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 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 .

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 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.

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

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 evaluate the factors that may have impact on se-rum digoxin concentration ( SDC ) as well as its drug -drug interaction.Methods Using systematic method , gathering the inpatients′SDC of Peking university first hospital from January to December , 2014.Using retrospective method , statistics and analysis of the influence factors inclu-ding dosage, age, gender, therapeutic drug monitoring value ( TDM), creatinine clearance ( CrCl ) , electrolyte and co -administration of pa-tients in cardiovascular department were carried out.Results There are 49.8%of the patients with their SDCs below 0.5 ng · mL-1 , 24.1%of the SDCs in the range of 0.5-0.8 ng · mL-1 , 25.7% of the SDCs in the range of 0.8 -2.0 ng· mL-1 , 4.2% of the SDCs are over 2.0 ng· mL-1.The significant factors which influence SDC are age , CrCl and co -administration with antibiotics and nitrates ( P <0.05 ).Conclusion The usage of digoxin in Peking university first hospital is fairly reasonable , however the SDC is a bit of low for a large proportion of the patience.Digoxin dosage should be adjusted individually especially based on the patients ’ age , CrCl and drug combination in order to meet the future goal for achieving personalized medicine.

Objective To investigate the distribution of related single nucleotide polymorphisms (SNPs) of drug transporters in healthy Chinese Han population.Methods 10 specific SNPs of 6 drug transporters,including organic anion transporting polypeptide 1B1 (OATP1B1),OATP1B3,organic cation transporter 1 (OCT1),P-glycoprotein (P-gp),multidrug resistance protein 2 (MRF2) and breast cancer resistance protein (BCRP),were determined in healthy Chinese Han volunteers by the established rapid polymerase chain reaction (PCR) methods and sequencing.Gene frequencies were calculated and compared with other populations in the 1000 genomes project.Results The minor allele frequencies of OATP1B1 388A ＞ G,OATP1B1 521T ＞ C,OATP1B3 699G ＞ A,OCT1 181C ＞ T,OCT1 1393G ＞ A,OCT1 1258delA,MDR1 3435T ＞ C,MRP2-24C ＞ T,BCRP 421C ＞ A and BCRP 376C ＞ T were 26.97％,6.25％,23.91％,0,0,0,38.47％,18.52％,31.97％ and 1.48％,respectively.By comparing the distribution of allele frequencies between test group and Mrican,the frequencies of the OATP1 B3 699G ＞ A variant alleles were 76.09％ and 35.63％,respectively;the frequencies of the MDR1 3435T ＞ C variant alleles were 61.53％ and 85.02％,respectively;the frequencies of the MRP2-24C ＞ T variant alleles were 18.52％ and 3.10％,respectively;the frequencies of the BCRP 421C ＞ A variant alleles were 31.97％ and 1.29％,respectively.And these differences were statistically significant (P ＜ 0.05).By comparing the distribution of allele frequencies between test group and American,the frequencies of the OATP1B1 388A ＞ G variant alleles were 26.97％ and 47.26％,respectively;the frequencies of the BCRP 421C ＞A variant alleles were 31.97％ and 14.12％,respectively.And these differences were statistically significant (P ＜ 0.05).By comparing the distribution of allele frequencies between test group and European,the frequencies of the OATP1B1 388A ＞ G variant alleles were 26.97％and 40.26％,respectively;the frequencies of the OATP1B1 521T ＞ C variant alleles were 6.25％ and 16.10％,respectively;the frequencies of the OCT1 181C ＞ T variant alleles were 0 and 6.26％,respectively;the frequencies of the BCRP 421C ＞ A variant alleles were 31.97％ and 9.44％,respectively.And these differences were statistically significant (P ＜ 0.05).There was no significant difference in the distribution of allele frequencies between test group and Japanese (P ＞ 0.05).Conclusion Significant differences were observed in the distributions of some SNPs between Chinese and other populations.It is important to analyze the distribution of the related genetic polymorphisms of drug transporters in Chinese people to guide rational drug use in clinical.