Taking guizhi fuling capsule (GZFL) for instance, a new method about reference Chinese medicine preparation which was used as standard substance for the quality evaluation of complex Chinese medicine preparation by the fingerprint of reference preparation instead of standard fingerprint was proposed. It could eliminate the errors from different instruments, chromatographic columns and solve the problem of similarity matching in the absence of standard fingerprint. The qualification of reference GZFL was evaluated according to the quality control method of GZFL from Chinese Pharmacopoeia. Then multiple batches of GZFL were estimated, taking fingerprint of reference preparation and standard fingerprint as references, respectively, at different instruments and chromatographic columns. Finally, the packaging and expiration date for reference GZFL were confirmed according to the results of stability investigation. The results indicated that the fingerprint of reference GZFL could be used to assess the quality of GZFL better than standard fingerprint. The data of accelerated stability and long-term stability test demonstrated that reference GZFL was stable in the conditions of double blister package. Therefore, reference GZFL can be used as standard substance in quality control of GZFL.
Capsules ; Drug Stability ; Drugs, Chinese Herbal ; chemistry ; standards ; Reference Standards

OBJECTIVETo investigate the efficiency, safety, and possible mechanisms of Qingre Buyi Decoction (QBD) in the treatment of acute radiation proctitis (ARP).

METHODSThis study was a single center, prospective, single blind, randomized, and placebo-controlled clinical trial. A total of 60 patients with ARP was equally and randomly distributed into the control group (conventional treatment) and the combination group (conventional treatment plus QBD). The changes of main Chinese medicine clinical symptoms and signs, including stomachache, diarrhea, mucous or bloody stool before and after treatment, and their adverse reactions were observed after the two-week treatment. Also, D-lactate and diamine oxidase (DAO) levels, hepatic and renal function were measured. Cure rates, effective rates, and recurrence rates were compared between the two groups.

RESULTSThe blood levels of both DAO and D-lactate were significantly decreased in the combination group as compared with those in the control group (P<0.05 or P<0.01). All main clinical symptoms and signs were alleviated more significantly in the combination group (P<0.01). The main symptom scores also were significantly decreased after treatment in the control group (P<0.01), except those for mucous or bloody stool (P>0.05). Compared to the control group, the improvements of stomachache, diarrhea, defecation dysfunction, and stool blood in the combination group were significantly better (P<0.05 or P<0.01). For the combination group, the curative rate, effective rate, and recurrence rate was 76.67%, 16.67%, and 6.67%, respectively. On the other hand, for the control group, the rate was 53.33%, 16.67%, and 30.00%, respectively. The total curative effect was significantly better in the combination group than in the control group (P<0.05). However, the recurrence rate was similar between the two groups (P>0.05). The hepatic and renal function remained normal in both groups (P>0.05). In addition, no severe adverse event was found in both groups.

CONCLUSIONSAddition of QBD to the conventional treatment can effectively alleviate the damage of intestinal mucosal barrier function and improve all main clinical symptoms and signs of the ARP. The combination of conventional treatment with Chinese herbal medicine QBD is effective and safe for ARP.

Acute Disease ; Adult ; Aged ; Anti-Inflammatory Agents ; administration & dosage ; Azulenes ; administration & dosage ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; therapeutic use ; Female ; Gastrointestinal Agents ; administration & dosage ; Glutamine ; administration & dosage ; Humans ; Integrative Medicine ; methods ; Male ; Middle Aged ; Norfloxacin ; administration & dosage ; Pain ; complications ; Proctitis ; complications ; drug therapy ; Sesquiterpenes ; administration & dosage ; Silicates ; administration & dosage ; Single-Blind Method ; Treatment Outcome

OBJECTIVETo evaluate the protective effect of N-acetylcysteine (NAC) on the intestinal barrier dysfunction in rats after extensive abdominal radiation with X ray.

METHODSTwenty-four Spraque-Dawley male rats were divided into normal control group (n=8), radiation group (n=8), and radiation+NAC group (300 mg/kg) (n=8). Radiation injury was induced by X ray with a single dose of 10 Gy. NAC was administered from 4 days before irradiation to 3 days after radiation. Three days after radiation, all the rats were euthanized. The terminal ileum was collected for crypt survival assay and ileal villi count. The tissue samples from mesenteric lymph nodes (MLN), spleen, and liver were harvested under sterile conditions for microbiological analysis and ileum samples were harvested for biochemical analysis. The blood levels of D-lactate, endotoxin and diamine oxidase (DAO) and the ileum samples levels of nitric oxide(NO) were also measured.

RESULTSRats in radiation+NAC group had a higher survival rate of intestinal crypt [(76.84+/-4.82)% vs (49.64+/-5.48)%, P<0.01], higher intestinal villus count [(8.56+/-0.68)/mm vs (4.02+/-0.54)/mm, P<0.01], lower NO concentration [(0.48+/-0.12) mumol/g vs (0.88+/-0.16) mumol/g, P<0.01], lower levels of D-lactate, endotoxin and DAO (P<0.05 or P<0.01), and significantly decreased enteric bacteria cultured from mesenteric lymph nodes and other tissues as compared with the radiation group (P<0.05 or P<0.01).

CONCLUSIONNAC protects the small intestine from radiation-induced injury maybe through the inhibition of NO in rats.

Acetylcysteine ; pharmacology ; Animals ; Dose-Response Relationship, Radiation ; Intestinal Mucosa ; drug effects ; metabolism ; microbiology ; Intestine, Small ; drug effects ; Male ; Nitric Oxide ; analysis ; Radiation Injuries ; metabolism ; physiopathology ; Rats ; Rats, Sprague-Dawley ; X-Rays ; adverse effects

OBJECTIVETo evaluate the endoscopy-assisted laparoscopic surgery in the treatment of early colon carcinoma.

METHODSThe data of 55 early colon cancer patients, including 30 male, 25 female with mean age of 54 years(ranged 42 to 68), undergone endoscopy-assisted laparoscopic surgery at the colon were reviewed retrospectively.

RESULTSFrom March 2002 to December 2007, 55 early colon cancer patients were treated with endoscopy-assisted laparoscopic surgery in our institute. In 53 cases, a laparoscopic and endoscopic cooperative bowel segment resection was performed at first. Of these 53 patients, 11 cases then received laparoscopic and endoscopic cooperative radical anatomical resection according to the result of frozen section. Two cases were transferred to open surgery because of small intestinal inflation after endoscopic location. The mean operative time of cooperation was 90 min (55-240 min), and the mean blood loss was 50 ml(10-200 ml). In 51 cases(92.7%), the time for flatus passage was 2 to 3 days. The mean postoperative hospital stay was 5 d(2-15 d). No postoperative complications were found. Follow-up data were obtained by clinical examination and personal communication via telephone. The median follow-up was 42 months(ranged 3-72). Most of the patients were alive except one case died of myocardial infarction during the follow-up period. None of the patients with early colon cancer treated by the cooperative surgery had relapse or metastasis. Two cases of T1N1Mx underwent adjuvant chemotherapy.

CONCLUSIONSEndoscopy-assisted laparoscopic surgery offers a minimal-invasive and safe therapeutic approach for early colon cancer. The early colon cancer may be a good indication for endoscopy-assisted laparoscopic surgery when the endoscopic mucosal resection is inadequate.

Adult ; Aged ; Colonic Neoplasms ; surgery ; Endoscopy ; Female ; Humans ; Laparoscopy ; methods ; Male ; Middle Aged ; Retrospective Studies

OBJECTIVETo observe whether garlicin could ameliorate pressure overload induced myocardial fibrosis in rats through partial inhibiting transforming growth factor beta1 (TGF-beta1) mediated Smads signal.

METHODSForty male SD rats were randomly divided into 4 groups, i. e., the sham-operation group, the model group, the garlicin group, and the Tetramethylpyrazine (TMP) group, 10 in each group. The pressure overload induced myocardial fibrosis rat model was prepared using coarctation of aorta. Three days after modeling 5.0 mg/kg garlicin injection was administered to rats in the garlicin group, 20 mg/kg TMP injection to rats in the TMP group by peritoneal injection, while normal saline was peritoneally injected to rats in the sham-operation group and the model group. Four weeks after medication, the changes of myocardial collagen were observed by picrosirius red staining. The myocardial collagen volume fraction (CVF) and perivascular collagen areas (PVCA) were calculated. The serum transforming growth factor beta1 (TGF-beta1) expression was detected using ELISA. The TGF-beta1 protein expression in the myocardial tissue was observed using immunohistochemical assay. The changes of myocardial Smad2 and Smad7 mRNA expressions were detected using Real-time RT-PCR. The effects of garlicin on TGF-beta1 mediated Smad Signaling through luciferase assay were further verified using Mv1 Lu-(CAGA) 12-Luc cell line response to TGF-beta1.

RESULTSCompared with the sham-operation group, the myocardial levels of CVF and PVCA, the serum TGF-beta1 level, and the TGF-beta1 protein expression in the myocardial tissue obviously increased in the model group (P < 0.05, P < 0.01). Compared with the model group, the PVCA level, the serum TGF-beta1 level, and the TGF-beta1 protein expression in the myocardial tissue of the garlicin group and the TMP group obviously decreased (P < 0.05, P 0O 01). The Smad2 mRNA expression was up-regulated while Smad7 mRNA expression down-regulated in the model group. The Smad2 mRNA expression was obviously down-regulated in the garlicin group and the TMP group (P < 0.05). The Smad7 mRNA expression was obviously up-regulated in the TMP group (P > 0.05). One to 2 microg/mL garlicin could obviously inhibit the luciferase activities of corresponding TGF-beta1, under the stimulation of 2 ng/mL TGF-beta1 (P < 0.05).

CONCLUSIONGarlicin ameliorated pressure overload induced myocardial fibrosis in rats through partial inhibiting TGF-beta-Smads signal pathway.

Allyl Compounds ; pharmacology ; Animals ; Cardiomyopathies ; etiology ; metabolism ; pathology ; Disulfides ; pharmacology ; Fibrosis ; Male ; Myocardium ; metabolism ; pathology ; Rats ; Rats, Sprague-Dawley ; Signal Transduction ; drug effects ; Smad Proteins ; metabolism ; Transforming Growth Factor beta1 ; metabolism

OBJECTIVETo investigate the effects of garlicin on fibroblasts proliferation and type I collagen synthesis and explore its anti-fibrosis mechanism.

METHODSGarlicin was added into the culture fluid of NIH3T3 cell, taking Radix Salviae miltiorrhizae as the control medicine. The spiking of H3-thymidine DNA was detected, also the hydroxyproline (HOP) concentration in the culture fluid by alkali digestion method and the protein expression of type I collagen in NIH3T3 cells by immunofluorescent staining.

RESULTSThe NIH3T3 cell growth and proliferation rate were obviously reduced after garlicin treatment concentration-dependently in range of 0.2 - 5 microg/mL; HOP level and protein expression of type I collagen also lowered.

CONCLUSIONGarlicin could inhibit NIH3T3 cell proliferation, reduce the synthesis and protein expression of type I collagen so as to exert the anti-fibrosis effect.

Allyl Compounds ; pharmacology ; Animals ; Cell Proliferation ; drug effects ; Collagen Type I ; biosynthesis ; Disulfides ; pharmacology ; Dose-Response Relationship, Drug ; Garlic ; chemistry ; Hydroxyproline ; analysis ; Mice ; NIH 3T3 Cells

OBJECTIVETo investigate the effects and prognosis of surgical treatment in primary gastrointestinal stromal tumors (GIST).

METHODSThe clinicopathological data of 73 patients with primary GIST underwent operation from April 1997 to December 2007 was retrospectively analyzed, and the prognosis was evaluated too.

RESULTSAmong the 73 cases, 68 cases received complete tumor resection, among which 12 cases underwent laparoscopic operation; while palliative resection and biopsy only were carried out in the other 5 cases. There was significant difference in survival rate between the two groups (P = 0.000). The 1-, 3-, 5-year survival rates of the 66 cases had been followed up was 91.0%, 78.2% and 74.1%, respectively. The malignancy risk grades of GIST was related to the survival rates on statistical analysis (P = 0.002). Significant differences were found in the survival rates between the patients with very low grade, low grade and high grade malignancy tumors (P = 0.012, 0.002).

CONCLUSIONSComplete tumor resection should be emphasized in primary GIST, and more attention should be paid to the initial surgical treatment. Extended surgical resection is required for tumors of higher malignancy risk. The indications of laparoscopic surgery in GIST should be selected with caution for tumor complete resection.

Adult ; Aged ; Aged, 80 and over ; Female ; Follow-Up Studies ; Gastrointestinal Stromal Tumors ; surgery ; Humans ; Male ; Middle Aged ; Prognosis ; Retrospective Studies ; Survival Analysis

OBJECTIVETo investigate the clinicopathological characteristics, surgical treatment and prognosis of gastrointestinal stromal tumors(GIST).

METHODSThe clinicopathological data of 84 patients with GIST undergone resection between April 1997 and June 2008 were analyzed retrospectively, and the prognosis was evaluated.

RESULTSOut of 84 cases, 42 tumors located in stomach, 24 in small intestine, 18 in other sites. Tumor sizes ranged from 0.5 to 25 cm(average 5.6 cm). Positive rate of CD117 expression determined by immunohistochemical methods was 96.4%. Seventy-nine cases underwent complete tumor resection, while 5 cases received palliative resection or biopsy. Seventy-eight patients were followed up and their 1-, 3-, 5-year survival rates were 92.0%, 79.2%, 72.0% respectively. The Fletcher's classification of malignancy risk groups for GIST was related to the survival rates(P=0.001). The differences of survival rate among very low risk group, low risk group and high-risk group were significant(P=0.003, P=0.000).

CONCLUSIONSComplete tumor resection in the initial operation of GIST should be emphasized. The Fletcher's classification of malignancy risk groups for GIST is related to the survival rate. Extended surgical resection is required for GIST of higher malignancy risk.

Adult ; Aged ; Aged, 80 and over ; Female ; Gastrointestinal Stromal Tumors ; mortality ; pathology ; surgery ; Humans ; Male ; Middle Aged ; Retrospective Studies ; Survival Rate

Hamartoma ; diagnosis ; pathology ; surgery ; Humans ; Infant ; Infant, Newborn ; Liver Diseases ; diagnosis ; pathology ; surgery ; Male

OBJECTIVETo evaluate the effect and possible mechanisms of diabetes control after small intestine exclusion surgery in Goto-Kakizaki (GK) rat with non-obese type 2 diabetes mellitus.

METHODSForty GK rats with non-obese type 2 diabetes mellitus underwent duodenal bypass (Group A, n = 8), which creates a shortcut for ingested nutrients bypassing duodenum alone; duodenal-jejunal bypass (Group B, n = 8), a stomach-preserving RYGB that excludes the duodenum and proximal jejunum; duodenum and total jejunum exclusion (Group C, n = 8); sub-total small intestine exclusion (Group D, n = 8), which creates a shortcut for ingested nutrients bypassing duodenum, jejunum and sub-total ileum; controls were pair-fed (PF) sham-operated and untreated GK rats (Group SO, n = 8). The rats were observed for 24 weeks after surgery. Body weight, food intake and fasting blood glucose level were tested at 0, 1, 3, 6, 12, 24 weeks after the operation in those groups. The concentrations of insulin and glucagon-like peptide-1 (GLP-1) concentrations were measured before (baseline) and then 30, 60, 120, and 180 minutes after OGTT at 0, 12, 24 weeks after the operation.

RESULTSMean operating time of all groups was similar. The mean body weight and food intake decreased significantly at 1 week after surgery (P < 0.01) and with no differences among the groups. Fasting blood glucose level decreased significantly after surgery in all the operation groups through the entire follow-up period (P < 0.05). No significant changes in fasting blood glucose level in SO group was found in 12 weeks after the operation, and it increased at 12 and 24 weeks after. Fasting blood glucose levels in group B decreased significantly compared with group A (P < 0.05), but no difference was found among group B, C and D (P > 0.05). Oral glucose-stimulated peak (30 min) levels of blood insulin and GLP-1 increased markedly in operation groups (A, B, C and D) after surgery (P < 0.01). Compared with group A, peak levels of blood insulin and GLP-1 in group B were strikingly higher (P < 0.05), but no difference was found when compared with group C or D (P > 0.05).

CONCLUSIONSIn spontaneously non-obese type 2 diabetes mellitus rats, small intestinal exclusion including proximal gut is effective in terms of glucose control and has no direct relation with body weight and food intake loss. Restoration of the first-phase insulin secretion and high secretion of GLP-1 in type 2 diabetic subjects after gastrointestinal bypass surgery seem to be helpful to diabetes control. Taking intestinal nutrient absorption into consideration, duodenal-jejunal bypass may be a better surgery for diabetes control.

Animals ; Blood Glucose ; analysis ; Body Weight ; Diabetes Mellitus, Type 2 ; surgery ; Disease Models, Animal ; Duodenum ; surgery ; Intestine, Small ; surgery ; Jejunum ; surgery ; Male ; Random Allocation ; Rats ; Rats, Inbred Strains