Efficacy and safety of Samtropin™ recombinant human growth hormone; a double-blind randomized clinical trial.

BACKGROUND: Recombinant human growth hormone (rhGH) can increase the growth rate in growth hormone deficient children (GHD). In this randomized clinical trial, we compared the efficacy and side effects of an Iranian brand; Samtropin with Norditropin. METHODS: The GHD children were randomly treated either with standard dose of Samtropin or Norditropin rhGH for one year. Upstanding height, height standard deviation score (HSDS), growth velocity (GV), serum levels of insulin like growth factor-1 (IGF-1), and bone age (BA) were determined before and during one year treatment concomitant side effects of treatment. RESULTS: We evaluated 22 subjects; 12 on Samtropin and, 10 on Norditropin. In each group, mean age was 12 yr and 50% of them were male. The mean differences in height, HSDS, IGF-1 and BA by Norditropin before and after 12 months were 8.8 cm, 0.5, 49 ng/ml and 2.8 yr, respectively. These measures by Samtropin were 9.1 cm, 0.6, 133 ng/ml, and 1.7 yr, respectively without any significant difference. The mean of GV by Samtropin was 9.1 vs. 8.8 cm by Norditropin without significant difference. Since the efficacy of Samtropin was found to be similar to Norditropin after 12 months; we switched to use only Samtropin for the next 12 months. The mean differences in height, HSDS, GV and BA in 20 children between months 12 and 24 were 7.0 cm, 1.6, 2.1 cm/yr and 1.0 yr, respectively (P < 0.001). We also found a non-significant decrease in IGF-1 levels. No side effects were observed. CONCLUSIONS: We need to conduct a post marketing surveillance with a large sample size in order to confirm our findings. TRIAL REGISTRATION: Registration code number in the Iranian Registry of Clinical Trials (IRCT): IRCT1138901181414N11.

Nitinol wire mesh fracture and traumatic left atrial thrombus in a patient with atrial septal defect amplatzer occluder.

Although wire device frame fracture associated with thrombus formation has been reported in some types of atrial septal defect occluders, it has not been detected in patients with Amplatzer devices. Here, we describe an unusual case of Nitinol wire mesh fracture associated with left atrial endocardial damage and thrombus formation in an adult with Amplatzer septal occluder.

Isolated tricuspid valve Libman-Sacks endocarditis and valvular stenosis: unusual manifestations of systemic lupus erythematosus.

The most common valves involved in systemic lupus erythematosus are the mitral and aortic valves. Although isolated tricuspid valve involvement is quite rare, the authors report such a case. A 42-year-old woman presented with exertional dyspnea and was found to have a cardiac murmur. Echocardiography showed a stenotic tricuspid valve with vegetations on all 3 cusps. No other valvular vegetation could be detected. Concomitant tricuspid regurgitation was noted too. Blood culture results were negative. Clinical findings and serologic tests confirmed the diagnosis of systemic lupus erythematosus. The patient was successfully treated with prednisolone and hydroxychloroquine, and follow-up echocardiography showed the disappearance of the vegetations.