1.A multi-center randomized double-blinded, placebo-controlled clinical study on efficacy of composite sophora colon-soluble capsules in treating ulcerative colitis of internal dampness-heat accumulation syndrome type.
Zhan-Qi TONG ; Bo YANG ; Xin-Yuan TONG
Chinese Journal of Integrated Traditional and Western Medicine 2011;31(2):172-176
OBJECTIVETo evaluate the clinical efficacy and safety of Composite Sophora Colon-soluble Capsules (CSCC) in treating patients with ulcerative colitis (UC) of internal dampness-heat syndrome type (IDHS) and compared with that of Mesalazine slow releasing granules (trade name: Etiasa).
METHODSAdopting randomized double-blinded double-simulated and positive drug controlled clinical design, 160 patients with UC of IDHS type were randomly assigned to two groups, 120 in the trial group was treated with CSCC plus Etiasa simulated placebo for 8 weeks, while 40 in the control group with Etiasa plus CSCC simulated placebo. Comprehensive therapeutic efficacy, effects on syndrome and safety of treatment were assessed, and changes of endoscopic features, Chinese medical syndrome scores and symptom score, activity index (AI) of UC, microscopic pathology in the two groups were observed and compared before and after treatment.
RESULTSAfter 8-week treatment, the clinical total effective rate in the two groups were 92.0% and 83.3%, the effective rate on Chinese medical syndrome in them were 91.7% and 85.0%, that on endoscopic features 92.0% and 83.3%, on microscopic changes 66.7% and 52.0%, respectively, showing insignificant difference between groups. Difference between groups in AI also showed no significance (1.03 +/- 1.87 vs 1.78 +/- 2.18, P > 0.05). However, the effects of decreasing Chinese medical syndrome score, and improving mucous pus blood stool and foul defecation in the trial group were more significantly (P < 0.05). No serious adverse event was seen in the 8-week treatment period.
CONCLUSIONSThe clinical efficacy of CSCC was not inferior to, or even better than that of Etiasa. It could be taken as a substitute of chemicals if with poor effect.
Adolescent ; Adult ; Aged ; Colitis, Ulcerative ; diagnosis ; drug therapy ; Double-Blind Method ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Male ; Medicine, Chinese Traditional ; Middle Aged ; Phytotherapy ; Sophora ; Treatment Outcome ; Young Adult
2.A multi-center, randomized, single-blind, controlled clinical study on the efficacy of composite sophora colon-soluble capsules in treating ulcerative colitis.
Zhan-qi TONG ; Bo YANG ; Bing-yue CHEN ; Mei-ling ZHAO
Chinese journal of integrative medicine 2010;16(6):486-492
OBJECTIVETo evaluate the safety and efficacy of composite sophora colon-soluble capsule (CSCC) in treating ulcerative colitis (UC) of the damp-heat accumulation syndrome pattern (DHAS) and to prepare a basis for a phase III clinical trial.
METHODSA multi-center, randomized, single-blind, and positive drug parallel-controlled design was adopted. There were 126 patients of UC-DHAS stratified and assigned equally to three groups. Patients in two CSCC treated groups, Groups T1 and T2, were treated orally with high (six capsules, thrice a day) and low (four capsules, thrice a day) doses CSCC, and patients in the control group were treated orally with Mesalazine Enteric-coated Tablets (four tablets, thrice a day), respectively, all for eight weeks. The clinical efficacy and safety of treatments were evaluated through clinical symptom observations and colonoscopic examinations.
RESULTS(1) Full analysis set (FAS) and per-protocol set (PPS) analyses showed the comprehensive curative effect in Groups T1, T2, and the control group, obtaining the values of 85.7%, 92.9%, and 71.4% (P=0.330), and 89.5%, 92.7%, and 73.2% (P=0.552), respectively, demonstrating no statistical significance among the three groups. (2) FAS and PPS analysis showed the efficacy on membranous lesions in Groups T1, T2, and the control group, obtaining the values of 83.3%, 92.9%, and 73.8% (P=0.063), and 86.8%, 92.7%, and 75.6% (P=0.070), respectively, showing statistical insignificance among the three groups. (3) FAS analysis showed an efficacy tendency on improving tenesmus (P=0.056). No changes were found in improving the other symptoms, and statistical significance was not shown among the three groups (P>0.05). PPS analysis showed the efficacy on single item symptom in Groups T1, T2, and the control group was not statistically significant among the three groups (P=0.082).
CONCLUSIONSThe comprehensive effect of CSCC in treating UC is basically equivalent to that of Mesalazine enteric-coated tablet; however, the tendency was shown to improve symptoms. Its efficacy could not be raised by increasing the dosage used. Therefore, the recommended dosage of CSCC is four capsules, three times a day.
Adult ; Capsules ; Colitis, Ulcerative ; drug therapy ; Colon ; drug effects ; pathology ; Female ; Humans ; Intestinal Mucosa ; drug effects ; pathology ; Male ; Medicine, Chinese Traditional ; Plant Extracts ; adverse effects ; pharmacology ; therapeutic use ; Single-Blind Method ; Sophora ; chemistry ; Treatment Outcome
3.Expression and clinical significance of BRCA1 in human esophageal squamous cell carcinoma.
Yi-xuan YANG ; Li-yan XUE ; Li-jia DONG ; Ming FU ; Qi-min ZHAN ; Tong TONG
Chinese Journal of Oncology 2012;34(12):905-909
OBJECTIVETo investigate the expression of BRCA1 in esophageal squamous cell carcinoma (ESCC) tissues and evaluate its correlation with clinicopathological features as well as the prognosis of ESCC patients.
METHODSThe expression of BRCA1 was detected by immunohistochemistry (IHC) in 201 specimens of T3 stage ESCC tissues and corresponding adjacent normal tissues using tissue microarray. The correlation between BRCA1 expression and clinicopathological features of ESCC was determined by chi-square analysis. The cumulative survival rate was analyzed by Kaplan-Meier method.
RESULTSThe positive rate of BRCA1 expression in ESCC tissues was significantly higher than that in adjacent normal tissues [88.6% (178/201) vs. 36.8% (74/201), P < 0.001]. There was a significant correlation between the expression of BRCA1 and lymph node metastasis. In the tumors with positive lymph nodes, strong positive expression of BRCA1 was found in 45.0% (49/109), while only 19.6% (18/92) in tumors without lymph node metastasis, showing a significant difference (P < 0.001). A close relationship was also found between the expression of BRCA1 and gross typing of tumors (P < 0.05). The expression of BRCA1 was not significantly correlated with gender, age, tumor location, differentiation, and tumor thrombus (P > 0.05). The results of Kaplan-Meier analysis indicated that ESCC patients with a higher positive rate of BRCA1 expression have a poorer prognosis (P < 0.05).
CONCLUSIONSThe expression of BRCA1 is related to the occurrence and development of esophageal carcinoma. BRCA1 protein may serve as a new potential biomarker in estimating the biological behavior of ESCC.
Adult ; Aged ; Aged, 80 and over ; BRCA1 Protein ; metabolism ; Biomarkers, Tumor ; metabolism ; Carcinoma, Squamous Cell ; metabolism ; pathology ; surgery ; Esophageal Neoplasms ; metabolism ; pathology ; surgery ; Female ; Humans ; Lymphatic Metastasis ; Male ; Middle Aged ; Neoplasm Staging ; Survival Rate
4.Alveolar stability under different combinations of positive end-expiratory pressure and tidal volume: alveolar microscopy in isolated injured rat lungs.
Hui LIU ; Claudius A STAHL ; Knut MOELLER ; Matthias SCHNEIDER ; Steven GANZERT ; Zhan-qi ZHAO ; Xiao-wen TONG ; Josef GUTTMANN
Chinese Medical Journal 2010;123(4):406-411
BACKGROUNDHigh positive end-expiratory pressure (PEEP) and low tidal volume (VT) ventilation is thought to be a protective ventilation strategy. It is hypothesized that the stabilization of collapsible alveoli during expiration contributes to lung protection. However, this hypothesis came from analysis of indirect indices like the analysis of the pressure-volume curve of the lung. The purpose of this study was to investigate isolated healthy and injured rat lungs by means of alveolar microscopy, in which combination of PEEP and VT is beneficial with respect to alveolar stability (I-E%).
METHODSAlveolar stability was investigated in isolated, non-perfused mechanically ventilated rat lungs. Injured lungs were compared with normal lungs. For both groups three PEEP settings (5, 10, 20 cmH2O) were combined with three VT settings (6, 10, 15 ml/kg) resulting in nine PEEP-VT combinations per group. Analysis was performed by alveolar microscopy.
RESULTSIn normal lungs alveolar stability persisted in all PEEP-VT combinations (I-E% (3.2 +/- 11.0)%). There was no significant difference using different settings (P > 0.01). In contrast, alveoli in injured lungs were extremely instable at PEEP levels of 5 cmH2O (mean I-E% 100%) and 10 cmH2O (mean I-E% (30.7 +/- 16.8)%); only at a PEEP of 20 cmH2O were alveoli stabilized (mean I-E% of (0.2 +/- 9.3)%).
CONCLUSIONSIn isolated healthy lungs alveolar stability is almost unaffected by different settings of PEEP and VT. In isolated injured lungs only a high PEEP level of 20 cmH2O resulted in stabilized alveoli whereas lower PEEP levels are associated with alveolar instability.
Animals ; Female ; Lung ; pathology ; Lung Injury ; pathology ; Microscopy ; Pulmonary Alveoli ; pathology ; Rats ; Rats, Wistar ; Tidal Volume ; physiology
5.Single-dose ceftriaxone versus multiple-dose cefuroxime for prophylaxis of surgical site infection.
Zhan-liang LI ; Sai-xiong TONG ; Bao-ming YU ; Wei-song TANG ; Zhi-yong WU ; Shi-bin WANG ; Yu-fei WU ; Wei-qi LU ; Meng LUO ; Jian WANG
Chinese Journal of Surgery 2003;41(5):372-374
OBJECTIVETo compare the effects and pharmacoeconomics of single-dose of ceftriaxone versus 3-day cefuroxime prophylaxis in patients undergoing gastric or colorectal resection.
METHODSThree hundred and five consecutive patients with gastric or colorectal cancer from 5 medical centers were randomly divided into ceftriaxone group (n = 153, receiving intravenously 1 g ceftriaxone 0.5 - 1 h prior to operation only) and cefuroxime group (n = 152, receiving 0.75 g cefuroxime preoperatively and the same dose q8h for 3 d). The patients' intra- and postoperative status, adverse responses and infectious complications were observed and documented, and pharmacoeconomic parameters were analyzed.
RESULTSThe disease distribution, operative procedures and patients' conditions in the 2 groups were comparable. No adverse responses to the test antibiotics were observed. Postoperative infectious complications occurred in 7 cases in the ceftriaxone group (4.58%) and 14 cases in the cefuroxime group (9.21%), respectively (P = 0.992), among which, 12 cases were surgical site infections (incisional, intra-abdominal): 2 cases in the ceftriaxone group (1.31%), and 10 cases in the cefuroxime group (6.58%), (chi(2) = 5.607, P = 0.018). The direct cost related to prevention and treatment of surgical site infections was 283.5 RMB in the ceftriaxone group and 811.1 RMB in the cefuroxime group (Z = 14.51, P = 0.000).
CONCLUSIONBoth ceftriaxone and cefuroxime are safe and effective for prevention of surgical site infections. Single-dose ceftriaxone prophylaxis is sufficient for gastric and colorectal operations, with a better cost-effectiveness ratio.
Adolescent ; Adult ; Aged ; Anti-Bacterial Agents ; administration & dosage ; economics ; therapeutic use ; Antibiotic Prophylaxis ; economics ; Ceftriaxone ; administration & dosage ; economics ; therapeutic use ; Cefuroxime ; administration & dosage ; economics ; therapeutic use ; Female ; Humans ; Male ; Middle Aged ; Prospective Studies ; Surgical Wound Infection ; prevention & control ; Treatment Outcome ; Young Adult
6.Clinical significance of abnormal expression of Aurora-A in human esophageal squamous cell carcinoma with or without lymph node metastasis.
Ji SHI ; Li-yan XUE ; Ning YIN ; Jun LU ; Ming FU ; Li-jia DONG ; Shu-juan SHAO ; Tong TONG ; Qi-min ZHAN
Chinese Journal of Oncology 2010;32(10):748-751
OBJECTIVEChina has the highest incidence and mortality of esophageal carcinoma in the world, and the esophageal squamous cell carcinoma (ESCC) is the major type. In this study, the authors investigated the expression of Aurora-A in stage T3 esophageal squamous cell carcinomas (ESCC) with positive and negative lymph node metastasis, and analyzed its relationship with prognosis of ESCC patients.
METHODSESCC tissue arrays including 212 specimens had been constructed. The expression of Aurora-A in both ESCC tissues and adjacent normal tissues was determined by immunohistochemical staining. The correlation between Aurora-A protein levels and lymph node status in ESCC and survival rate were statistically analyzed.
RESULTSThe positive expression of Aurora-A was 74.07% (140/189) in tumor tissues and 18.52% (35/189) in adjacent normal tissues, showing a significant difference between them (χ(2) = 105.162, P < 0.05). In tumors with positive lymph nodes, strong positive expression of Aurora-A was found in 42.99% (46/107), while only 7.37% (7/95) in tumors with negative lymph nodes, with a statistically significant difference (χ(2) = 36.132, P < 0.05). The cumulative survival rate of the patients with strong Aurora-A-positive tumors was significantly lower than that in patients with Aurora-A-negative tumors (P = 0.0042, P < 0.05).
CONCLUSIONThe positive expression of Aurora-A in ESCC tissues is much higher than that in adjacent normal tissues. The expression of Aurora-A is higher in lymph node-positive tumors than in the lymph node-negative ones. There is a significantly longer cumulative survival rate in patients with negative Aurora-A expression than that in patients with strong positive Aurora-A expression.
Adult ; Aged ; Aged, 80 and over ; Aurora Kinases ; Carcinoma, Squamous Cell ; enzymology ; pathology ; Esophageal Neoplasms ; enzymology ; pathology ; Female ; Humans ; Lymphatic Metastasis ; Male ; Middle Aged ; Neoplasm Staging ; Protein-Serine-Threonine Kinases ; metabolism ; Survival Rate
7.Systematic analysis of drug dispensing errors and preventive measures in outpatient pharmacies
Jiang JIANG ; Yuan LI ; Yu CHAI ; Qi ZHAN
Journal of Pharmaceutical Practice 2022;40(2):188-192
Objective To understand the current situation of dispensing errors and effective prevention and control measures in outpatient pharmacies in domestic hospitals, in order to further improve the quality of drug dispensing. Methods The Chinese journal database was retrieved from 2015 to 2020 for the literature on the dispensing errors of outpatient pharmacies and the continuous improvement of the quality after the measures were taken in secondary and tertiary hospitals. Results Of the 146 literatures retrieved, 13 were included in the analysis (11 in tertiary hospitals and 2 in secondary hospitals). Before the improvement, the median of the drug dispensing error rate was 5.1‰, and after the improvement it was 1.1‰. Before and after the improvement, the types of drug dispensing errors were mainly quantity errors (52.5% vs. 51.3%), variety errors (28.3% vs. 28.7%), specifications and dosage forms errors (6.2% vs. 6.7%), and labeling errors (2.1% vs. 2.9%). The improvement measures taken for the reasons of dispensing errors have a high overlap rate, and they are concentrated in two aspects: personnel factors and drug factors. Conclusion The use of continuous quality improvement tools in hospital outpatient pharmacy to control and prevent dispensing errors is still a hotspot of current research. The composition of the types of errors after improvement has basically not changed. The implemen-tation of standardized operating procedures and other continuous improvement comprehensive measures can effectively reduce the incidence of dispensing errors, and contribute to the implementation of the “Expert Consensus on Medication Error Management in China”.
8.Quantitative detection of DD3 mRNA in prostate cancer tissues by real-time fluorescent quantitative reverse transcription polymerase chain reaction.
Zhi-hua TAO ; Xiao-lu MAO ; Cai-hong WANG ; Xiao-dong CHEN ; Kai-yuan YU ; Zhi-liang WENG ; Yuan-ping HU ; Xiao-hua ZHANG ; Hui XIE ; Ou-chen WANG ; Qi-tong SONG ; Cheng-di LI ; Zhan-guo CHEN
National Journal of Andrology 2007;13(2):130-133
OBJECTIVETo analyze the expression of DD3 mRNA in the prostate tissues.
METHODSDD3 mRNA was detected by realtime fluorescent quantitative reverse transcription polymerase chain reaction (FQ-RT-PCR) based on the Taqman technique in the tissues of 27 patients with non-prostate cancer( NPCa), 21 prostate cancer( PCa), 39 benign prostatic hyperplasia (BPH) and 15 normal prostate (NP). The ROC curve was used to evaluate the diagnostic value of DD3 mRNA.
RESULTSDD3 mRNA expression was not detected in the NPCa tissues. The median expressions of DD3 mRNA in PCa, BPH and NP tissues were 7. 2 x 10(6), 2. 5 x 10(4) and 1.5 x 10(4) copies/mg tissue, respectively. The DD3 mRNA expression levels were significantly different between nonmalignant and malignant tissues (P < 0.01). No significant differences in DD3 mRNA expression were detected between the NP and BPH tissues and no significant correlation was found between the DD3 mRNA expression and clinical pathological parameters. The AUC-ROC was 0.937 (95% CI: 0.879 - 0.995) at cutoff value 1.4 x 10(5) copies/mg tissue. The sensitivity, specificity, accuracy, positive predictive value, negative predictive value, positive likelihood ratio and negative likelihood ratio for DD3 were 90.5%, 85.0%, 86.7%, 76.0%, 94.3%, 6.03 and 0.11 respectively.
CONCLUSIONThe DD3 mRNA expression is confined to prostate tissues and highly upregulated in PCa tissues. It has a potential application value in the early diagnosis of prostate cancer and the follow-up of the patient.
Aged ; Aged, 80 and over ; Antigens, Neoplasm ; biosynthesis ; genetics ; Humans ; Male ; Middle Aged ; Neoplasm Staging ; Prostatic Hyperplasia ; metabolism ; pathology ; Prostatic Neoplasms ; metabolism ; pathology ; RNA, Messenger ; genetics ; ROC Curve ; Reverse Transcriptase Polymerase Chain Reaction
9.Novel MYBPC3 mutations in Chinese patients with hypertrophic cardiomyopathy
Zhan-Feng MA ; Wen-Ling LIU ; Da-Yi HU ; Wen-Li XIE ; Tian-Gang ZHU ; Yi-Hong SUN ; Song-Na YANG ; Cui-Lan LI ; Lei LI ; Xiao-Yun ME ; Jin-Gang YANG ; Tian-Chang LI ; Hong BIAN ; Qi-Guang TONG ; Jie XIAO ; Guo-Hong WANG ; Wei CUI ; Rui-Yun FAN ; Yun-Tian LI
Chinese Journal of Cardiology 2009;37(8):734-738
Objective To screen the MYBPC3 gene mutations in Han Chinese patients with hypertrophic cardiomyopathy ( HCM ). Methods Sixty-six patients with HCM were enrolled for the study. The exons in the functional regions of MYBPC3 were amplified with PCR and the products were sequenced. Results Four novel mutations and four common polymorphisms were identified in this patient cohort. A Lys301fs mutation in exon10 was evidenced in a H30, and when he was 47 years old, he had the chest tightness, shortness of breath with septal hypertrophy of 18. 7mm; a Asp463stop mutation in exonl7 was detected in a H48, he was 24 years old 24-year-old when a medical examination showed ventricular septal hypertrophy of 15.4 mm; both Gly523Arg mutation in exonl8 and Tyr847His mutation in exon26 were found in a H53 with onset age 36 years old, feeling chest tightness after excise and his ventricular septal hypertrophy was 27 mm that time. MYBPC3 mutatons occurred in 4. 5% patients in this cohort. These mutations were not found in 100 non-HCM control patients. Conclusion MYBPC3 mutation is presented in a small portion of Han Chinese patients with HCM.
10.CT observation of retromaxillary posterior ethmoid.
Jin Feng LIU ; Qi Tong LIU ; Jin Yu LIU ; Zhan Feng YAN ; Ning Yu WANG
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2018;32(2):121-124
To investigate the morphologic characteristics of the retromaxillary posterior ethmoid.A total of 103 outpatients encountered in our hospital during March 2012 and December 2012,who completed paranasal sinus CT examination,were included in this study.Patients had no sinus trauma,surgery or tumor history.Their paranasal sinus CT scans were analyzed from scheduled axial and coronal plane.The incidence and imaging features of the retromaxillary posterior ethmoid were observed.The retromaxillary posterior ethmoid(RMPE)was the posterior ethmoid cell that expanded along the lamina papyracea toward the infraorbital region.RMPE was located behind the posterior wall of the maxillary sinus and under the orbital floor.The occurrence rate of the RMPE was 74.3%.The ethmomaxillary septum is the bony septum the between the maxillary sinus and posterior ethmoid.Anatomical confirmation of RMPE is based mainly on the presence of the ethmomaxillary septum.RMPE is located at the back of ethmomaxillary septum.The sagittal angulation of the ethmomaxillary septum ranged from 22 to 87 degrees,with an average of(50.34±12.10)degrees.The ethmomaxillary septum is important for anatomic recognition of the RMPE.Accurate identification of the RMPE before ESS can help improve the removal of the posterior ethmoid sinus.
Ethmoid Bone
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Ethmoid Sinus
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diagnostic imaging
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Humans
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Maxillary Sinus
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Paranasal Sinus Diseases
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diagnostic imaging
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Tomography, X-Ray Computed