Effect of chitosan chewing gum on reducing serum phosphorus in hemodialysis patients: a multi-center, randomized, double-blind, placebo-controlled trial.

BACKGROUND: HS219 (40 mg chitosan-loaded chewing gum) is designed to bind salivary phosphorus as an add-on to available phosphorus binders. We performed a randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of HS219 in hemodialysis (HD) patients with hyperphosphatemia as an add-on to phosphorus binders. METHODS: Sixty-eight HD patients who were maintained on calcium carbonate (n=33) or sevelamer hydrochloride (n=35) were enrolled. The primary end point was a change in serum phosphorus levels. Secondary end points included changes in levels of salivary phosphorus, serum calcium, parathyroid hormone (PTH), and intact fibroblast growth factor (iFGF) 23. RESULTS: Sixty-three patients chewed either HS219 (n=35) or placebo (n=28) for 30 min, three times a day, for 3 weeks. HS219 was well tolerated and safe. However, HS219 was not superior to placebo with additional reduction of serum phosphorus with respect to phosphorus binders at the end of the chewing period. There were no significant effects of HS219 on reduction of salivary phosphorus, serum calcium, iPTH, or iFGF23 levels. CONCLUSIONS: The chitosan-loaded chewing gum HS219 does not affect serum and salivary phosphorus levels in Japanese HD patients with hyperphosphatemia. Our findings do not support previous findings that 20 mg of chitosan-loaded chewing gum reduces serum and salivary phosphorus levels. TRIAL REGISTRATION: [corrected] ClinicalTrials.gov NCT01039428, 24 December, 2009.

[Hepatic arterial infusion with subsequent hepatectomy for a sigmoid colon cancer patient with hepatic metastases-a case report].

It is common to use systemic chemotherapy, instead of hepatic arterial infusion (HAI) of 5-fluorouracil (5-FU) or other cytotoxic agents, for unresectable hepatic metastases in colorectal cancer patients. Nevertheless, systemic administration of anticancer agents such as FOLFOX or FOLFIRI is sometimes difficult to continue for infirm patients. A 71-year-old female who had undergone sigmoidectomy for sigmoid colon cancer received HAI for 12 months because of big bilobar hepatic metastases and poor performance status. Thereafter, a two-stage hepatectomy(first, left lobe: second, S7+8 and S5) was performed successfully. She has been alive for 2.5 years after the first operation but with two small lung metastases in the left lobe. Because of bad performance status and her weak social and familial conditions, treatment with standard systemic chemotherapy could not be continued. In such cases, HAI should be performed if the metastases are limited to the liver.

[Sustained remission of blastic plasmacytoid dendritic cell neoplasm with ABVD chemotherapy].

Blastic plasmacytoid dendritic cell neoplasm is a rare but clinically aggressive tumor known to be derived from the precursors of plasmacytoid dendritic cells with frequent cutaneous involvement. Though the majority of patients initially respond to multi-agent chemotherapy, most cases without hemopoietic stem cell transplantation relapse within a year. We describe a case of a 71-year-old man with a dark-purple subcutaneous nodule (5×3 cm) under his right auricle. Histologic examination of the excisional biopsy specimen revealed a diffuse proliferation of blast cells with irregular nuclei, fine chromatin and one to several small nucleoli in the dermis extending to the subcutaneous soft tissues. The tumor cells expressed CD123, CD56, CD4, CD7, LCA, and TdT but not CD3, CD20, CD79a, CD10, CD68, CD163, myeloperoxidase (MPO), or naphthol-ASD-chloroacetate (ASD-Ch) esterase. A diagnosis of blastic plasmacytoid dendritic cell neoplasm was made. He did not have any other lesions except for the solitary skin nodule. He had refractory cytopenia with multilineage dysplasia (RCMD) and renal dysfunction. It was difficult for him to receive hemopoietic stem cell transplantation because of his advanced age and renal dysfunction. We had previously experienced successful treatment with ABVD chemotherapy for interdigitating dendritic cell sarcoma after ineffective CHOP chemotherapy. The plasmacytoid dendritic cell is one of the precursor cells of the interdigitating dendritic cell. Therefore we tried to apply ABVD therapy to him. The first course of ABVD induced complete remission. Although the therapies were reduced and postponed because of various complications, he is now in complete remission that has lasted for 21 months. Although previously not reported, ABVD therapy is useful for patients with blastic plasmacytoid dendritic cell neoplasm who cannot receive hemopoietic stem cell transplantation.

Therapeutic results of computed-tomography-guided transcatheter arterial chemoembolization for local recurrence of hepatocellular carcinoma after initial transcatheter arterial chemoembolization: the results of 85 recurrent tumors in 35 patients.

The aim of this study was to retrospectively evaluate the long-term results of transcatheter arterial chemoembolization (TACE) for the treatment of local recurrence of hepatocellular carcinoma (HCC) after the first TACE. Between September 1992 and October 2004, 85 recurrent HCC nodules of 35 patients were treated by TACE. During the median follow-up period of 15.5 months (range 1.9-58.6 months), 58 of the 85 treated tumors developed local recurrence again after the second TACE. The overall 6-, 12-, and 36-month recurrence-free rates of these tumors after the second TACE were 47.0%, 36.2%, and 25.8%, respectively. Local recurrence of HCC after the first TACE was treated by a second TACE with equivalent efficacy as that of the initial TACE, if segmental chemoembolization was achieved. We regard TACE as the treatment of choice for the management of local recurrence of HCC.

Local therapeutic results of computed tomography-guided transcatheter arterial chemoembolization for hepatocellular carcinoma: results of 265 tumors in 79 patients.

PURPOSE: To elucidate the local therapeutic results of computed tomography (CT)-guided transcatheter arterial chemoembolization (TACE) as initial treatment for hepatocellular carcinoma (HCC), and to verify factors which affect local therapeutic results. METHODS: From 1992 to 2002, 265 tumors of 79 HCC patients were treated by 139 sessions of CT-guided TACE as initial treatment. Among these 265 tumors, 182 constituted multiple new lesions, and the remaining 83 tumors were single new lesions. Local recurrence was retrospectively ascertained on follow-up CT images obtained after TACE. RESULTS: The overall local recurrence-free rates (LR-FRs) after a single TACE session at 6, 12, and 36 months were 67%, 49%, and 28%; those of the single new lesions were 80%, 66%, and 32%; and those of tumors with complete lipiodol accumulation were 82%, 68%, and 41%, respectively. LR-FRs of tumors of the single new lesions, and those of tumors with complete lipiodol accumulation, were significantly higher than the LR-FRs of multiple new lesions and tumors with incomplete lipiodol accumulation, respectively. For single new lesions < or =4 cm and the tumors that were one of multiple new lesions, there were no significant differences in the LR-FRs regarding the number of TACE sessions on the basis of patient, tumor location, or tumor size. CONCLUSION: Local therapeutic results of single new lesions were better than those of multiple new lesions, and the local therapeutic effect of TACE was not affected by the number of treatments on the basis of patient, tumor location, or tumor size.

Growth rate of locally recurrent hepatocellular carcinoma after transcatheter arterial chemoembolization: comparing the growth rate of locally recurrent tumor with that of primary hepatocellular carcinoma.

We compared the growth rate of locally recurrent hepatocellular carcinoma (HCC) with that of primary HCC. After the first treatment by transcatheter arterial chemoembolization (TACE), 60 locally recurrent HCC nodules were reviewed. The tumor volume doubling time (DT) of locally recurrent HCC was significantly shorter than that of primary HCC. The 95% lower threshold value was 17.7 days. The 6-, 12-, and 36-month recurrence-free rates of the tumors having DTs more than 70 days after the second TACE (77.7%, 53.8%, and 40.4%) were significantly higher than those of the tumors having DTs less than 70 days (26.7%, 26.7%, and 17.8%). Locally recurrent HCCs cannot double in diameter in less than 53 days. In the case that an equivocal lesion smaller than the section collimation depicted during a contrast-enhanced computed tomography (CECT) screening cannot be ruled out as local recurrence, the next CECT screening should be performed 2 months later.

Increased intima-media thickness of the carotid artery in Japanese female type 2 diabetic patients with 'midband lipoprotein'.

Among a number of different lipoprotein abnormalities, 'midband lipoprotein' migrating at a position between LDL and VLDL on polyacrylamide gel electrophoresis (PAGE), is an atherogenic lipoprotein and intima-media thickness (IMT) of the carotid artery is a useful marker of atherosclerotic diseases. The present study evaluated relationships between the presence of 'midband lipoprotein' and carotid IMT in subjects with type 2 diabetes. The average IMT of the carotid artery was determined from the means of maximal thicknesses of both left and right common carotid arteries, carotid bulb, and internal carotid artery using ultrasound B mode imaging in 118 Japanese patients (72 men, 46 women) and 43 healthy controls. Multivariate regression analyses indicated that the duration of diabetes and presence of 'midband lipoprotein' were independent determinants of carotid artery IMT in 46 female subjects with diabetes, and these subjects were then subclassified into midband-positive (n=24) and midband-negative (n=22) groups. IMT of the carotid artery was significantly different between midband-positive (0.98+/-0.32mm) and midband-negative (0.79+/-0.17mm) groups (P=0.02). These findings suggest that 'midband lipoprotein' is a possible risk factor for IMT of the carotid artery in Japanese female type 2 diabetic patients.

[Estimation of glomerular filtration rate by inulin clearance: comparison with creatinine clearance].

Inulin clearance (Cin) is widely believed to be the gold standard of the glomerular filtration rate (GFR). However, in Japan, Cin has not been officially recognized by the Ministry of Health, Labour and Welfare of Japan for clinical use. Creatinine clearance (Ccr) has been used to estimate the renal function of patients, but there have been many studies in which Ccr estimates were GFR falsely high because the metabolism and tubular excretion of creatinine widely varied according to the pathophysiological state of the patient. In the present study, we determined Cin and Ccr simultaneously in 116 adult patients with renal diseases and diabetic mellitus. The clearance study was performed by the modified Wesson's method. The inulin preparation was FFI-1010 (Fuji Yakuhin Co. Ltd.). Inulin in serum and urine was determined by the newly devised enzymatic assay (Toyobo Co. Ltd.), which is specific for inulin. The mean Cin was 35.0 +/- 14.4 ml/min/1.73 m2. The mean Ccr(the enzyme assay) was 63.6 +/- 24.1 ml/min/1.73 m2 and that of the kinetic Jaffe assay was 55.3 +/- 19.3 ml/min/1.73 m2. Mean Ccr/Cin was 1.93 +/- 0.73, 1.69 +/- 0.62, respectively. This ratio was significantly different(p < 0.05) in the degree of reduction of Cin, with values of 2.07 +/- 0.82 (Cin < 40 ml/min/1.73 m2) and 1.64 +/- 0.32(40 < Cin < 80 ml/min/1.73 m2), respectively. Only 8 patients were classified into the same degree of reduced renal function (the Guideline of Japanese Society of Nephrology). The findings of this study suggest that the GFR determined by Ccr could misjudge the renal function of patient and delay the administration of proper treatment of the patient. Introduction of Cin into the clinical field is necessary to avoid this delay.

Growth rate of primary single hepatocellular carcinoma: determining optimal screening interval with contrast enhanced computed tomography.

To determine the optimal screening interval for detecting small (< 20 mm) hepatocellular carcinoma (HCC) in a high-risk group using multiphase contrast-enhanced computed tomography (CECT), we evaluated the growth rate of primary single HCC. Forty-nine primary single HCC cases were reviewed. CECT screening was performed more than two times preceding to the diagnosis in 29 cases, and HCC nodule was identified at least two times in 22 cases. The initial nodule sizes ranged between 3 and 30 mm. Doubling time of tumor volume ranged from 34.8 to 496.4 days, with a geometric mean of 93.5 days, and a 95% lower threshold value of 27.1 days. It means that HCC will not double in diameter within 3 months. Therefore CECT screening at intervals of 3 months will detect new nodules at 10-20 mm in size and CECT screening at intervals of longer than 3 months will detect new nodules but they might be larger than 20 mm in size.

Computed tomography-guided transarterial chemoembolization as the initial therapy for hepatocellular carcinoma: experience of 75 cases in a single institute.

We present the survival rates of 75 nonruptured hepatocellular carcinoma cases initially treated with computed tomography-guided transarterial chemoembolization in a single institute. The 1-, 3-, and 5-year survival rates were 93.9%, 74.7%, and 47.4% in 50 Child's A cases; 75.0%, 43.6%, and 6.8% in 20 Child's B cases; and 60.0%, 40.0%, 0.0% in 5 Child's C cases, respectively. The 1-, 3-, and 5-year survival rates of the 38 estimated resectable hepatocellular carcinoma cases (Child's A, tumors limited in a single lobe) were 94.7%, 82.0%, and 44.6%, respectively. The 1-, 3-, and 5-year survival rates of the 41 cases with estimated indication for percutaneous ethanol injection therapy (tumors less than 3 cm in diameter and three or fewer in number) were 96.8%, 84.6%, and 55.5% in 31 Child's A cases; and 90.0%, 46.7%, and 0% in 10 Child's B cases, respectively. In conclusion, computed tomography-guided transarterial chemoembolization is an excellent primary therapy for hepatocellular carcinoma.