In order to obtain the phase I clinical trial data safely and accurately , the subjects management is very important .The purpose of this paper is to introduce the subjects management model during recruitment , screening and observation and discuss the phase I subjects management strategy , according to the author ’ s practical experience and the working model of phase I clinical trials in hospital .

OBJECTIVETo investigate the efficacy of biofeedback therapy for fecal incontinence in patients with mid or low rectal cancer.

METHODSTwenty-four patients with mid or low rectal cancer received biofeedback treatments after restorative resection and therapeutic efficacy was evaluated using anorectal manometry and Vaizey and Wexner scoring systems. Eighteen inpatients without defecating difficulties were selected as control group.

RESULTSThe parameters of anorectal manometry in patients with rectal cancer were significantly lower than those in the control group (P<0.01). After biofeedback therapy, the maximum squeeze pressure, resting pressure and maximum tolerated volume were significantly increased, from (118.3+/-42.9) mm Hg to (193.2+/-38.2) mm Hg, (27.8+/-9.0) mm Hg to (47.9+/-9.3) mm Hg,(97.5+/-52.8) ml to (189.1+/-39.0) ml, respectively (all P<0.01), while no significant difference in sensory threshold was observed (P=0.101). Post-treatment Vaizey (10.5+/-2.3 vs 12.9+/-2.8) and Wexner (7.5+/-2.5 vs 10.1+/-2.6) scores were significantly decreased compared with those before biofeedback (P<0.01).

CONCLUSIONBiofeedback therapy can improve the anal function in patients with rectal cancer after restorative resection.

Aged ; Anal Canal ; surgery ; Biofeedback, Psychology ; Fecal Incontinence ; etiology ; therapy ; Female ; Humans ; Male ; Middle Aged ; Postoperative Complications ; therapy ; Pressure ; Rectal Neoplasms ; pathology ; surgery ; Treatment Outcome

Objective: To observe the efficacy of electroacupuncture (EA) plus Yi Jin Jing (Sinew-transforming Qigong Exercises) for knee osteoarthritis (KOA). Methods: A total of 60 patients with KOA were divided into an observation group and a control group according to the random number table method, with 30 cases in each group. Patients in the observation group received the treatment of EA plus Yi Jin Jing (Sinew-transforming Qigong Exercises), while patients in the control group only received EA treatment. Both groups were treated for 5 weeks. The changes of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and visual analog scale (VAS) scores in the two groups were observed after treatment. Results: After treatment, the total effective rate in the observation group (92.3％) was significantly higher than that in the control group (70.0％), (P<0.05); the WOMAC and VAS scores in both groups were significantly lower than those before treatment, showing statistical significance (all P<0.01); there were significant differences in the post-treatment changes in the WOMAC and VAS scores between the two groups (P<0.05, P<0.01). Conclusion: EA plus Yi Jin Jing (Sinew-transforming Qigong Exercises) is clinically effective for KOA. This combined treatment can alleviate clinical symptoms.

Chronic obstructive pulmonary disease (COPD)is a common chronic respiratory system disease that could not be cured,and the prevalence and cost of which is high.Triple inhaled therapy of inhaled corticosteroid/long-acting β2-agonist/long-acting bronchodilators (ICS/ LABA/LAMA) improves lung function,symptoms and health status and reduces exacerbations compared to ICS/LABA or LAMA monotherapy.Single-inhaler combination of ICS/LABA/LAMA can improve patient compliance and efficacy.However,it's hard to change the specific dose of one single compound through a single-inhaler combination of three compounds.This review aimed to provide information for the rational clinical use of the single inhaler of triple therapy in the future.

Objective To provide the pharmaceutical care plan for pa-tients receiving bleomycin , which has reached toxicity dose , to prevent the drug-induced pulmonary injury.Methods Regimen was laid down for aiding doctors to prevent the potential pulmonary toxicity through tak-ing part in the therapeutic process of an ovarian cancer patient given ble-omycin which has reached toxicity dose.Results and Conclusion From three aspects of preventing , monitoring and treating , a reasonable indi-vidualized dosing regimen for patients with advanced cancer palliative care was devoleped.The adverse reactions of chemotherapy should be monitored and prevented for enhancing the quality of patients′life.

Following the reformation of the new drug classification , it be-comes a new issue of how to confirm the bioequivalence for category 2 new drugs, i.e., the Modified New Products.There are occasional cases when the modified ones are bio -( pharmacokinetic ) but not clinical -equivalent compare to their reference products , and vice versa.If it comes up with different results , clinical-equivalence is considered to be more powerful compare to bio -equivalent result , and the regulatory approval will be done mainly based on clinical rather than bio -equivalent result alone.The present paper provides decision -making cases done by different authorities on products for which the bio -equivalent results are negative while they are proved to be clinically equivalent .These cases provide new ways of thinking for local pharmaceutical companies and can also be used as references for China Food and Drug Administration ( CFDA) in reviewing the same kind of products .

OBJECTIVEThe purpose of this review is to discuss some critical issues of isoflavones protective against the development of prostate cancer (PCa).

DATA SOURCESData cited in this review were obtained primarily from PubMed and Embase from 1975 to 2015.

STUDY SELECTIONArticles were selected with the search terms "isoflavone", "Phytoestrogen", "soy", "genistin", and "PCa ".

RESULTSIsoflavones do not play an important role on prostate-specific antigen levels reduction in PCa patients or healthy men. The effect of isoflavones on sex hormone levels and PCa risk may be determined by equol converting bacteria in the intestine, specific polymorphic variation and concentrations of isoflavones. The intake of various types of phytoestrogens with lower concentrations in the daily diet may produce synergistic effects against PCa. Moreover, prostate tissue may concentrate isoflavones to potentially anti-carcinogenic levels. In addition, it is noteworthy that isoflavones may act as an agonist in PCa.

CONCLUSIONSIsoflavones play a protective role against the development of PCa. However, careful consideration should be given when isoflavones are used in the prevention and treatment of PCa.

Humans ; Isoflavones ; therapeutic use ; Male ; Phytoestrogens ; therapeutic use ; Prostatic Neoplasms ; prevention & control

Objective To investigate the health literacy level and health related behavior of high school students in Xuhui District of Shanghai, and to provide basis for health literacy intervention. Methods Using qualitative and quantitative methods, the quantitative part adopted the multi-stage stratified sampling method.A total of 355 aged 15-18 from senior high schools in Xuhui District were selected for face-to-face survey.The qualitative part adopted the form of group interviews, and 20 students from two senior high schools in Xuhui District were selected for interviews. Results The health literacy level of high school students in Xuhui District was 27.32%, which was lower than that of adults in the same period.Among the three dimensions, the level of basic knowledge and concept literacy was the highest, followed by the level of health basic skills literacy, the level of healthy lifestyle and behavior literacy was the lowest; among the six types of health problems, the level of infectious disease prevention literacy and basic medical literacy was at a low level.Statistical analysis of the correct answer rate showed that the answer rate of various questions in the health literacy survey was quite different.Further analysis of the health-related behavioral characteristics of high school students showed that most students had correct health concept and awareness of health change, but they encountered resistance in the process of knowledge transformation into action, which mainly came from academic burden, school education, peer influence and so on.The main channels for high school students to obtain health-related information were classroom, parents, school and various media.They had a high degree of trust in medical professionals and encountered difficulties in seeking health information. Conclusion The health literacy level of senior high school students in Xuhui District of Shanghai needs to be improved.We should explore a health intervention model more suitable for the behavioral characteristics of this group weak links in their health literacy.

Purpose: To evaluate the use of signal intensity index (SII) of skull-base invasion in nasopharyngeal carcinoma (NPC) using magnetic resonance imaging (MRI), select a best cut-off SII value to predict the outcome of NPC. Materials and Methods: One hundred and twenty-two NPC patients (92 men, 30 women) with skull-base invasion were included. All patients underwent MRI, signal intensities on T1-weighted imaging (T1WI) were measured for each invaded site and its contralateral normal counterpart. The SIIs were calculated, receiver operating characteristic curves were constructed. The optimal cut-off values were extracted. The overall survival (OS) rates of 5-year follow-up were performed. Results: Sensitivities for differentiating skull-base invasion from normal contralateral anatomy were 98.9%, 88.5% and 70.0%, and specificities were 98.9%, 96.0% and 74.4%, respectively. There were three cut-off values for differentiating invasion from normal anatomy of skull-base, 49%, 98%, and 60%. Significant difference in OS rates (84.2% vs. 57.1%, p=0.007) was seen for SII threshold values > 60% and those ≤ 60%. Conclusions: The SII might be a useful means of differentiating invasion from normal tissue at the skull-base in NPC. The cut-off value of quantitative SII at the skull-base may aid in monitoring the response to treatment of NPC patients.

Objective To provide a reasonable treatment plan for the patients with the use of genotype detection and drug interaction analysis.Methods Clinical pharmacists participated in one case treatment of an epileptic patients with severe drug eruption,by analyzing the causes of severe drug eruption combined with antiepileptic drug gene test results,the reasonable use of antiepileptic drugs was suggested.Results and Conclusion The patients were discharged from hospital.By combination of disease,medication,genotype and other factors,the effectiveness and safety of treatment were improved.