Gundgurthi Abhay, Garg M K, Dutta M K, Pakhetra R
Department of Endocrinology, Army Hospital (Research and Referral), Delhi Cantt -110010.
J Assoc Physicians India. 2013 May;61(5):320-4.
Adrenal insufficiency is often diagnosed by short synacthen test using intravenous Injection Synacthene, which is not marketed in India officially. To overcome this problem this study was planned to validate and use Acton Prolongatum (Ferring pharmaceuticals) as intramuscular ACTH stimulation test for evaluation of adrenal function.
This study was planned in two groups. First group called validation group, was studied for validation of intramuscular ACTH test and second group called study group, was evaluated for efficacy of intramuscular ACTH test to detect adrenal insufficiency. Twenty five units of ACTH (Acton Prolongatum) was injected intramuscularly and blood sample was collected after 60 minutes for estimation of cortisol. All subjects with one hour post ACTH cortisol < 18.0 microg/dl were diagnosed as having adrenal insufficiency.
This study was carried out in 61 subjects in validation group and 89 patients in study group. Basal and post ACTH serum cortisol were within normal range in healthy adults, patients with diabetes mellitus and primary hypothyroidism in validation group. Basal cortisol ranged from 4.67-18.39 microg/dl and post ACTH serum cortisol ranged from 20.01-44.95 microg/dl in these groups. Patients with known adrenal insufficiency had significantly low basal cortisol level than controls (2.86 +/- 2.66 vs. 10.35 +/- 4.37 microg/dl, p < 0.001), and post ACTH serum cortisol was < 18.0 microg/dl in all. Among study group 37 patients (41.6%) were diagnosed as adrenal insufficiency using post ACTH cortisol levels. Basal cortisol (< 3.0 microg/dl) could detect only 60% of these patients. Basal cortisol level has sensitivity of 60% and specificity of 100% to detect AI when compared to ACTH stimulated cortisol levels.
Intramuscular ACTH test using Acton Prolongatum is effective in evaluation of adrenal function in all suspected cases of primary or secondary adrenal insufficiency. Basal cortisol has poor sensitivity to diagnose AI.
肾上腺功能不全常通过使用静脉注射辛纳科特（Synacthene）的短促肾上腺皮质激素试验来诊断，而该药物在印度未正式上市。为解决这一问题，本研究计划验证并使用阿克通长效型（Acton Prolongatum，辉凌制药公司生产）进行肌肉注射促肾上腺皮质激素刺激试验以评估肾上腺功能。
本研究分为两组。第一组称为验证组，用于验证肌肉注射促肾上腺皮质激素试验；第二组称为研究组，评估肌肉注射促肾上腺皮质激素试验检测肾上腺功能不全的有效性。肌肉注射25单位促肾上腺皮质激素（阿克通长效型），60分钟后采集血样以测定皮质醇。所有促肾上腺皮质激素注射后1小时皮质醇<18.0微克/分升的受试者被诊断为肾上腺功能不全。
验证组有61名受试者，研究组有89名患者参与了本研究。在验证组中，健康成年人、糖尿病患者和原发性甲状腺功能减退患者的基础及促肾上腺皮质激素注射后血清皮质醇均在正常范围内。这些组的基础皮质醇范围为4.67 - 18.39微克/分升，促肾上腺皮质激素注射后血清皮质醇范围为20.01 - 44.95微克/分升。已知肾上腺功能不全的患者基础皮质醇水平显著低于对照组（2.86±2.66对10.35±4.37微克/分升，p<0.001），且所有患者促肾上腺皮质激素注射后血清皮质醇均<18.0微克/分升。在研究组中，37名患者（41.6%）根据促肾上腺皮质激素注射后皮质醇水平被诊断为肾上腺功能不全。基础皮质醇（<3.0微克/分升）仅能检测出这些患者中的60%。与促肾上腺皮质激素刺激后的皮质醇水平相比，基础皮质醇水平检测肾上腺功能不全的敏感性为60%，特异性为100%。
使用阿克通长效型进行肌肉注射促肾上腺皮质激素试验对所有疑似原发性或继发性肾上腺功能不全的病例评估肾上腺功能有效。基础皮质醇对诊断肾上腺功能不全的敏感性较差。
