BACKGROUNDHemocoagulase Agkistrodon for injection is a single component thrombin which has passed phases I and II clinical trials. The purpose of this phase III clinical trial was to evaluate the effect of Hemocoagulase Agkistrodon on hemostasis and coagulation in abdominal skin and subcutaneous incisions and to assess the safety of this agent in surgical patients.

METHODSThis is a phase III, prospective, randomized, double-blind, and controlled multicenter clinical trial including 432 consecutive patients randomized into either a study group (injected with hemocoagulase Agkistrodon at 2 U, n = 324) or a control group (injected with hemocoagulase Atrox, n = 108). The hemostatic time, hemorrhagic volume, hemorrhagic volume per unit area, blood coagulation, and adverse events were measured and compared between the two groups.

RESULTSThe mean hemostatic time in the study group was (36.8 +/- 18.7) seconds; the hemorrhagic volume was (3.77 +/- 3.93) g; and the hemorrhagic volume per unit area was (0.091 +/- 0.125) g/cm(2). In the control group, the corresponding values were (38.1 +/- 19.7) seconds, (4.00 +/- 4.75) g, and (0.095 +/- 0.101) g/cm(2), respectively. No significant difference in values existed between the two groups (P > 0.05). Blood coagulation results and hepatic and renal function were also similar between the two groups. Adverse events were reported in two cases, but were deemed non-drug-related.

CONCLUSIONSHemocoagulase Agkistrodon has good hemostatic and coagulative function and is safe for the use of arresting capillary hemorrhage that occurs while incising the abdomen during surgery.

Abdomen ; surgery ; Adolescent ; Adult ; Aged ; Agkistrodon ; Animals ; Batroxobin ; adverse effects ; pharmacology ; Blood Coagulation ; drug effects ; Double-Blind Method ; Evidence-Based Medicine ; Female ; Hemostasis ; drug effects ; Hemostatics ; pharmacology ; Humans ; Male ; Middle Aged ; Prospective Studies

BACKGROUNDAnorectal malignant melanoma was a rare disease with extremely poor prognosis. The aim of this study was to explore the clinical characteristic, diagnosis and treatment strategies of anorectal malignant melanoma.

METHODSThe data of 57 patients with anorectal malignant melanoma was collected and retrospectively analyzed.

RESULTSRectal bleeding and anal mass were found to be common symptoms of anorectal malignant melanoma. The preoperative diagnosis rate of anorectal malignant melanoma was 48.6%. The overall 3-year and 5-year survival rate was 38.0% and 21.3% respectively. The 3-year survival rates of stage I and II patients were 63.0% and 16.7% respectively (P = 0.000), and the 5-year survival rates were 33.3% and 11.1% (P = 0.001), which both had significant statistic differences. The 3-year survival rate of patients undergone abdmoninoperineal resection and patients undergone wide local excision were 36.7% and 53.0% respectively (P = 0.280), while the 5-year survival rate were 24.1% and 23.1% (P = 0.642), which both had no significant statistic differences.

CONCLUSIONSThis study identified no survival advantage to abdominoperineal resection in treatment of anorectal malignant melanoma, and we propose that wide local excision could be considered as the initial treatment of choice.

Adult ; Aged ; Aged, 80 and over ; Anus Neoplasms ; diagnosis ; mortality ; pathology ; surgery ; Female ; Humans ; Male ; Melanoma ; diagnosis ; mortality ; pathology ; surgery ; Middle Aged ; Neoplasm Recurrence, Local ; Neoplasm Staging ; Survival Rate

BACKGROUNDLate stent malapposition was frequently observed after DES implantation, which has been associated with the occurrence of late stent thrombosis due to poor neointimal coverage. This study was designed to evaluate the frequency of late stent malapposition at least 1 year after different DESs implantation by optical coherence tomography (OCT).

METHODSAngiographic and OCT examinations were given to 68 patients who had received total 126 various DESs implantation for at least 1 year to detect late stent malapposition. Malapposed strut distance (MSD), malapposed strut area (MSA), reference lumen area (RLA) and reference stent area (RSA) were checked with off-line OCT analysis.

RESULTSTotally 26 Cypher Select stents, 15 Taxus Liberte stents, 51 Partner stents and 34 Firebird I stents were examined. Among 68 patients who underwent DES implantation, 7 patients (10.3%) had late malapposition. Average RSA, MSA and MSD were (7.9 +/- 2.8) mm(2),(2.0 +/- 1.6) mm(2) and (590 +/- 270) microm respectively. According to the MSA/RSA ratio, 4 patients had slight malapposition, 2 patients had moderate malapposition and 1 patient had severe malapposition.

CONCLUSIONSLate stent malapposition is detected frequently after implantation of DES, but if this predisposes to late stent thrombosis and requires any specific therapy needs to be further elucidated.

Adult ; Aged ; Drug-Eluting Stents ; adverse effects ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Tomography, Optical Coherence ; methods

BACKGROUNDAs an important determinant of patient satisfaction, waiting time, has gained increasing attention in the field of health care services. The present study aimed to illustrate the distribution characteristics of waiting time in a community hospital and explore the impact of potential measures to reduce outpatient waiting time based on a computer simulation approach.

METHODSDuring a one-month study period in 2006, a cross-sectional study was conducted in a community hospital located in Shanghai, China. Baseline data of outpatient waiting time were calculated according to the records of registration time and payment time. A simulation technique was adopted to investigate the impact of perspective reform methods on reducing waiting time.

RESULTSData from a total of 10,092 patients and 26,816 medical consultations were collected in the study and 19,947 medical consultations were included. The average of the total visit time for outpatients in this hospital was 43.6 minutes in the morning, 19.1 minutes in the afternoon, and 34.3 minutes for the whole day studied period. The simulation results suggested that waiting time for outpatients could be greatly reduced through the introduction of appointment system and flexible demand-orientated doctor scheduling according to the numbers of patients waiting at different time of the workday.

CONCLUSIONAdoption of an appointment system and flexible management of doctor scheduling may be effective way to achieve decreased waiting time.

Adult ; Aged ; Aged, 80 and over ; Appointments and Schedules ; Computer Simulation ; Cross-Sectional Studies ; Female ; Hospitals, Community ; Humans ; Male ; Middle Aged ; Outpatients ; Patient Satisfaction ; Time Factors

BACKGROUNDMultiple endocrine neoplasia type 1 (MEN1) is an autosomal dominant cancer syndrome which is caused by germline mutations of the tumor suppressor gene MEN1. This study aimed to identify mutations in a Chinese pedigree with MEN1.

METHODSA large Chinese family with MEN1 was collected. All of the coded regions and their adjacent sequences of the MEN1 gene were amplified and sequenced.

RESULTSIn this family, a heterozygous cytosine insertion in exon 10 (c.1546_1547insC) inducing a frame shift mutation of MEN1 was found in the proband and the other two suffering members of his family. This mutation was linked to a novel single nucleotide polymorphism (SNP) in intron 3 (IVS3 + 18C > T).

CONCLUSIONSThe mutation in exon 10 of MEN1 gene might induce development of parathyroid hyperplasia and pituitary adenoma and cosegregate with MEN1 syndrome. The significance of the new found IVS3 + 18C > T of MEN1 needs a further investigation.

Humans ; Male ; Middle Aged ; Multiple Endocrine Neoplasia Type 1 ; genetics ; Mutation ; Polymorphism, Single Nucleotide ; Proto-Oncogene Proteins ; genetics ; Sequence Analysis, DNA

BACKGROUNDNosocomial infection in early post-transplantation period is a tough problem for kidney transplantation. Few reports have explored the relations between biochemical parameters and nosocomial infection in kidney transplantation. This retrospective study was carried out to describe the characteristics of nosocomial infection in the very early period of kidney transplantation and to determine the risk factors in biochemical parameters and their alterations.

METHODSPatients who underwent their first kidney transplantation from January 2001 to March 2009 in Beijing Chao-Yang Hospital were recruited and the nosocomial infectious episodes were collected for this study. Gender, age, donor type, delayed graft function (DGF) and biochemical parameters such as serum uric acid, lipids files and albumin on day 0 (before transplantation) and day 1 (24 hours after transplantation) and their changes were analyzed with Logistic regression models for nosocomial infection.

RESULTSA total of 405 patients (315 men and 90 women) were involved in this study. There were 80 patients experiencing 113 infection episodes and 105 strains of microorganism were identified. In univariate analysis, there were significant differences in DGF, albumin on day 0, lipoprotein (a) (Lp(a)) on day 1, change in low density lipoprotein-cholesterol (LDL-C, day 1-day 0) and change in uric acid (day 1-day 0) between nosocomial infection patients and noninfectious patients (P < 0.05). In multivariate analysis, change in uric acid (day 1-day 0) (OR 5.139, 95%CI 1.176-22.465, P < 0.05), change in LDL-C (day 1-day 0) (OR 4.179, 95%CI 1.375-12.703, P < 0.05) and DGF (OR 14.409, 95%CI 1.603-129.522, P < 0.05) were identified as independent risk factors for nosocomial infection in kidney transplantation.

CONCLUSIONSMost nosocomial infections in early postoperative period of kidney transplantation are bacterial, especially with Gram-negative bacteria. The most common infection sites are respiratory tract, urinary tract and surgical site. DGF, decrease of LDL-C and increase of uric acid could increase the risk for nosocomial infections.

Adult ; Case-Control Studies ; Cholesterol, LDL ; blood ; Cross Infection ; etiology ; Female ; Humans ; Kidney Transplantation ; adverse effects ; Male ; Middle Aged ; Retrospective Studies ; Risk Factors ; Uric Acid ; blood

BACKGROUNDAdjuvant chemotherapy has become an important component of standard therapy for breast cancer. However, until now, there have been few reports on the surgical site infections (SSI) after breast cancer surgery, specially after adjuvant chemotherapy. To study the risk factors of SSI of breast cancer, we analyzed patients diagnosed with breast cancer and treated with surgery.

METHODSFifty-five patients diagnosed with breast cancer and received breast conserving or modified radical operations in our hospital during January 2008 to March 2008 were selected. Factors (patients' age, body mass index (BMI), diabetes mellitus, no or administered adjuvant chemotherapy, with or without onset of myelosuppression and the degree, surgical approaches, duration of operation, postoperative drainage duration and total drainage volume) associated with SSI were retrospectively reviewed and statistically analyzed by single factor analysis.

RESULTSFive patients suffered SSI (5/55, 9.1%); nineteen receiving adjuvant chemotherapy experienced Grade III + myelosuppression, among which 4 had SSI; only 1 out of the remaining 36 patients without adjuvant chemotherapy had SSI. The difference between the two groups was significant (P = 0.043). The incidence of SSI in patients with post-operative drainage tube indwelling longer than 10 days was 5/21, whereas no SSI occurred in that less than 10 days (P = 0.009). In our study, there was no significant difference in other associated factors.

CONCLUSIONSConcurrent Grade III + myelosuppression after adjuvant chemotherapy is an important risk factor of SSI in breast cancer and needs further study. No SSI was detected with indwelling time of post operative drainage less than 10 days.

Adult ; Aged ; Aged, 80 and over ; Bone Marrow ; drug effects ; Breast Neoplasms ; surgery ; Chemotherapy, Adjuvant ; adverse effects ; Female ; Granulocyte Colony-Stimulating Factor ; pharmacology ; Humans ; Middle Aged ; Retrospective Studies ; Risk Factors ; Surgical Wound Infection ; etiology

BACKGROUNDThe second-trimester maternal serum screening in twin pregnancy is still controversial, as the serum marker levels in twins are not as clear as those in singletons. This study aimed to evaluate the relationship between the levels of the second-trimester maternal serum free beta-human chorionic gonadotropin (free beta-HCG) and alpha-fetoprotein (AFP) in normal twin and singleton pregnancies and to estimate feasible analysis methods for utilizing these markers in second trimester screening for twin pregnancy.

METHODSOn the basis of a prospective population-based study of second-trimester maternal serum screening, the concentrations of maternal serum AFP and free beta-HCG of 195 normal twin pregnancy and 26,512 singleton controls at gestational weeks 15 to 20 were measured by time-resolved fluoroimmunoassay in one laboratory. The levels of markers were compared between the twins and singletons using weight-correction and gestational age-specific model.

RESULTSAccording to the research protocol, 95 communities were randomly sampled, which covered the whole Jiangsu province, the east of China. A total of 26 803 pregnant women (98%), from the target population accepted prenatal screening for maternal serum AFP, beta-HCG detection, and all babies were followed up for at least six months. There were 197 (0.73%) twin pregnancies, of which one case had fetal trisomy 18, and one case with fetal anencephaly. The others were normal twin pregnancy. From a total enrollment of 26 803 women participants, 26 512 women with normal singleton pregnancies were selected as the model controls. The other 291 pregnancies, including trisomy 21, neural tube defect (NTD), trisomy 18, and other fetal abnormalities, were excluded. No significant differences were found in the medians of gestational age-specific maternal serum free beta-hCG and AFP in normal twin pregnancy comparing with twice those in model controls with the exception of the medians for free beta-hCG during the 16th gestational week (P = 0.012).

CONCLUSIONThe weight-correction and gestational age-specific levels of Chinese Han population maternal serum free beta-hCG and AFP in normal twins were twice the levels as those in the singleton controls during the 17-19 gestational weeks.

Adult ; Chorionic Gonadotropin, beta Subunit, Human ; blood ; Female ; Humans ; Pregnancy ; blood ; Pregnancy Trimester, Second ; Twins ; alpha-Fetoproteins ; analysis

BACKGROUNDMonochorionic multiple pregnancies (MMPs) are associated with higher rates of perinatal morbidity and mortality caused by interfetal vascular anastomoses in the monochorionic placenta, which can lead to fetal health interactions. In some circumstances, selective feticide of the affected fetus is necessary to save the healthy co-twin. We evaluated the effects and safety of our initial experiences using bipolar cord coagulation for the management of complicated MMPs.

METHODSUsing ultrasound-guided bipolar cord coagulation, we performed selective feticide on 14 complicated MMPs (5 with twin-twin transfusion syndrome, 4 with acardia, 3 with discordant structural anomalies, and 2 with severe selective intrauterine growth restriction). One patient with monochorionic triplets received the procedure twice to terminate 2 affected fetuses for different indications. Data regarding the operations, complications and neonatal outcomes were analyzed.

RESULTSCord occlusions were successfully performed in 13/14 (93%) cases. The failure happened in an acardiac fetus and the pregnancy was terminated by induction. The included cases delivered at a mean gestational age of 35.4 weeks with a perinatal survival rate of 11/13 (85%). Three operation-related complications occurred (21%), including membrane rupture of the terminated sac (1 case), preterm labor at 28 weeks gestation (1 case), and chorioamniotic membrane separation (1 case). Amnioinfusion was indicated in 11 procedures to expand the target sacs for entering the trocar and obtaining sufficient working space. However, in all 4 cases of acardia, the acardiac sacs showed extreme oligohydramnios and could not be well expanded by infusion; thus, the trocar had to be inserted from the sac of the preserved co-twin.

CONCLUSIONSThe application of bipolar cord coagulation in complicated MMPs is safe and improves the prognosis. Amnioinfusion is useful in helping to expand the target sac when the working space is limited.

Adult ; Female ; Humans ; Postoperative Complications ; etiology ; Pregnancy ; Pregnancy Complications ; surgery ; Pregnancy Reduction, Multifetal ; methods ; Pregnancy, Multiple ; Umbilical Cord ; surgery

BACKGROUNDThe cytochrome P450 lanosterol 14alpha-demethylase (Erg11p) encoded by ERG11 gene is the primary target for azole antifungals. Changes in azole affinity of this enzyme caused by amino acid substitutions have been reported as a mechanism of azole antifungal resistance. This study aimed to investigate the relationship between amino acid substitutions in Erg11p from fluconazole resistant Candida albicans (C. albicans) isolates and their cross-resistance to azoles.

METHODSMutations in ERG11 gene were screened in 10 clinical isolates of fluconazole resistant C. albicans strains. DNA sequence of ERG11 was determined by PCR based DNA sequencing.

RESULTSIn the 10 isolates, 19 types of amino acid substitutions were found, of which 10 substitutions (F72S, F103L, F145I, F198L, G206D, G227D, N349S, F416S, F422L and T482A) have not been reported previously. Mutations in ERG11 gene were detected in 9 isolates of fluconazole resistant C. albicans, but were not detected in 1 isolate.

CONCLUSIONSAlthough no definite correlation was found between the type of amino acid substitutions in Erg11p and the phenotype of cross-resistance to azoles, the substitutions F72S, F145I and G227D in our study may be highly associated with resistance to azoles because of their special location in Erg11p.

Antifungal Agents ; pharmacology ; Candida albicans ; drug effects ; genetics ; Cytochrome P-450 Enzyme System ; genetics ; Drug Resistance, Fungal ; Fluconazole ; pharmacology ; Fungal Proteins ; genetics ; Microbial Sensitivity Tests ; Mutation