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Objective:To study the safety and treatment outcomes of portal vein embolization (PVE) combined with lenvatinib plus an anti-programmed death-1(PD-1) antibody to treat patients with initially unreasectable hepatocellular carcinoma (uHCC).Methods:This study retrospectively analyzed the data of six patients with uHCC who received first-line combined systemic therapy with lenvatinib plus an anti-PD-1 antibody, and then underwent pre-hepatectomy PVE at the Department of Liver Surgery at Zhongshan Hospital, Fudan University from May 2019 to November 2020. All enrolled patients were males, aged (54.6±6.2) (ranged 46 to 63) years. Tumor response and liver volume were evaluated by medical imagings once every 2 months (±2 weeks) and evaluated using the Response Evaluation Criteria in Solid Tumours (version 1.1). Patients were followed-up by outpatient interviews or by phone calls to record their survival and tumor outcome status.Results:Three of the six enrolled patients had Barcelona Clinic Liver Cancer stage A and three had stage B disease. One patient achieved a partial response and five patients had stable diseases. The mean ± s. d. future liver remnant (FLR) percentage was (29.0±8.9) % before PVE and the combination therapy, and was (41.3±10.8) % before the last evaluation for liver surgery ( t=10.79, P<0.001). Hepatectomy was carried out in five patients, and one patient who failed to develop significant FLR hypertrophy did not undergo hepatectomy. Grade B post-hepatectomy liver failure and major postoperative complications (i.e. pleural effusion requiring additional percutaneous drainage) occurred in one patient. After a median post-operative follow-up of 4.5 (range: 1.0-12.3) months, all five patients were alive and were tumor free. Conclusion:PVE followed by hepatectomy is feasible in a uHCC patients receiving systemic therapy with lenvatinib and an anti-PD-1 antibody.
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Objective:To investigate the clinical efficacy of the combination therapy of lenvatinib and programmed death-1 (PD-1) antibodies in unresectable or advanced hepatocellular carcinoma (HCC).Methods:The retrospective and descriptive study was conducted. The clinico-pathological data of 59 patients with unresectable or advanced HCC who were admitted to Zhongshan Hospital of Fudan University from September 2018 to January 2020 were collected. There were 54 males and 5 females, aged from 25 to 73 years, with a median age of 52 years. All 59 patients underwent combination therapy with lenvatinib and PD-1 antibodies including 43 cases undergoing first-line therapy and 16 cases who cannot tolerate first-line therapy or with tumor progressed after first-line therapy undergoing second-line therapy. Observation indicators: (1) clinical efficacy; (2) adverse drug reactions and treatment; (3) follow-up and survival. Follow-up was performed using outpatient examination or telephone interview to detect tumor diameter of the target lesion, overall survival and progression free survival of patients up to December 2020. Measurement data with skewed distribution were expressed as M ( P25,P75) or M (range). Count data were represented as absolute numbers and (or) percentages. The Kaplan-Meier method was used to calculate the median duration of response (DoR), median overall survival time, median progression free survival time, survival rates and draw survival curves. Results:(1) Clinical efficacy: the objective response rate (ORR), complete response rate (CR), partial response rate (PR), stable disease rate (SD), progression disease rate (PD), time to response (TTR) and median DoR of 59 HCC patients were 37.3%(22/59), 11.9%(7/59), 25.4%(15/59), 37.3%(22/59), 25.4%(15/59), 2.6 months(2.1 months, 4.0 months), 6.3 months[95% confidence interval ( CI) as 2.2 to 10.5 months], respectively. The ORR, CR, PR, SD, PD and TTR of 43 HCC patients undergoing first-line therapy were 41.9%(18/43), 16.3%(7/43), 25.6%(11/43), 37.2%(16/43),20.9%(9/43), 2.2 months(2.0 months, 3.5 months), respectively. The median DoR of 43 patients undergoing first-line therapy was not reached. The ORR, CR, PR, SD, PD, TTR and median DoR of 16 HCC patients undergoing second-line therapy were 4/16, 0, 4/16, 6/16, 6/16, 3.8 months (3.6 months, 4.1 months), 4.2 months(95% CI as 2.0 to 6.3 months), respectively. Six of 59 HCC patients underwent R 0 resection due to tumor converting to resectable HCC with the conversion and resection rate of 10.2%(6/59). Among the 6 patients, 5 cases undergoing first-line treatment had the conversion and resection rates of 11.6% (5/43) and 1 case undergoing second-line treatment had the conversion and resection rates of 1/16, respectively. (2) Adverse drug reactions and treatment: 25 of 59 HCC patients underwent 3 to 4 grade adverse drug reactions with the incidence of 42.4%(25/59). Among the 25 patients, 10 cases including 5 cases undergoing first-line therapy and 5 cases undergoing second-line therapy had the level of gamma glutamyltransferase >5×upper limit of normal (ULN), 9 cases including 4 cases undergoing first-line therapy and 5 cases undergoing second-line therapy had the level of aspartate aminotransferase >5×ULN, 5 cases including 4 cases undergoing first-line therapy and 1 case undergoing second-line therapy occurred gastrointestinal hemorrhage, 4 cases undergoing first-line therapy had the level of white blood cell count <2.0×10 9/L, 4 cases including 1 case undergoing first-line therapy and 3 cases under-going second-line therapy had the level of total bilirubin >3×ULN, 3 cases undergoing first-line therapy had the level of neutrophil count <1.0×10 9/L, 3 cases including 2 cases undergoing first-line therapy and 1 case undergoing second-line therapy occurred ascites, 2 cases including 1 case undergoing first-line therapy and 1 case undergoing second-line therapy had the level of platelet count <50.0×10 9/L, 2 cases undergoing first-line therapy had the level of alanine aminotransferase >5×ULN, 2 cases undergoing first-line therapy occurred hyponatremia, 2 cases including 1 case undergoing first-line therapy and 1 case undergoing second-line therapy occurred pulmonary infection, 2 cases including 1 case undergoing first-line therapy and 1 case undergoing second-line therapy occurred type 1 diabetes, 1 case undergoing first-line therapy occurred hypokalemia, 1 case undergoing first-line therapy occurred myocarditis, 1 case undergoing first-line therapy occurred hypophysistis, 1 case undergoing first-line therapy occurred bullous dermatitis, 1 case undergoing first-line therapy occurred hypertension. Three of 59 HCC patients underwent 5 grade adverse drug reactions ,with the incidence of 5.1%(3/59), including 1 case undergoing first-line therapy with immune hepatitis, 1 case undergoing second-line therapy with immune pneumonia and 1 case undergoing second-line therapy with immune enteritis. Some of patients underwent multiple adverse drug reactions at the same time. Twenty five patients undergoing 3 to 4 grade adverse drug reactions were relieved with the treatment of drug reduction, drug withdrawal, symptomatic treatment or hormone therapy. Three patients undergoing 5 grade adverse drug reactions died after being treated with high-dose hormone shock and hepatoprotective treatment. (3) Follow-up and survival: all 59 patients were followed up for 1.5 to 25.2 months, with a median follow-up time of 13.3 months. Of them, patients undergoing first-line therapy were followed up for 1.9 to 25.2 months, with a median follow-up time of 13.5 months. During follow-up,20 cases undergoing first-line therapy died with the fatality rate of 46.5%(20/43). Patients undergoing second-line therapy were followed up for 1.5 to 24.4 months, with a median follow-up time of 10.8 months. During follow-up, 10 cases undergoing second-line therapy died with the fatality rate of 10/16. Up to the latest follow-up, the tumor diameter of the target lesion in all 59 patients, in patients undergoing first-line therapy and in patients undergoing second-line therapy was 75 mm(38 mm, 125 mm), 74 mm(36 mm, 116 mm), 84 mm(48 mm,150 mm), respectively. The ratio of tumor diameter of the target lesion at latest follow-up to tumor diameter of the target lesion at baseline were -9.05%(-27.3%, 19.7%), -16.1%(-28.8%, 13.6%), 13.2%(-24.7%, 23.5%) for all 59 patients, patients undergoing first-line therapy and patients undergoing second-line therapy, respectively. The median overall survival time and median progression free survival time of patients undergoing first-line therapy and patients undergoing second-line therapy were 17.1 months(95% CI as 11.0 to 23.2 months), 10.8 months(95% CI as 5.0 to 16.6 months) and 10.8 months(95% CI as 9.2 to 12.4 months), 3.0 months(95% CI as 1.6 to 4.4 months), respectively. Conclusion:For unresectable or advanced HCC, combination therapy with lenvatinib and PD-1 antibodies can obtain effective antitumor activity and less incidence of adverse drug reactions.
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Objective To investigate the effect of sitagliptin in the treatment of elderly patients with type 2 diabetes mellitus complicated with coronary heart disease and its influence on Hcy,irisin and chemerin.Methods From January 2015 to June 2016,600 elderly patients with type 2 diabetes mellitus complicated with coronary heart disease in the Sixth People's Hospital of Cixi were selected and divided into observation group and control group,with 300 cases in each group.The control group received metformin treatment,the observation group was given sitagliptin combined with metformin.Before and after treatment,the blood FBG,HbA1c and BMI,Hcy,irisin and chemerin levels were detected.Results After treatment,the FBG,HbA1 c and BMI levels in the observation group were significantly lower than those in the control group [(6.28 ± 1.43) mmol/L vs.(7.03 ± 1.04) mmol/L,t =5.256;(6.17 ± 1.02) ％ vs.(7.02 ± 0.98) ％,t =7.446;(21.03 ± 2.04) kg/m2 vs.(23.02 ± 1.23) kg/m2,t =14.469] (all P ＜ 0.05).The level of Hcy in the observation group after treatment was significantly lower than that in the control group [(7.48 ± 1.03) μmol/L vs.(10.38 ± 1.74) μmol/L,t =17.868,P ＜ 0.05].After treatment,the blood irisin level in the observation group was significantly higher than that in the control group [(3.28 ± 0.89) μg/mL vs.(2.43 ± 0.38)μg/mL,t =15.213,P ＜ 0.05].After treatment,the chemerin level in the observation group was significantly lower than that in the control group [(210.38 ± 9.84)ng/mL vs.(231.38 ± 10.03)ng/mL,t =24.379,P ＜ 0.05].Conclusion Sitagliptin in the treatment of elderly patients with type 2 diabetes mellitus complicated with coronary heart disease can effectively regulate the levels of Hcy,irisin and chemerin,and improve the curative effect.
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Objective@#To investigate the early clinical efficacy of bone cement modified with mineralized collagen in the treatment of osteoporotic vertebral compression fractures with percutaneous vertebroplasty(PVP).@*Methods@#All 98 cases of sin-gle vertebral osteoporotic compression fracture from June 2017 to August 2018 were studied. Forty-eight cases were treated with bone cement modified with mineralized collagen (modified group) and 50 cases were treated with traditional bone cement (traditional group). The basic clinical information including age, sex and bone mineral density of all patients were analyzed. The injectable time, volume, distribution (bone cement in the vertebra showing a whole mass without interruption or loss is known as type O while bone cement in the vertebra showing two masses with a small amount or none in the middle is known as type H) and leakage of bone cement during operation, visual analogue score(VAS), Oswestry disability index (ODI), height of anterior, middle and posterior columns of injured vertebrae and the incidence of adjacent vertebral fractures were compared between the two groups.@*Results@#There were no significant differences in age, sex, bone mineral density T value and bone ce-ment injection volume between the two groups. VSA score, ODI, anterior and middle column heights were significantly improved on the first day and 6 months after operation (P<0.05), but there was no significant difference between the two groups (P>0.05). In-traoperative cement injectable time was shorter in the traditional group than the modified group,and there was significant different between the two groups (t=3.428, P=0.002). The incidence of adjacent vertebral re-fracture was 12% in the traditional group and 2% in the modified group. There was significant different between the two groups (χ2=7.061, P=0.029). The leakage rate of bone cement was 10% in the traditional group and 6% in the modified group, andthere was significant difference between the two groups (χ2=7.963, P=0.019). The distribution of bone cement (O/H) in the traditional group was 20/30 and that in the modified group was 19/29, and there was significant difference between the two groups (χ2=38.992, P<0.001).@*Conclusion@#Modified bone cement has the same clinical effect as traditional bone cement in relieving pain and restoring the height of injured vertebra in the treat-ment of osteoporotic vertebral compression fractures with PVP. However, the injectable time of modified bone cement is longer. The leakage rate and the incidence of re-fracture of adjacent vertebrae are significantly reduced.
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Objective To investigate the early clinical efficacy of bone cement modified with mineralized collagen in the treatment of osteoporotic vertebral compression fractures with percutaneous vertebroplasty(PVP). Methods All 98 cases of sin?gle vertebral osteoporotic compression fracture from June 2017 to August 2018 were studied. Forty?eight cases were treated with bone cement modified with mineralized collagen (modified group) and 50 cases were treated with traditional bone cement (traditional group). The basic clinical information including age, sex and bone mineral density of all patients were analyzed. The injectable time, volume, distribution (bone cement in the vertebra showing a whole mass without interruption or loss is known as type O while bone cement in the vertebra showing two masses with a small amount or none in the middle is known as type H) and leakage of bone cement during operation, visual analogue score(VAS), Oswestry disability index (ODI), height of anterior, middle and posterior columns of injured vertebrae and the incidence of adjacent vertebral fractures were compared between the two groups. Results There were no significant differences in age, sex, bone mineral density T value and bone ce?ment injection volume between the two groups. VSA score, ODI, anterior and middle column heights were significantly improved on the first day and 6 months after operation (P<0.05), but there was no significant difference between the two groups (P>0.05). In?traoperative cement injectable time was shorter in the traditional group than the modified group,and there was significant different between the two groups (t=3.428, P=0.002). The incidence of adjacent vertebral re?fracture was 12% in the traditional group and 2% in the modified group. There was significant different between the two groups (χ2=7.061, P=0.029). The leakage rate of bone cement was 10% in the traditional group and 6% in the modified group, andthere was significant difference between the two groups (χ2=7.963, P=0.019). The distribution of bone cement (O/H) in the traditional group was 20/30 and that in the modified group was 19/29, and there was significant difference between the two groups (χ2=38.992, P<0.001). Conclusion Modified bone cement has the same clinical effect as traditional bone cement in relieving pain and restoring the height of injured vertebra in the treat?ment of osteoporotic vertebral compression fractures with PVP. However, the injectable time of modified bone cement is longer. The leakage rate and the incidence of re?fracture of adjacent vertebrae are significantly reduced.
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Objective To investigate the correlation between cardiac function and homocysteine (Hcy) level in type 2 diabetes mellitus (T2DM) patients.Methods From May 2015 to April 2016,120 patients with T2DM in the Sixth People＇s Hospital of Cixi were selected.According to the level of Hcy,the patients were divided into DM group (Hcy level ＜15μmol/L,42 cases) and Hcy+DM group (Hcy level≥15 μmol/L,78 cases).And 50 healthy people were selected as control group.The correlations between various physiological and cardiac functional parameters and Hcy level among the three groups were analyzed.Results The levels of Hcy,HbA1c and FBG in the DM group were significantly higher than those in the control group [Hcy:(11.26 ±2.16)μmol/L vs.(8.24 ±1.25)μmol/L,HbA1c:(7.46 ±1.47)%vs.(5.02 ±1.73)%,FBG:(7.87 ±2.75) mmol/L vs.(5.78 ±2.83)mmol/L,all P＜0.05].The E/A value and LVEF value in the DM group were significantly lower than those in the control group (all P＜0.05).The Hcy,HbA1c,and FBG levels in the Hcy +DM group were significantly higher than those in the DM group,and the E/A value and LVEF value in the Hcy +DM group were significantly lower than those in the DM group (all P ＜0.05 ).Spearman＇s correlation coefficient analysis showed that there was a positive correlation between HbA1c and FBG levels and Hcy levels (r＝0.157,0.112,all P＜0.05),but there was a negative correlation between E/A and LVEF values and Hcy levels (r＝-0.264,-0.394,all P＜0.05).Logistic regression analysis showed that the independent risk factor affecting the E/A and LVEF values was Hcy levels ( P ＝0.015,0.001 ). Conclusion The level of Hcy in patients with diabetes can reflect the status of heart function.The higher the level of Hcy,the worse the heart function.The detection of Hcy level can help to predict and evaluate cardiac function in patients.
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Objective: To study the influence and curative effect of carvedilol on serum matrix metalloproteinase -2, 9 and 10 (MMP-2, 9 and 10) in the patients with chronic congestive heart failure (CHF). Methods:Totally 76 patients with CHF were select-ed and randomly divided into the observation group and the control group. All the patients were given routine medical treatment, inclu-ding cardiotonic treatment ( digoxin) , diuresis ( thiadiazide) , vascular dilation ( nitrate ester) and so on. The patients in the observa-tion group were additionally given carvedilol for 6 months. The changes of serum MMP-2, 9 and 10 levels in the patients before the treatment and 6 months after the medical treatment were observed, and the curative effect and safety were studied as well. Results:Af-ter the 6-month medical treatment, the serum MMP-2, 9 and 10 levels in all the patients were obviously declined(P<0. 05), and the declining rates in the observation group were much higher than those in the control group(P<0. 05). Meanwhile, the total clinical effi-ciency of the observation group was 94. 74%, which was higher than that of the control group (78. 95%) (P<0. 05). Conclusion:Carvedilol has favorable curative effect and safety in the treatment of CIF, and the underlying mechanism may be relative to the de-crease of serum MMP-2, 9 and 10 levels.