部分中文FOSRENOL处方资料（仅供参考） 药品名称 通用名：碳酸镧 英文名：Lanthanum carbonate 商品名：FOSRENOL 开发与上市厂商：Shire 剂型：咀嚼片 规格 250mg、500mg、750mg、1g 药理作用　　 本品在上消化道的酸性环境下解离，与食物中的磷酸盐结合形成不溶性的磷酸镧复合物以抑制磷酸盐的吸收，从而降低体内血清磷酸盐和磷酸钙的水平。为了更有效地结合食物中的磷酸盐，本品宜随餐或在餐后立即服用。 健康志愿者服用本品后，血浆中的镧浓度很低；而终末期肾病患者服用本品的平均血浆镧峰浓度（C）为1.0mg/ml。剂量增加，血浆镧浓度也会随之小幅提升。本品在进食期间和进食后30分钟服用，对体内镧浓度几无影响。 体外试验显示，镧与a1-酸性糖蛋白、血清白蛋白及转铁蛋白等人血浆蛋白高度结合（>99％）。动物试验表明，大多数组织中的镧浓度系逐渐增加，且比血浆镧浓度高几个数量级（尤其在消化道、骨骼及肝脏中）。目前尚无证据表明镧可以透过血脑屏障。 药代动力学 本品既不是细胞色素P450（CYP）的底物，也不是其抑制剂。枸橼酸盐与本品单剂1000mg同服不影响本品的吸收。本品和地高辛、美托洛尔、华法林等药物同服时不影响这些药物的吸收。停止治疗后，镧从血浆中清除的消除半衰期（tl/2）为53小时。动物试验表明，胆汁排泄是镧消除的主要途径。在终末期肾病患者的透析液中未检测到镧。 适应症 本品适用于治疗终末期肾病患者的高磷酸盐血症。 用法用量　　 本品应随餐或于餐后立即服用。推荐初始剂量为一日750~1500mg，每隔2~3周逐步增加剂量，直至达到血清磷酸盐的目标水平。 临床研究中，患者最大日剂量可达3750mg。对大多数患者而言，本品一日1500~3000mg已可使血浆磷酸盐水平降至6.0mg/dl以下。 本品应完全咀嚼后再吞咽。 任何疑问，请遵医嘱！ Fosrenol 500mg, 750mg & 1000mg chewable tablets 1. Name of the medicinal product Fosrenol 500 mg chewable tablets Fosrenol 750 mg chewable tablets Fosrenol 1000 mg chewable tablets 2. Qualitative and quantitative composition Each chewable tablet contains lanthanum carbonate hydrate corresponding to 500 mg, 750 mg or 1000 mg lanthanum. 500 mg chewable tablets also contain on average 1066 mg of dextrates, containing glucose. 750 mg chewable tablets also contain on average 1599 mg of dextrates, containing glucose. 1000 mg chewable tablets also contain on average 2132 mg of dextrates, containing glucose. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Chewable tablet. 500 mg: White, round, beveled-edge flat tablets embossed with 'S405/500' on one side. 750 mg: White, round, beveled-edge flat tablets embossed with 'S405/750' on one side. 1000 mg: White, round, beveled-edge flat tablets embossed with 'S405/1000' on one side. 4. Clinical particulars 4.1 Therapeutic indications Fosrenol is indicated in adult patients as a phosphate binding agent for use in the control of hyperphosphataemia in chronic renal failure patients on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD). Fosrenol is also indicated in adult patients with chronic kidney disease not on dialysis with serum phosphate levels ≥1.78 mmol/L in whom a low phosphate diet alone is insufficient to control serum phosphate levels. 4.2 Posology and method of administration Fosrenol is for oral administration. The tablets must be chewed completely and not swallowed whole. To aid with chewing the tablets may be crushed. Adults, including elderly (> 65 years) Fosrenol should be taken with or immediately after food, with the daily dose divided between meals. Patients should adhere to recommended diets in order to control phosphate and fluid intake. Fosrenol is presented as a chewable tablet therefore avoiding the need to take additional fluid. Serum phosphate levels should be monitored and the dose of Fosrenol titrated every 2-3 weeks until an acceptable serum phosphate level is reached, with regular monitoring thereafter. Control of serum phosphate level has been demonstrated at doses starting from 750 mg per day. The maximum dose studied in clinical trials, in a limited number of patients, is 3750mg. Patients who respond to lanthanum therapy, usually achieve acceptable serum phosphate levels at doses of 1500 – 3000 mg lanthanum per day. Paediatric population The safety and efficacy of Fosrenol in children and adolescents below the age of 18 years has not been established (see section 4.4 and 5.1). Hepatic impairment The effect of hepatic impairment on Fosrenol pharmacokinetics has not been assessed. Due to its mechanism of action and the lack of liver metabolism doses in hepatic impairment should not be modified, but patients should be monitored carefully (see sections 4.4 and 5.2). 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypophosphataemia. 4.4 Special warnings and precautions for use Tissue deposition of lanthanum has been shown with Fosrenol in animal studies. In 105 bone biopsies from patients treated with Fosrenol, some for up to 4.5 years, rising levels of lanthanum were noted over time (see section 5.1). No clinical data are available on deposition of lanthanum in other human tissues. The use of Fosrenol in clinical studies beyond 2 years is currently limited. However, treatment of subjects with Fosrenol for up to 6 years has not demonstrated a change in the benefit/risk profile. Patients with acute peptic ulcer, ulcerative colitis, Crohn's disease or bowel obstruction were not included in clinical studies with Fosrenol. Fosrenol should be used in these patients following careful assessment of benefit and risk. Fosrenol is known to cause constipation (see section 4.8) and therefore caution should be exercised in patients predisposed to bowel obstruction (e.g. previous abdominal surgery, peritonitis). Patients with renal insufficiency may develop hypocalcaemia. Fosrenol does not contain calcium. Serum calcium levels should therefore be monitored at regular time intervals for this patient population and appropriate supplements given. Lanthanum is not metabolised by liver enzymes but it is most likely excreted in the bile. Conditions resulting in a marked reduction of bile flow may be associated with incrementally slower elimination of lanthanum, which may result in higher plasma levels and increased tissue deposition of lanthanum (see sections 5.2 and 5.3). As the liver is the principal organ of elimination of absorbed lanthanum monitoring of liver function tests is recommended. Safety and efficacy of Fosrenol have not been established in children and adolescents; use in children and adolescents is not recommended (see section 4.2). Fosrenol should be discontinued if hypophosphataemia develops. Abdominal x-rays of patients taking Lanthanum Carbonate may have a radio-opaque appearance typical of an imaging agent. Patients with rare glucose-galactose malabsorption should not take this medicine. 4.5 Interaction with other medicinal products and other forms of interaction Lanthanum carbonate hydrate may increase gastric pH. It is recommended that compounds, which are known to interact with antacids, should not be taken within 2 hours of dosing with Fosrenol (e.g. chloroquine, hydroxychloroquine and ketoconazole). In healthy subjects, the absorption and pharmacokinetics of lanthanum were not affected by co-administration of citrate. Serum levels of fat-soluble vitamins A, D, E and K, were not affected by Fosrenol administration in clinical studies. Human volunteer studies have shown that co-administration of Fosrenol with digoxin, warfarin or metoprolol does not produce clinically-relevant changes in the pharmacokinetic profiles of these drugs. In simulated gastric juice, lanthanum carbonate hydrate did not form insoluble complexes with warfarin, digoxin, furosemide, phenytoin, metoprolol or enalapril, suggesting a low potential to affect the absorption of these drugs. However, interactions with drugs such as tetracycline and doxycycline are theoretically possible and if these compounds are to be co-administered, it is recommended that they are not to be taken within 2 hours of dosing with Fosrenol. The bioavailability of oral ciprofloxacin was decreased by approximately 50% when taken with Fosrenol in a single dose study in healthy volunteers. It is recommended that oral floxacin formulations are taken at least 2 hours before or 4 hours after Fosrenol. Phosphate binders (including Fosrenol) have been shown to reduce the absorption of levothyroxine. Consequently, thyroid hormone replacement therapy should not be taken within 2 hours of dosing with Fosrenol and closer monitoring of TSH levels is recommended in patients receiving both medicinal products. Lanthanum carbonate hydrate is not a substrate for cytochrome P450 and does not significantly inhibit the activities of the major human cytochrome P450 isoenzymes, CYP1A2, CYP2D6, CYP3A4, CYP2C9 or CYP2C19 in vitro. 4.6 Fertility, pregnancy and lactation There are no adequate data from the use of Fosrenol in pregnant women. One study in rats showed reproductive foetotoxicity (delayed eye opening and sexual maturation) and reduced pup weights at high doses (see section 5.3). The potential risk for humans is unknown. Fosrenol is not recommended for use during pregnancy. It is unknown whether lanthanum is excreted in human breast milk. The excretion of lanthanum in milk has not been studied in animals. Caution should be used in taking a decision whether to continue/discontinue breast feeding or to continue/discontinue therapy with Fosrenol, taking into account the potential benefit of breast feeding to the child and the potential benefit of Fosrenol therapy to the nursing mother. 4.7 Effects on ability to drive and use machines Fosrenol may induce dizziness and vertigo, which may impair the ability to drive and use machinery. 4.8 Undesirable effects The most commonly reported adverse drug reactions, with the exception of headache and allergic skin reactions, are gastrointestinal in nature; these are minimized by taking Fosrenol with food and generally abated with time with continued dosing (see section 4.2). The following convention was used for frequency of adverse drug reactions: Very common (≥1/10); Common (≥1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥1/10,000 to < 1/1,000); Very rare (< 1/10,000), not known (cannot be estimated from the available data). Infections and Infestations   Uncommon Gastroenteritis, laryngitis Blood and lymphatic system disorders   Uncommon Eosinophilia Endocrine disorders   Uncommon Hyperparathyroidism Metabolism and nutrition disorders   Common Hypocalcaemia Uncommon Hypercalcaemia, hyperglycaemia, hyperphosphataemia, hypophosphataemia, anorexia, appetite increased Nervous system disorders   Very Common Headache Uncommon Dizziness, taste alteration Ear and Labyrinth disorders   Uncommon Vertigo Gastrointestinal disorders   Very Common Abdominal pain, diarrhoea, nausea, vomiting Common Constipation, dyspepsia, flatulence Uncommon Eructation, indigestion, irritable bowel syndrome, dry mouth, oesophagitis, stomatitis, loose stools, tooth disorder, gastro-intestinal disorder NOS* Skin and subcutaneous tissue disorders   Uncommon Alopecia, sweating increased Musculoskeletal and connective tissue disorders   Uncommon Arthralgia, myalgia, osteoporosis General disorders and administration site conditions   Uncommon Asthenia, chest pain, fatigue, malaise, peripheral oedema, pain, thirst Investigations   Uncommon Blood aluminium increased, increase in GGT, increases in hepatic transaminases, alkaline phosphatase increased, weight decrease. * Not otherwise specified Post marketing experience: During post-approval use of Fosrenol, cases of Allergic Skin Reactions (including skin rashes, urticaria and pruritus) have been reported which show a close temporal relationship to lanthanum carbonate therapy. In clinical trials, Allergic Skin Reactions were seen in both Fosrenol and placebo/active comparator groups at a frequency of Very Common (≥1/10) Although there have been a number of additional isolated reactions reported, none of these reactions are considered unexpected in this patient population. Transient QT changes have been observed but these were not associated with an increase of cardiac adverse events. 4.9 Overdose No case of overdose has been reported. The highest daily dose of lanthanum administered to healthy volunteers during Phase I studies was 4718mg given for 3 days. The adverse events seen were mild to moderate and included nausea and headache. 5. Pharmacological properties 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Drugs for treatment of hyperkalaemia and hyperphosphataemia. ATC code: V03A E03 Fosrenol contains lanthanum carbonate hydrate. The activity of lanthanum carbonate hydrate as a phosphate binder is dependent on the high affinity of lanthanum ions, which are released from the carbonate salt in the acid environment of the stomach, for dietary phosphate. Insoluble lanthanum phosphate is formed which reduces the absorption of phosphate from the gastro-intestinal tract. A total of 1130 patients with chronic renal failure treated with maintenance haemodialysis or CAPD were studied in two phase II and two phase III studies. Three studies were placebo controlled (1 fixed dose and 2 titrated dose designs) and one included calcium carbonate as an active comparator. During these studies, 1016 patients received lanthanum carbonate, 267 received calcium carbonate and 176 received placebo. Two placebo-controlled, randomised studies enrolled patients on dialysis after a washout from previous phosphate binders. After titration of lanthanum carbonate to achieve a serum phosphate level between 1.3 and 1.8mmol/L in one study (doses up to 2250mg/day), or ≤1.8mmol/L in a second study (doses up to 3000mg/day), patients were randomised to lanthanum carbonate or placebo as maintenance treatment. After the 4-week randomised placebo-controlled phase, the serum phosphate concentration rose between 0.5 and 0.6mmol/L in the placebo group, in both studies, relative to patients who remained on lanthanum carbonate therapy. There were 61% patients on lanthanum carbonate who maintained their response, compared to 23% on placebo. The active comparator study demonstrated that serum phosphate levels were reduced to target levels of 1.8mmol/l at the end of the 5 week titration period, in 51% of the lanthanum group compared with 57% of the calcium carbonate group. At week 25 the percentage of randomised patients showing controlled serum phosphate levels was similar in the two treatment groups, 29% on lanthanum and 30% on calcium carbonate (using a missing=failure approach). Mean serum phosphate levels were reduced by a similar amount in both treatment groups. Further long-term extension studies have demonstrated maintenance of phosphate reduction for some patients following continued administration of at least 2 years of lanthanum carbonate. Hypercalcaemia was reported in 0.4% of patients with Fosrenol compared with 20.2% on calcium-based binders in comparative studies. Serum PTH concentrations may fluctuate depending on a patient's serum calcium, phosphate and vitamin D status. Fosrenol has not been shown to have any direct effects on serum PTH concentrations. In the long-term bone studies a trend towards increasing bone lanthanum concentrations with time in the control population was observed from the averaged data, the median rising 3-fold from a baseline of 53 μg/kg at 24 months. In patients treated with lanthanum carbonate, the bone lanthanum concentration increased during the first 12 months of lanthanum carbonate treatment up to a median of 1328μg/kg (range 122-5513μg/kg). Median and range concentrations at 18 and 24 months were similar to 12 months. The median at 54 months was 4246μg/kg (range 1673-9792μg/kg). Paired bone biopsies (at baseline and at one or two years) in patients randomised to either Fosrenol or calcium carbonate in one study and patients randomised to either Fosrenol or alternative therapy in a second study, showed no differences in the development of mineralization defects between the groups. Paediatric population The European Medicines Agency has deferred the obligation to submit the results of studies with Fosrenol in one or more subsets of the paediatric population in treatment of hyperphosphataemia. See 4.2 for information on paediatric use. 5.2 Pharmacokinetic properties As binding between lanthanum and dietary phosphorus occurs in the lumen of the stomach and upper small intestine, the therapeutic effectiveness of Fosrenol is not dependent on levels of lanthanum in the plasma. Lanthanum is present in the environment. Measurement of background levels in non-lanthanum carbonate hydrate-treated chronic renal failure patients during Phase III clinical trials revealed concentrations of <0.05 to 0.90 ng/mL in plasma, and <0.006 to 1.0 μg/g in bone biopsy samples. Absorption Lanthanum carbonate hydrate has low aqueous solubility (<0.01 mg/mL at pH 7.5) and is minimally absorbed following oral administration. Absolute oral bioavailability is estimated to be <0.002% in humans. In healthy subjects, plasma AUC and Cmax increased as a function of dose, but in a less than proportional manner, after single oral doses of 250 to 1000 mg lanthanum, consistent with dissolution-limited absorption. The apparent plasma elimination half-life in healthy subjects was 36 hours. In renal dialysis patients dosed for 10 days with 1000 mg lanthanum 3 times daily, the mean (± sd) peak plasma concentration was 1.06 (± 1.04) ng/mL, and mean AUClast was 31.1 (± 40.5) ng.h/mL. Regular blood level monitoring in 1707 renal dialysis patients taking lanthanum carbonate hydrate for up to 2 years showed no increase in plasma lanthanum concentrations over this time period. Distribution Lanthanum does not accumulate in plasma in patients or in animals after repeated oral administration of lanthanum carbonate hydrate. The small fraction of orally administered lanthanum absorbed is extensively bound to plasma proteins (>99.7%) and in animal studies, was widely distributed to systemic tissues, predominantly bone, liver and the gastrointestinal tract, including the mesenteric lymph nodes. In long-term animal studies, lanthanum concentrations in several tissues, including the gastrointestinal tract, bone and liver increased over time to levels several orders of magnitude above those in plasma. An apparent steady-state level of lanthanum was attained in some tissues, e.g. the liver whereas levels in gastrointestinal tract increased with duration of treatment. Changes in tissue lanthanum levels after withdrawal of treatment varied between tissues. A relatively high proportion of lanthanum was retained in tissues for longer than 6 months after cessation of dosing (median % retained in bone ≤100% (rat) and ≤87% (dog), and in the liver ≤6% (rat) and ≤82 % (dog). No adverse effects were associated with the tissue deposition of lanthanum seen in long-term animal studies with high oral doses of lanthanum carbonate (see 5.3) (See section 5.1 for information regarding changes in lanthanum concentrations in bone biopsies taken from renal dialysis patients after one year of treatment with lanthanum containing versus calcium containing phosphate binders). Metabolism Lanthanum is not metabolised. Studies in chronic renal failure patients with hepatic impairment have not been conducted. In patients with co-existing hepatic disorders at the time of entry into Phase III clinical studies, there was no evidence of increased plasma exposure to lanthanum or worsening hepatic function after treatment with Fosrenol for periods up to 2 years. Elimination Lanthanum is excreted mainly in the faeces with only around 0.000031% of an oral dose excreted via the urine in healthy subjects (renal clearance approximately 1mL/min, representing <2% of total plasma clearance). After intravenous administration to animals, lanthanum is excreted mainly in the faeces (74% of the dose), both via the bile and direct transfer across the gut wall. Renal excretion was a minor route. 5.3 Preclinical safety data Preclinical data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeated dose toxicity or genotoxicity. Lanthanum carbonate hydrate reduced gastric acidity in the rat in a safety pharmacology study. In rats administered high doses of lanthanum carbonate hydrate from day 6 of gestation to day 20 post partum there were no maternal effects, but reduced pup weight and delays in some developmental markers (eye and vaginal opening) were seen. In rabbits given high daily doses of lanthanum carbonate hydrate during gestation, maternal toxicity with reduced maternal food intake and body weight gain, increased pre- and post-implantation losses and decreased pup weight were seen. Lanthanum carbonate hydrate was not carcinogenic in mice or rats. In mice, an increase in gastric glandular adenomas was seen in the high-dose group (1500 mg/kg/day). The neoplastic response in the mouse is considered to be related to an exacerbation of spontaneous pathological stomach changes and to be of little clinical significance. Studies in animals have shown deposition of lanthanum in tissues, mainly the gastrointestinal tract, mesenteric lymph nodes, liver and bone (see section 5.2). However, life-time studies in healthy animals do not indicate a hazard for man from the use of Fosrenol. Specific immunotoxicity studies have not been performed. 6. Pharmaceutical particulars 6.1 List of excipients Dextrates (hydrated) Colloidal anhydrous silica Magnesium stearate. 6.2 Incompatibilities Not applicable. 6.3 Shelf life 3 years. 6.4 Special precautions for storage This medicinal product does not require any special storage conditions. 6.5 Nature and contents of container White cylindrical HDPE bottles containing a rayon coil fitted with a tamper evident, child resistant polypropylene screw cap. Pack sizes 500 mg: 90 tablets (Multipack containing 90 (2 packs of 45) chewable tablets). 750 mg: 90 tablets (Multipack containing 90 (6 packs of 15) chewable tablets). 1000 mg: 90 tablets (Multipack containing 90 (6 packs of 15) chewable tablets). 6.6 Special precautions for disposal and other handling No special requirements. 7. Marketing authorisation holder Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham Basingstoke Hampshire, RG24 8EP United Kingdom 8. Marketing authorisation number(s) PL 08081/0042 PL 08081/0043 PL 08081/0044 9. Date of first authorisation/renewal of the authorisation 12 September 2006 / 19 March 2009 10. Date of revision of the text 21 March 2013 新的研究报告证明FOSRENOL（R）具有长期的有效性、安全性和耐受性 ***碳酸镧(FOSRENOL)治疗透析有关的高磷酸盐血症 -FOSRENOL 是末期肾病患者的治疗选择（最新六年试验数据证明） -FOSRENOL 体外磷酸盐结合亲合力 ASN 会议上公布的其它数据显示，在 pH 3 的条件下，FOSRENOL 的磷酸盐结合亲合力比 sevelamer hydrochloride (HCl)（盐酸司维拉姆）高200多倍。在 pH 5-7 的条件下，FOSRENOL 的亲合力比 sevelamer HCl 高四倍，显示出 FOSRENOL 体外良好的 pH 结合亲合力与独立性。此外，胆汁酸的出现并未影响 FOSRENOL 这种磷酸盐结合剂的稳定性，但却导致 sevelamer HCl 的磷酸盐结合亲合力下降了13倍以上，从而造成其中的磷酸盐释出。pH 值对 FOSRENOL 体内磷酸盐结合力的影响的临床相关性尚未建立。 Shire 全球临床医药部门副总裁 Raymond Pratt 博士表示：“Shire 很高兴在 ASN 上公布这些体外及临床数据。公司致力于为全球市场带来像 FOSRENOL 这样有效的治疗选择，以造福末期肾病患者。FOSRENOL目前在美国有售，未来数月将在欧洲推出。Shire 为能够给需要一种有效且耐受性好的磷酸盐结合剂的患者提供另一种不含钙的药品选择而深感自豪。” -治疗高磷酸盐血症 即使采取低磷饮食，大部分末期肾病患者还是会患上高磷酸盐血症（血液中磷的浓度过高）。如不得到有效治疗，高磷酸盐血症可能导致肾性骨营养不良(renal osteodystrophy)，造成一系列骨疾病，表现为骨痛、脆骨症、骨骼畸形和骨折。此外，有证据表明高磷酸盐血症还可能引起心血管疾病，透析患者中近半数就死于心血管疾病。 Fosrenol是一种咀嚼性片剂, 不需用水送服, 这对因严重肾病限制了液体摄入的病人而言有重要好处。 新发表的研究报告表明FOSRENOL(R)具有长期的疗效、安全性和耐药性。 巴辛斯托克, 2005年10月24日 /美通社-亚洲网/ -- 采用FOSRENOL(R)治疗的70%晚期肾病患者控制磷酸盐。 本月新发表的Nephron 临床惯例研究报告表明，FOSRENOL(R)(lanthanum carbonate)在多达3年的时间□成功地降低和保持平均血清磷酸盐水平，与此同时，晚期肾病患者表现出安全性和耐药性。 这项研究对全世界将近100万人来说是一个大有希望的好消息。这些人即将面临hyperphosphataemia的严重后果，事实证明，这种疾病与长期的发病率和死亡率相关。hyperphosphataemia是一种血液中磷酸盐含量过高的病症，它是晚期肾病的几乎不可避免的后果，多数患者仍然控制不利。 曼彻斯特肾病学及移植研究所的试验负责人Alastair Hutchison博士说：“这些资料非常令人信服，并且证明FOSRENOL(R)长期降低患者的磷酸盐水平的有效性、安全和耐药性。FOSRENOL(R)还可减轻服药负担，这对常常已经服用多种药物的肾病患者是一个重要好处。这些结果增加了FOSRENOL(R)已经广泛的资料，并且进一步证明这种有效的新药是控制磷酸盐的一个重要步骤。” 这些结果来自对518名和161名用FOSRENOL(R)治疗分别为1年和3年的研究延伸。在延长之前，服用FOSRENOL(R)的患者继续治疗，服用碳酸钙的患者转为FOSRENOL(R)。 在第一次六个月的研究结束时，继续用FOSRENOL(R)治疗的患者的平均血清磷酸盐水平为1.76 mmol/L (5.46 mg/dl)。到第二次两年的试验结束时，69%的服用FOSRENOL(R)的患者在所有试验阶段的血清磷酸水准为5.6mg/dl，表明FOSRENOL(R)降低hyperphosphataemia发病率的长期疗效。在进行研究时，肾病结果品质计画(K/DOQI)的血清磷酸盐指南目标为5.6 mg/dl。此外，在延伸之前，碳酸钙中断并转为FOSRENOL(R)之后的hypercalcaemia发病率为2.7%，而在双盲阶段为20.2%。在这项试验期间，FOSRENOL(R)也有很强的长期耐药性 。 Shire全球临床药物公司副总裁Ray Pratt博士说：“Shire对发表这些资料感到十分高兴。这些资料进一步表明，有确凿的证据证明FOSRENOL(R)用于患有hyperphosphataemia的透析患者的疗效、安全性和耐药性。FOSRENOL(R)目前在美国市场销售，今后几个月将在欧洲销售。Shire为能够向需要有效和耐药性强的磷酸盐粘合剂的患者提供一种非成功的无钙新药感到非常自豪。” Hyperphosphataemia是一种相对说来未被认识的疾病，即使它在欧洲影响到18万人，在美国影响到22.4万人(4)。不幸的是，由于身体摆脱过多磷酸盐的能力下降，这种疾病几乎是慢性肾衰竭的必然结果。磷酸盐随日常饮食进入体内。 如果治疗不当，hyperphosphataemia可能引起长期的健康危险，导致肾osteodystrophy (最终引起骨痛、骨脆和骨骼变形)，并且可能造成心血管疾病，肾透析患者将近半数死于心血管病。 肾透析患者需要采取难以接受的无味道的低磷酸盐饮食，以帮助解决这个问题。尽管透析本身试图解决这种不平衡，但是研究表明，许多肾透析患者的血清磷酸盐水平超过2.1mmol/L (6.5 mg/dL)，远远高于目前1.78 mmol/L (5.5 mg/dL)的指导上限。因此，磷酸盐合剂疗法对于控制磷酸盐至关重要。 尽管有几种磷酸盐合剂可供使用，但是目前的磷酸盐控制仍有问题。超过6,000名血液透析患者的平均血清磷酸盐水平为2.0 mmol/L (6.2 mg/dL)，多达30%患者的磷酸盐水平甚至高于2.26 mmol/L (7.0 mg/dL)。这些新资料表明，FOSRENOL(R)有可能大大改善hyperphosphataemia的治疗。 最常见的副作用:是胃肠反应，例如恶心和呕吐，一般说来会随着服药的继续减轻。导致临床试验中断的最常见副作用是胃肠反应（恶心、呕吐和腹泻）。试验中报告的其他副作用包括透析移植并发症、头痛、腹痛和高血压。尽管研究报告的目的不是发现骨折和死亡率危险的差异，但是在长达叁年的时间□，用FOSRENOL(R)治疗的患者与服用其他药物的患者没有区别。治疗的时间和临床计画中观察时间过短，无法断定FOSRENOL(R)在叁年后对骨折或死亡率危险没有影响。虽然镧在动物的胃肠道、肝和骨骼中积聚，但是在人体中的临床意义并不为人所知。患有急性消化道溃疡、溃疡、Crohn氏病或肠梗阻的病人没有包括在FOSRENOL(R)临床研究中。对患有这些疾病的病人应该慎重。哺乳期或怀孕的患者不得服用FOSRENOL(R)。十八岁以下的患者不得服用FOSRENOL(R)。 -------------------------------------------------- 注：以下产品不同规格和不同价格，购买以咨询为准！ -------------------------------------------------- 产地国家: 加拿大 原产地英文商品名: FOSRENOL TABLET CHEW 250mg/tab 90tabs/bottle 原产地英文药品名: LANTHANUM CARBONATE 中文参考商品译名: FOSRENOL咀嚼片 250毫克/片 90片/瓶 中文参考药品译名: 碳酸镧 生产厂家中文参考译名: SHIRE 生产厂家英文名: SHIRE --------------------------------------------------------------- 产地国家: 德国 原产地英文商品名: FOSRENOL TABLET CHEW 250mg/tab 90tabs/bottle 原产地英文药品名: LANTHANUM CARBONATE 中文参考商品译名: FOSRENOL咀嚼片 250毫克/片 90片/瓶 中文参考药品译名: 碳酸镧 生产厂家中文参考译名: SHIRE 生产厂家英文名: SHIRE ------------------------------------------------------------------ 产地国家: 美国 原产地英文商品名: FOSRENOL TABLET CHEW 500mg/tab 90tabs/bottle 原产地英文药品名: LANTHANUM CARBONATE 中文参考商品译名: FOSRENOL咀嚼片 500毫克/片 90片/瓶 中文参考药品译名: 碳酸镧 生产厂家中文参考译名: SHIRE 生产厂家英文名: SHIRE ------------------------------------------------------------------ 产地国家: 美国 原产地英文商品名: FOSRENOL TABLET CHEW 750mg/tab 90tabs/bottle 原产地英文药品名: LANTHANUM CARBONATE 中文参考商品译名: FOSRENOL咀嚼片 750毫克/片 90片/瓶 中文参考药品译名: 碳酸镧 生产厂家中文参考译名: SHIRE 生产厂家英文名: SHIRE ------------------------------------------------------------------ 产地国家: 美国 原产地英文商品名: FOSRENOL TABLET CHEW 1000mg/tab 90tabs/bottle 原产地英文药品名: LANTHANUM CARBONATE 中文参考商品译名: FOSRENOL咀嚼片 1000毫克/片 90片/瓶 中文参考药品译名: 碳酸镧 生产厂家中文参考译名: SHIRE 生产厂家英文名: SHIRE 该药品相关信息网址1: http://www.fosrenol.com/ 该药品相关信息网址2: http://www.drugs.com/fosrenol.html 该药品相关信息网址3: http://www.rxlist.com/fosrenol-drug.htm