Objective: To evaluate the efficacy and safety of hybutimibe monotherapy or in combination with atorvastatin in the treatment of primary hypercholesterolemia. Methods: This was a multicenter, randomized, double-blind, double-dummy, parallel-controlled phase Ⅲ clinical trial of patients with untreated primary hypercholesterolemia from 41 centers in China between August 2015 and April 2019. Patients were randomly assigned, at a ratio of 1∶1∶1∶1∶1∶1, to the atorvastatin 10 mg group (group A), hybutimibe 20 mg group (group B), hybutimibe 20 mg plus atorvastatin 10 mg group (group C), hybutimibe 10 mg group (group D), hybutimibe 10 mg plus atorvastatin 10 mg group (group E), and placebo group (group F). After a dietary run-in period for at least 4 weeks, all patients were administered orally once a day according to their groups. The treatment period was 12 weeks after the first dose of the study drug, and efficacy and safety were evaluated at weeks 2, 4, 8, and 12. After the treatment period, patients voluntarily entered the long-term safety evaluation period and continued the assigned treatment (those in group F were randomly assigned to group B or D), with 40 weeks' observation. The primary endpoint was the percent change in low density lipoprotein cholesterol (LDL-C) from baseline at week 12. Secondary endpoints included the percent changes in high density lipoprotein cholesterol (HDL-C), triglyceride (TG), apolipoprotein B (Apo B) at week 12 and changes of the four above-mentioned lipid indicators at weeks 18, 24, 38, and 52. Safety was evaluated during the whole treatment period. Results: Totally, 727 patients were included in the treatment period with a mean age of (55.0±9.3) years old, including 253 males. No statistical differences were observed among the groups in demographics, comorbidities, and baseline blood lipid levels. At week 12, the percent changes in LDL-C were significantly different among groups A to F (all P<0.01). Compared to atorvastatin alone, hybutimibe combined with atorvastatin could further improve LDL-C, TG, and Apo B (all P<0.05). Furthermore, there was no significant difference in percent changes in LDL-C at week 12 between group C and group E (P=0.991 7). During the long-term evaluation period, there were intergroup statistical differences in changes of LDL-C, TG and Apo B at 18, 24, 38, and 52 weeks from baseline among the statins group (group A), hybutimibe group (groups B, D, and F), and combination group (groups C and E) (all P<0.01), with the best effect observed in the combination group. The incidence of adverse events was 64.2% in the statins group, 61.7% in the hybutimibe group, and 71.0% in the combination group during the long-term evaluation period. No treatment-related serious adverse events or adverse events leading to death occurred during the 52-week study period. Conclusions: Hybutimibe combined with atorvastatin showed confirmatory efficacy in patients with untreated primary hypercholesterolemia, which could further enhance the efficacy on the basis of atorvastatin monotherapy, with a good overall safety profile.
Male ; Humans ; Middle Aged ; Atorvastatin/therapeutic use* ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use* ; Hypercholesterolemia/drug therapy* ; Cholesterol, LDL/therapeutic use* ; Anticholesteremic Agents/therapeutic use* ; Treatment Outcome ; Triglycerides ; Apolipoproteins B/therapeutic use* ; Double-Blind Method ; Pyrroles/therapeutic use*

OBJECTIVETo investigate the effect of Nutrition MCT and Nutrition MF enteral nutrition on nutritional status of patients after major abdominal operation.

METHODSIn a double- blinded and randomized cross- cover study, Nutrition MCT and Nutrition MF enteral nutrition were fed in patients when the gut function restored after operation. The total calorie was 104.6 kJ(25 kcal) x kg(-1) x d(-1) and the period of full dose of enteral nutrition was 5 days. The blood samples were collected before operation,before enteral nutrition and the sixth day after full dose of enteral nutrition for the measurement of pre- albumin, total protein,albumin, transferrin and triglyceride. The urine, stool and drainage fluid were collected to analyze nitrogen balance.

RESULTSThe plasma protein and fat were obviously dropped in patients after abdominal operation and improved after the enteral nutrition support in two groups. However, the pre- albumin level increased more in patients of Nutrition MCT than Nutrition MF.

CONCLUSIONNutrition MCT can obviously improve the nutritional status of patients after major abdominal operation.

Abdomen ; surgery ; Adult ; Aged ; Cross-Over Studies ; Double-Blind Method ; Enteral Nutrition ; methods ; Female ; Humans ; Male ; Middle Aged ; Nutritional Status ; Proteins ; therapeutic use ; Triglycerides ; therapeutic use

Cholesterol, LDL ; blood ; Diabetes Mellitus, Type 2 ; complications ; Humans ; Hyperlipidemias ; blood ; drug therapy ; etiology ; Hypolipidemic Agents ; therapeutic use ; Simvastatin ; therapeutic use ; Triglycerides ; blood

OBJECTIVETo investigate the effect of dietary calcium on plasma lipoprotein profile in castrated and ovariectomized hamsters.

METHODSMale, castrated, female and ovariectomized hamsters (n=36 each group) were randomly divided into three sub-groups (n=12) and fed one of the three diets containing 0, 2, and 8 g calcium per kg diet for a period of six weeks. Changes in plasma lipoprotein profile were monitored at the end of week 0, 3 and 6.

RESULTSPlasma total cholesterol (TC), non-high density lipoprotein cholesterol (non-HDL-C), triacylglycerols (TG) and TC/HDL-C were decreased only in intact female and ovariectomized hamsters. In contrast, three levels of dietary calcium had no effect on lipoprotein profiles in both intact male and castrated hamsters.

CONCLUSIONBeneficial modification of lipoprotein profile by dietary calcium was gender-dependent at least in hamsters.

Animals ; Calcium, Dietary ; therapeutic use ; Cholesterol ; blood ; Cholesterol, Dietary ; adverse effects ; Cholesterol, HDL ; blood ; Cricetinae ; Female ; Male ; Triglycerides ; blood

OBJECTIVE: To assess the influence of apolipoprotein E (ApoE) gene polymorphisms on the therapeutic effect of lipid-lowering statins in patients with ischemic cerebral infarction. METHODS: One hundred and six patients with ischemic cerebral infarction who orally took lipid-lowering statins for 3 months were enrolled. Changes in serum triacylglycerol (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) before and after the drug administration were analyzed. ApoE gene polymorphisms were detected by real-time fluorescent quantitative PCR, and genotypes of ApoE gene in patients with different effects were compared. RESULTS: The detection rates for E2/E2, E2/E3, E3/E3, E2/E4 and E3/E4 genotypes were 0.94%, 11.32%, 63.21%, 1.89% and 22.64%, respectively. And the detection rates for E2, E3 and E4 alleles were 7.55%, 80.19% and 12.26%, respectively. Biochemical phenotypes included E2 type (13 cases, 12.26%), E3 type (69 cases, 65.09%) and E4 type (24 cases, 22.65%). Before administration, TG and TC of E2 type were the highest (P<0.05), but no significant difference was detected in HDL-C and LDL-C among the three phenotypes (P>0.05).Following the drug administration, TG, TC and LDL-C were decreased, while HDL-C was increased. HDL-C of E2 type was the highest, TC and LDL-C of E4 type were the highest (P<0.05). The E3/E3 ratio in low-efficiency group at admission was lower than that in the high-efficiency group, while the E3/E4 ratio was higher than that in the high-efficiency group (P<0.05). The proportion of E3 allele in low-efficiency group was lower than that in high-efficiency group, while the proportion of E4 allele was higher than that in high-efficiency group (P<0.05). CONCLUSION ApoE gene polymorphisms are closely correlated with the therapeutic effect of lipid-lowering statins in patients with ischemic cerebral infarction. The lipid-lowering effects are more significant in patients with E2 and E3 genotypes, but were poor in those with the E4 genotype. Personalized regimens should be applied.
Apolipoproteins E/genetics* ; Cerebral Infarction/genetics* ; Genotype ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use* ; Lipids ; Polymorphism, Genetic ; Triglycerides

OBJECTIVE: To study the changes in metabolic markers and clinical outcome after treatment with different drug regimens in children with bipolar affective disorder. METHODS: A retrospective analysis was performed on the medical data of 220 children with bipolar affective disorder who attended the hospital from January 2017 to January 2020. According to the treatment method, 112 children treated with atypical antipsychotic drugs alone were enrolled as the control group, and 108 children treated with atypical antipsychotic drugs combined with mood stabilizer were enrolled as the study group. The two groups were compared in terms of baseline data, changes in related metabolic markers[fasting insulin (FIN), glycosylated hemoglobin (HbAlc), total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C)] after treatment, incidence rate of metabolic syndrome, and clinical outcome. RESULTS: There were no significant differences in the baseline data including age, sex, and course of disease between the two groups ( CONCLUSIONS Atypical antipsychotic drugs combined with mood stabilizer in the treatment of bipolar disorder in children have little effect on the level of metabolic markers, and the curative effect is significant.
Antipsychotic Agents/therapeutic use* ; Biomarkers/blood* ; Bipolar Disorder/drug therapy* ; Child ; Cholesterol, HDL ; Humans ; Mood Disorders ; Retrospective Studies ; Triglycerides

INTRODUCTIONIntravenous lipid is commonly used as part of total parenteral nutrition (TPN) in premature babies. The gold standard of measuring lipid tolerance involves measuring serum triglyceride levels. Many hospitals in Asia do not have this facility and rely on visual turbidity to titrate the rate of lipid infusion. The aim of this study was to determine if visual turbidity correlates with serum triglyceride levels.

MATERIALS AND METHODSTwenty-seven samples were taken from 8 babies on intravenous (IV) lipid infusion for the analysis of serum triglyceride levels and visual turbidity (assessed by 2 senior neonatologists independently). Serum turbidity was classified either as clear or turbid. Lipid intolerance was defined as triglyceride levels greater than 200 mg/dL (2.25 mmol/L).

RESULTSBoth neonatologists similarly classified 20 out of 27 specimens. Serum triglyceride levels for clear samples (n = 10) were significantly lower than those for turbid samples (n = 10) (P <0.01). The clear specimens all had normal serum triglyceride levels (mean, 1.16 mmol/L; range, 0.43 to 1.96). Not all turbid specimens had unacceptable serum triglyceride levels (mean, 2.37 mmol/L; range, 1.37 to 5.75). In the remaining 7 specimens, there was a difference in opinion regarding serum turbidity. The triglyceride levels for these 7 samples were all normal (mean, 1.17 mmol/L; range, 0.66 to 1.72).

CONCLUSIONSerum turbidity may be used as a screening tool in assessing lipid tolerance in babies on TPN as all clear samples had acceptable serum triglyceride level if we set the maximum cutoff at 2.25 mmol/L. Patients with turbid samples should ideally have their serum triglyceride taken to confirm lipid intolerance before altering their lipid infusion rate as they may have acceptable triglyceride levels.

Drug Combinations ; Fat Emulsions, Intravenous ; administration & dosage ; therapeutic use ; Gestational Age ; Humans ; Hyperlipidemias ; blood ; prevention & control ; Infant, Newborn ; Infant, Premature ; blood ; Nephelometry and Turbidimetry ; Parenteral Nutrition, Total ; methods ; Phospholipids ; administration & dosage ; therapeutic use ; Prognosis ; Sorbitol ; administration & dosage ; therapeutic use ; Triglycerides ; blood

BACKGROUNDHyperinsulinemia and insulin resistance are present in the majority of women with polycystic ovary syndrome (PCOS). Both metformin and rosiglitazone can improve the ovulation and endocrine disorders of the patients. How about the combination of the two? It is rarely reported. This study aimed to compare the therapeutic efficacy of metformin versus metformin plus rosiglitazone in patients with PCOS.

METHODSFifty-eight women with PCOS were randomly assigned to two groups. Metformin group (29) was treated with metformin mono-therapy and metformin plus rosiglitazone group (29) was treated with metformin plus rosiglitazone for 6 months. Treatment was discontinued once pregnancy was diagnosed.

RESULTSFasting insulin, postprandial insulin, the homeostatic model assessment of insulin resistance (HOMA-IR), luteinizing hormone (LH), triglyceride, lower density cholesterol and testosterone level decreased significantly in both groups (P < 0.05). Metformin plus rosiglitazone had a better effect than metformin mono-therapy. Body mass index decreased by 7.8% in metformin group while no significant change in metformin plus rosiglitazone group. There were eight pregnancies, six in metformin plus rosiglitazone group (one abortion) and two in metformin group. There was no congenital anomaly at birth and seven infants developed well at one year's follow-up.

CONCLUSIONSMetformin can improve insulin resistance and imbalance of endocrine hormones. Metformin plus rosiglitazone has a more pronounced therapeutic effect and achieved more pregnancies than mono-therapy with metformin. The use of metformin and rosiglitazone before pregnancy has no obvious side effect on the development of the infants. Our study might suggest that metformin is the better choice in PCOS patients with serious obese and rosiglitazone plus metformin would be more effective in patients with severe insulin resistance or those do not respond to metformin.

Adolescent ; Adult ; Female ; Humans ; Hypoglycemic Agents ; adverse effects ; therapeutic use ; Insulin Resistance ; physiology ; Luteinizing Hormone ; blood ; Metformin ; adverse effects ; therapeutic use ; Polycystic Ovary Syndrome ; blood ; drug therapy ; Testosterone ; blood ; Thiazolidinediones ; adverse effects ; therapeutic use ; Triglycerides ; blood ; Young Adult

OBJECTIVETo study the therapeutic effect of Shenle capsule (SLC) in treating mesangial proliferating glomerulonephritis (MsPGN) and to explore its therapeutic mechanism and clinical indication.

METHODSAdopting case control method, taking angiotensin-converting enzyme inhibitor (benazepril) as control agent, the 142 cases of MsPGN were randomly divided into 3 groups, treated with SLC (Group A, n = 36), SLC plus benazepril (Group B, n = 68) and benazepril alone (Group C, n = 38) respectively. Changes of fibrinogen, lipids, renal function and urinary protein were observed.

RESULTSThe total effective rate in Group A was higher than that in Group C, but with insignificant difference. The total effective rate in Group B after 3 courses of treatment was 89.74%, which was higher than that in Group C and Group A (P < 0.05). Levels of cholesterol (CH), triglyceride (TG), serum creatinine, fibrinogen and urinary protein (UP) were significantly lowered in Group A after treatment, with the levels of CH, TG and UP lower than those in Group C, while CH, TG and fibrinogen were unchanged in Group C after treatment.

CONCLUSIONSLC is superior in higher efficacy and less side-effects in treating MsPGN, its effect is related with the degree of kidney pathological changes, it is more effective in treating patients with mild pathological change than in those with severe change. The outcome of combined use of SLC and angiotensin-converting enzyme inhibitor would be better.

Adolescent ; Adult ; Aged ; Angiotensin-Converting Enzyme Inhibitors ; therapeutic use ; Benzazepines ; therapeutic use ; Child ; Cholesterol ; blood ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Glomerulonephritis, Membranoproliferative ; blood ; drug therapy ; Humans ; Male ; Middle Aged ; Phytotherapy ; Proteinuria ; drug therapy ; Triglycerides ; blood

The alterations in atherogenic index of plasma (AlP) in type 2 diabetic patients and their normoglycemic first-degree relatives (NFDR) were investigated, and the effects of Acarbose or Glimepiride on AIP in 99 type 2 diabetic patients were evaluated. Triglycerride (TG), total cholesterol, high density lipoprotein-cholesterol (HDL-C) levels were analyzed, and Log (TG/HDL-C) was calculated as AIP in 62 type 2 diabetic patients and their 67 NFDR from 29 type 2 diabetic pedigrees and in 45 healthy controls without family histories of diabetes. Also analyzed were the same parameters in 99 type 2 diabetic patients before and after therapy with Acarbose or Glimepiride. The results revealed that diabetic patients and their NFDR had significantly higher AIP than did the controls, whereas no significant differences were seen between diabetic patients and their NFDR. Positive correlation of AIP between type 2 diabetic patients and their offspring were observed (r = 0.241, P < 0.05). After 8 weeks therapy with Acarbose, the AIP of type 2 diabetic patients was decreased significantly, and no differences were observed for AIP levels in Glimepiride group although the AIP was lower when compared with the untreated level. As a significant inverse correlation of small dense low density lipoprotein (sdLDL) with AIP was confirmed, our data suggest that diabetic patients and their NFDR from type 2 diabetic pedigrees had significantly higher AIP than did controls; AIP could be decreased by therapy with Acarbose in type 2 diabetic patients; Glimepiride may bring potential benefit to type 2 diabetic patients by influencing sdLDL.
Acarbose ; therapeutic use ; Atherosclerosis ; blood ; Body Mass Index ; Case-Control Studies ; Cholesterol, HDL ; blood ; Diabetes Mellitus, Type 2 ; blood ; drug therapy ; Humans ; Hypoglycemic Agents ; therapeutic use ; Pedigree ; Sulfonylurea Compounds ; therapeutic use ; Triglycerides ; blood