A new, alternative risk score for sarcopenia in Chinese patients with type 2 diabetes mellitus.

OBJECTIVE: To develop a new, alternative sarcopenia risk score to screen for sarcopenia in type 2 diabetes patients in China and to demonstrate its validity. RESEARCH DESIGN AND METHODS: The data for this study came from a multicenter, cross-sectional study that had been designed to estimate the prevalence of sarcopenia among adults with type 2 diabetes and had been conducted in several hospitals in Beijing, China. A total of 1125 participants were randomly divided into two groups: an exploratory population and a validation population. A multivariable logistic regression model using the backward stepwise likelihood ratio method to estimate the probability of sarcopenia was fitted with candidate variables in the exploratory population. A new, alternative sarcopenia risk score was developed based on the multivariable model. The internal and external validations were performed in the exploratory and validation populations. The study was registered at Chinese Clinical Trial Registry (ChiCTR-EOC-15006901). RESULTS: The new, alternative sarcopenia risk score included five variables: age, gender, BMI, total energy intake per day, and the proportion of calories supplied by protein. The score ranged from - 2 to 19. The area under the receiver operating characteristic (ROC) curve of the risk score for the prediction of sarcopenia in type 2 diabetes patients was 0.806 (95% CI 0.741-0.872) and 0.836 (95% CI 0.781-0.892) in the exploratory and validation populations, respectively. At the optimal cutoff value of 12, the sensitivity and specificity of the score for the prediction of sarcopenia were 70.9% and 81.0% in the exploratory population and 53.7% and 88.8% in the validation population, respectively. The Hosmer-Lemeshow goodness-of-fit test showed a good calibration with the risk score in external validation (χ2 = 4.459, P = 0.813). CONCLUSIONS: The new, alternative sarcopenia risk score appears to be an effective screening tool for identification of sarcopenia in Chinese patients with type 2 diabetes in clinical practice. Clinical trial registration Chinese Clinical Trial Registry, ChiCTR-EOC-15006901.

Effectiveness and Safety of Zercepac and Reference Trastuzumab in the Neoadjuvant Setting for Early-Stage Breast Cancer: A Retrospective Cohort Study.

Aim: Since the high cost of reference trastuzumab limits its clinical application, this study aimed to compare the effectiveness and safety of the Zercepac and reference product trastuzumab in neoadjuvant therapy for HER2-positive breast cancer. Methods: This study retrospectively collected clinical data of patients with early-stageHER2-positive breast cancer, who received trastuzumab, pertuzumab, docetaxel, and platinum as neoadjuvant therapy from November 2020 to July 2021. Patients were divided into the Zercepac and reference trastuzumab groups. Reduction in tumor size, clinical response based on RECIST1.1 criteria, pathological complete response (pCR), and adverse events (AEs) were evaluated. Multivariate logistic regression analyses were used to adjust confounders. Results: A total of 105 patients were included in the study, among them, 65 were in the Zercepac group and 40 were in the reference trastuzumab group. The percentage of tumor shrinkage from baseline was comparable between the Zercepac and reference trastuzumab group (47.6 ± 18.6% vs. 43.0 ± 19.9%, p = 0.235). Clinical partial response rate was similar between the two groups (81.5% vs. 70.0%, p = 0.172). There were 28 cases of pCR (70.0%) in the reference trastuzumab group and 46 cases of pCR (70.8%) in the Zercepac group (p = 0.933). The choice of Zercepac or reference trastuzumab was not significantly associated with pCR (OR = 0.96, 95%CI: 0.41-2.28, p = 0.933). Adverse events (AEs) were observed in all patients, and the incidence of ≥3 grade AEs was comparable between the two groups (81.5% vs. 70.0%, p = 0.172). Conclusion: Zercepac has similar effectiveness and safety profile compared with reference trastuzumab in neoadjuvant therapy, which provides treatment options for patients with HER2-positive breast cancer.

Development and validation of a machine learning algorithm-based risk prediction model of pressure injury in the intensive care unit.

The study aimed to establish a machine learning-based scoring nomogram for early recognition of likely pressure injuries in an intensive care unit (ICU) using large-scale clinical data. A retrospective cohort study design was employed to develop and validate a top-performing clinical feature panel accessibly in the electronic medical records (EMRs), which was in the mode of a quantifiable nomogram. Clinical factors regarding demographics, admission cause, clinical laboratory index, medical history and nursing scales were extracted as risk candidates. The performance improvement was based on the application of the machine learning technique, comprising logistic regression, decision tree and random forest algorithm with five-fold cross-validation (CV) technique. The comprehensive assessment of sensitivity, specificity and the area under the receiver operating characteristic curve (AUROC) was considered in the evaluation of predictive performance. The receiver operating characteristic curves revealed the top performance for the logistic regression model in respect to machine learning improvement, achieving the highest sensitivity and AUC among three types of classifiers. Compared against the 23-point Braden scale routinely recorded online, an incorporated nomogram of logistic regression model and Braden scale achieved the best performance with an AUC of 0.87 ± 0.07 and 0.84 ± 0.05 in training and test cohort, respectively. Our findings suggest that the machine learning technique potentiated the limited predictive validity of routinely recorded clinical data on pressure injury development during ICU hospitalisation. Easily accessible electronic records held the potentials to substitute the traditional Braden score in the prediction of pressure injury in intensive care unit. Preoperative prediction of pressure injury facilitates the exemption from the severe consequences.

Metabolic and Nutritional Characteristics in Middle-Aged and Elderly Sarcopenia Patients with Type 2 Diabetes.

Sarcopenia is considered to be a new complication of type 2 diabetes (T2DM) leading to increased risk of adverse outcome. We performed a survey to evaluate glucose metabolism and nutritional status in sarcopenia patients with T2DM. Diabetic participants aged ≥50 years were grouped into a probable sarcopenia group with low muscle strength (n = 405) and a nonsarcopenia group with normal muscle strength (n = 720) according to the revised recommendations from EWGSOP2 (2018). Compared to the controls, the probable sarcopenia participants were older and had lower waist-to-hip ratio and BMI, longer diabetes duration, higher fasting plasma glucose level and glycosylated hemoglobin (HbA1c), decreased estimated glomerular filtration rate and lower bone mineral content, lower fatless upper arm circumference, lower appendicular skeletal muscle mass index (ASMI), and muscle quality in both genders. Multivariable logistic regression analysis showed increased age, male, low BMI, and increased HbA1c, combined with diabetic nephropathy and decreased serum albumin levels, were risk factors associated with low muscle strength in diabetes patients. In conclusion, diabetic patients with sarcopenia had worse glucose metabolism and nutritional status, decreased renal function and reduced muscle quality ,and muscle mass with a greater likelihood of osteoporosis, who need an overall health management to improve outcomes. This clinical trial registration is registered with the Chinese Clinical Trial Registry, ChiCTR-EOC-15006901.

Correlations of MRP1 gene with serum TGF-ß1 and IL-8 in breast cancer patients during chemotherapy.

PURPOSE: To investigate the expressions of multidrug resistance-associated protein 1 (MRP1) gene, serum transforming growth factor beta-1 (TGF-ß1) and interleukin-8 (IL-8) in patients with breast cancer during chemotherapy, and to analyze their correlations in chemotherapy. METHODS: 346 breast cancer patients admitted to the Department of Surgery (Breast) of Nanjing Drum Tower Hospital from March 2015 to December 2017 were included as study subjects. All selected patients received chemotherapy in our hospital. Quantitative reverse transcription- polymerase chain reaction (qRT-PCR) and enzyme-linked immunosorbent assay (ELISA) were adopted to detect the expression levels of MRP1 mRNA, as well as MRP1, TGF-ß1 and IL-8 proteins in patients before chemotherapy and at 1, 2, 4 and 8 weeks after chemotherapy. Correlations of MRP1 protein/mRNA with clinical features of patients were analyzed, and Pearson's correlation analysis was performed to examine correlations of MRP1 protein/mRNA with TGF-ß1 and IL-8 proteins. RESULTS: The expressions of MRP1 mRNA as well as MRP1, TGF-ß1 and IL-8 proteins were increased with the prolongation of chemotherapy time, and there were statistically significant differences between the two time points (p

Subthreshold depression among diabetes patients in Beijing: Cross-sectional associations among sociodemographic, clinical, and behavior factors.

BACKGROUND: This study explores the prevalence of subthreshold depression (SubD) and its association with factors in type 2 diabetes mellitus (T2DM) patients. METHODS: This cross-sectional study involved 808 outpatients with T2DM from ten hospitals in Beijing between September 2015 and January 2016. All participants completed the Patient Health Questionnaire 9-item (PHQ-9) to evaluate depressive status, with scores between 5 and 14 considered SubD. Conditional logistic regression was conducted to investigate the variables associated with SubD in T2DM patients. RESULTS: T2DM patients with SubD comprised 11.6% (n = 94) of the sample. The odd ratios for the variables having significant positive associations with SubD were: being a women (OR = 1.90; 95%CI: 1.09-3.32), divorced/widowed (OR = 3.27; 95%CI: 1.46-7.30), comorbidity of cerebrovascular disease (OR = 2.00; 95%CI: 1.06-3.76), more diabetic complications (OR = 8.04; 95%CI: 2.77-23.31), and higher HbA1c in men (OR = 2.41; 95%CI: 1.25-4.64). Being older (OR = 0.78; 95%CI: 0.62-0.98), exercising more (OR = 0.44; 95%CI: 0.22-0.91) and poverty (OR = 0.36; 95%CI: 0.19-0.69) were negatively related to SubD. LIMITATIONS: The sample was mainly recruited from hospital settings, which limits generalization. The study's cross-sectional design precludes making causal inferences. CONCLUSIONS: The proportion of SubD was estimated to be 11.6% among T2DM patients in Beijing. Having more diabetic complications and being divorced/widowed made the odds of having SubD 8-fold and 3-fold higher than not having it, respectively. The relationship between SubD and diabetes necessitates early screening for milder forms of depression, which can alleviate the social burden and individual impairment from major depression or other chronic diseases.

Telmisartan combined with probucol effectively reduces urinary protein in patients with type 2 diabetes: A randomized double-blind placebo-controlled multicenter clinical study.

BACKGROUND: Persistent proteinuria is an important factor contributing to the progression of diabetic nephropathy. The present randomized double-blind placebo-controlled multicenter clinical study evaluated the efficacy and safety of telmisartan combined with the antioxidant probucol in reducing urinary protein levels in patients with type 2 diabetes (T2D). METHODS: Patients with T2D and 24-h proteinuria 0.5-3 g were enrolled in the study and randomly assigned to one of two groups: a telmisartan or a probucol + telmisartan group. Both groups were given telmisartan 80 mg q.d. for 48 weeks. The probucol + telmisartan group was given probucol 500 mg b.i.d. for the first 24 weeks, with the dosage then reduced to 250 mg b.i.d. for the remaining 24 weeks. The telmisartan group was given probucol placebo. RESULTS: In all, 160 patients were enrolled in the present study. The 24-h proteinuria levels were significantly reduced in the probucol + telmisartan compared with telmisartan group. For patients with baseline 24-h proteinuria levels <1.0 g, both treatments resulted in significant reductions in 24-h proteinuria levels after 48 weeks treatment. However, in patients with baseline 24-h proteinuria levels ≥1.0 g, 24-h proteinuria levels after 48 weeks treatment were only reduced in the probucol + telmisartan group. There was no significant difference between the two groups for either adverse cardiovascular or other events. CONCLUSIONS: In patients with diabetic nephropathy, probucol combined with telmisartan more effectively reduces urinary protein levels than telmisartan alone.

[The predictive factors of good glycaemic control in Chinese patients receiving biphasic insulin as part 30: a subgroup analyses from the A1 chieve study].

OBJECTIVE: To identify the baseline factors associated with achievement of glycosylated haemoglobin A1c (HbA1c) < 7.0% in Chinese patients receiving biphasic insulin as part 30 (BIAsp 30), who were previously inadequately controlled with oral anti-diabetic drugs (OADs). METHODS: A1 chieve was a multinational, prospective, open-label, 24-week non-interventional study in patients with type 2 diabetes initiating insulin analogues in 28 countries. The patients were enrolled to take BIAsp 30 according to physician's clinical judgments, who was also responsible for the treatment regimen and dosage adjustment. Primary safety endpoints were the incidence of serious drug adverse reactions (SADRs) including serious hypoglycaemia. Major efficacy endpoints were change in HbA1c, fasting plasma glucose (FPG), 2h post-prandial plasma glucose (2 hPG) from baseline. Relationships between baseline predictive baseline factors and achievement of HbA1c < 7.0% after treatment were examined using multivariate analysis. RESULTS: In China, 4 100 patients initiated BIAsp 30 [54.2% males, age (56.2 ± 13.6) years]. No SADRs were reported. Mean HbA1c was reduced from (9.3 ± 2.1)% to (7.0 ± 1.0)%; FPG was reduced from (10.2 ± 3.3) mmol/L to (6.8 ± 1.3) mmol/L. Changes in 2 hPG after breakfast, lunch and dinner were (-5.6 ± 4.7), (-4.9 ± 4.3) and (-4.2 ± 4.1) mmol/L, respectively (all P < 0.001). The proportion of patients achieving HbA1c < 7.0% increased from 9.7% at baseline to 54.2% at week 24. Multivariate analysis revealed a negative relationship between baseline HbA1c, FPG, 2 hPG and HbA1c < 7.0% after treatment. CONCLUSIONS: In the Chinese subgroup of the A1 chieve study, lower baseline HbA1c, FPG, 2 hPG were predictive factors for achieving HbA1c < 7.0% after 24-week treatment of BIAsp 30, indicating that the earlier initiation of BIAsp 30 in patients poorly controlled with OADs, the more helpful for them to achieve treatment target.

Parents' perception and their decision on their children's vaccination against seasonal influenza in Guangzhou.

BACKGROUND: Seasonal influenza epidemic occurs every year in Guangzhou, which can affect all age groups. Young children are the most susceptible targets. Parents can decide whether to vaccinate their children or not based on their own consideration in China. The aim of this study was to identify factors that are important for parental decisions on vaccinating their children against seasonal influenza based on a modified health belief model (HBM). METHODS: A cross-sectional study was conducted in Guangzhou, China. A total of 335 parents who had at least on child aged between 6 months and 3 years were recruited from women and children's hospital in Guangzhou, China. Each eligible subject was invited for a face-to-face interview based on a standardized questionnaire. RESULTS: Uptake of seasonal influenza within the preceding 12 months among the target children who aged between 6 months and 36 months was 47.7%. Around 62.4% parents indicated as being "likely/very likely" to take their children for seasonal influenza vaccination in the next 12 months. The hierarchical logistic regression model showed that children's age (odds ratio [OR] =2.59, 95% confidence interval [CI]: 1.44-4.68), social norm (OR = 2.08, 95% CI: 1.06-4.06) and perceived control (OR = 2.96, 95% CI: 1.60-5.50) were significantly and positively associated with children's vaccination uptake within the preceding 12 months; children with a history of taking seasonal influenza vaccine (OR = 2.50, 95% CI: 1.31-4.76), perceived children's health status (OR = 3.36, 95% CI: 1.68-6.74), worry/anxious about their children influenza infection (OR = 2.31, 95% CI: 1.19-4.48) and perceived control (OR = 3.21, 95% CI: 1.65-6.22) were positively association with parental intention to vaccinate their children in the future 12 months. However, anticipated more regret about taking children for the vaccination was associated with less likely to vaccinate children within the preceding 12 months (OR = 0.21, 95% CI: 0.08-0.52). CONCLUSIONS: The modified HBM provided a good theoretical basic for understanding factors associated with parents' decisions on their children's vaccination against seasonal influenza.

Improvements in quality of life associated with biphasic insulin aspart 30 in type 2 diabetes patients in China: results from the A1chieve® observational study.

BACKGROUND: Based on the 24-week, prospective, non-interventional, observational study, A1chieve®, we investigated how health-related quality of life (HRQoL) changed, and the predictors of such changes, in Chinese people with type 2 diabetes mellitus (T2DM) after starting with, or switching to, biphasic insulin aspart 30 (BIAsp 30). METHODS: In total, 8,578 people with T2DM starting treatment with, or switching to, BIAsp 30 were recruited from 130 urban hospitals in China. HRQoL was assessed at baseline and 24 weeks using the EuroQol-5 dimensions (EQ-5D) questionnaire. Descriptive statistics, paired t-test, and chi-square test were conducted and the linear ordinary least squares regression model was used to determine predictors for changes in EQ-5D score. RESULTS: Haemoglobin A1c (HbA1c) decreased from 9.5% to 7.0% after 24 weeks. The reported HRQoL measured by the EQ-5D visual analogue scale score increased by 6.2 (p < 0.001) from 75.8 to 82.0, and EQ-5D index score increased by 0.018 (p < 0.001) from 0.875 to 0.893 for the cohort over 24 weeks. The percentage of patients reporting no problems in the mobility, pain/discomfort, and anxiety/depression dimensions of EQ-5D increased significantly (p < 0.001) from 88.4% to 91.4%, 77.3% to 82.8%, and 74.2% to 77.1%, respectively. Patients with higher HbA1c levels at baseline, major hypoglycaemia or micro-complications exhibited significantly larger changes in EQ-5D scores than those with lower baseline HbA1c levels, without major hypoglycaemia or micro-complications after controlling for demographics and other baseline characteristics. CONCLUSIONS: BIAsp 30 treatment was associated with improved glycaemic control and HRQoL in T2DM patients in China. Patients with worse health conditions were more likely to experience larger improvements in HRQoL than those with better health conditions. TRIAL REGISTRATION: ClinicalTrials.gov, NCT00869908 .

[An analysis of hypoglycemic agents used among patients with type 2 diabetes in Beijing communities].

OBJECTIVE: To compare the coverage rate of the hypoglycemic agents base on 2009 and 2012 versions of the national essential medicine list among patients with type 2 diabetes mellitus (T2DM) in Beijing communities. METHODS: A total of 900 patients with T2DM were enrolled in the study from four community health service centers in Beijing and followed up for one year. The following data were collected and analyzed, including patients characteristics, the proportion of patients with glycosylated hemoglobin A1c (HbA1c) less than 7% and the coverage rate of the hypoglycemic agents. RESULTS: (1) The coverage rate of using the hypoglycemic agents in 2012 version of the national essential medicine list was significantly higher than that in 2009 version (91.4% vs 42.9%, χ(2) = 481.09, P < 0.05). The coverage rates of the seven hypoglycemic agents in national essential medicine list were significantly different (χ(2) = 1519.65, P < 0.05) . The coverage rates of acarbose (48.9%), metformin(40.7%) and human insulin (31.1%) were higher than those of glimepiride (9.4%), glipizide (3.0%), glibenclamide (0.6%) and animal insulin (0.2%). (2) After one year follow-up, the proportion of the patients with HbA1c less than 7% was higher than that at the baseline(53.6% vs 32.3%, χ(2) = 77.26, P < 0.05). The coverage rate of using the hypoglycemic agents in 2012 version of the national essential medicine list was significantly higher than that in 2009 version (85.5% vs 37.4%, χ(2) = 376.367, P < 0.05). The coverage rates of acarbose (49.7%), metformin (36.3%) and insulin (30.4%) were still higher than those of glimepiride (6.3%), glipizide (2.2%) , glibenclamide (0.4%) and animal insulin(0.0%). CONCLUSION: The hypoglycemic agents in 2012 version of the national essential medicine list could meet the current need of the type 2 diabetes patients in Beijing communities better than those in 2009 version.

Efficacy and safety of valsartan in reducing blood pressure and albuminuria in Chinese patients with essential hypertension: a multicenter prospective open-label observational study.

OBJECTIVE: To evaluate the efficacy and safety of 80 or 160 mg/day valsartan in Chinese adult patients with essential hypertension and albuminuria. METHODS: A multicenter prospective open-label observational study was conducted. Adult hypertensive patients with albuminuria were treated with 80 or 160 mg/day valsartan. Blood pressure (BP) was recorded at weeks 4, 8 and 12. Albuminuria was selectively measured at week 12. RESULTS: The intent-to-treat (ITT) population included 1180 patients. Mean sitting systolic BP (MSSBP) and diastolic BP (MSDBP) at baseline was 153.5 [14.41] (mean [SD]) and 88.2 [11.99] (mean [SD]) mmHg. MSSBP and MSDBP at week 4 (mean [SD]: 139.1 [12.02] and 82.2 [8.54] mmHg), week 8 (mean [SD]: 135.3 [10.46] and 80.2 [7.55] mmHg) and week 12 (mean [SD]: 132.1 [9.80] and 78.1 [6.88] mmHg) were significantly lower than baseline (p < 0.001). The BP control rate of ITT patients at week 12 was 17.8%. Diabetic patients exhibited lower BP control rate than non-diabetic patients (14.0 vs. 22.4%, p < 0.001). A total of 904 patients had albuminuria assessed at week 12. UACR and UAER at week 12 were lower compared with baseline (p < 0.05). In all, 171 patients (18.9%) returned to normal albuminuria and albuminuria normalization percentage in diabetic patients exceeded that of non-diabetic patients (26.3 vs. 12.1%, p < 0.001). Albuminuria declined by more than 50% in 340 patients (37.6%) and more diabetic patients exhibited such decline in albuminuria than non-diabetic patients (41.7 vs. 33.8%, p < 0.05). No serious drug-related adverse effects (AEs) were observed. LIMITATIONS: Prior antihypertensive treatment before valsartan administration may interfere with the efficacy of subsequent treatment. The discrepancy between 80 and 160 mg may affect patient outcomes and occurrence of AEs. CONCLUSIONS: Valsartan can safely and effectively reduce BP and albuminuria in Chinese adult patients with essential hypertension and albuminuria. Valsartan has the more dramatic effect on albuminuria in diabetic patients than non-diabetic patients.

Comparative utility of MRI perfusion with MSIDR and DWIBS for the characterization of breast tumors.

BACKGROUND: In recent years, breast magnetic resonance imaging (MRI) has been used to evaluate the morphology and functional markers of breast lesions, which might influence local staging and surgical planning. PURPOSE: To evaluate the feasibility of a one stop MRI protocol combined with diffusion-weighted imaging with background body signal suppression (DWIBS), T2*-weighted perfusion imaging (T2*-PWI) and delayed contrast-enhanced T1-weighted MRI (T1W-C+). MATERIAL AND METHODS: All experiments were conducted with a 3-T clinical MRI scanner. The apparent diffusion coefficient (ADC) and detectability of lesions in DWIBS, the maximal signal intensity drop rate (MSIDR) in T2*-PWI and the intensity increasing rate (IIR) on T1W-C+ were compared between breast malignancies (n = 29) and benign lesions (n = 31). The time-signal curves in the T2*-PWI sequences were classified into two subtypes (a and b) according to the end of the curve. The ADC, MSIDR, the first maximal signal intensity decrease time (MSIDT), and IIR between the malignant and benign lesions were statistically analyzed by unpaired t-tests. RESULTS: Overall, 90% of the lesions were detected by DWIBS. There were significant differences in ADC, MSIDR, and IIR between the carcinomas and benign lesions. The Ib subtype in T2*-PWI demonstrated a specificity of 66.7% in differentiating between carcinomas and benign lesions. At a fixed specificity of 93.5%, the MSIDR, IIR, and ADC differentiated breast carcinomas from benign lesions with sensitivities of 82.8%, 44.8%, and 86.2%, respectively. CONCLUSION: DWIBS might be a compensation sequence for detecting breast lesions in pre-contrast sequences. MSIDR from T2*-PWI had the best specificity index, and the two subtypes in the T2*-PWI curve were helpful in the differential diagnosis of carcinomas from benign lesions.

In vitro and in vivo inhibition of MRP gene expression and reversal of multidrug resistance by siRNA.

Clinical drug resistance to chemotherapeutic agents is one of the major hindrances in the treatment of human cancers. One mechanism by which a living cell can achieve multidrug resistance (MDR) is via the active efflux of a broad range of anti-cancer drugs through the cellular membrane by MDR proteins. Over-expression of multidrug resistance-associated protein 1 (MRP1) is one of the important MDR phenotypes. RNA interference (RNAi) is a fundamental cellular mechanism for silencing gene expression that can be harnessed for the development of new drugs. In our study, by using lipofectamin(TM) 2000 (Invitrogen, Carlsbad, CA, USA) in vitro and electric pulse in vivo to delivery siRNA, we successfully inhibited MRP1 both at mRNA and protein level as determined by reverse transcription-PCR and western blot or immunohistochemistry. Furthermore, the efficacy of chemotherapeutic drugs (epirubicin) to tumour cells dramatically improved both in vivo and in vitro. These studies demonstrate that through efficient delivery siRNA, MRP1-mediated MDR can be reversed and siRNA can be used for further study in clinical cancer therapy.

[The relationship between the C589T polymorphism of IL-4 gene and cholelithiasis].

OBJECTIVE: To investigate the relationship between IL-4 gene polymorphism and cholelithiasis in Chinese population. METHODS: Polymerase chain reaction combined with restriction enzyme digestion was used to detect the polymorphism of IL-4 gene in 81 cholecystolithiasis, 41 patients with biliary duct stone. RESULTS: There were no significant differences of the IL-4 gene polymorphism genotypes and alleles between 81 cholecystolithiasis patients (CC11.1%, CT34.6%, TT54.3%; C28.4.7%, T71.6%). There were significant differences of the IL-4 gene polymorphism genotypes and alleles between 41 patients with biliary duct stone (CC48.8%, CT36.6%, TT14.6%; C67.1%, T32.9%). CONCLUSIONS: The C589T polymorphism of IL-4 gene was not associated with cholecystolithiasis patients in Chinese, but was related to patients with biliary duct stone in Chinese.