To perform an evaluation of the on-going prospective clinical trials on particle radiation therapy and their impact on the current clinical practice as well as future clinical research and development.Furthermore,to briefly present the results of the registration trial of the IONTRIS particle therapy system at the Shanghai Proton and Heavy Ion Center.We used data from the clinicaltrials,gov and the Particle Therapy Collaborative Organization Group (PTCOG) website.After excluding retrospective and in silico studies,we examined and analyzed the prospective clinical trials for their ion type,targeting disease site,and nature.At the time of this analysis,149 prospective trials were identified on proton and carbon-ion radiation therapy,including 20 were carbon-ion and 129 trials were proton radiation focused,respectively.Except for 15 randomized phase Ⅱ/Ⅲ and Ⅲ trials,134 trials were phase 0-Ⅱ trials.Tumors from nearly all body parts were covered by the on-going trials,but trials on pediatric,GI,lung,prostate,and breast cancer account for the majority.The majority of the currently on-going trials focus on the efficacy and adverse-effects of the new dose/fractionation schemes of particle therapy as well as the use of particle therapy on new indications.Few studies invcstigate the addition of adjuvant therapy or imaging technology used in adjunct with particle therapy.Randomized trials that compare particle radiation therapy versus photon radiation is relatively uncommon.Despite the prevailing use of proton and heavy-ion radiation therapy for cancer treatment,～ 150 prospective clinical trials associated with particle radiation therapy are identified.As the majority of trials aim to investigate more efficacious dose/fractionation and the application of particle therapy on new indications,improved outcome from and expanded utilization of particle radiation therapy can be expected.

Objective To discuss the effects of silencing of iASPP gene on human bladder cancer cells. Methods RNAi silencing of iASPP gene in bladder cancer cell 5637 and T24 cells were used by lentiviral mediated interfering short hairpin RNAs. Cell proliferation was tested by MTT assay, and rate of colony was tested by colony formation assay. Cell cycles were tested by using fluorescence-activated cell sorting. Results Down-regulation of iASPP could inhibit the growth and proliferation of human bladder cancer cells (P＜0.05). iASPP know-down could decrease the colony formation of 5637 and T24 cells (P＜0, 05). Knocking down of iASPP in 5637 and T24 cells showed cell arrested at G1. Conclusions Silencing of iASPP gene could inhibit proliferation and colony formation of bladder cancer, iASPP might be an important target for gene therapy of bladder cancer.

Objective To explor the value of Tei index for evaluation the cardiac function of patients with chronic heart failure(CHF).Methods Tei index in 60 patients with CHF(CHF group) and 30 normal controls(control group) were evaluated and compared with the levels of NT-ProBNP and the NYHA class,and the sensitivity and specificity of Tei index for CHF diagnosis were appraised.Results (1) Tei index in CHF group was significantly higher than that in control group.When Tei index was more than and equal to 0.45,the sensitivity,specificity,positive predictive value,and negative predictive value of Tei index for diagnosing CHF were 85.6％,90.4％,89.8％ and 78.0％.(2)There was a remarkable positive correlation between Tei and Log NT-ProBNP(r =0.84,P ＜ 0.01).(3)There were significant differences in Tei index among NYHA Ⅱ,Ⅲ,Ⅳ class [(0.47 ± 0.06),(0.56 ± 0.08),(0.64 ±0.13)].Conclusion Tei index can be used to diagnose CHF and evaluate the degree of it.

Objective To observe the application of amniotic membrane in conjunctival sac plasty.Methods 24 cases with different eye diseases were performed with conjunctival sac plasty,in which 11 eyes were performed with amniotic membrane transplantation,5 eyes with symblepharon which adhered with cornea or emerged neovascularization were performed with amniotic membrane transplantation and lamellar keratoplasty,other 8 eyes were performed with amniotic membrane transplantation and conjunctival fornixe.They were followed up for 6~12 months.Results There was no inflammation observed after operation.The transplanted amniotic membrane turned transparent and the conjunctiva at sewing location crawled to amnion 10 d after operation.One month later,the neonatal conjunctiva covered transplanting region completely.Among the 24 eyes,9 eyes were healed,13 eyes were improved,and 2 were ineffective.Conclusion Amniotic membrane is a kind of effective material during conjunctival sac plasty for narrow conjunctival sac.

Objective To study the early response and acute/subacute adverse effects after particle radiation therapy for adenoid cystic carcinoma (ACC) of the head and neck.Methods Between May 2015 and March 2016,a total of 8 patients with ACC of the head and neck were treated using proton and/or carbon-ion radiation therapy.Three patients had early stage and 5 had locally advanced disease.Five patients had an R2 and three achieved an R1 resection.Results Seven patients received intensitymodulated proton therapy (IMPT) followed by intensity-modulated carbon-ion therapy (IMCT) boost.One patient received IMPT only.Among the five patients who had an R2 resection,2/3 patients had partial response (PR)/stable disease (SD) at the end of radiation,0/3 achieved PR/complete response (CR) at 1-month follow-up,and 1/2 achieved PR/CR at 3-months' follow-up after the completion of radiation,respectively.Two patients experienced Grade Ⅲ mucositis during radiation therapy.No patient experienced moderate or severe skin reactions.At the time of this analysis,all patients are alive and no patient had disease progression or recurrence.Conclusions The short-term outcomes indicated that particle therapy is safe and potentially efficacious in the management of head and neck ACC.However,longer follow up is needed to assess late toxicities and long-term efficacy.

Purpose: Enhanced recovery after surgery (ERAS) is an evidence-based perioperative measure to improve outcomes. Although the benefits of ERAS are well proven for other surgeries, little is known about its effect on off-pump coronary artery bypass graft (OPCABG) surgery. Thus, this study aimed to explore the effect of an ERAS protocol in patients who underwent OPCABG surgery. Methods: This quasi-experimental study included 94 participants (traditional care group = 47 vs ERAS group = 47). An ERAS protocol was established by a multidisciplinary team. Knowledge of coronary artery disease, fasting time, water deprivation time, extubation time of the tracheal tube and pericardial and mediastinal drainage tube, off-bed activity participation rate, length of hospital stay, hours of intensive care unit (ICU) stay, expenses in ICU, incidence rates of ICU delirium and postoperative nausea and vomiting, and the 6-Minute Walk Test on postoperative day 7 were recorded and calculated between the groups. Results: Demographics, lifestyle, and disease severity showed no significant difference between the two groups (p > .05). The ERAS group patients had improved understanding of coronary artery disease (t = −3.89, p < .01), shorter fasting time (t = 7.98, p < .01), shorter water deprivation time (t = 9.29, p < .01), increased off-bed activity participation (t = 17.67, p < .01), and the improved 6-Minute Walk Test on postoperative day 7 (t = −3.23, p < .01). Conclusions The ERAS protocol is safe and effective for patients undergoing OPCABG surgery.

Purpose: Enhanced recovery after surgery (ERAS) is an evidence-based perioperative measure to improve outcomes. Although the benefits of ERAS are well proven for other surgeries, little is known about its effect on off-pump coronary artery bypass graft (OPCABG) surgery. Thus, this study aimed to explore the effect of an ERAS protocol in patients who underwent OPCABG surgery. Methods: This quasi-experimental study included 94 participants (traditional care group = 47 vs ERAS group = 47). An ERAS protocol was established by a multidisciplinary team. Knowledge of coronary artery disease, fasting time, water deprivation time, extubation time of the tracheal tube and pericardial and mediastinal drainage tube, off-bed activity participation rate, length of hospital stay, hours of intensive care unit (ICU) stay, expenses in ICU, incidence rates of ICU delirium and postoperative nausea and vomiting, and the 6-Minute Walk Test on postoperative day 7 were recorded and calculated between the groups. Results: Demographics, lifestyle, and disease severity showed no significant difference between the two groups (p > .05). The ERAS group patients had improved understanding of coronary artery disease (t = −3.89, p < .01), shorter fasting time (t = 7.98, p < .01), shorter water deprivation time (t = 9.29, p < .01), increased off-bed activity participation (t = 17.67, p < .01), and the improved 6-Minute Walk Test on postoperative day 7 (t = −3.23, p < .01). Conclusions The ERAS protocol is safe and effective for patients undergoing OPCABG surgery.

Objective : To investigate the serum levels of antibodies against SARS-CoV-2 after inoculation of an inactivated SARS-CoV-2 vaccine, so as to provide insights into the evaluation of the vaccine immunogenicity. Methods : In this single-arm Objective performance criteria trial, residents aged 18 to 59 years and inoculated with an inactivated SARS-CoV-2 vaccine in Xihu District, Hangzhou City from October to December of 2020 were selected using a cluster sampling method. Blood samples were collected prior to inoculation, 14 and 28 days post-inoculation of the first dose, and 28 days post-inoculation of the second dose. Serum levels of anti-SARS-CoV-2 IgM and IgG antibodies were detected using the magnetic particle-based chemiluminescence immunoassay. The seroconversion of antibodies and dynamic changes of antibody levels were analyzed. Results : Totally 310 participants were enrolled, including 133 subjects on day 14 post-inoculation of the first dose, 97 subjects on day 28 post-inoculation of the first dose and 254 subjects on day 28 post-inoculation of the second dose. The seroconversion rates of anti-SARS-CoV-2 IgG antibody were 6.02%, 28.87% and 98.43%, and the median IgG antibody levels were 1.76 ( interquartile range, 3.25 ), 5.69 ( 9.95 ) and 52.05 ( 47.60 ) AU/mL ( P<0.05 ), respectively, while the seroconversion rates of anti-SARS-CoV-2 IgM antibody were 9.02%, 11.34% and 12.99%, and the median IgG antibody levels were 1.89 ( 3.28 ), 2.06 ( 4.71 ) and 2.65 ( 4.01 ) AU/mL ( P>0.05 ), respectively. In addition, higher serum levels of anti-SARS-CoV-2 IgG and IgM antibodies were detected post-inoculation relative to pre-inoculation ( P<0.05 ), and higher serum IgG antibody levels were found in subjects aged 18 to 39 years than in those aged 40 to 59 years ( P<0.05 ). Conclusions Inoculation of two doses of the inactivated SARS-CoV-2 vaccine achieves a high immunogenicity among residents aged 18 to 59 years 28 days post-inoculation, and the anti-SARS-CoV-2 IgM antibody is detectable in some residents following inoculation of the first dose.

The electrospray ionization-ion mobility spectrometric (ESI-IMS) technique has the potential as an analytical separation tool in analyzing polypeptides and amino acids for fast screening unknown samples in anti-chemical and biological terror attacks. A method for detecting several polypeptides and amino acids was developed based on ESI-IMS using air as drift gas at room temperature. The ion mobility of four amino acids and two polypeptides dissolved in methanol was determined on the system at elution rate of 2 mL/ min. The spectra of these compounds had characteristics of finger-printing maps. The limit of detection of this instrument for Substance P could reach 855 ng / mL in 1 min. The results showed that a small, self-contained ESI-IMS instrument with reservoirs of air could be used to quickly detect and accurately identify polypeptides and amino acids.

Background:After deifnitive chemoradiotherapy for non-metastatic nasopharyngeal carcinoma (NPC), more than 10% of patients will experience a local recurrence. Salvage treatments present signiifcant challenges for locally recur-rent NPC. Surgery, stereotactic ablative body radiotherapy, and brachytherapy have been used to treat locally recur-rent NPC. However, only patients with small-volume tumors can beneift from these treatments. Re-irradiation with X-ray—based intensity-modulated radiotherapy (IMXT) has been more widely used for salvage treatment of locally recurrent NPC with a large tumor burden, but over-irradiation to the surrounding normal tissues has been shown to cause frequent and severe toxicities. Furthermore, locally recurrent NPC represents a clinical entity that is more radio-resistant than its primary counterpart. Due to the inherent physical advantages of heavy-particle therapy, precise dose delivery to the target volume(s), without exposing the surrounding organs at risk to extra doses, is highly feasible with carbon-ion radiotherapy (CIRT). In addition, CIRT is a high linear energy transfer (LET) radiation and provides an increased relative biological effectiveness compared with photon and proton radiotherapy. Our prior work showed that CIRT alone to 57.5 GyE (gray equivalent), at 2.5 GyE per daily fraction, was well tolerated in patients who were pre-viously treated for NPC with a deifnitive dose of IMXT. The short-term response rates at 3–6months were also accept-able. However, no patients were treated with concurrent chemotherapy. Whether the addition of concurrent chemo-therapy to CIRT can beneift locally recurrent NPC patients over CIRT alone has never been addressed. It is possible that the beneifts of high-LET CIRT may make radiosensitizing chemotherapy unnecessary. We therefore implemented a phase I/II clinical trial to address these questions and present our methodology and results. Methods and design:The maximal tolerated dose (MTD) of re-treatment using raster-scanning CIRT plus concur-rent cisplatin will be determined in the phase I, dose-escalating stage of this study. CIRT dose escalation from 52.5 to 65 GyE (2.5 GyE×21–26 fractions) will be delivered, with the primary endpoints being acute and subacute toxicities. Effcacy in terms of overall survival (OS) and local progression-free survival of patients after concurrent chemotherapy plus CIRT at the determined MTD will then be studied in the phase II stage of the trial. We hypothesize that CIRT plus chemotherapy can improve the 2-year OS rate from the historical 50% to at least 70%. Conclusions:Re-treatment of locally recurrent NPC using photon radiation techniques, including IMXT, provides moderate effcacy but causes potentially severe toxicities. Improved outcomes in terms of effcacy and toxicity proifle are expected with CIRT plus chemotherapy. However, the MTD of CIRT used concurrently with cisplatin-based chemo-therapy for locally recurrent NPC remains to be determined. In addition, whether the addition of chemotherapy to CIRT is needed remains unknown. These questions will be evaluated in the dose-escalating phase I and randomized phase II trials.