OBJECTIVETo evaluate the efficacy and safety of tiaogan Lipi Recipe (TLR) in treating non-alcoholic fatty liver disease (NAFLD) patients of Gan stagnation Pi deficiency syndrome (GSP-DS).

METHODSA randomized, double blind, placebo-controlled clinical trial was performed. Totally 99 NAFLD patients of GSPDS were randomly allocated into two groups, 66 patients in the treatment group (treated with-TLR, one dose per day) and 33 patients in the control group (treated with placebos, one dose per day). The therapeutic course for all was 12 weeks. All patients received lifestyle interventions including moderate aerobic exercise, moderate caloric restriction, and dietary changes. Clinical symptoms, CT indices, liver functions and blood lipids were observed before and after treatment.

RESULTSAfter 12 weeks of treatment, the total score of clinical symptoms decreased in the two groups (P <0. 01), and it was lower in the treatment group than in the control group (P <0. 05). Liver/spleen CT ratio increased in the treatment group (P <0. 01), and it was higher in the treatment group than in the control group (P <0. 01). After treatment levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT) all decreased in the treatment group (P <0. 05, P <0. 01), while levels of ALT decreased in the control group (P <0. 05). Besides, all the 3 levels mentioned above were lower in the treatment group than in the control group (P <0. 05). Levels of total cholesterol (CHO) and triglyceride (TG) decreased in the two groups (P <0. 05), and they were lower in the treatment group (P <0. 05). Total effective rates of TCM syndrome, abdominal CT, liver functions, and blood lipids were 79. 69% (51/64 cases), 54. 69% (35/64 cases), 67. 65% (23/34 cases), and 67. 39% (31/46 cases) in the treatment group, while they were 56. 25% (18/32 cases), 25. 00% (8/32 cases), 33. 33% (6/18 cases), and 55. 56% (10/18 cases) in the control group. All were superior in the treatment group (P <0.05, P <0.01, respectively).

CONCLUSIONTLR combined with lifestyle intervention could safely and effectively improve clinical symptoms of NAFLD patients of GSPDS, elevate liver/spleen CT ratios, and play a role in liver protection, anti-inflammation, and lowering blood lipids.

Alanine Transaminase ; metabolism ; Aspartate Aminotransferases ; metabolism ; Cholesterol ; Double-Blind Method ; Drugs, Chinese Herbal ; therapeutic use ; Humans ; Lipids ; Non-alcoholic Fatty Liver Disease ; drug therapy ; Syndrome ; Triglycerides ; gamma-Glutamyltransferase ; metabolism

Objective To observe the role of rosiglitazone in unclipped kidneys of two-kidney- one-clip hypertensive rats and examine its relationship to angiotensinⅡreceptors.Methods Two- kidney-one-clip hypertensive rats were divided randomly into 4 groups as follows:positive control group (CONT),traditional antihypertensive drugs group (TAHD,reserpine 50?g?kg~(-1)?d~(-1), dihydralazine 6.25 mg?kg~(-1)?d~(-1) and hydrochlorothiazide 6.25 mg?kg~(-1)?d~(-1),regular-dose rosiglitazone group (RRGL,rosiglitazone 5 mg?kg~(-1)?d~(-1)),and high-dose rosiglitazone group (HRGL, rosiglitazone 20 mg?kg~(-1)?d~(-1)).Sham operation rats were as negative controls.Each group had 8 rats. Animals were monitored and sacrificed at 10th week.Results Blood systolic pressure in TAHD group and HRGL group was significantly lower than that in CONT group [TAHD(137?27 ) mm Hg and HRGL (143?16) mm Hg vs CONT (191?25 ) mm Hg,P＜0.05],but no significant difference between the former two groups was found.Nor did the blood systolic pressure between RRGL group [(176?18) mm Hg] and CONT group.At 10th week,rats in SHAM group and treated groups had lower urinary urinary protein excretion rate,glomerular injury score and wall-to-lumen ratio of arteriole than those in CONT group [vs CONT urinary protein excretion rate (44.60?17.40) mg/24 h,P＜0.05; vs CONT glomerular injury score 60.85?33.05,P＜0.05;vs CONT wall-to-lumen ratio of arteriole 2.33?1.01,P＜0.01,except TAHD group].Though with the similar level of blood pressure,blood glucose and lipid,HRGL,compared with TAHD group showed lower urinary protein excretion rate [HRGL (16.78?3.50) mg/24 h vs TAHD (27.94?12.79) mg/24 h,P＜0.05],decreased glomerular injury score (HRGL 18.04?7.76 vs TAHD 27.92?6.39,P＜0.05) and wall-to-lumen ratio of arteriole (HRGL 1.75?0.38 vs TAHD 2.16?0.90,P＜0.05) in the cortexes of unclipped right kidneys.The expression of type 1 angiotensinⅡreceptor (AT1R) mRNA was no difference in HRGL group and TAHD group,but the expression of type 2 angiotensinⅡreceptor (AT2R) mRNA was more intensive in HRGL group.Conclusion Rosiglitazone can protect the kidneys from hypertensive injury,especially in high dose.The beneficial effects seem incompletely dependent on the metabolism modulating and reduction of blood pressure,but in relationship to the upregulation of AT2R mRNA.

Intraventricular hemorrhage (IVH) is a neurological urgency with a high mortality and unfavorable prognosis. Fast removal of intraventricular blood should be considered as a priority. The current treatments of IVH mainly focus on external ventricular drain and endoscopic aspiration, but neither way can remove the blood in the fourth ventricle easily and relieve the compression of brainstem. Here we report a unique procedure to solve this problem. A 41-year-old male patient who had suffered sudden attack of headache and disturbance of consciousness for 2 h was diagnosed as having high density lesion in the whole ventricular system by computed tomographic (CT) imaging. An emergent bilateral ventriculopuncture and intraventricular hematoma removal under non-line-of-sight was performed immediately; the catheter was extended to the fourth ventricle to maximally remove the hematoma. Postoperative CT scan demonstrated total removal of IVH and no sign of extra brain damage.
Adult ; Cerebral Hemorrhage ; therapy ; Drainage ; methods ; Fourth Ventricle ; Hematoma ; therapy ; Humans ; Male ; Punctures ; Tomography, X-Ray Computed

OBJECTIVETo observe clinical effects of posterior short-segment fixation with undermining decompress by posterior ligament complex for the treatment of upper lumbar burst fractures.

METHODSFrom October 2010 to March 2013,23 patients with upper lumbar burst fractures (Denis B type) were treated by posterior short-segment fixation with undermining decompress by posterior ligament complex. There were 18 males and 5 females aged from 26 to 64 years old with an average of 45.7 years old. Twelve patients were caused by falling down, 5 cases were caused by traffic accident, 4 cases were the bruise injury caused by heavy object and 2 cases were caused by other injury. Fourteen patients were L1 fracture and 9 patients were L2 fracture. Thirteen patients were combined with nerve injuries (degree D according to ASIA classification). Internal fixation were removed from 12 to 20 months with an average of 14.3 months. JOA scores and imaging changes were recorded and compared at different time points.

RESULTSAll patients were followed up from 18 to 24 months with an average of 20.4 months. Thirteen patients with nerve injuries were completely recovered at 3 to 6 months after operation. JOA score at 1 year after operation was 20.63 ± 0.92, and 20.38 ± 1.06 at 3 months after removal of internal fixation,which were improved obviously than 9.90 ± 2.73 at 3 months after operation. (P > 0.05) Anterior height of injured vertebrae, vertebral body angle and local Cobb angle was (95.0 ± 0.53)%, (2.78 ± 1.36) and (2.43 ± 1.52) °respectively, and improved obviously than that of before operation (P < 0.05). There was no statistical significance in JOA scores at 3 months after removal of internal fixation and 1 year after operation (P > 0.05).

CONCLUSIONposterior short-segment fixation with undermining decompress by posterior ligament complex for the treatment of upper lumbar burst fractures has advantages of minimally invasive, could effective recover vertebrae height, maintain stability of spine, decrease low back pain. It is a safe and effective operative method.

Adult ; Decompression, Surgical ; Female ; Fracture Fixation, Internal ; methods ; Humans ; Lumbar Vertebrae ; injuries ; Male ; Middle Aged ; Spinal Fractures ; surgery

OBJECTIVETo observe effects of Ligustrazine on serum S100p protein and neuron-specific enolase (NSE) in elderly patients undergoing orthopedics operations.

METHODSTotally 60 patients undergoing selective total hip replacement, 65-80 years old, who were in line with American Society of Anesthesiologists (ASA) grade I or II, were randomly assigned to the Ligustrazine group (Group L) and the normal saline control group (Group S). The right internal jugular vein catheters were placedcephalad and ensured theirs tips in jugular venous bulbs after anesthesia induction and tracheal intubation. Patients in Group L received 2 mg/kg Ligustrazine Injection (40 drops within one minute) and those inGroup S received equal volume of normal saline via central veins before operations. Other medicines were the same for all patients during and after operation. Five millimeter blood sample was collected frominternal jugular venous bulbs before operation (T0), 24 h (T1), 72 h (T2), 168 h (7th day, T3) after operation. Serum was collected after centrifuge. S100β protein and NSE concentration were analyzed usingELISA. Mini-mental state examinations (MMSE) were scored by the same doctor at T0, T1, T2, and T3,respectively.

RESULTSThere was no statistical difference in MMSE scores, serum S1000 protein, or NSE at TO (P > 0.05). Compared with TO, S100 P protein and NSE concentration increased and MMSE scores decreased at T1, T2, and T3 in the two groups. All indices except S100P protein and NSE at T3 were statistically different between Group L and Group S (P < 0.05).

CONCLUSIONSerum S100P protein and NSE could be changed by pre-operation injecting Ligustrazine at certain dose in elderly patients undergoing orthopedics operations.

Aged ; Aged, 80 and over ; Arthroplasty, Replacement, Hip ; Humans ; Phosphopyruvate Hydratase ; blood ; Pyrazines ; therapeutic use ; S100 Calcium Binding Protein beta Subunit ; blood

OBJECTIVETo investigate the expression of a novel metastasis-inducing protein human anterior gradient-2 (AGR2) in breast cancer and its clinical and prognostic significance.

METHODSAGR2 expression was assessed in 160 cases of breast cancer and 20 cases of benign breast diseases by immunohistochemistry using tissue chip technology. In addition the expression of ERa, PR and c-erbB-2 in breast cancer was also evaluated. Follow-up information of 5-year duration was available in 127 patients with breast cancer. Kaplan-Meier analysis and COX regression model were used to analyze the correlation between AGR2 expression and the follow-up clinical data.

RESULTSThe expression of AGR2 was significantly higher in breast cancers than that in benign diseases (68.3% vs. 25.0% , P < 0.01). There was a negative correlation between AGR2 expression and the histological grade of breast cancer (P <0.05) , whereas positive correlations was found between the expression of AGR2 and ERalpha (P <0.05), and between the expression of AGR2 and PR (P <0.01). In the subgroup of ERalpha-positive breast cancer, Logistic regression model demonstrated AGR2 and TNM stage were important factors affecting lymph node metastasis (both P < 0.01). Kaplan-Meier analysis demonstrated that a positive expression of AGR2 was associated with poor overall survival and relapse-free survival (both P <0.01). Moreover, COX regression model confirmed the expression of AGR2 as an independent prognostic factor among patients with ERa-positive breast cancer (P <0.01).

CONCLUSIONSThe abnormal expression of AGR2 may play a role in the pathogenesis and progression of breast cancer. The metastasis-inducing capability of AGR2 may be partly regulated through the ER pathway. Therefore, AGR2 may be a useful molecular marker for prognostication for patient with hormone-responsive breast cancer.

Antineoplastic Agents, Hormonal ; analysis ; BRCA2 Protein ; genetics ; metabolism ; Biomarkers, Tumor ; analysis ; Breast Neoplasms ; diagnosis ; genetics ; metabolism ; Estrogen Receptor alpha ; metabolism ; Female ; Gene Expression Regulation, Neoplastic ; genetics ; Humans ; Immunohistochemistry ; Neoplasm Metastasis ; diagnosis ; Neoplasm Staging ; Prognosis ; Proteins ; genetics ; metabolism ; Receptor, ErbB-2 ; analysis ; metabolism

AIMTo develop an HPLC-MS assay for determination of donepezil in human plasma and to investigate the pharmacokinetics and bioequivalence of donepezil capsule in healthy volunteers.

METHODSA randomized crossover design was performed in 20 healthy volunteers. In the two study periods, a single 5 mg dose of either capsule or tablet was administered to each volunteer. After spiked with the internal standard (phenoprolamine) and treated with saturated sodium bicarbonate, plasma was extracted with ethyl acetate and separated with a C18 reversed phase column. LC-ESIMS was used in the selected ion monitoring (SIM) mode with target ions at m/z 380 for donepezil and m/z 344 for phenoprolamine. The fragmentor voltage was 120 V. The main pharmacokinetic parameters of donepezil and the bioequivalence of its two preparations were calculated.

RESULTSThe main pharmacokinetic parameters T1/2, Tmax and Cmax were (63 +/- 10) h, (3.3 +/- 0.4) h and (8.5 +/- 0.4) microgram.L-1 for the capsule; (57 +/- 9) h, (3.4 +/- 1.0) h and (8.1 +/- 1.0) microgram.L-1 for the tablet, respectively. The relative bioavailability of the donepezil capsule was 102% +/- 11%.

CONCLUSIONThe assay was shown to be sensitive, accurate and convenient. The two preparations of donepezil were bioequivalent.

Adult ; Area Under Curve ; Biological Availability ; Capsules ; chemistry ; Cholinesterase Inhibitors ; administration & dosage ; pharmacokinetics ; Chromatography, High Pressure Liquid ; Cross-Over Studies ; Humans ; Indans ; administration & dosage ; pharmacokinetics ; Male ; Piperidines ; administration & dosage ; pharmacokinetics ; Spectrometry, Mass, Electrospray Ionization ; Tablets ; chemistry ; Therapeutic Equivalency

To establish a method for detecting microdialysis recovery of tetramethylpyrazine (TMP) and ferulic acid (FA) and investigating the influencing factors, providing the basis for further in vivo microdialysis experiments. The concentration of FA and TMP in dialysates were determined by high pressure liquid chromatography ( HPLC) and probe recovery were calculated respectively. The influence of the flow rates, medium concentration, temperature and in vivo probe stability on the recovery of FA and TMP were investigated by using concentration difference method (incremental method and decrement method). The recovery obtained by incremental method were similar to by decrement method. The in vitro recovery rate of FA and TMP decreased with the increase of 1-2.5 μL min(-1), and increased obviously with the temperature of 25-42 degrees C under the same conditions. The concentration of FA and TMP had no obvious effect on the probe recovery under the same flow rate. In addition, the recovery of TMP and FA remained stable and showed similar trends under the condition of four concentration cycles, indicating that the intra day reproducibility of the concentration difference method was good. The recovery of brain microdialysis probes in vivo 8 h maintained a relatively stable, but certain differences existed between different brain microdialysis probes, demonstrating that each probe was required for recovery correction in vivo experiment. Microdialysis sampling can be used for the local brain pharmacokinetic study of FA and TMP, and retrodialysis method can be used in probe recovery of FA and TMP in vivo.
Animals ; Brain ; metabolism ; Chromatography, High Pressure Liquid ; Coumaric Acids ; analysis ; isolation & purification ; pharmacokinetics ; Drugs, Chinese Herbal ; Humans ; Microdialysis ; methods ; Pyrazines ; analysis ; isolation & purification ; pharmacokinetics ; Rats

OBJECTIVETo investigate the clinical phenotype and genetic characteristics of an azoospermia patient with ring 22 chromosome syndrome.

METHODSWe analyzed the clinical data of an azoospermia patient with ring 22 chromosome syndrome and reviewed relevant literature.

RESULTSThe patient was a short 29-year-old male, with bilateral testes small in size and soft in texture. Seminal examination indicated azoospermia. Chromosome analysis showed the karyotype of the patient to be 46, XY, r (22) (p11, q25). The level of testosterone was low, and the testicular tissue was brittle and easy to break. Pathological microscopy revealed reduced number of Sertoli cells and germ cells in the seminiferous tubules and thinner layers of cells. All the germ cells were spermatogonia. Neither spermatocytes nor sperm cells were found, which suggested complete spermatogenic failure. Mild interstitial fibrosis was visible in part of the seminiferous tubule walls.

CONCLUSIONPatients with ring 22 chromosome syndrome usually represent normal clinical phenotypes. However, this kind of genetic abnormality often induces severe testicular damage and spermatogenic arrest, which may result in azoospermia.

Adult ; Azoospermia ; etiology ; genetics ; Chromosomes, Human, Pair 22 ; Humans ; Male ; Oligospermia ; Ring Chromosomes ; Spermatogenesis ; Spermatogonia ; Syndrome

AIMTo develop a HPLC-ESI-MS assay for determination of eperisone hydrochloride in human plasma and investigate the pharmacokinetics and bioequivalence of two eperisone hydrochloride tablets in human.

METHODSBuflomedil hydrochloride was used as the internal standard. After alkalized with saturated sodium bicarbonate solution, plasma was extracted with diethylether-cyclohexane (1:1) and separated using HPLC on a reversed-phase C18 column with a mobile phase of 10 mmol x L(-1) ammonium acetate buffer solution (adjusted to pH 3.88 with acetic acid)-methanol (20:80). HPLC-ESI-MS was performed in the selected ion monitoring (SIM) mode using target ions at m/z 260 for eperisone and m/z 308 for the internal standard. A randomized crossover design was performed in 20 healthy volunteers. In the two study periods, a single 100 mg dose of each tablet was administered to each volunteer.

RESULTSCalibration curve was linear over the range of 0.02-20 microg x L(-1). The limit of quantification for eperisone hydrochloride in plasma was 0.02 microg x L(-1). The main pharmacokinetics parameters T1/2, Tmax and Cmax were (2.7 +/- 0.4) h, (1.1 +/- 0.5) h and (2.8 +/- 2.8) microg x L(-1) for the reference tablet; (2.8 +/- 0.5) h, (1.1 +/- 0.4) h and (3 +/- 4) microg x L(-1) for the test tablet, respectively. The relative bioavalability of the test tablet was (101 +/- 13)%.

CONCLUSIONThe assay was proved to be sensitive, accurate and convenient. The two formulations were bioequivalent.

Adult ; Chromatography, High Pressure Liquid ; Humans ; Male ; Propiophenones ; administration & dosage ; pharmacokinetics ; Spectrometry, Mass, Electrospray Ionization ; Tablets ; Therapeutic Equivalency