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Perspective of biosimilars: A brief comment on immunogenicity of human insulin biosimilars based on viewing of severe adverse events of epoetin α and roferon A

Yongyi GAO ; Gang HAN ; Xiujun LI

Chinese Journal of Endocrinology and Metabolism.2013;29(8):637-641. doi:10.3760/cma.j.issn.1000-6699.2013.08.001

A number of biosimilars will be soon marketing due to the expiration of patent protection of their originators.Unlike classical chemical drugs,biotherapeutics are proteins with large and complex molecules produced by biological high-tech with sophisticated manufactural procedures.This leads to the difficulties of the copy of biosimilars from their originators,and the almost inevitable distinctions between the two products.Thus biosimilars are only similar but not identical to their reference drugs in terms of stracture,action,and safety.It is important for physicians to understand these differences before using biosimilars.Optimal management by a national regulatory authority with rigorous standards is very important in all aspects of authorization of the development,production,marketing,and postmarketing surveillances for biosimilars.

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Approach to the patient with empty sella combined with adrenal adenoma

Junfeng HAN ; Mingxi XU ; Fang LIU ; Yuqian BAO ; Songhua WU ; Weiping JIA

Chinese Journal of Endocrinology and Metabolism.2013;29(8):711-713. doi:10.3760/cma.j.issn.1000-6699.2013.08.019

Clinical characteristics were analyzed retrospectively in a patient with empty sella and adrenal adenoma with regard to the elaborated diagnosis and treatment.Although empty sella syndrome alone was common,clinical combination with adrenal adenoma was rarely reported.It was difficult to diagnose due to complex symptoms and hormone levels.This case could help increase awareness of the disease and accumulate the experience in diagnosis and treatment.

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Approach to the patients with ectopic ACTH syndrome

Jing SUI ; Hui GUO ; Yi WANG ; Jing ZHAO ; Bingyin SHI

Chinese Journal of Endocrinology and Metabolism.2013;29(8):714-718. doi:10.3760/cma.j.issn.1000-6699.2013.08.020

Clinical features of 2 cases of ectopic ACTH syndrome with manifestation of severe hypercortisonism are described with the aim of exploring effective therapies.

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Approach to the patient with pregnancy-associated fulminant type 1 diabetes mellitus

Weixia JIAN ; Xueru CHEN ; Weixing WANG ; Jie JIN ; Qing SU

Chinese Journal of Endocrinology and Metabolism.2013;29(8):719-721. doi:10.3760/cma.j.issn.1000-6699.2013.08.021

One case with fulminant type 1 diabetes during the third trimester of pregnancy was reported.If a patient manifests abrupt onset of hyperglycemia,nausea,vomiting,and bellyache during pregnancy or immediately after delivery,fulminant type 1 diabetes should be considered.

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Progress of research in adrenal cortical cells model

Zhiqiang PAN ; Zhaoqin FANG

Chinese Journal of Endocrinology and Metabolism.2013;29(8):730-734. doi:10.3760/cma.j.issn.1000-6699.2013.08.026

This paper describes the biological characteristics of human and mouse adrenal cortical carcinoma cell lines and presents research progress made in rat and bovine primary cultured adrenal cortical cells.The effect of angiotensin Ⅱ,potassium,adrenocorticotropic hormone and cAMPon different adrenal cortical cell lines were compared and analyzed,regarding the differences of steroid hormone secreted.The article suggests that it is necessary to develop and establish some ideal adrenal cortex cell models for furtherstudying the mechanisms of steroid hormone synthesis and secretion.

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Study on CXCL5 gene polymorphisms in obese patients with type 2 diabetes mellitus

Yanru ZHAO ; Ximing QI ; Fuzai YIN ; Bo LIU ; Yu ZHOU ; Wen LIU

Chinese Journal of Endocrinology and Metabolism.2013;29(9):772-773. doi:10.3760/cma.j.issn.1000-6699.2013.09.009

The association between CXCL5 gene polymorphism and obese patients with type 2 diabetes mellitus (T2DM) was explored.The distribution of CXCL5 gene promoter region-156G/C polymorphism revealed no significant difference between normal control group and T2DM group (P＞0.05).The frequency of C allele gene in obesity group was higher than that in non-obesity group(P＜0.05).The results suggest that the CXCL5 promoter gene -156G/C polymorphsim has no relation with T2DM,but it is a risk factor for obesity.

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Correlation between polymorphism of estrogen receptor gene and non-alcoholic fatty liver disease in postmenopausal women

Muxu ZHAI ; Shukai SUN ; Honghua FEI ; Yiqun PENG ; Eryuan LIAO

Chinese Journal of Endocrinology and Metabolism.2013;29(9):788-791. doi:10.3760/cma.j.issn.1000-6699.2013.09.014

Genotypes of estrogen receptor gene (ER) α and β in 110 patients with non-alcoholic fatty liver disease (NAFLD) and 100 control subjects were examined by polymerase chain reaction-based restriction fragment length polymorphism.The haplotype analysis was conducted by SHEsis on-line computing platform.The results showed that there were no differences in the genotype frequencies and allele frequencies of ERα at Xba Ⅰ and Pvu Ⅱ enzyme cutting sites between two groups (P ＞ 0.05).There existed significant differences in the genotype frequencies and allele frequencies of ERβ at Rsa Ⅰ and Alu Ⅰ enzyme cutting sites between these two groups (P ＜ 0.05 or P ＜0.01).The risk of NAFLD in postmenopausal women with R or a allele was 1.833 (95％ CI1.209-2.779,P＜0.05)or 1.782 (95％ CI 1.037-3.061,P＜0.05) fold of that with allele r or A.The frequency of r-A haplotype in ERβ was significantly lower in NAFLD group than that in control group (OR =0.529,95％ CI 0.348-0.805).Logistic regression analysis showed the relationship of fasting blood glucose,triglyceride,body mass index,diastolic pressure,Alu Ⅰ genotype with NAFLD (all P＜0.01).The risk of NAFLD in postmenopausal women with Aa/aa genotype was 1.345 (95％ CI 1.028-2.505,P＜0.05) folds of that with AA genotype.

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The prevalence of vitamin D deficiency in intensive care unit and its influence on prognosis

Jieyu HU ; Zhaoyan CHEN ; Hua QIN ; Yingjun SUO ; Zuojie LUO

Chinese Journal of Endocrinology and Metabolism.2013;29(10):827-831. doi:10.3760/cma.j.issn.1000-6699.2013.10.002

Objective To investigate the prevalence of vitamin D deficiency in medical intensive care unit (ICU) and its relationship with severity of disease and prognosis.Methods A prospective study was performed to evaluate vitamin D status in 216 patients admitted to the medical intensive care unit.The incidence of hypovitaminosis D was observed.Acute Physiology and Chronic Health Evaluation Ⅱ (APACHE Ⅱ) score,days kept in ICU and on ventilator,main laboratory findings,and mortality rate were compared among patients with different serum 25-hydroxyvitamin D [25 (OH) D] levels.Potential risk factors for mortality were analyzed by multivariate logistic regression analysis.Results One hundred and fifty-three patients (70.8％) developed hypovitaminosis D.25 (OH) D deficiency was identified in 95 (44.0％),25 (OH) D insufficiency in 58 (26.8％),and 25 (OH) D sufficiency in 63 (29.2％) patients.APACHE Ⅱ score,positive blood culture,the incidence of multiple organ dysfunction syndrome(MODS),and mortality rate were higher in deficiency group compared with the other two groups [APACHE Ⅱ score:deficiency group 25 (20,28) score,insufficiency group 22 (17,26) score,sufficiency group 19 (18,20) score,P＜0.01 ; positive blood culture:deficiency group 18.9％,insufficiency group 13.8％,sufficiency group 3.2％,P=0.015 ; MODS:deficiency group 48.4％,insufficiency group 43.1％,sufficiency group 25.4％,P=0.025; mortality rate:deficiency group 40％,insufficiency group 24.1％,sufficiency group 15.9％,P =0.003].25 (OH)D levels were negatively correlated with APACHE Ⅱ score and mortality rate (r =-0.325,P＜0.01 ; r=-0.276,P＜0.01,respectively).Analysis by multiple logistic regression demonstrated that 25 (OH) D deficiency (OR =3.005,95 ％ CI 1.321-5.875,P =0.008) was independent risk factor for mortality.Conclusions This study demonstrates that vitamin D deficiency is highly prevalent among patients admitted into ICU.Vitamin D deficiency is associated with disease severity,and seems to be an independent risk factor for mortality.

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Association between serum 25-hydroxyvitamin D3 concentration, parathyroid hormone, and arterial stiffness in patients with type 2 diabetes

Xiaokun MA ; Zhizhen LI ; Guijun QIN ; Huimiao LIU ; Gaofei REN

Chinese Journal of Endocrinology and Metabolism.2013;29(10):836-839. doi:10.3760/cma.j.issn.1000-6699.2013.10.004

Objective To evaluate the association between serum 25-hydroxyvitamin D3 [25 (OH) D3],parathyroid hormone,and arterial stiffness in patients with type 2 diabetes.Methods Serum 25 (OH) D3 and parathyroid hormone(PTH) were determined in a cross-sectional sample of 258 patients aged 30 years and over.Arterial stiffness was assessed by pulse wave velocity(PWV) obtained with a VP-1000 pulse wave unit.Fasting plasma HbA1c,lipid profile,calcium,and high sensitive-C reactive protein were determined.Results (1)The prevalence of vitamin D3 deficiency was high(79.84％) in patients with type 2 diabetes.(2) Those with lowered serum vitamin D3 levels had raised PWV [(1610.76 ± 142.70 vs 1527.95 ± 58.02) cm/s,P＜0.05].(3) Multiple stepwise regression analysis showed that 25 (OH) D3 was an impact factor of PWV risk score,which was independent of age,duration of diabetes,and systolic blood pressure(β =-0.256,P＜0.01).(4) Serum PTH was positively correlated with PWV (r =0.210,P ＜ 0.05) and systolic blood pressure (r =0.229,P ＜ 0.05),but negatively correlated with 25 (OH) D3 (r =-0.153,P ＜ 0.05).Conclusions 25 (OH) D3 deficiency is common in patients with type 2diabetes,and a low serum 25 (OH) D3 level is significantly associated with increased arterial stiffness in these patients.The association of serum PTH with arterial stiffness may result via changes in vitamin D and blood pressure.

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Prevalence and characterization of testicular adrenal rest tumors in children and adolescent males with congenital adrenal hyperplasia

Zhe SU ; Minlian DU ; Yanhong LI ; Huamei MA ; Hongshan CHEN ; Qiuli CHEN

Chinese Journal of Endocrinology and Metabolism.2013;29(8):648-652. doi:10.3760/cma.j.issn.1000-6699.2013.08.003

Objective To summarize the prevalence,risk factors,and characteristics of testicular adrenal rest tumors(TART) in children and adolescent males with congenital adrenal hyperplasia(CAH) due to 21-hydroxylase deficiency (21-OHD).Methods During past 4 years,there were 44 males with CAH caused by 21-OHD undergone testicular ultrasound scan in our clinic.We have diagnosed 13 cases of TART and summarized the characterizations.Results The prevalence of TART in our group was 29.5％ with 11 cases of salt wasters and 2 cases of simple virilizers.The median age of TART diagnosis was 10.2 years.The median follow-up period of TART was 3.0 years.History of poor control of CAH was found in every case before diagnosis of TART.The doses of hydrocortisone were increased in 5 cases of TART who refused operations or had small TART,resulting in tumor regression in two of those five patients.Testis-sparing surgeries were performed in 8 patients with symptoms relieved; 7 of those eight patients presented elevated FSH and LH after operations.Conclusions Prevalence of TART in our CAH children and adolescent males was 29.5％.Testicular ultrasound was useful in TART screening.TART should be considered when a CAH patient with poor control,especially in post-pubertal one.Delayed management of TART may lead to impaired testicular function.Increased doses of glucocorticoid may be effective in TART of small size.Testis-sparing surgery should be also considered if necessary.

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