Approach to the patients with transient neonatal diabetes mellitus / 中华内分泌代谢杂志

[Summary]_ Transient neonatal diabetes mellitus is a kind of rare special types of diabetes. It should be distinguished from type 1 diabetes. Genetic analysis can be used to define the subtype of neonatal diabetes mellitus, which helps us to select the most appropriate treatment and to predict the disease recurrence. Sulfonylureas is able to improve insulin secretion in most patients with transient neonatal diabetes mellitus and provide effective glycemic control. A case of transient neonatal diabetes mellitus is reported in order to call attention to the diagnosis and treatment of this disease.

Efficacy of parathyroid hormone (1-34) and elcatonin in postmenopausal women with osteoporosis：A randomized and controlled trial for 18 months / 中华内分泌代谢杂志

Objective Recombinant human parathyroid hormone(1-34) [ rhPTH(1-34)] is the unique anabolic substance acting on the skeleton. The efficacy and safety of long-term administration of rhPTH(1-34) in Chinese postmenopausal women have not been evaluated. This study compared the clinical efficacy and safety of rhPTH(1-34) with elcatonin for treating postmenopausal women with osteoporosis in 11 urban areas of China. Methods A total of453 postmenopausal women with osteoporosis were enrolled in an 18-month, multi-center, randomized, controlled study. They were randomized to receive either rhPTH(1-34) 20 μg(200 U) daily for 18 months, or elcatonin 20 U weekly for 12 months. Lumbar spine ( L1-4) and femoral neck bone mineral density (BMD), fracture rate, back pain as well as biochemical markers of bone turnover ( serum bone-specific alkaline phosphatase was measured by radioimmunoassay; C-telopeptide/ creatinine ( CTX/ Cr) measured by quantitative sandwich enzyme-linked immunosorbent assay) at 6, 12, and 18 months. Adverse events were recorded. Results rhPTH(1-34) increased lumbar BMD more significantly than that did by elcatonin at 6 months( M6), 12 months (M12), and 18 months(M18; 4. 3% vs 1. 94% , 6. 8% vs 2. 72% , 9. 51% vs 2. 86% , P<0. 01). There was only a small but significant increase of femoral neck BMD at M18(2. 64% , P<0. 01) in rhPTH(1-34) groups. There were greater increases in bone turnover markers in the rhPTH(1-34) group than in the elcatonin group at M6, M12, and M18[serum bone-specific alkaline phosphatase(BSAP) 93. 67% vs -3. 56% , 117. 78% vs -4. 12% , 49. 24% vs-5. 81% , P<0. 01; urinary CTX/ Cr 250% vs -29. 5% , 330% vs -41. 4% , 273 % vs -10. 6% , P<0. 01]. rhPTH (1-34) showed similar effect of pain relief as elcatonin. The incidence of clinical fractures was 5. 36% (6 / 112) in elcatonin group and 3. 23% ( 11 / 341 ) in rhPTH ( 1-34 ) group ( P = 0. 303 ). Both treatments were well tolerated. Hypercaluria(9. 38% ) and hypercalcemia(7. 04% ) in rhPTH(1-34) group was transient and caused no clinical symptoms. Pruritus(8. 21% vs 2. 68, P=0. 044) and redness of injection site(4. 40% vs 0, P=0. 024) were more frequent in rhPTH(1-34). Nausea / vomiting(16. 07% vs 6. 16% , P = 0. 001) and hot flushes(7. 14% vs 0. 59% , P<0. 001) were more common in elcatonin group. Conclusion rhPTH(1-34) treatment was associated with greater increases in lumbar spine BMD and bone formation markers. It could increase femoral BMD after 18 months treatment. rhPTH(1-34) could ameliorate back pain effectively. The results of the present study indicate that rhPTH(1-34) is an effective, and safe agent in treating postmenopausal women with osteoporosis.

Biphasic insulin aspart 30 improved glycemic control in Chinese patients with type 2 diabetes poorly controlled on oral glucose-lowering drugs: a subgroup analysis of the A₁chieve study / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>The effectiveness and safety of initiating biphasic insulin aspart 30 in patients who were poorly controlled on oral glucose-lowering drugs were studied in randomized controlled trials, while results from clinical practice remain limited. This subgroup analysis was to provide such findings from a large-scale non-interventional study.</p><p><b>METHODS</b>A1chieve was a multinational, prospective, open-label, non-interventional, 24-week study in patients with type 2 diabetes initiating insulin analogues in 28 countries across Asia, Africa, Europe, and Latin America. After physician had taken the decision to use this insulin, any patient with type 2 diabetes who was not treated with or who had started the study insulin within 4 weeks before inclusion was eligible. Patients were treated with study insulin alone or in combination with oral glucose-lowering drugs. Data on adverse drug reactions, hypoglycemia and glycemic control were collected at baseline, week 12 and 24. This is a report of a Chinese subgroup analysis from the A1chieve study.</p><p><b>RESULTS</b>Totally, 4 100 patients constituted this subgroup. No serious adverse drug reactions were reported. Rates of total, major, nocturnal hypoglycemic events (events/patient per year) were 1.47, 0.10, 0.31 at baseline and 1.35, 0.00, 0.22 at week 24, respectively. Glycemic control was improved as measured by hemoglobin A1c (mean 9.3% to 7.0%, reduction -2.3%), fasting plasma glucose (mean 10.2 to 6.8 mmol/L, reduction -3.5 mmol/L) and postprandial plasma glucose (mean 14.4 to 8.8 mmol/L, reduction -5.6 mmol/L), all P < 0.001. Change in mean body weight was +0.3 kg (P < 0.001).</p><p><b>CONCLUSION</b>In this subgroup analysis of the A1chieve study, biphasic insulin aspart 30 improved glycemic control with low risk of hypoglycemia.</p>

A survey on the current status of type 2 diabetic patients who failed to achieve the glycemic control target / 中华内分泌代谢杂志

Objective To investigate the current status of type 2 diabetic patients who failed to achieve the glycemic control target, and provide theoretic evidences for making corresponding strategies. Methods The 2 diabetic patients who failed to reach the glycemic target were recruited from 181 hospitals in 26 cities and received a standard questionnaire, the conditions of their blood glucose level, lifestyle intervention, blood sugar monitoring, and drug therapy were recorded. Totally 3 861 questionnaires with complete information were collected. And the causes which account for glycemic control status were analyzed. Results Among these patients, the mean HbA1c was 7.9%, the mean fasting plasma glucose was 8.2 mmol/L, and the mean postprandial plasma glucose was 11.5 mmol/L. Only 25.6% of patients take their diet control strictly as prescribed and 44. 5% of patients have little exercise. 35. 8% and 47.8% of patients did not monitor their fasting and postprandial plasma glucose,respectively. Glycemic control in the patients aged ＞ 60 years was similar to the younger patients, but the hypoglycemia incidence in the elder group reached 35.5%, which was higher than those in the other 2 groups (20.8% and 21.4%, both P＜0. 05 ). The proportion of patients with mono-therapy and combination therapy was 46. 1% and 51.7%, while the proportion with combination therapy rose in the patients aged ＞60 years (58.7%;Compared with the other age-groups, all P＜0.05 ). 75 % of patients have adjusted their drug administration regimen since initial treatment. Conclusions Inadequate or inappropriate drug therapy regimen is a major cause responsible for this poor glycemic control status. In addition, the unhealthy life styles, insufficient blood sugar monitoring, and poor compliance were also important causes. Thus, for these patients, it is necessary to further enhance patients' education, to improve life style intervention, as well as to select more effective, safer, and compliant drug therapy regimens. Finally, the glycemic control target for the elder patients should be more flexible.

A randomized, multicenter, active-controlled trial to compare the efficacy of recombinant human parathyroid hormone (1-34) with that of elcatonin in postmenopausal women with osteoporosis in China / 中华内科杂志

Objective To compare the clinical efficacy and safety between recombinant human parathyroid hormone ( rhPTH) ( 1 -34) and elcatonin in the treatment of postmenopausal women with osteoporosis in China.Methods This 6 month, multicenter, randomized and controlled study enrolled 205 postmenopausal women with osteoporosis.They were randomized to receive either rhPTH (1 -34) 20 μg (200 U) daily or elcatonin 20 U weekly.Lumbar spine (L1-4 ) and femoral neck bone mineral density (BMD) and biochemical markers of bone turnover were measured. In the meantime adverse events were recorded. Results The results showed that both rhPTH ( 1 -34) and elcatonin increased L1-4 BMD significantly at the endpoint of the study, but femoral neck BMD did not change significantly.From baseline to endpoint, BMD of L1-4 and femoral neck in the rhPTH( 1-34) group increased by 5.51% (P <0.01) and 0.65% (P >0.05), but BMD of L1-4 and femoral neck in elcatonin group increased by 1.55% (P <0.05) and 0.11% (P>0.05).Moreover, the rhPTH(1-34) group had better improvement in L1-4 BMD than the elcatonin group at 3, 6 months, but there was no difference of BMD in these two groups with regard to femoral neck.There were greater mean increases of the bone markers in the rhPTH( 1-34) group than those in the elcatonin group at 3, 6 months [serum bone-specific alkaline phosphatase ( BSAP) 36.79% vs 0.31% ; 92.42% vs -0.17% ; the ratio of urine N-telopeptide of type I collagen and creatinine (NTX/Cr) 48.91% vs -5.32% ; 68.82% vs - 10.86%].Both kinds of treatment were well tolerated and there were no differences between the two groups in the rates of adverse events and serious adverse events.Conclusion It is concluded that rhPTH (1 -34) has more positive effects on bone formation than elcatonin as shown by the greater increments of L1-4 BMD and bone formation markers and the less occurrence of adverse events as well as no significant change in hepatic, renal or hemopoietic function.

A comparison of the efficacy and safety of domestic orlistat and imported orlistat in Chinese overweight and obese patients / 中华内科杂志

Objective To compare the clinical efficacy and safety of domestic orlistat and imported orlistat in Chinese overweight and obese patients. Methods In a randomized, double-blinded and positive-controlled study, 228 adults (BMI 24-< 40 kg/m~2) evaluated at seven research centers were randomized to receive domestic orlistat or imported orlistat 120 mg 3 times a day with an energy-controlled diet for 24 weeks. Results After 24 weeks, domestic orlistat treated patients got significant weight-loss (5.0±3.7) kg, which was comparable with that of imported orlistat treated patients (4.5±3.5) kg (P=0.3922).Compared with the findings before treatment, there was significant decrease of systolic blood pressure (4.4±11.5)mm Hg (1 mm Hg=0.133 kPa) and serum levels of TC (0.54±0.79) mmol/L and LDL-C (0.32±0.64) mmol/L in the domestic orlistat treated group(compared with levels of baseline, P< 0. 0001). There was no significant difference between the two groups in the changes of blood pressure and lipid levels. Both groups had similar adverse event profiles, most of which were mild and transient gastrointestinal events. There were no serious adverse events in beth groups. Conclusions Domestic orlistat combined with a light low-energy diet promoted significant weight loss, which was comparable with that of imported orlistat after 24 weeks of treatment. There was also improvement in blood pressure and serum levels of TC and LDL-C. Domestic orlistat was as effective and safe as imported orlistat in the treatment of obesity.

An independent association detected between metabolic syndrome and obstructive sleep apnea-hypopnea syndrome / 中华内分泌代谢杂志

Objective To investigate possible independent association between metabolic syndrome (MS) and obstructive sleep apnea-hypopnea syndrome (OSAHS). Methods According to polysomnography (PSG) examination, 82 obese patients were divided into OSAHS group (n = 55) and non OSAHS group (n = 27) and 30subjects with normal weight were recruited as the control group. PSG parameters such as AHI (apnea hyponea index), oxygen saturation (Spo2,) in obese patients were measured. MS-associated parameters, such as fasting blood glucose (FBG), fasting insulin (FINS), plasma lipid profile, insulin homeostasis model assessment of insulin resistance (HOMA-IR) and blood pressure, height, body weight, waist circumference, were measured in all cases. The prevalence of MS and the parameters were compared among different groups. The correlations between them were analyzed. Results The prevalence of MS in obese patients with OSAHS was significantly higher than that in obese patients without OSAHS (69.09% vs 37.04%, P <0.01). Systolic blood pressure and diastolic blood pressure (DBP), FBG and HOMA-IR were higher in subjects with OSAHS than those without OSAHS (P <0.05 or P <0.01). Multiple stepwise regression showed that DBP was negatively correlated with Spo2, FINS and HOMA-IR were positively correlated with AHI. Conclusion OSAHS is found to be independently associated with MS, which may be a risk factor of cardiovascular disease and other systemic diseases.

Relationship between serum IGF-Ⅱand peripheral neuropathy in type 2 diabetics / 中国实用内科杂志

Objective To evaluate the possible relationship between IGF-Ⅱand peripheral neuropathy in type 2 diabetes.Methods Seventy-one type 2 diabetic patients without peripheral neuropathy(Group A),Seventy-seven patients with peripheral neuropathy(Group B)and thiry healthy subjects(Group C)were recruited.Serum IGF-Ⅱwas determined in all subjects.Other clinical parameters(fasting plasma glucose、fasting plasma insulin,et al)and nerve conduction velocity were determined in Group A and Group B.Results Group B had significantly lower levels of IGF-Ⅱ,compared to GroupA and Ⅲ(P

Relationship between aldose reductase gene expression in peripheral blood mononuclear cells and the risk of diabetic nephropathy in type 2 diabetic patients / 中华内分泌代谢杂志

Aldose reductase (AR) mRNA level in peripheral blood mononuclear cells was assayed by RT-PCR. There was a positive correlation between PBMC AR mRNA level and urinary albumin excretion rate in type 2 diabetic patients. The result suggests that AR activity is related to the pathogenesis of diabetic nephropathy.

Inhibitory effect of pioglitazone on TGF-?1 gene expression in renal cortex of diabetic rats / 中华内分泌代谢杂志

Diabetic model of SD rats was induced by streptozotocin injected intraperitoneally. Transforming growth factor (TCF)-?1 mRNA level was significantly decreased in renal cortex of diabetic rats by treatment of Pioglitazone. The result suggests that the protection of Pioglitazone against diabetic nephropathy seems to be related to the decrease of TGF-?1 gene expression in renal cortex.