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<p><b>BACKGROUND</b>Recombinant human parathyroid hormone (1-34) (rhPTH (1-34)) is the first agent in a unique class of anabolic therapies acting on the skeleton. The efficacy and safety of long-term administration of rhPTH (1-34) in Chinese postmenopausal women had 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.</p><p><b>METHODS</b>A total of 453 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 were measured. Adverse events were recorded.</p><p><b>RESULTS</b>rhPTH (1-34) increased lumbar BMD significantly more than did elcatonin after 6, 12, and 18 months of treatment (4.3% vs. 1.9%, 6.8% vs. 2.7%, 9.5% vs. 2.9%, P < 0.01). There was only a small but significant increase of femoral neck BMD after 18 months (2.6%, P < 0.01) in rhPTH groups. There were larger increases in bone turnover markers in the rhPTH (1-34) group than those in the elcatonin group after 6, 12, and 18 months (serum bone-specific alkaline phosphatase (BSAP) 93.7% vs. -3.6%; 117.8% vs. -4.1%; 49.2% vs. -5.8%, P < 0.01; urinary C-telopeptide/creatinine (CTX/Cr) 250.0% vs. -29.5%; 330.0% vs. -41.4%, 273.0% 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 3.2% (11/341) in rhPTH (1-34) group (P = 0.303). Both treatments were well tolerated. Hypercaluria (9.4%) and hypercalcemia (7.0%) in rhPTH (1-34) group were transient and caused no clinical symptoms. Pruritus (8.2% vs. 2.7%, P = 0.044) and redness of injection site (4.4% vs. 0, P = 0.024) were more frequent in rhPTH (1-34). Nausea/vomiting (16.1% vs. 6.2%, P = 0.001) and hot flushes (7.1% vs. 0.6%, P < 0.001) were more common in elcatonin group.</p><p><b>CONCLUSIONS</b>rhPTH (1-34) was associated with greater increases in lumbar spine BMD and bone formation markers. It could increase femoral BMD after 18 months of treatment. rhPTH could improve back pain effectively. The results of the present study indicate that rhPTH (1-34) is an effective, safe agent in treating Chinese postmenopausal women with osteoporosis.</p>
Subject(s)
Aged , Female , Humans , Middle Aged , Bone Density , Calcitonin , Therapeutic Uses , China , Osteoporosis, Postmenopausal , Drug Therapy , Parathyroid Hormone , Therapeutic Uses , Treatment OutcomeABSTRACT
<p><b>OBJECTIVE</b>To investigate the prevalence of peripheral arterial disease (PAD) in China type 2 diabetic patients and to demonstrate the relationships between putative risk factors and PAD.</p><p><b>METHODS</b>In total 1,397 type 2 diabetic patients aged 50 years and older were enrolled and determined ankle-brachial index (ABI) and brachial-ankle pulse wave velocity (baPWV) in 15 Class III Grade A hospitals in 7 major cities of China.</p><p><b>RESULTS</b>Mean patient age was 63.7 +/- 8.2 years and mean duration of diabetes mellitus was 9.39 +/- 7.4 years. Two hundreds and seventy-two (19.47%) patients were diagnosed as PAD by ABI < 0.9, 122 (18.37%) in male and 150 (20.46%) in female. PAD patients had a significantly longer duration of diabetes mellitus, higher hemoglobin A1c, and a significantly lower mean body mass index than non-PAD ones. Aging, smoking, and systolic blood pressure were found to be positively related with the prevalence of PAD. In terms of lipid profiles, no variable was found to relate with PAD. Notably, baPWV showed as the same significant guiding index for PAD, almost matched with ABI.</p><p><b>CONCLUSIONS</b>PAD is a common complication in China type 2 diabetic patients. Therefore, PAD screening and treatment should be emphasized for diabetic patients with high risk factors.</p>
Subject(s)
Aged , Female , Humans , Male , Middle Aged , China , Epidemiology , Diabetic Angiopathies , Epidemiology , Peripheral Vascular Diseases , Epidemiology , Prevalence , Risk Factors , Urban PopulationABSTRACT
The aim of this Post-Marketing Surveillance study was to assess efficacy,safety and acceptance of acarbose treatment in Chinese type 2 diabetic patients under day-to-day practice conditions.A total of 2 480 patients were enrolled by 231 physicians throughout China into an open,prospective,uncontrolled,non- randomised,multi-centre study.Main efficacy parameters were the changes in fasting and postprandial blood glucose concentrations as well as in HbA-(1C) levels after acarbose treatment.The majority of patients had been previously treated with other oral anti-diabetic medication or insulin and received concomitant anti-diabetics during the mean observation period of 13.5 weeks.Most patients started on a daily acarbose dose of 50 mg t.i.d. Acarbose treatment reduced fasting blood glucose concentrations by 56.1 mg/dl ( 18 mg/dl glucose = 1 mmol/L glucose) and 2h-postprandial values by 111.3 mg/dl over the study period.HbA-(1C) decreased by 1.9% and body weight by 0.9 kg.76 acarbose-relatod adverse events occurred;two patients experienced serious adverse events. The attending physicians assessed treatment efficacy as“very good”or“good”for 90.1% of the patients, tolcrability for 89.1% and acarbose acceptance for 87.1% of the patients.Acarbose is efficacious,safe and well accepted by Chinese type 2 diabetic patients under day-to-day routine conditions,both as anti-diabetic mono- therapy and in combination with other anti-dlabetic drugs.
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Objective To evaluate the first-phase insulin release and insulin sensitivity in patients with newly-diagnosed type 2 diabetes.Methods A total of 332 patients with newly-diagnosed type 2 diabetes were classified into two groups of normal or abnormal islet function according to arginine stimulation test,and their results were evaluated.Results (1)Body weight,body mass index (BMI),waist circumference,hip circumference,femoral circumference,fasting serum true insulin and triglyceride in normal islet function group were significantly higher than those in abnormal group (all P
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Objective To evaluate the pathophysiological change of diabetes and its significance in the treatment of newly-diagnosed type 2 diabetic patients.Methods A total of 322 newly-diagnosed type 2 diabetic patients were included in this study and were divided into 2 groups with normal or impaired islet first-phase insulin secretion according to arginine stimulation test.The former group was assigned to repaglinide (Novo Norm), rosiglitazone (Avandia) and mefformin subgroups and the latter one to repaglinide,rosiglitazone and glipizide subgroups randomly.Results (1)Compared with baseline,fasting plasma glucose,2 h postprandial plasma glucose and HbA_(1C) were significantly decreased in all subgroups after 3 and 6 months of treatment (all P