Masato Nishioka

Cinacalcet Effectively Reduces Parathyroid Hormone Secretion and Gland Volume Regardless of Pretreatment Gland Size in Patients with Secondary Hyperparathyroidism

BACKGROUND AND OBJECTIVES Cinacalcet is effective in reducing serum parathyroid hormone (PTH) in patients with secondary hyperparathyroidism. However, it has not been proven whether parathyroid gland size predicts response to therapy and whether cinacalcet is capable of inducing a reduction in parathyroid volume. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS This 52-week, multicenter, open-label study enrolled hemodialysis patients with moderate to severe secondary hyperparathyroidism (intact PTH >300 pg/ml). Doses of cinacalcet were adjusted between 25 and 100 mg to achieve intact PTH <180 pg/ml. Ultrasonography was performed to measure the parathyroid gland size at baseline, week 26, and week 52. Findings were also compared with those of historical controls. RESULTS Of the 81 subjects enrolled, 56 had parathyroid glands smaller than 500 mm(3) (group S) and 25 had at least one enlarged gland larger than 500 mm(3) (group L). Treatment with cinacalcet effectively decreased intact PTH by 55% from baseline in group S and by 58% in group L. A slightly greater proportion of patients in group S versus group L achieved an intact PTH <180 pg/ml (46 versus 32%) and a >30% reduction from baseline (88 versus 78%), but this was not statistically significant. Cinacalcet therapy also resulted in a significant reduction in parathyroid gland volume regardless of pretreatment size, which was in sharp contrast to historical controls (n = 87) where parathyroid gland volume progressively increased with traditional therapy alone. CONCLUSIONS Cinacalcet effectively decreases serum PTH levels and concomitantly reduces parathyroid gland volume, even in patients with marked parathyroid hyperplasia.

Effect of Intravenous Saccharated Ferric Oxide on Serum FGF23 and Mineral Metabolism in Hemodialysis Patients

Background/Aims: Fibroblast growth factor-23 (FGF23) plays a central role in the development of hypophosphatemia and inappropriately low 1,25-dihydroxyvitamin D induced by iron therapy for iron-deficiency anemia. The aim of this study was to examine the effect of intravenous saccharated ferric oxide on serum FGF23 levels and mineral metabolism in hemodialysis patients. Methods: This prospective study enrolled 27 hemodialysis patients who had iron-deficiency anemia defined by a hemoglobin concentration <10.5 g/dl and serum ferritin <100 ng/ml. Intravenous saccharated ferric oxide at a dose of 40 mg was administered three times weekly over 3 weeks. The dose of active vitamin D and phosphate binders was kept unchanged. Serum FGF23, intact parathyroid hormone (PTH) and other parameters were prospectively monitored for 5 weeks. Results: Serum FGF23 levels were markedly elevated [3,453 (338–6,383) pg/ml] at baseline. After 3 weeks of intravenous saccharated ferric oxide treatment, serum FGF23 further increased to 4,701 (1,251–14,396) pg/ml, and returned to the baseline values after 2 weeks of observation. There was also a significant decrease in intact PTH but no changes in serum calcium and phosphorus. Conclusions: Intravenous saccharated ferric oxide induces further increase in elevated FGF23 levels in hemodialysis patients. This increase does not induce hypophosphatemia and inappropriately low 1,25-dihydroxyvitamin D in the absence of functioning kidney, but may result in transient PTH suppression – possibly by directly acting on the parathyroid.

Clinical efficacy and cost-effectiveness of lanthanum carbonate as second-line therapy in hemodialysis patients in japan

BACKGROUND AND OBJECTIVES Lanthanum carbonate (LC) is a nonaluminum, noncalcium phosphate binder that is effective for hyperphosphatemia in dialysis patients. However, its efficacy and cost-effectiveness as second-line therapy have not been fully examined. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS We first conducted a multicenter, open-label, 16-week clinical trial to examine the effect of additive LC in 116 hemodialysis patients who had uncontrolled hyperphosphatemia with conventional phosphorus-lowering therapy alone. Based on these clinical data, a state transition model was developed to evaluate the benefits and costs associated with LC as second-line therapy. Reduced risks for cardiovascular morbidity and mortality among patients treated with LC arise through more of the population achieving the target phosphorus levels. Uncertainty was explored through sensitivity analysis. RESULTS After 16 weeks of additive LC treatment, mean serum phosphorus levels decreased from 7.30 ± 0.90 to 5.71 ± 1.32 mg/dl, without significant changes in serum calcium or intact parathyroid hormone levels. A subsequent cost-effectiveness analysis showed that compared with conventional treatment, additive LC incurred an average additional lifetime cost of

Carpal Tunnel Syndrome and Plasma β2-microglobulin Concentration in Hemodialysis Patients

22,054 per person and conferred an additional 0.632 quality-adjusted life years (QALYs). This resulted in an incremental cost-effectiveness ratio of

Behaviour of various substances in patients on CAPD, with special reference to assessment of peritoneal function.

34,896 per QALY gained. Applying a cost-effectiveness threshold of

Effects of Cefotaxime on Blood Coagulation in Patients with Renal Insufficiency

50,000 per QALY, a probabilistic sensitivity analysis showed that additive LC had a 97.4% probability of being cost-effective compared with conventional treatment. CONCLUSIONS Our results indicate that the use of LC as second-line therapy would be cost-effective among hemodialysis patients with uncontrolled hyperphosphatemia in Japan.

Clinical experience with the Valli catheter

Abstract:  As of the end of June 2005, 27 of 96 dialysis outpatients at our clinic had developed carpal tunnel syndrome (CTS). Of 19 patients who had undergone dialysis for 30 years or longer, 15 had CTS, whereas none of the 38 patients who had received dialysis for less than 10 years had CTS. These data reflect trends in CTS development: from 1983 the incidence of CTS increased for many years, but more recently there has been a decline in new cases of CTS. Comparison of the 27 CTS and 69 non‐CTS dialysis patients at our clinic showed that those in the CTS group were older and had a longer duration of dialysis. Patients in the CTS group were found to have had a high plasma β2‐microglobulin (BMG) level in the distant past (15–21 years ago), but conversely had a much lower BMG level in recent years. Simple correlation analysis and multiple logistic regression analysis showed that the presence of CTS was correlated with high BMG levels in the distant past, in addition to age and duration of dialysis. These findings suggest that reduction of the plasma BMG level due to advances in dialysis therapy in recent years has contributed to the decreased incidence of CTS.

Studies on the changes of plasma apoproteins and lipids in CAPD patients in comparison with HD patients

無尿および非糖尿病のCAPD患者14名につき, 血液および排液中の尿素窒素, クレアチニン, β2-マイクログロブリン, リゾチーム, α1-マイクログロブリン, アルブミン, グルコース濃度を測定し, クリアランス, 透析排液/血漿濃度比 (D/P比), 除去量, 除水量/総糖負荷量比 (除水能) を求め分子量, CAPD歴, 腹膜炎経験との関係を調べ以下の結果を得た. 腹膜機能の指標としてクリアランス, D/P比に差を認めなかった. 除水能とCAPD歴には有意差は認めなかったが, 除水能低下と腹膜炎回数には有意差を認め, 腹膜炎予防の重要性が示された. 除水能低下時および腹膜炎後は尿素窒素より大きい分子量の物質のクリアランス, D/P比とも, 高値にあったが, 一方, CAPDを中断し除水能回復を認めた症例ではクリアランス, D/P比とも, 中断前に比べ低下した. これより中分子以上のクリアランス, D/P比を求めることがクリアランス機能亢進による二次的な除水能低下を早期に予測し加えてCAPDを中断することが除水能回復を図る治療法として有用であることが示された.

Studies on the Small Thyroid Carcinoma in the Dialysis Patients with Hyperparathyroidism

Pathologically and clinically, patients with chronic renal insufficiency (patients undergoing long term haemodialysis) tend to haemorrhage; in fact, haemorrhage is a characteristic cause of death (Takeuchi et al. 1986). Antibiotics which inhibit vitamin K metabolism in the body may aggravate this haemorrhagic tendency (Uchida 1985). Cefotaxime differs from these antibiotics in terms of its chemical structure, and so exerts little influence on blood coagulation (Iwata 1984). In the present study, the effect of cefotaxime on blood coagulation was investigated in patients with chronic renal insufficiency (undergoing long term haemodialysis).

The indications and post operative clinical course of subtotal parathyroidectomy for renal osteodystrophy

従来使用されてきたCAPD用カテーテルは, 腹腔内位置移動や被包化現象のため, 排液障害がしばしば発生し治療には難渋する. 今回我々は主にこの排液障害を防止する目的で開発されたValli catheter (Valli cath.) を, 慢性腎不全症例5例に臨床使用し, 検討を加えた.使用したValli cath.の形状は, 腹腔外部はTenckhoff double cuff catheter (Tenckhoff d. c. cath.) と同様であるが, 腹腔内部はカテーテル先端を3.5×8cmの楕円形バルーンで覆い, 腹腔内臓器より隔絶している.カテーテル留置法は, 全症例とも観血的開腹術 (腰椎麻酔下4例, 局所麻酔下1例) で挿入した. 観察期間は最長15ヵ月, 最短2ヵ月 (総53 patient-months), 平均10.6 patient-monthsで, 現在全例ともCAPD療法継続中である. この期間中, 全症例ともバルーンの形状は良好に保たれ, ダグラス窩に固定され, 注排液障害もなく, また注排液速度もTenckhoff cathと比較すると早い結果を得た.出口部感染, トンネル感染, カフ感染等はこの期間中発生しなかった. しかし, Valli cathの腹腔外部形状はTenckhoff d. c. cathと同一であることより, これらの合併症は同頻度で発生する可能性があり, さらに材質, 形状等につき研究開発される必要がある.