BACKGROUND Bariatric and metabolic surgery have been routinely performed following the rapid increase in obesity and metabolic diseases worldwide.Of all evolving procedures,Roux-en-Y gastric bypass(RYGB)is considered ...BACKGROUND Bariatric and metabolic surgery have been routinely performed following the rapid increase in obesity and metabolic diseases worldwide.Of all evolving procedures,Roux-en-Y gastric bypass(RYGB)is considered the gold standard for surgical treatment of patients with type 2 diabetes mellitus(T2DM)and obesity.RYGB was introduced in China nearly 20 years ago,but the number of RYGB surgeries only accounts for 3.1%of the total number of weight loss and metabolic surgeries in China,it’s effect on Chinese people still needs further study.AIM To investigate the effect and safety of a modified gastric bypass performed in Chinese patients with T2DM.METHODS Patients with obesity and T2DM who underwent modified gastric bypass,with>5-year follow-up data,were analyzed.RESULTS All 37 patients underwent uneventful laparoscopic surgery,no patient was switched to laparotomy during the surgery,and no severe complications were reported.Average weight and body mass index of the patients reduced from 84.6±17.3(60.0–140.0)kg and 30.9±5.0(24.7–46.2)kg/m2 to 67.1±12.2(24.7–46.2)kg and 24.6±3.9(17.7–36.5)kg/m2,respectively,and fasting plasma glucose and glycated hemoglobin decreased from 7.4±3.4 mmol/L and 8.2%±1.7%preoperatively to 6.5±1.3 mmol/L and 6.5%±0.9%5-years postoperatively,respectively.Only 29.7%(11/37)of the patients used hypoglycemic drugs 5-years postoperatively,and the complete remission rate of T2DM was 29.7%(11/37).Triglyceride level reduced significantly but high-density lipoprotein increased significantly(both P<0.05)compared with those during the preoperative period.Liver and renal function improved significantly postoperatively,and binary logistic regression analysis revealed that the patients’preoperative history of T2DM and fasting C-peptide were significant prognostic factors influencing complete T2DM remission after RYGB(P=0.006 and 0.012,respectively).CONCLUSION The modified gastric bypass is a safe and feasible procedure for Chinese patients with obesity and T2DM,exhibiting satisfactory amelioration of weight problems,hyperglycemia,and combination disease.展开更多
AIM:To determine the role of diabetes mellitus(DM) and other associated factors in Chinese hepatocellular carcinoma(HCC) patients with cirrhosis,compared with those HCC patients without cirrhosis,in the single setting...AIM:To determine the role of diabetes mellitus(DM) and other associated factors in Chinese hepatocellular carcinoma(HCC) patients with cirrhosis,compared with those HCC patients without cirrhosis,in the single setting of hepatitis B virus(HBV) infection,after other known concomitant diseases were excluded.METHODS:A total of 482 patients,treated at the China-Japan Friendship Hospital,Ministry of Health(Beijing,China),in the period January 2003 to June 2009,and with a hospital discharge diagnosis of HCC,were included.Demographic,clinical,laboratory,metabolic and instrumental features were analyzed.RESULTS:Of the total,310 patients were diagnosed with HBV infection and,following the inclusion and exclusion criteria,224 were analyzed,including 122 patients(54.5%) with cirrhosis(the case group) and 102 patients without cirrhosis(the control group).Twentyseven patients(12.1%) were diabetic,including 19 in the case group and 8 in the control group(19/122=15.6% vs 8/102=7.8%,P=0.077).Thirty-one possible relevant parameters were compared by univariate analysis,and 9 variables were selected for multivariable analysis,including DM(P=0.077),past history of HBV infection(P=0.005),total bilirubin(P<0.001),albumin level(P<0.001),international normalized ratio(INR)(P<0.001),alanine aminotransferase(P=0.050),platelet(P<0.001),total cholesterol(P= 0.047),and LDL cholesterol(P=0.002) levels.Diabetes showed a statistical difference by multivariable analysis [odds ratio(OR) 4.88,95% confidence interval(CI):1.08-21.99,P=0.039],although no significant difference was found in univariate analysis.In addition,three cirrhosis-related parameters remained statistically different,including INR(OR 117.14,95% CI:4.19-3272.28,P=0.005),albumin(OR 0.89,95% CI:0.80-0.99,P=0.027),and platelet count(OR 0.992,95% CI:0.987-0.999,P=0.002).CONCLUSION:Besides the three cirrhosis-related parameters,DM was found to be the sole independent factor associated with HCC in patients with HBV-related cirrhosis,compared with those without cirrhosis.展开更多
Diabetes has become a growing concern in Japan, both medically and financially. The medical cost of diabetes was estimated at 1215 billion yen for fiscal year 2011. We analyzed the length of stay (LOS) in a hospital f...Diabetes has become a growing concern in Japan, both medically and financially. The medical cost of diabetes was estimated at 1215 billion yen for fiscal year 2011. We analyzed the length of stay (LOS) in a hospital for type 2 diabetes mellitus patients who participated in educational programs to determine factors affecting LOS. Data on 991 patients obtained from 28 Red Cross hospitals in 2008 were used. For the analysis, we used the Box-Cox transformation model and Hausman test. The results revealed that patients aged 75 years and above and those with comorbidities and complications were prone to longer LOS. The analysis also revealed significant differences in LOS across the hospitals, even after controlling for patient characteristics. Finally, we applied the least squares method to determine the effects of hospital and regional factors and revealed that patients’ LOS was affected by the region’s average LOS. Regional corporations and networks appeared to be important in improving educational programs.展开更多
Objectives: The cost-utility analysis of Liraglutide is aimed at evaluating whether Liraglutide is cost-effective or not after Chinese reformation on medical insurance. The analysis is based on the results of clinical...Objectives: The cost-utility analysis of Liraglutide is aimed at evaluating whether Liraglutide is cost-effective or not after Chinese reformation on medical insurance. The analysis is based on the results of clinical trial conducted in Asia. Methods: We applied a Markov model to estimate the quality-adjusted life years, medical cost and incidence of diabetes-related complications for patients receiving the Liraglutide as an add-on to the metformin treatment. Baseline characteristics were taken from a China’s study while the treatment effect is from an Asian study. The related medical cost and utility score were obtained from a local study in China. Having set 30 years’ simulations, the incremental cost-effectiveness ratio was calculated comparing with glimepiride treatment. The ratio would be compared with the willingness to pay for a quality-adjusted-life-year (QALY) which is three times of the GDP per capita in Beijing. Sensitivity analysis was also performed. Result: During a period of 30 years, the base-case analysis which takes discount rate at 3% shows that Liraglutide 1.8 mg results in an average incremental cost of CNY 82,671.49, an improvement in 0.12 QALYs and a reduction of incidence of diabetes-related complications comparing to glimepiride. The associated incremental cost-effectiveness ratio is CNY 688,929.08. Conclusion: Long-term project shows that taking Liraglutide as an add-on to the metformin treatment will lead to increasing quality-adjusted life years and reduction of incidence of diabetes-related complications. When the price of Liraglutide is reduced by 43 percent in China’s yuan, Liraglutide will be cost-effective in China from the healthcare system perspective taking three times of GDP per capita as our WTP threshold.展开更多
AIM: To determine the association of diabetes mellitus (DM) and international normalized ratio (INR) level in hepatocellular carcinoma (HCC) patients. METHODS: Our present study included 375 HCC patients who were trea...AIM: To determine the association of diabetes mellitus (DM) and international normalized ratio (INR) level in hepatocellular carcinoma (HCC) patients. METHODS: Our present study included 375 HCC patients who were treated at the China-Japan Friendship Hospital, Ministry of Health (Beijing, China), in the period from January 2003 to April 2012, and with a hospital discharge diagnosis of HCC. The demographic, clinical, laboratory, metabolic and instrumental features were analyzed. χ2 test, Student's t test and Mann-Whitney U test were used to compare the differences between HCC patients with and without DM. Unconditional multivariable logistic regression analysis was used to determine the association of DM and INR level in HCC patients. A sub-group analysis was performed to assess the effect of liver cirrhosis or hepatitis B virus (HBV) infection on the results. The Pearson correlation test was used to determine the relationship between INR level and fasting glucose. In addition, association between diabetes duration, and diabetes treatment and INR level was determined considering the potentially different effects. RESULTS: Of the total, 63 (16.8%) patients were diabetic (diabetic group) and 312 (83.2%) patients were diagnosed without diabetes (non-diabetic group). Their mean age was 56.4 ± 11.0 years and 312 (83.2%) patients were male. Compared with patients without DM, the HCC patients with diabetes were older (59.5 ± 10.3 vs 55.8 ± 11.1, P=0.015), had a lower incidence of HBV infection (79.4% vs 89.1%, P=0.033), had increased levels of systolic blood pressure (SBP) (133 ± 17 vs 129 ± 16 mmHg, P=0.048) and INR (1.31 ± 0.44 vs 1.18 ± 0.21, P=0.001), had lower values of hemoglobin (124.4 ± 23.9 vs 134.2 ± 23.4, P=0.003) and had a platelet count (median/interquartile-range: 113/64-157 vs 139/89-192, P=0.020). There was no statistically significant difference in the percentages of males, overweight or obesity, drinking, smoking, cirrhosis and Child classification. After controlling for the confounding effects of age, systolic blood pressure, hemoglobin, platelet count and HBV infection by logistic analyses, INR was shown as an independent variable [odds ratio (OR)=3.650; 95%CI: 1.372-9.714, P=0.010]. Considering the effect of liver cirrhosis on results, a sub-group analysis was performed and the study population was restricted to those patients with cirrhosis. Univariate analysis showed that diabetic patients had a higher INR than non-diabetic patients (1.43 ± 0.51 vs 1.25 ± 0.23, P=0.041). After controlling for confounding effect of age, SBP, hemoglobin, platelet count and HBV infection by logistic analyses, INR level remained as the sole independent variable (OR=5.161; 95%CI: 1.618-16.455, P=0.006). No significant difference in the relationship between INR level and fasting glucose was shown by Pearson test (r=0.070, P=0.184). Among the 63 diabetic patients, 35 (55.6%) patients had been diagnosed with DM for more than 5 years, 23 (36.5%) received oral anti-diabetic regimens, 11 (17.5%) received insulin, and 30 (47.6%) reported relying on diet alone to control serum glucose levels. No significant differences were found for the association between DM duration/treatment and INR level, except for the age at diabetes diagnosis. CONCLUSION: The INR level was increased in HCC patients with DM and these patients should be monitored for the coagulation function in clinical practice.展开更多
Background Glycemic control prevents onset and progression of diabetes-related long-term complications. The objective of this study was to demonstrate that twice daily insulin lispro low mix 25 is noninferior to twice...Background Glycemic control prevents onset and progression of diabetes-related long-term complications. The objective of this study was to demonstrate that twice daily insulin lispro low mix 25 is noninferior to twice daily human insulin mix 30/70 in achieving glycemic control as measured by hemoglobin Alc （HbAlc）, from baseline to endpoint, in patients with type 1 or 2 diabetes. Methods In this phase IV, crossover, open-label, multicenter study, 117 Chinese patients with diabetes were randomly assigned to one of two treatment sequence groups. One group received 12-week treatment with twice daily human insulin mix 30/70 followed by 12-week treatment with twice daily insulin lispro low mix 25, while the other group received the reverse treatment sequence. HbAlc, baseline-to-endpoint change in HbAlc, proportion of patients achieving target HbAlc ≤ 7% and 〈 6.5%, fasting blood glucose, and daily insulin doses were measured for each period. Safety and tolerability were also assessed. Results A statistically significant reduction （P≤0.0001） of HbAlc was achieved after each treatment （human insulin mix 30/70： mean HbA1c=7.91% （95% CI： 7,67%, 8.15%）; insulin lispro low mix 25： mean HbA1c=7.96% （95% CI： 7.72%, 8.20%））. The 95% Cl （-0.20, 0.10） of the difference between the two treatments satisfied the prespecified noninferiority margin of 0.3% （lower limit of 95% CI 〉 -0.3%）. No statistically significant differences between treatments were observed for any of the secondary efficacy measures. The incidence of treatment-emergent adverse events and hypoglycemia between the two treatments and treatment sequence groups was similar. Three serious adverse events were reported （human insulin mix 30/70 group： 2 patients （1.7%, hypoglycemic coma and cardiac failure）; insulin lispro low mix 25 group： 1 patient （0.9%, stroke））. All serious adverse events were resolved and no patients died during the study. Conclusion The results support noninferiority of twice daily insulin lispro low mix 25 versus twice daily human insulin mix 30/70 in HbAlc control in Chinese patients with type 1 or 2 diabetes.展开更多
Objective:To assess the efficacy of compound Bai Yu San(CBYS)as a new treatment option,in healing diabetic skin ulcer.Materials and Methods:A total of 64 diabetic patients with skin ulcer were enrolled and randomly as...Objective:To assess the efficacy of compound Bai Yu San(CBYS)as a new treatment option,in healing diabetic skin ulcer.Materials and Methods:A total of 64 diabetic patients with skin ulcer were enrolled and randomly assigned to experimental group(n=33)and control group(n=31).In the control group,normal saline(NS)was used to cleanse the wound.After debridement,the wound was dressed with modern materials.In the experimental group,the NS‑cleansed wound was dressed with CBYS.The infection rate,healing rate,treatment cost,and patient satisfaction between the two groups were compared.Results:On the 35th day after treatment,the infection rate and healing rate showed no between‑group difference(P>0.05);the experimental group showed lower treatment cost and higher satisfaction than the control group(P<0.05).Conclusion:As a new treatment option for diabetes‑induced skin ulcer,CBYS can effectively control the infection,promote the healing,reduce treatment cost,and increase patient satisfaction.Dressing with CBYS can be clinically replicated in the treatment of diabetic skin ulcer.展开更多
目的探讨院校-社区联合开展中医养生保健在老年2型糖尿病患者中的应用效果。方法选取2020年8月至2021年7月扬州市中医院收治的84例老年2型糖尿病患者作为研究对象,按照随机数字表法分为对照组(42例)和干预组(42例)。对照组患者采用常规...目的探讨院校-社区联合开展中医养生保健在老年2型糖尿病患者中的应用效果。方法选取2020年8月至2021年7月扬州市中医院收治的84例老年2型糖尿病患者作为研究对象,按照随机数字表法分为对照组(42例)和干预组(42例)。对照组患者采用常规治疗护理,干预组患者在常规治疗护理的基础上采用院校-社区联合开展中医养生保健社会实践方法。比较两组患者的遵医依从率、血糖水平、并发症发生率及生活质量。结果干预组患者的按时按量服药、血糖水平监测、合理饮食、适量运动遵医依从率高于对照组,差异有统计学意义(P<0.05)。干预组患者干预后的空腹血糖(FBG)、餐后2 h血糖(2 h PBG)及糖化血红蛋白(HbA1c)水平均低于对照组,差异有统计学意义(P<0.05)。干预组患者的并发症总发生率低于对照组,差异有统计学意义(P<0.05)。干预组患者干预后的生活质量综合评定问卷各维度评分均高于对照组,差异有统计学意义(P<0.05)。结论院校-社区联合实施的中医养生保健对老年2型糖尿病患者进行干预,可有效提高其遵医依从性,有助于控制血糖水平,减少并发症的发生,提高生活质量。展开更多
Background Duloxetine, a selective serotonin and noradrenaline reuptake inhibitor, has been shown to be effective in treatment of diabetic peripheral neuropathic pain and approved for the management of patients with d...Background Duloxetine, a selective serotonin and noradrenaline reuptake inhibitor, has been shown to be effective in treatment of diabetic peripheral neuropathic pain and approved for the management of patients with diabetic peripheral neuropathic pain （DPNP） in the United States, European Union, and many other countries. This study assessed the efficacy and safety of duloxetine in Chinese patients with diabetic peripheral neuropathic pain. Methods This double-blind, randomized, placebo-controlled, flexible-dose study treated adult patients with diabetic peripheral neuropathic pain and baseline Brief Pain Inventory （BPI） 24-hour average pain severity ratings ≥4 with duloxetine 60 mg to 120 mg once daily or placebo for 12 weeks. Dose adjustments of duloxetine or matching placebo were based upon investigator＇s judgment of clinical response. Change from baseline to endpoint in BPI average pain was the primary efficacy outcome. Secondary outcome measures included BPI-severity and -Interference, Patient Global Impression of Improvement, Clinical Global Impressions of Severity, EuroQol： 5 Dimensions, Athens Insomnia Scale, and safety measures. Results Of 215 patients randomized, 88.4% and 82.1% of patients in placebo and duloxetine groups, respectively,completed the study. Mean change from baseline to endpoint in BPI average pain was not statistically different between the treatment groups （P=0.124）. Duloxetinetreated patients showed significantly greater pain reduction compared with those in placebo group at weeks 1,2, and 4 （P=0.004, P=0.009, and P=0.006, respectively） but not at weeks 8 （P=0.125） and 12 （P=0.107）. Duloxetine-treated patients experienced statistically significant improvement in Patient Global Impression of Improvement, Clinical Global Impression of Severity, area under the curve for pain relief, BPI-severity pain right now, and BPI-interference walking ability. Patients treated with duloxetine 120 mg once daily showed significantly greater pain reduction on the Brief Pain Inventory average pain score relative to placebo. Duloxetine-treated patients reported nausea, somnolence, anorexia, and dysuria significantly more than placebo. Conclusions Although the primary study endpoint was not achieved, the overall observed response pattern suggests the efficacy of duloxetine in the treatment of Chinese patients with diabetic peripheral neuropathic pain. The safety profile for duloxetine is similar to that reported in other global trials.展开更多
文摘BACKGROUND Bariatric and metabolic surgery have been routinely performed following the rapid increase in obesity and metabolic diseases worldwide.Of all evolving procedures,Roux-en-Y gastric bypass(RYGB)is considered the gold standard for surgical treatment of patients with type 2 diabetes mellitus(T2DM)and obesity.RYGB was introduced in China nearly 20 years ago,but the number of RYGB surgeries only accounts for 3.1%of the total number of weight loss and metabolic surgeries in China,it’s effect on Chinese people still needs further study.AIM To investigate the effect and safety of a modified gastric bypass performed in Chinese patients with T2DM.METHODS Patients with obesity and T2DM who underwent modified gastric bypass,with>5-year follow-up data,were analyzed.RESULTS All 37 patients underwent uneventful laparoscopic surgery,no patient was switched to laparotomy during the surgery,and no severe complications were reported.Average weight and body mass index of the patients reduced from 84.6±17.3(60.0–140.0)kg and 30.9±5.0(24.7–46.2)kg/m2 to 67.1±12.2(24.7–46.2)kg and 24.6±3.9(17.7–36.5)kg/m2,respectively,and fasting plasma glucose and glycated hemoglobin decreased from 7.4±3.4 mmol/L and 8.2%±1.7%preoperatively to 6.5±1.3 mmol/L and 6.5%±0.9%5-years postoperatively,respectively.Only 29.7%(11/37)of the patients used hypoglycemic drugs 5-years postoperatively,and the complete remission rate of T2DM was 29.7%(11/37).Triglyceride level reduced significantly but high-density lipoprotein increased significantly(both P<0.05)compared with those during the preoperative period.Liver and renal function improved significantly postoperatively,and binary logistic regression analysis revealed that the patients’preoperative history of T2DM and fasting C-peptide were significant prognostic factors influencing complete T2DM remission after RYGB(P=0.006 and 0.012,respectively).CONCLUSION The modified gastric bypass is a safe and feasible procedure for Chinese patients with obesity and T2DM,exhibiting satisfactory amelioration of weight problems,hyperglycemia,and combination disease.
基金Supported by Grant No 30772859 from the National Natural Science Foundation of China
文摘AIM:To determine the role of diabetes mellitus(DM) and other associated factors in Chinese hepatocellular carcinoma(HCC) patients with cirrhosis,compared with those HCC patients without cirrhosis,in the single setting of hepatitis B virus(HBV) infection,after other known concomitant diseases were excluded.METHODS:A total of 482 patients,treated at the China-Japan Friendship Hospital,Ministry of Health(Beijing,China),in the period January 2003 to June 2009,and with a hospital discharge diagnosis of HCC,were included.Demographic,clinical,laboratory,metabolic and instrumental features were analyzed.RESULTS:Of the total,310 patients were diagnosed with HBV infection and,following the inclusion and exclusion criteria,224 were analyzed,including 122 patients(54.5%) with cirrhosis(the case group) and 102 patients without cirrhosis(the control group).Twentyseven patients(12.1%) were diabetic,including 19 in the case group and 8 in the control group(19/122=15.6% vs 8/102=7.8%,P=0.077).Thirty-one possible relevant parameters were compared by univariate analysis,and 9 variables were selected for multivariable analysis,including DM(P=0.077),past history of HBV infection(P=0.005),total bilirubin(P<0.001),albumin level(P<0.001),international normalized ratio(INR)(P<0.001),alanine aminotransferase(P=0.050),platelet(P<0.001),total cholesterol(P= 0.047),and LDL cholesterol(P=0.002) levels.Diabetes showed a statistical difference by multivariable analysis [odds ratio(OR) 4.88,95% confidence interval(CI):1.08-21.99,P=0.039],although no significant difference was found in univariate analysis.In addition,three cirrhosis-related parameters remained statistically different,including INR(OR 117.14,95% CI:4.19-3272.28,P=0.005),albumin(OR 0.89,95% CI:0.80-0.99,P=0.027),and platelet count(OR 0.992,95% CI:0.987-0.999,P=0.002).CONCLUSION:Besides the three cirrhosis-related parameters,DM was found to be the sole independent factor associated with HCC in patients with HBV-related cirrhosis,compared with those without cirrhosis.
文摘Diabetes has become a growing concern in Japan, both medically and financially. The medical cost of diabetes was estimated at 1215 billion yen for fiscal year 2011. We analyzed the length of stay (LOS) in a hospital for type 2 diabetes mellitus patients who participated in educational programs to determine factors affecting LOS. Data on 991 patients obtained from 28 Red Cross hospitals in 2008 were used. For the analysis, we used the Box-Cox transformation model and Hausman test. The results revealed that patients aged 75 years and above and those with comorbidities and complications were prone to longer LOS. The analysis also revealed significant differences in LOS across the hospitals, even after controlling for patient characteristics. Finally, we applied the least squares method to determine the effects of hospital and regional factors and revealed that patients’ LOS was affected by the region’s average LOS. Regional corporations and networks appeared to be important in improving educational programs.
文摘Objectives: The cost-utility analysis of Liraglutide is aimed at evaluating whether Liraglutide is cost-effective or not after Chinese reformation on medical insurance. The analysis is based on the results of clinical trial conducted in Asia. Methods: We applied a Markov model to estimate the quality-adjusted life years, medical cost and incidence of diabetes-related complications for patients receiving the Liraglutide as an add-on to the metformin treatment. Baseline characteristics were taken from a China’s study while the treatment effect is from an Asian study. The related medical cost and utility score were obtained from a local study in China. Having set 30 years’ simulations, the incremental cost-effectiveness ratio was calculated comparing with glimepiride treatment. The ratio would be compared with the willingness to pay for a quality-adjusted-life-year (QALY) which is three times of the GDP per capita in Beijing. Sensitivity analysis was also performed. Result: During a period of 30 years, the base-case analysis which takes discount rate at 3% shows that Liraglutide 1.8 mg results in an average incremental cost of CNY 82,671.49, an improvement in 0.12 QALYs and a reduction of incidence of diabetes-related complications comparing to glimepiride. The associated incremental cost-effectiveness ratio is CNY 688,929.08. Conclusion: Long-term project shows that taking Liraglutide as an add-on to the metformin treatment will lead to increasing quality-adjusted life years and reduction of incidence of diabetes-related complications. When the price of Liraglutide is reduced by 43 percent in China’s yuan, Liraglutide will be cost-effective in China from the healthcare system perspective taking three times of GDP per capita as our WTP threshold.
基金Supported by National Natural Science Foundation of China,No. 81273975the Research Fund of the China-Japan Friendship Hospital, Ministry of Health, No. 2010-QN-01
文摘AIM: To determine the association of diabetes mellitus (DM) and international normalized ratio (INR) level in hepatocellular carcinoma (HCC) patients. METHODS: Our present study included 375 HCC patients who were treated at the China-Japan Friendship Hospital, Ministry of Health (Beijing, China), in the period from January 2003 to April 2012, and with a hospital discharge diagnosis of HCC. The demographic, clinical, laboratory, metabolic and instrumental features were analyzed. χ2 test, Student's t test and Mann-Whitney U test were used to compare the differences between HCC patients with and without DM. Unconditional multivariable logistic regression analysis was used to determine the association of DM and INR level in HCC patients. A sub-group analysis was performed to assess the effect of liver cirrhosis or hepatitis B virus (HBV) infection on the results. The Pearson correlation test was used to determine the relationship between INR level and fasting glucose. In addition, association between diabetes duration, and diabetes treatment and INR level was determined considering the potentially different effects. RESULTS: Of the total, 63 (16.8%) patients were diabetic (diabetic group) and 312 (83.2%) patients were diagnosed without diabetes (non-diabetic group). Their mean age was 56.4 ± 11.0 years and 312 (83.2%) patients were male. Compared with patients without DM, the HCC patients with diabetes were older (59.5 ± 10.3 vs 55.8 ± 11.1, P=0.015), had a lower incidence of HBV infection (79.4% vs 89.1%, P=0.033), had increased levels of systolic blood pressure (SBP) (133 ± 17 vs 129 ± 16 mmHg, P=0.048) and INR (1.31 ± 0.44 vs 1.18 ± 0.21, P=0.001), had lower values of hemoglobin (124.4 ± 23.9 vs 134.2 ± 23.4, P=0.003) and had a platelet count (median/interquartile-range: 113/64-157 vs 139/89-192, P=0.020). There was no statistically significant difference in the percentages of males, overweight or obesity, drinking, smoking, cirrhosis and Child classification. After controlling for the confounding effects of age, systolic blood pressure, hemoglobin, platelet count and HBV infection by logistic analyses, INR was shown as an independent variable [odds ratio (OR)=3.650; 95%CI: 1.372-9.714, P=0.010]. Considering the effect of liver cirrhosis on results, a sub-group analysis was performed and the study population was restricted to those patients with cirrhosis. Univariate analysis showed that diabetic patients had a higher INR than non-diabetic patients (1.43 ± 0.51 vs 1.25 ± 0.23, P=0.041). After controlling for confounding effect of age, SBP, hemoglobin, platelet count and HBV infection by logistic analyses, INR level remained as the sole independent variable (OR=5.161; 95%CI: 1.618-16.455, P=0.006). No significant difference in the relationship between INR level and fasting glucose was shown by Pearson test (r=0.070, P=0.184). Among the 63 diabetic patients, 35 (55.6%) patients had been diagnosed with DM for more than 5 years, 23 (36.5%) received oral anti-diabetic regimens, 11 (17.5%) received insulin, and 30 (47.6%) reported relying on diet alone to control serum glucose levels. No significant differences were found for the association between DM duration/treatment and INR level, except for the age at diabetes diagnosis. CONCLUSION: The INR level was increased in HCC patients with DM and these patients should be monitored for the coagulation function in clinical practice.
文摘Background Glycemic control prevents onset and progression of diabetes-related long-term complications. The objective of this study was to demonstrate that twice daily insulin lispro low mix 25 is noninferior to twice daily human insulin mix 30/70 in achieving glycemic control as measured by hemoglobin Alc （HbAlc）, from baseline to endpoint, in patients with type 1 or 2 diabetes. Methods In this phase IV, crossover, open-label, multicenter study, 117 Chinese patients with diabetes were randomly assigned to one of two treatment sequence groups. One group received 12-week treatment with twice daily human insulin mix 30/70 followed by 12-week treatment with twice daily insulin lispro low mix 25, while the other group received the reverse treatment sequence. HbAlc, baseline-to-endpoint change in HbAlc, proportion of patients achieving target HbAlc ≤ 7% and 〈 6.5%, fasting blood glucose, and daily insulin doses were measured for each period. Safety and tolerability were also assessed. Results A statistically significant reduction （P≤0.0001） of HbAlc was achieved after each treatment （human insulin mix 30/70： mean HbA1c=7.91% （95% CI： 7,67%, 8.15%）; insulin lispro low mix 25： mean HbA1c=7.96% （95% CI： 7.72%, 8.20%））. The 95% Cl （-0.20, 0.10） of the difference between the two treatments satisfied the prespecified noninferiority margin of 0.3% （lower limit of 95% CI 〉 -0.3%）. No statistically significant differences between treatments were observed for any of the secondary efficacy measures. The incidence of treatment-emergent adverse events and hypoglycemia between the two treatments and treatment sequence groups was similar. Three serious adverse events were reported （human insulin mix 30/70 group： 2 patients （1.7%, hypoglycemic coma and cardiac failure）; insulin lispro low mix 25 group： 1 patient （0.9%, stroke））. All serious adverse events were resolved and no patients died during the study. Conclusion The results support noninferiority of twice daily insulin lispro low mix 25 versus twice daily human insulin mix 30/70 in HbAlc control in Chinese patients with type 1 or 2 diabetes.
基金Jiangsu TCM Bureau Project(YB2015043)Jiangsu Science and Technology Department Project(BK20161606).
文摘Objective:To assess the efficacy of compound Bai Yu San(CBYS)as a new treatment option,in healing diabetic skin ulcer.Materials and Methods:A total of 64 diabetic patients with skin ulcer were enrolled and randomly assigned to experimental group(n=33)and control group(n=31).In the control group,normal saline(NS)was used to cleanse the wound.After debridement,the wound was dressed with modern materials.In the experimental group,the NS‑cleansed wound was dressed with CBYS.The infection rate,healing rate,treatment cost,and patient satisfaction between the two groups were compared.Results:On the 35th day after treatment,the infection rate and healing rate showed no between‑group difference(P>0.05);the experimental group showed lower treatment cost and higher satisfaction than the control group(P<0.05).Conclusion:As a new treatment option for diabetes‑induced skin ulcer,CBYS can effectively control the infection,promote the healing,reduce treatment cost,and increase patient satisfaction.Dressing with CBYS can be clinically replicated in the treatment of diabetic skin ulcer.
文摘目的探讨院校-社区联合开展中医养生保健在老年2型糖尿病患者中的应用效果。方法选取2020年8月至2021年7月扬州市中医院收治的84例老年2型糖尿病患者作为研究对象,按照随机数字表法分为对照组(42例)和干预组(42例)。对照组患者采用常规治疗护理,干预组患者在常规治疗护理的基础上采用院校-社区联合开展中医养生保健社会实践方法。比较两组患者的遵医依从率、血糖水平、并发症发生率及生活质量。结果干预组患者的按时按量服药、血糖水平监测、合理饮食、适量运动遵医依从率高于对照组,差异有统计学意义(P<0.05)。干预组患者干预后的空腹血糖(FBG)、餐后2 h血糖(2 h PBG)及糖化血红蛋白(HbA1c)水平均低于对照组,差异有统计学意义(P<0.05)。干预组患者的并发症总发生率低于对照组,差异有统计学意义(P<0.05)。干预组患者干预后的生活质量综合评定问卷各维度评分均高于对照组,差异有统计学意义(P<0.05)。结论院校-社区联合实施的中医养生保健对老年2型糖尿病患者进行干预,可有效提高其遵医依从性,有助于控制血糖水平,减少并发症的发生,提高生活质量。
文摘Background Duloxetine, a selective serotonin and noradrenaline reuptake inhibitor, has been shown to be effective in treatment of diabetic peripheral neuropathic pain and approved for the management of patients with diabetic peripheral neuropathic pain （DPNP） in the United States, European Union, and many other countries. This study assessed the efficacy and safety of duloxetine in Chinese patients with diabetic peripheral neuropathic pain. Methods This double-blind, randomized, placebo-controlled, flexible-dose study treated adult patients with diabetic peripheral neuropathic pain and baseline Brief Pain Inventory （BPI） 24-hour average pain severity ratings ≥4 with duloxetine 60 mg to 120 mg once daily or placebo for 12 weeks. Dose adjustments of duloxetine or matching placebo were based upon investigator＇s judgment of clinical response. Change from baseline to endpoint in BPI average pain was the primary efficacy outcome. Secondary outcome measures included BPI-severity and -Interference, Patient Global Impression of Improvement, Clinical Global Impressions of Severity, EuroQol： 5 Dimensions, Athens Insomnia Scale, and safety measures. Results Of 215 patients randomized, 88.4% and 82.1% of patients in placebo and duloxetine groups, respectively,completed the study. Mean change from baseline to endpoint in BPI average pain was not statistically different between the treatment groups （P=0.124）. Duloxetinetreated patients showed significantly greater pain reduction compared with those in placebo group at weeks 1,2, and 4 （P=0.004, P=0.009, and P=0.006, respectively） but not at weeks 8 （P=0.125） and 12 （P=0.107）. Duloxetine-treated patients experienced statistically significant improvement in Patient Global Impression of Improvement, Clinical Global Impression of Severity, area under the curve for pain relief, BPI-severity pain right now, and BPI-interference walking ability. Patients treated with duloxetine 120 mg once daily showed significantly greater pain reduction on the Brief Pain Inventory average pain score relative to placebo. Duloxetine-treated patients reported nausea, somnolence, anorexia, and dysuria significantly more than placebo. Conclusions Although the primary study endpoint was not achieved, the overall observed response pattern suggests the efficacy of duloxetine in the treatment of Chinese patients with diabetic peripheral neuropathic pain. The safety profile for duloxetine is similar to that reported in other global trials.
