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Objective To investigate the efficacy and safety of lenvatinib combined with sintilimab as the second-line therapy for advanced intrahepatic cholangiocarcinoma (ICC). Methods A retrospective analysis was performed for the clinical data of the patients with advanced ICC who were admitted to Beijing Ditan Hospital from October 31, 2019 to October 31, 2021 and could not undergo surgery or experienced metastasis after surgery. All patients were treated with lenvatinib combined with sintilimab as the second-line therapy. The patients were followed up, and the RECIST1.1 criteria were used to assess treatment outcome. The primary endpoint was time to progression (TTP), and the secondary endpoints were tumor objective response rate (ORR), disease control rate (DCR), overall survival (OS) time, and safety. The Kaplan-Meier method was used to plot survival curves, and the log-rank test was used for comparison between groups. Results A total of 27 patients were enrolled, among whom there were15 male patients (55.6%) and 12 female patients (44.4%), with a median age of 58 years (range 33-73 years). The median TTP for these patients was 5.5 (95% confidence interval [ CI ]: 1.7-9.3) months, and 13 patients (48.1%) died of disease progression, with a median OS time of 11.2 (95% CI : 5.0-17.4) months. The overall ORR and DCR were 40.7% and 70.3%, respectively. Of all patients, 66.7% experienced varying degrees of adverse events, and among these patients, 44.4% had an increase in alanine aminotransferase, 44.4% had an increase in aspartate aminotransferase, 37.0% had hypertension, 29.6% had an increase in bilirubin, 29.6% experienced diarrhea, and 25.9% each experienced proteinuria, anorexia, and weakness. No treatment-related death was observed, and only 1 patient developed grade Ⅳ immune-related hepatotoxicity and was relieved without sequelae after corticosteroid therapy, resulting in permanent withdrawal of sintilimab. The patients with lymph node metastasis had a significantly shorter median TTP than those without lymph node metastasis (4.5 months vs 18.8 months, P =0.035), and the patients who achieved disease remission had a significantly longer median TTP [11.6 months (95% CI : 5.6-17.6) vs 2.8 months (95% CI : 1.8-3.8), P < 0.001]; the patients with lymph node metastasis had a shorter median OS time [9.6 months (95% CI: 7.9-11.3) vs 21.9 months (95% CI : 0-44.9), P =0.053], and the patients who achieved disease remission had a significantly longer median OS time [16.6 months (95% CI : 9.0-24.2) vs 6.9 months (95% CI : 3.6-10.2), P =0.011]. Conclusion Lenvatinib combined with sintilimab has a marked clinical effect and a low incidence rate of serious adverse events as the second-line therapy for advanced ICC, and therefore, it is a safe and effective treatment regimen.
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Objective To evaluate the effect of continuous glucose monitoring system(CGMS) in improving the current status of type 1 diabetes mellitus(T1DM) control and reducing the economic burden of the patients.Methods One hundred and fifteen patients with T1DM were randomly assigned to the CGMS group and the self-monitoring of blood glucose(SMBG) group respectively.The patients in CGMS group were on 72 h CGMS every 6 months, while SMBG group only with SMBG to guide the insulin dose adjustment.The levels of blood glucose and the statistics of the number of hypoglycemia and diabetic ketoacidosis were taken as the main observational indexes every 6 months.The chronic complication and the statistics of the number of hospitalizations and the total cost of treatment were made as the secondary observational index every 12 months.Results 2 h postprandial plasma glucose(2hPG) and mean blood glucose(MBG) in the CGMS group were lower than those in the SMBG group [(10.7±1.9 vs 11.5±2.7) mmol/L, (9.7±0.5 vs 10.6±0.7) mmol/L, P<0.05] in the clinical follow-up visit after 6 months.The per capita number of hypoglycaemia in the CGMS group was lower than that in the SMBG group[(7.9±2.6 vs 9.2±3.4) times, P<0.05].In the outpatient follow-up re-visit to the patients after 6 months, fasting plasma glucose(FPG), 2hPG, MBG, and HbA1C of the patients in the CGMS group were lower than those in the SMBG group(t=4.71~9.75, P<0.05), the per capita numbers of hypoglycemia and DKA in the CGMS group were lower than those in the SMBG group(t=3.61~4.37, P<0.05).Conclusion The application of real-time continuous glucose monitoring in T1DM outpatient management may reduce the whole-day blood glucose of the patients, decrease the incidence risk of hypoglycemia, and improve the compliance of the treatment while without increasing the economic burden of the disease.
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Objective@#To investigate the safety and efficacy of radiofrequency ablation (RFA) with percutaneous iohexol-ethanol injection (PIEI), compared with RFA plus transcatheter arterial chemoembolization (TACE) for patients with primary liver cancer(PLC)in high-risk locations.@*Methods@#From January 2012 to December 2014, 54 patients with PLC in high-risk locations were enrolled. They were divided into Group A (RFA combined with PIEI) and Group B (RFA plus TACE). The efficacy and adverse events were assessed.@*Results@#54 patients had 74 lesions in high-risk locations. There were 26 cases with 40 lesions in Group A, and 28 cases with 34 lesions in Group B. The complete ablation rate of Group A was significantly higher than that of Group B (92.5% vs 70.6%, P=0.014). The two-year local tumor progressionrateand two-year overall survival rate were similar between these two groups (Group A 20.0% vs Group B 38.2%, P=0.083; 90.3% vs 84.3%, P=0.523). Furthermore, the surgery-related severe adverse events of Group A (7.1%, one case of liver abscess and one case ofhematobilia) were more common than that of Group B (0%, P=0.491). No significant differences were found in common adverse events including fever, pain, elevation of aminotransferase and bilirubin.@*Conclusions@#Compared with RFA plus TACE, RFA plus PIEI resulted inbetter complete ablation rate in patients with primary liver cancer in high risk locations. Prospective, randomized, controlled trials are warranted for further evaluation.
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Objective To explore the diagnosis of cystinosis.Methods The clinical and biochemical information, and gene detection results in a child with cystinosis was retrospective analyzed.Results Four-year-old female presented with photophobia and corneal crystal was found by ophthalmic examination at 2 years old, bilateral kidney stone was found, accompanied by development delay and rickets at 3 years old. Gas chromatography analysis in urine showed that a variety of amino acids were increased, and urine sugar and urinary micro-protein were also increased, which were in accordance with fanconi syndrome. The blood free carnitine was decreased, ester acyl carnitine spectrum was normal, and multi-amino acids such as lysine, valine and arginine were decreased. Gene analysis showed a homozygous mutation of c.696C>G (p.323 N>K) inCTNS gene, which was a known mutation. Both her parents were carrier of heterozygous mutation of c.696C>G inCTNS gene.Conclusion Child with kidney stone, renal damage, combined by multi-system damage such as eyes, bone, and thyroid should be paid attention to identify the cystinosis.
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Objective To explore the impacts of subclinical hypothyroidism (SCH) on chronic complications of type 2 diabetes mellitus. Methods Totally 448 patients with type 2 diabetes were divided into diabetes plus SCH group (n=148) and control group (T2DM without SCH,n=300).The patient's general information,past medical history,chronic complications of diabetes including diabetic nephropathy ( DN ), diabetic retinopathy ( DR), diabetic peripheral neuropathy ( DPN ),peripheral arterial disease (PAD),diabetic foot (DF),ancillary and laboratory test results were analyzed. Results The age,duration of diabetes,incidence of coronary heart disease and levels of fasting C-peptide,total cholesterol,triacylglycerol,lipoprotein (a),hs-CRP,LDL-C,UAER and thyroid stimulating hormone (TSH) [(6.8 ± 3.5) mIU/L vs. (2.1 ± 1.3) mlU/L], antithyroidperoxidase antibody (TPO-Ab) [(253.6 ± 287.1 ) kU/L vs. (46.2 ± 80.7)] kU/L and thyroglobulin antibodies (TG-Ab) [( 57.8 ± 83.5 ) kU/L vs. ( 39.4 ± 45.3 ) kU/L] were significantly higher,but the ankle brachial index(ABI) and E/A value were lower in diabetes plus SCH group than in control group (P＜0.01 or 0.05).The prevalences of DN( 63％ vs.46％,P＜0.01),DR (40％vs.29％,P＜0.05),DPN (34％ vs.24％,P＜0.05),PAD (51％ vs.38％,P＜0.05) and DF (22％ vs.12％,P＜0.01) were higher in diabetes plus SCH group than in control group.Logistic regression analysis demonstrated that high level of TSH was independent risk factor for DN(β=0.1273,OR =1.1361) and DF (β=0.1153, OR =1.1222). Conclusions Subclinical hypothyroidism is an independent risk factor for diabetic nephropathy and diabetic foot,so the elderly with longer duration of diabetes should regularly be checked in thyroid ffunction to early find hypothyroidism.