with basal insulin:The GetGoal-L-C randomized trial",published on"Diabetes,Obesity&Metabolism" in February 2018[Yang W,Min K,Zhou Z,et al. Diabetes,Obesity&Metabolism,2018,20(2):335-343] with open access, which demonstrated efficacy and safety of lixisenatide in a predominantly Asian population with uncontrolled type 2 diabetes as add-on therapy to basal insulin.
6.Clinical management of primary hypomagnesemia with secondary hypocalcemia
Yongfeng HUANG ; Zhuo ZHANG ; Li YAN ; Yan LI ; Mingtong XU ; Shaoling ZHANG ; Huisheng XIAO ; Ying GUO ; Guojuan LAO ; Kan SUN
Chinese Journal of Endocrinology and Metabolism 2022;38(3):239-243
Primary hypomagnesemia with secondary hypocalcemia(HSH) is a rare cause of hypoparathyroidism. This article presents a case of a 26-year-old male with recurrent generalized weakness and tetany, and a literature review of diagnosis and treatment of primary HSH. The biochemical tests revealed the patient had severe hypomagnesemia, mild hypocalcemia, hypokalemia, and hypoparathyroidism. Transient receptor potential melastatin-6(TRPM6) gene mutation were detected by gene test, which confirmed the diagnosis of primary HSH. The patient had been treated with long term oral magnesium supplementation, who remained asymptomatic during the follow-up. Primary HSH is a rare autosomal-recessive disorder caused by mutations in the TRPM6 gene which encoding a magnesium permeable channel expressed in the intestine and the kidney. The primary defect is impaired intestinal absorption of magnesium with secondary renal excretion, leading to a series of clinical symptoms. The treatment is mainly through lifelong magnesium supplementation.
7.Cinepazide maleate injection reduced the disability rate for acute ischemic stroke patients: a multicenter, randomized, double-blind, parallel-group, placebo-controlled phase Ⅳ clinical trial
Jun NI ; Huisheng CHEN ; Guofang CHEN ; Yong JI ; Fei YI ; Zhuobo ZHANG ; Yi YANG ; Jin WU ; Xueli CAI ; Bei SHAO ; Jianfeng WANG ; Yafang LIU ; Deqin GENG ; Xinhui QU ; Xiaohong LI ; Yan WEI ; Jianping DING ; Hua LYU ; Yining HUANG ; Yonghua HUANG ; Bo XIAO ; Tao GONG ; Liying CUI
Chinese Journal of Neurology 2020;53(10):790-797
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.
8.Effects of cinepazide maleate injection on blood pressure in patients with acute ischemic stroke and hypertension
Huisheng CHEN ; Yi YANG ; Jun NI ; Guofang CHEN ; Yong JI ; Fei YI ; Zhuobo ZHANG ; Jin WU ; Xueli CAI ; Bei SHAO ; Jianfeng WANG ; Yafang LIU ; Deqin GENG ; Xinhui QU ; Xiaohong LI ; Yan WEI ; Shugen HAN ; Runxiu ZHU ; Jianping DING ; Hua LYU ; Yining HUANG ; Yonghua HUANG ; Bo XIAO ; Tao GONG ; Xiaofei YU ; Liying CUI
Chinese Journal of Internal Medicine 2022;61(8):916-920
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.
9.Efficacy and safety of cinepazide maleate injection in acute ischemic stroke patients with obvious motor function deficit
Jun NI ; Huisheng CHEN ; Guofang CHEN ; Yong JI ; Fei YI ; Zhuobo ZHANG ; Yi YANG ; Jin WU ; Xueli CAI ; Bei SHAO ; Jianfeng WANG ; Yafang LIU ; Deqin GENG ; Xinhui QU ; Xiaohong LI ; Yan WEI ; Jianping DING ; Hua LYU ; Yining HUANG ; Yonghua HUANG ; Bo XIAO ; Tao GONG ; Liying CUI
Chinese Journal of Neurology 2022;55(5):474-480
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.