[Treatment of type 2 diabetes mellitus patients of qi-yin deficiency phlegm-stasis inter-obstruction syndrome by jiangtang xiaozhi capsule and pioglitazone tablet: a non-inferiority randomized controlled trial].

UNLABELLED: OBJECTIVE; To evaluate the efficacy and safety of Jiangtang Xiaozhi Capsule (JTXZC) in treating type 2 diabetes mellitus (T2DM) of qi-yin deficiency phlegm-stasis inter-obstruction syndrome (QYDPSIOS), and to observe its effect on inflammatory factors and fibrinolytic factors. METHODS: By adopting a randomization grouping, parallel control, and prospective study, 73 T2DM patients of QYDPSIOS were assigned to two groups by random digit table, the Pioglitazone Tablet group (36 cases, as the control) and the JTXZC group (37 cases). All patients maintained their basic therapies and lifestyle as previous after recruitment. Patients in the JTXZC group took JTXZC, 4 pills each time, three times per day, while those in control group took Pioglitazone Tablet, 15 mg each time, once daily. The therapeutic course for all was 8 weeks. The body weight (BW), the height, body mass index (BMI), waist circumference (WC), hip circumference, waist-to-hip ratio (WHR), and scoring of Chinese medicine (TCM) symptoms were observed. Levels of fasting blood glucose (FBG), 2 h postprandial blood glucose (2 h PBG), glycated hemoglobin (HbA1c), tumor necrosis factor alpha (TNF-alpha), nuclear factor kappaB (NF-kappaB), and plasminogen activator inhibitor 1 (PAL-1) were detected. The safety indices such as liver and renal functions and adverse reactions were also observed. RESULTS: Compared with before treatment, BW, BMI, HbA1c, and PBG were obviously lower after 8-week treatment than before treatment in the JTXZC group (P < 0.05). There was no statistical difference in post-treatment BW, BMI, HbA1c, or 2 h PBG between the two groups (P < 0.05). Compared with before treatment, levels of TNF-alpha and PAI-1 were lowered after 8 weeks of treatment in both groups (P < 0.01). The level of NF-kappaB was obviously lowered after 8 weeks of treatment in the control groups (P < 0.05), but it also decreased in the JTXZC group with no statistical difference. The scorings of CM symptoms were somewhat improved after treatment in the two groups (P < 0.01). Besides, better effects were obtained in the JTXZC group (P < 0.05). No severe adverse event occurred in either group during the whole therapeutic course. CONCLUSIONS: JTXZC showed similar therapeutic effect to pioglitazone. Both of them could effectively improve patients' clinical symptoms, the inflammation and fibrinolytic activities in different pathways, with no severe adverse reaction.

Influence of high blood glucose fluctuation on endothelial function of type 2 diabetes mellitus rats and effects of Panax Quinquefolius Saponin of stem and leaf.

OBJECTIVE: To observe the influence of high blood glucose fluctuation on the endothelial function of type 2 diabetes mellitus (T2DM) rats and the effects of Panax Quinquefolius Saponin (PQS) of stem and leaf. METHODS: The T2DM model was induced by intraperitoneal injection of a small dose of streptozotocin (STZ, 35 mg/kg) plus high fat and high caloric laboratory chow. Then, diabetic rats were divided into steady high blood glucose (SHG) group and fluctuant high blood glucose (FHG) group according to fasting blood glucose coefficient of variation (FBG-CV), and then, the FHG group rats were divided into 4 groups according to the level of FBG-CV and fasting blood glucose: PQS 30 mg/(kg·d) group, PQS 60 mg/(kg·d) group, metformin hydrochloride control (MHC) group, and FHG control group, 10 in each group. Meanwhile, 10 rats without any treatment were used as normal control (NOR) group. Eight weeks later, the aortic arteries histology, plasma hepatocyte growth factor (HGF), and serum nitric oxide (NO), endothelin-1 (ET-1), tumor necrosis factor α (TNF-α), and soluble intercellular adhesion molecule 1 (sICAM-1) were measured. RESULTS: In comparison with the NOR group, the level of plasma HGF and serum NO, ET-1 and TNF-α, and sICAM-1 in SHG and FHG control groups were all significantly increased (P<0.01); in comparison with the SHG group, plasma HGF and serum NO, ET-1, TNF-α, and sICAM-1 in FHG group were all significantly increased further (P<0.01 or P<0.05); meanwhile, in comparison with the FHG control group, the level of plasma HGF and serum NO, ET-1, TNF-α, and sICAM-1 in PQS and MHC groups were all decreased significantly (P<0.01). However, comparison of the aortic arteries histology among groups showed no significant differences either before or after treatment. CONCLUSION: Blood glucose fluctuation could facilitate the development of vascular endothelial dysfunction in T2DM rats, while PQS could improve the endothelial function of T2DM rats with high blood glucose fluctuation, which may be related to its effects of relieving vessel stress, decreasing vasoconstrictor ET-1 production, preventing compensated increase of NO, and reducing inflammatory reaction.

[Clinical study of Jiangtang Xiaozhi Capsule in treating type 2 diabetes mellitus patients].

OBJECTIVE: To evaluate the efficacy and safety of Jiangtang Xiaozhi Capsule (JTXZC) in treating type 2 diabetes mellitus (T2DM) patients of qi-yin deficiency and inter-obstruction between phlegm and stasis. METHODS: Adopting prospective, randomized, controlled trial design, 73 T2DM patients of qi-yin deficiency and inter-obstruction between phlegm and stasis syndrome, were randomly assigned to two groups, the pioglitazone tablet group (36 cases) and the JTXZC group (37 cases). The therapeutic course for all was 8 weeks. The body weight, height, body mass index (BMI), waistline (WC), hipline, waist-to-hip ratio (WHR), and scoring for Chinese medicine (CM) symptoms assessment were observed. The fasting blood glucose (FBG), 2-h postprandial blood glucose (PBG), glycated hemoglobin (HbA1c), plasma total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), plasma insulin (FINS) were detected. The HOMA-IR was also calculated. The safety indices such as liver and renal functions, adverse reactions were also observed. RESULTS: The levels of HbA1c were lowered after treatment in the two groups after 8 weeks of treatment, showing statistical difference when compared with before treatment (-0.59% +/- 1.99% and -0.27% +/- 2.73%, P < 0.05). The PBG level also decreased with statistical difference (-1.71 +/- 2.52 mmol/L and -0.72 +/- 4.17 mmol/L, P < 0.05), but there was no statistical difference between the two groups. The body weight, BMI, TG obviously decreased (P < 0.05). The CM symptoms efficacy and CM symptom scoring were significantly reduced in the two groups (P < 0.01). Besides, better effects were shown in the JTXZC group (P < 0.05). No severe adverse event occurred in either group during the therapeutic course. There was no statistical difference in the incidence of adverse events (P > 0.05). CONCLUSIONS: JTXZC showed similar therapeutic effects to pioglitazone. They both could effectively im- prove clinical symptoms with no severe adverse reaction.

[Effects of Chinese herbal drug-containing serum on oxidative damage and apoptosis of umbilical vein endothelial cells induced by oxidized low-density lipoprotein].

OBJECTIVE: To investigate the effects of Chinese herbal drug-containing serum, prepared by administration of Chinese herbal medicine for activating blood (Xiongshao Capsule, XS) or for activating blood and detoxifying (Xiongshao Capsule plus Huanglian Capsule, XSHL) in rats, on cell viability, oxidative damage and apoptosis of human umbilical vein endothelial cells (HUVECs) induced by oxidized low-density lipoprotein (ox-LDL). METHODS: Thirty-two rats were randomly divided into 4 groups: control group, positive control group (simvastatin 1.8 mg/kg), activating blood (XS, 0.135 g/kg) group, and activating blood and detoxifying (XS Capsule 0.135 g/kg and Huanglian Capsule 0.135 g/kg, XSHL) group. Corresponding drugs were continuously administered to the rats for 7 days and then drug-containing serum was harvested 1 hour after the last administration. HUVECs isolated from newborn children by collagenase digestion were stimulated by ox-LDL (100 µg/mL) [corrected] and incubated with corresponding drug-containing serum for 24 hours. Untreated HUVECs were also used as a normal control. The morphology and structure of HUVECs were observed by an inverted microscope. Cell viability was measured by methyl thiazolyl tetrazolium method, and cell membrane damage was determined by lactate dehydrogenase (LDH) leakage. Activity of superoxide dismutase (SOD) was examined by spectrophotometry, and content of malondialdehyde (MDA) in the cell lysate was examined by thiobarbituric acid assay. HUVECs were stained with Annexin V-fluorescein isothiocyanate and propidium iodide and analyzed on a flow cytometry to determine apoptosis. RESULTS: Compared with the normal HUVECs, the cell viability and the activity of SOD were significantly decreased while the content of MDA and apoptosis rate were significantly increased after 24-hour ox-LDL stimulation (P<0.01, P<0.05). Simvastatin-, XS-, and XSHL-containing serum significantly promoted the ox-LDL-stimulated HUVEC viability and inhibited early apoptosis (P<0.01, P<0.05), while had no significant effect on LDH leakage. Simvastatin-containing serum and XS-containing serum also showed significant decrease in MDA content and increase in SOD activity, while XSHL-containing serum showed no significant effects. There was no significant difference between the XS-containing serum group and the XSHL-containing serum group. CONCLUSION: Both sera containing XSHL and XS show protective action against the oxidative damage and apoptosis of HUVECs induced by ox-LDL.

[Analysis on associated risk factors and syndrome types in diabetes mellitus type 2 patients complicated with non-alcoholic fatty liver].

OBJECTIVE: To explore the risk factors and the main TCM syndrome types associated with the diabetes mellitus type 2 (DM2) patients complicated with non-alcoholic fatty liver (FL). METHODS: Adopted controlled trial method, the age, stature, body weight, and body mass index (BMI) of 180 DM2 patients were compared with those complicated with or without FL. And some related laboratory indexes, including the age, stature, body weight, BMI, fasting blood glucose (FBG), C-peptide (CP), glycosylated hemoglobin (HbA1c), triglyceride (TG), total cholesterol (TC), high and low density lipoprotein cholesterol (HDL-C and LDL-C), and 2 h post-prandial CP (2 h CP), were compared as well. Moreover, patients' TCM syndrome types were classified. RESULTS: No significant differences were found between DM2 patients complicated with or without FL in aspects of FBG, HbA1c, TC, LDL-C and age, stature (P > 0.05), but significant difference did show between them in aspects of CP (4.09 +/- 2.40 microg/L vs 2.47 +/- 1.74 microg/L), 2h CP (6.38 +/- 5.46 microg/L vs 4.35 +/- 2.92 microg/L), TG (2.81 +/- 2.33 mmol/L vs 1.93 +/- 1.92 mmol/L), HDL-C (1.07 +/- 0.06 mmol/L vs 1.19 +/- 0.32 mmol/L) as well as in body weight (73.4 +/- 11.7 kg vs 61.4 +/- 10.1 kg) and BMI (26.0 +/- 3.67 vs 22.8 +/- 3.23), respectively (P < 0.05 or P < 0.01). Moreover, phlegm-dampness type was more liable to appear in DM2 patients complicated FL. CONCLUSIONS: Obesity, insulin resistance and lipid metabolism disorder are the chief risk factors in DM2 patients complicated with FL and phlegm-dampness is the chief pathogenesis.