Objective:To evaluate the safety and effectiveness of the accurate puncture during sacral neuromodulation (SNM) guided with 3D printing navigation template based on reconstruction techniques using fusing sacral CT and MRI images.Methods:Totally 42 patients operated with SNM were selected in Renji Hospital, School of Medicine, Shanghai Jiaotong University from July 2016 to August 2017. The patients were randomly divided into control group ( n=22) and experimental group ( n=20) using random number table. The conventional cross-positioning technique under X-ray was used for puncture during SNM in the control group. While in the experimental group, the sacral CT and MRI images were fused for reconstruction and design of the navigation template, printed by 3D technique for the puncture in SNM. The times of punctures, the average time for puncture operation, the time of intraoperative testing of the stimulator device, the minimum onset voltage of the stimulator, the X-ray radiation dose, postoperative curative effect (rate of secondary transformation) and the incidence rate of complications were compared between the two methods using independent-simple t test or χ 2 test. Results:Compared to control group, fewer times of punctures, shorter time needed for puncture operation, shorter time of intraoperative testing of the stimulator, smaller radiation dose and minimum effective voltage were found in the experimental group ( P<0.05). There were 15 and 16 patients who completed the secondary transformation in the control group and experimental group, and there was no significant difference between the two groups (χ2=0.757, P=0.384). There were 3 cases of complications in the control group, including 2 cases of infection and 1 case of bleeding, while no complications in the experimental group. Conclusions:CT and MRI images fusion reconstruction-guided 3D printing navigation template can help perform accurate and safe punctures in SNM. Compared to conventional puncture positioned under X-ray, it can effectively improve the puncture efficiency, and reduce the radiation dose in the operation.

The pediatric population is different from adults in their physi-ological function and tissues structure, and therefore they should not be assumed simply as the small adults.The drug development for pediatric population is helpful to improve the health of children in the whole coun-try.However, the clinical investigation of medicinal products for adults can not apply for children and there has not available guidance for chil-dren for a while.Accordingly, Chinese Food and Drug Administration ( CFDA) issues the guidance for clinical investigation of medicinal prod-ucts in the pediatric population, which ensure the clinical trials are more scientific and ethic. This paper means to interpret the guidance and therefore to help the development of clinical trials in pediatric population.

The pediatric population is different from adults in their dis-ease types and medication use in clinics.The drug clinic trial in pediatric population provides reliable clinic data for new drug development and medication use, and is helpful to promote the health of children.Howev-er, considering the specificity of children, it is changeable to conduct the drug clinic trials, especially for the study protocol design.Accordingly, CFDA issues the guidance for clinical investigation of medicinal products in the pediatric population, which ensure the clinical trials are more sci-entific and ethic.This paper means to interpret the guidance and there-fore to help the development of clinical trials in pediatric population.

OBJECTIVETo evaluate the effect on pre-exposure prophylaxis (PrEP) to prevent HIV infection in high risk populations.

METHODSA computerized literature searching had been carried out in PubMed, EMbase, Ovid, Web of Science, Science Direct, Wanfang, Tsinghua Tongfang database and related websites to collect relevant papers (from establishment to June 2012) with the key words of pre-exposure prophylaxis, HIV, AIDS, high risk populations, relative risk, reduction. All randomized controlled trials (RCT) papers about using single or compound antiretroviral drugs (ARVs) orally or topically before HIV exposure or during HIV exposure in high risk populations were enrolled. Meta-analysis was conducted using Stata 10.0 to calculate the pooled RR value (95%CI). Consistency test was performed and publication bias was evaluated.

RESULTSFinally 5 RCT papers were enrolled, including 10 271 persons who were at high risk of HIV infection. The number of the experimental group was 5929, among which 116(1.96%) became infected. The number of the control group was 4342, among which 201(4.63%) became infected. Meta-analysis showed that the pooled relative risk (RR) and 95%CI was 0.49 (0.39 - 0.61), P < 0.05, indicating that the persons in experimental group had a 0.49 times lower risk of HIV infected, as compared with the control group. Publication bias analysis revealed a symmetry funnel plot. The fail-safe number was 825.

CONCLUSIONPrEP was an effective and safe protection measure to reduce HIV infection in high risk populations.

Anti-HIV Agents ; administration & dosage ; therapeutic use ; HIV Infections ; prevention & control ; Humans ; Randomized Controlled Trials as Topic ; Risk

OBJECTIVETo explore the relation between the expressions of PD-ECGF and VEGF and the evolution of capillary hemangioma, so as to provide theoretical basis for treatment.

METHODSFourty cases with capillary hemangioma, proved by pathologic method, were randomly selected and divided into proliferative (n=22) and involuted groups (n=18), according to the Mulliken standard. 8 specimens from 8 children with prepuce operation were used as control group. All the specimens were fixed, embedded and underwent HE staining. The expression of PD-ECGF, VEGF and CD34 in endothelial cells were detected by immunohistochemistry. The microvessel-density (MVD) was also calculated. The results were analyzed by SPSS12.0.

RESULTSThe positive expression rates of PD-ECGF and VEGF were 95.45% (21/22) and 86.36% (19/22) in proliferative hemangioma, 77.78% (14/18) and 66.67% (12/ 18) in involuted hemangioma, 37.50% (3/8) and 37.50% (3/8) in normal skin. MVD in proliferative and involuted hemangioma and normal skin was 93.68 +/- 20.56, 51.94 +/- 20.73 and 17.50 +/- 5.30, respectively. There was a significant difference in PD-ECGF expression and MVD between the proliferative and involuted groups, or between the hemangioma and control groups (P < 0.05). The VEGF was significantly different between the proliferative and involuted groups, or between the proliferative and control groups (P < 0.05), but not between the involuted and control groups (P > 0.05). The expression of VEGF, PD-ECGD and MVD showed a positive relationship.

CONCLUSIONSPD-ECGF and VEGF have a synergetic effect in the proliferation of micro-vessels. PD-ECGF may enhance the activity of thymidine phosphorylase. They play an important role in the proliferation and involution of hemangioma.

Child, Preschool ; Female ; Hemangioma, Capillary ; metabolism ; pathology ; Humans ; Infant ; Male ; Neoplastic Syndromes, Hereditary ; metabolism ; pathology ; Thymidine Phosphorylase ; metabolism ; Vascular Endothelial Growth Factor A ; metabolism

Objective To study the acceptability of pre-exposure prophylaxis (PrEP)program on prevention of human immunodeficiency virus (HIV)infection among female sex workers (FSWs) in Guangxi of China.Methods A cross-sectional survey using convenience sampling was administered among 405 FSWs in Nanning,Liuzhou and Beihai cities of Guangxi,China.Self-designed questionnaire,face to face interviews were used to collect HIV-related risk behaviors,knowledge and acceptability of PrEP.Results After an introduction on PrEP,presuming that it was effective,safe and free of charge,85.9％ of the 405 FSWs said they would use it.Data from logistic regression analysis showed that significant factors of intent to use PrEP would include the followings:workplace (OR=2.256,P=0.009),monthly income (OR=0.257,P=0.004),family closeness (OR＝0.338,P＝0.012),knowledge on HIV/AIDS (OR＝2.802,P=0.028),HIV/AIDS risk was introduced from a strange client (OR＝0.363,P＝0.049),whether the gatekeeper ordering the use of condom (OR＝0.432,P=0.010),whether consistent using condom with clients (OR＝3.010,P＝0.002),whether ever using drugs to prevent STD infection (OR=3.570,P=0.049) etc.Conclusion Awareness on HIV/AIDS knowledge and self-protection seemed the main influential factors while health education might promote the acceptability of PrEP.

OBJECTIVETo study the clinicopathologic features of uterine papillary serous carcinoma (UPSC) and the roles of adjuvant therapy.

METHODSSixty-one cases of UPSC with operation done and followed up for a period of 4 to 9 years were enrolled into the study. The histology of slides specimens were reviewed and immunohistochemical study was performed. The follow-up and survival data were analyzed.

RESULTSAll of the 61 patients were post-menopausal, with a median age of 68 years. The clinical presentations included abnormal vaginal bleeding, abdominal symptoms and abnormal Pap smears. The median size of the tumors was 7.5 cm (range=1.2 to 14.8 cm). There were 27.9% cases in FIGO stage I (8.2% in stage IA, 14.8% in stage IB and 4.9% in stage IC), 9.8% in stage II, 32.8% in stage III and 29.5% in FIGO stage IV. The histologic features were similar to those of the ovarian counterpart, with tumor cells containing the high-grade nuclei and arranged in complex papillae. Psammoma bodies were identified in 24.6% of the cases. Immunohistochemical study showed that the tumor cells demonstrated diffuse and strong nuclear staining for p53 and Ki-67. They were negative for estrogen receptor and progesterone receptor. Fifteen of the 61 cases (24.6%) showed no evidence of myometrial invasion. However, ten of the 15 cases had extrauterine disease, with peritoneal (6/15) and nodal (9/15) involvement. Tumors with deep myometrial invasion, lymphovascular permeation and nodal metastasis were associated with worse prognosis by univariate analysis. Fifty-six patients received adjuvant therapy. The number of patients receiving adjuvant chemotherapy alone, adjuvant radiotherapy alone and combined adjuvant chemotherapy/radiotherapy were 42, 24 and 10, respectively. The median survivals of the chemotherapy group and non-chemotherapy group (with or without radiotherapy) were 66.4 months and 32.8 months, respectively.

CONCLUSIONSUPSC has distinctive clinical and pathologic features. The tumor stage, lymph node status, lymphovascular permeation and depth of myometrial invasion were important prognostic factors. Adjuvant chemotherapy for stage III/IV tumors or recurrent UPSC may have survival benefit.

Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Carcinoma, Papillary ; drug therapy ; pathology ; radiotherapy ; surgery ; Chemotherapy, Adjuvant ; Cisplatin ; administration & dosage ; Cystadenocarcinoma, Serous ; drug therapy ; pathology ; radiotherapy ; surgery ; Female ; Follow-Up Studies ; Humans ; Lymphatic Metastasis ; Menopause ; Middle Aged ; Neoplasm Invasiveness ; Neoplasm Staging ; Paclitaxel ; administration & dosage ; Radiotherapy, Adjuvant ; Survival Rate ; Uterine Neoplasms ; drug therapy ; pathology ; radiotherapy ; surgery

BACKGROUNDAlzheimer's disease (AD) is a neurodegenerative disorder and the leading cause of dementia in the elderly. The two hallmark lesions in AD brain are deposition of amyloid plaques and neurofibrillary tangles (NFTs). Hypercholesteremia is one of the risk factors of AD. But its role in the pathogenesis of AD is largely unknown. The aim of this study was to investigate the relationship between hypercholesteremia and tau phosphorylation or beta-amyloid (Abeta), and evaluate the effect of atorvastatin on the level of tau phosphorylation and Abeta in the brains of rats fed with high cholesterol diet.

METHODSSprague-Dawley (SD) rats were randomly divided into normal diet control group, high cholesterol diet group, and high cholesterol diet plus atorvastatin (Lipitor, 15 mg x kg(-1) x d(-1)) treated group. Blood from caudal vein was collected to measure total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL) and high-density lipoprotein (HDL) at the end of the 3rd and the 6th months by an enzymatic method. The animals were sacrificed 6 months later and brains were removed. All left brain hemispheres were fixed for immunohistochemistry. Hippocampus and cerebral cortex were separated from right hemispheres and homogenized separately. Tau phosphorylation and Abeta in the brain tissue were determined by Western blotting (using antibodies PHF-1 and Tau-1) and anti-Abeta40/anti-Abeta42, respectively.

RESULTSWe found that high cholesterol diet led to hypercholesteremia of rats as well as hyperphosphorylation of tau and increased Abeta level in the brains. Treatment of the high cholesterol diet fed rats with atorvastatin prevented the changes of both tau phosphorylation and Abeta level induced by high cholesterol diet.

CONCLUSIONSHypercholesteremia could induce tau hyperphosphorylation and Abeta production in rat brain. Atorvastatin could inhibit tau hyperphosphorylation and decrease Abeta generation. It may play a protective role in the patho-process of hypercholesteremia-induced neurodegeneration in the brain.

Administration, Oral ; Amyloid beta-Peptides ; metabolism ; Animals ; Antibodies, Monoclonal ; Atorvastatin Calcium ; Blotting, Western ; Brain ; drug effects ; metabolism ; Enzyme-Linked Immunosorbent Assay ; Heptanoic Acids ; administration & dosage ; pharmacology ; therapeutic use ; Immunohistochemistry ; Male ; Phosphorylation ; drug effects ; Pyrroles ; administration & dosage ; pharmacology ; therapeutic use ; Rats ; Rats, Sprague-Dawley ; tau Proteins ; metabolism

Objective To explore the safety and efficacy of cochlear implantation among elderly patients with severe to profound hearing loss. Methods Eight pre-elderly and elderly patients with an medium age of 58 years who suffered from bilateral severe to profound sensorineural hearing loss received cochlear implantation between November 2008 and November 2009. The patients' tolerance to implant surgery and the occurrence of complications were observed. Three months after switch-on, aided threshold and speech performance were measured. Results The surgery was uneventful in all cases with normal intraoperative neural response telemetry elicited. Three months after switch-on, average aided threshold across speech frequencies was 35 -50 dB HL measured in sound field with warble tone. The results of speech audiometry showed large variation between individuals. Some patients achieved good performance in monosyllable recognition test, disyllables threshold test and sentences recognition test under both bubble noise and quiet conditons. Conclusions Pre-elderly and elderly patients can endure a state of general anesthesia for cochlear surgery without complications. Cochlear implant can provide reconstruction of speech recognition capabilities for elderly patients suffering from severe to profound hearing loss. Cochlear implantation can improve the quality of life of elderly patients with hearing loss.

OBJECTIVETo evaluate and compare the efficacy and safety of Nedaplatin (NDP)-based regimen and cisplatin (DDP)-based regimen for head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), esophageal cancer and ovary epithelial cell carcinoma.

METHODSSingle agent group: NDP was administered at a dose of 100 mg/m(2) on D1, every 3 weeks for at least 2 cycles. Combination chemotherapy group: combined with 5-Fu, NVB, VDS + 5-Fu, PTX or CTX respectively, NDP 80 mg/m(2) on D1 or DDP 30 mg/m(2) on D1-3, every 3 weeks for at least 2 cycles was given.

RESULTSOf 237 patients in this trial, 37 were treated by single Nedaplatin, 139 by NDP-based regimen, 61 by DDP-based regimen in the control group. The response rate of single Nedaplatin chemotherapy for advanced NSCLC was 10.5% (2/19), for ovary carcinoma (1/3) and HNSCC (1/1). For NSCLC and ovary carcinoma patients who had failed in the previous DDP-based chemotherapy, the response rates by single NDP chemotherapy were still 9.1% and 33.3%. The response rate of NDP-based combination regimen for NSCLC, ovary carcinoma, HNSCC and esophageal cancer was 33.9% (21/62), 44.8% (13/29), 20.0% (3/15) and 18.2% (4/22), respectively, which was not statistically different from the rate of controlled group treated by DDP-based regimen. For chemonaive NSCLC, the effect of NDP-based combination regimen (35.7%) was significantly superior to the effect of DDP-based regimen (17.1%) (P = 0.045). The most common adverse events of nedaplatin were myelosuppression (leukopenia, thrombocytopenia, anemia), nausea and vomiting. The myelosuppression and renal toxicity of NDP-based regimen were similar to that of DDP-based regimen, but vomiting was milder than that of DDP-based regimen (54% vs. 75.4%), and grade I/II liver toxicity was more common in the NDP-based regimen than in DDP-based regimen (10.8% vs. 0).

CONCLUSIONNedaplatin is effective in the treatment for HNSCC, NSCLC and ovary carcinoma. Compared with the control group treated by DDP-based regimen, nedaplatin-based combination chemotherapy has similar effect on HNSCC, NSCLC, ovary carcinoma and esophageal cancer. Gastrointestinal reaction of nedaplatin is milder than that of cisplatin but the liver function during chemotherapy must be monitored closely.

Adolescent ; Adult ; Aged ; Antineoplastic Agents ; therapeutic use ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; Cisplatin ; administration & dosage ; Esophageal Neoplasms ; drug therapy ; Female ; Fluorouracil ; administration & dosage ; Head and Neck Neoplasms ; drug therapy ; Humans ; Leukopenia ; chemically induced ; Lung Neoplasms ; drug therapy ; Lymphatic Metastasis ; Male ; Middle Aged ; Nausea ; chemically induced ; Organoplatinum Compounds ; administration & dosage ; therapeutic use ; Ovarian Neoplasms ; drug therapy ; Vinblastine ; administration & dosage ; analogs & derivatives