Objective To summarize experience of anti-cancer drug management for clinical trials,and to explore a more efficient and standardized management model of anti-cancer drugs used in clinical trials.Methods Based on our current work in central pharmacy,the particularity and complexity of anti-cancer drug management for clinical trials were analyzed.In the meantime,we identified high-risk parts in the drug management process.Based on those risks,feasible measures were taken and presented in detail.Results Management of anti-cancer drugs used in clinical trials has its characteristics,such as long cycle,low error-tolerant rate,closed-loop model,etc.Recognizing these representative high-risk parts during the trials and making responses,including standardization of drug management records and disposition of drugs and packaging returned by subjects,should be achieved as soon as possible.Conclusion Establishing and observing strict rules and regulations,improving the hardware and software performance of the central pharmacy as well as implementing risk-based drug management is beneficial to conduct clinical trials normatively.

Objective To observe the value of shear wave viscoelastography(SWV)for differentiating lung peripheral inflammatory masses and malignant tumors.Methods Conventional gray-scale ultrasound and SWV were prospectively performed in 70 patients with lung peripheral inflammatory mass or malignant tumor.The patients were divided into malignant group(n=42)and inflammatory group(n=28)according to pathological results.Clinical and ultrasonic data,including the maximum diameter of lesions,the mean Young's modulus(Emean),mean viscosity(Vmean),and mean dispersion slope(Dmean)were compared between groups.Receiver operating characteristic curves of ultrasonic parameters being significantly different between groups were drawn,and area under the curves(AUCs)were calculated to evaluate the efficacy of each parameter for differentiating lung peripheral inflammatory mass or malignant tumor.Results In malignant group,the maximum diameter and Emean of lesions were both higher,while Vmean and Dmean of lesions were both lower than those in inflammatory group(all P＜0.05).Vmean and Dmean of lesions had moderately/good efficacy for differentiating lung peripheral inflammatory mass or malignant tumor(AUC=0.843,0.866),both better than that of conventional ultrasound and Emean(AUC=0.673,0.685)(all P＜0.05).The combination of Emean,Vmean and Dmean had good efficacy for differentiating lung peripheral inflammatory masses and malignant tumors,with AUC of 0.874.Conclusion The viscous parameters of SWV could effectively differentiating lung peripheral inflammatory masses and malignant tumors.

Objective:To assess the clinical efficacy and safety of image-guided γ-ray stereotactic body radiation therapy(IG γ-SBRT)in treating advanced pancreatic cancer.Methods:A total of fifty-six patients with advanced pancreatic cancer admitted to Senior Department of Oncology Medicine of the Fifth Medical Center of Chinese PLA General Hospital(Department of Oncology of the Sixth Medical Center)from February 2017 to September 2020 were selected.All patients were treated with IG γ-SBRT,and the 50%-60%of isodose curve covered the planned target volume(PTV).The peripheral dose of each time was 3.0-4.5 Gy,and there were 10-11 times of treatment.The therapeutic effect was observed and was evaluated by follow-up.The visual analog scale(VAS)score was adopted to assess the situation of the pain of patients before and 3 months after treatment,and the adverse reaction of them.Results:In the 56 patients,52 cases occurred epigastric pain with VAS ranging from 3 to 10 points,among which 32 patients accompanied by symptoms such as lower back pain and abdominal distension.After 3 months of treatment,the results of reexamination and follow-up indicated that there were 48 patients whose VAS scores decreased 3 scores and above 3 scores on the basis of original scores,and the efficiency of treating pain was 92.3%.In addition,the VAS scores of 3 patients decreased 1-2 scores on the basis of original scores,which ratio was 5.85%of the total number of people.All 56 patients were reexamined at the 3rd month after treatment,and 13 cases of them obtained complete response(CR),and 37 cases obtained partial response(PR),and 1 case obtained progressive disease(PD),and 5 cases obtained stable disease(SD),and the objectively response rate(ORR)was 89.3%,and the locally control rate was 98.2%.In addition,median progression-free survival(PFS)was 6.5 months,and 1-year survival rate was 62.5%(35/56),and 2-year survival rate was 23.2%(13/56).The adverse reactions of 56 patients were the adverse reactions of digestive system and blood system,among which 47 patients occurred upper digestive tract reaction,and the incidence of adverse reactions was 83.9%(47/56).A total of 43 patients occurred myelosuppression,and the incidence of myelosuppression was 76.8%(43/56).Conclusion:IG γ-SBRT can effectively relieve the symptoms of metastatic pancreatic cancer,and improve the effectiveness of treatment,the local control rate and survival rate.The tolerance of adverse reaction of that is favorable,and the safety of that is higher.

Objective:To evaluate the efficacy and safety of 532-nm picosecond laser in the treatment of early-stage facial seborrheic keratosis.Methods:A total of 95 patients with early-stage facial seborrheic keratosis were prospectively enrolled from the Department of Dermatology, General Hospital of Ningxia Medical University between December 2020 and September 2022. All the patients received a session of 532-nm picosecond laser treatment, and were followed up for 6 months. A 4-point scale was used to evaluate the overall improvement of skin lesions for assessing the clinical efficacy. A VISIA skin detector was used to quantitatively determine the characteristic counts, absolute scores, and percentiles of brown spots before and after treatment, and the paired sample t-test was used to compare the quantitative indicators of brown spots before and after treatment. The patients′ pain grades were evaluated, and adverse reactions were recorded. Results:All the 95 patients with early-stage facial seborrheic keratosis received a session of 532-nm picosecond laser treatment, and completed a 6-month follow-up. All the patients achieved over 25% regression of skin lesions in the treatment area, of whom 10 received mild improvement, 17 received favorable improvement, and 68 received marked improvement, with the response rate being 89.47% (85/95). The examination with the VISIA skin detector showed that the characteristic counts (195.19 ± 51.06) and absolute scores (28.80 ± 6.20 points) of brown spots significantly decreased, while the percentiles of brown spots (38.48% ± 10.80%) significantly increased at 6 months after treatment compared with the corresponding baseline indicators (211.48 ± 50.94, 35.16 ± 6.84 points, 30.61% ± 10.27%, t = 12.73, 16.90, -15.73, respectively, all P < 0.001). All the patients experienced varying degrees of pain during the treatment, with the pain scores being 2 - 6 (3.64 ± 1.67) points, but all of them could tolerate the pain and completed the treatment. Temporary postinflammatory hyperpigmentation and hypopigmentation occurred in 9 (9.47%) and 4 (4.21%) patients respectively, and the skin color restored to normal during the 6-month follow-up. Conclusion:The 532-nm picosecond laser was safe and effective for the treatment of early-stage facial seborrheic keratosis.

Objective    To evaluate the effectiveness and safety of proximal aortic repair (PAR) versus total arch replacement (TAR) for treatment of acute type A aortic dissection (ATAAD). Methods     An electronic search was conducted for clinical controlled studies on PAR versus TAR for patients with ATAAD published in Medline via PubMed, EMbase, The Cochrane Library, Web of Science, Wanfang Database and CNKI since their inception up to April 30, 2022. The quality of each study included was assessed by 2 evaluators and the necessary data were extracted. STATA 16 software was used to perform statistical analysis of the available data. Results    A total of 28 cohort studies involving 7 923 patients with ATAAD were included in this meta-analysis, of whom 5 710 patients received PAR and 2 213 patients underwent TAR, and 96.43% of the studies (27/28) were rated as high quality. The meta-analysis results showed that: (1) patients who underwent PAR had lower incidences of 30 d mortality [RR=0.62, 95%CI (0.50, 0.77), P<0.001], in-hospital mortality [RR=0.64, 95%CI (0.54, 0.77), P<0.001], and neurologic deficiency after surgery [RR=0.84, 95%CI (0.72, 0.98), P=0.032] than those who received TAR; (2) the cardiopulmonary bypass time [WMD=–52.07, 95%CI (–74.19, –29.94), P<0.001], circulatory arrest time [WMD=–10.14, 95%CI (–15.02, –5.26), P<0.001], and operation time [WMD=–101.68, 95%CI (–178.63, –24.73), P<0.001] were significantly shorter in PAR than those in TAR; (3) there was no statistical difference in mortality after discharge, rate of over 5-year survival, renal failure after surgery and re-intervention, volume of red blood cells transfusion and fresh-frozen plasma transfusion, or hospital stay between two surgical procedures. Conclusion     Compared with TAR, PAR has a shorter operation time and lower early and in-hospital mortality, but there is no difference in long-term outcomes or complications between the two procedures for patients with ATAAD.

Objective:To measure the morphological parameters of the fetal vertebral centrum ossification centers (COC) in the second-third trimester using MRI susceptibility weighted imaging (SWI), and to explore the growth and development trajectory of the vertebrae.Methods:Fetus in the second-third trimester with normal vertebrae development were prospectively and continuously included in Shandong Provincial Hospital Affiliated to Shandong First Medical University from December 2015 to December 2021, and the SWI scanning of fetal spine was performed. The following morphometric parameters of the C4, T6, L3, S1 vertebrae COC were measured, including sagittal diameter, transverse diameter, height, cross-sectional area and volume. The linear and nonlinear regression analysis was used to derive the best-fit curve for each parameters and gestational age.Results:A total of 112 fetuses were recruited with gestatonal age 21-39 (29.4±3.9) weeks, including 30 cases of C4, 58 cases of T6, 92 cases of L3, 62 cases of S1. Fetal spine in utero with global curvature was kyphosis, presenting two primary curves (thoracic and sacral kyphosis). The morphological parameters sagittal diameter, transverse diameter, height, cross-sectional area and volume of C4 followed the quadratic polynomial rule during 25 to 38 weeks (R 2=0.938, 0.943, 0.952, 0.957, 0.982). During 21 to 38 weeks, the sagittal diameter, transverse diameter and height of the T6 followed the exponential growth pattern (R 2=0.915, 0.923, 0.849) and the growth of the area and volume followed the quadratic polynomial growth pattern (R 2=0.943, 0.961). The L3 followed the quadratic polynomial rule during 21 to 39 weeks (R 2=0.910, 0.916, 0.914, 0.942, 0.948) The sagittal diameter, transverse diameter and height of the S1 followed the linear growth pattern (R 2=0.905, 0.911, 0.922) and the area and volume followed the quadratic polynomial growth pattern (R 2=0.930, 0.964) during 23 to 39 weeks. Conclusions:The growth and development of C4, T6, L3 and S1 COC of fetus in the second-third trimester has a good correlation with gestational age. The growth of fetal vertebral COC in the early stage is slow, but with the growth of gestational age, the growth rate of vertebral bodies accelerates.

Objective:To investigate the clinical and molecular features of patients with CD7 +relapsed or refractory acute myeloid leukemia(r/rAML)and the prognosis of allogeneic hematopoietic stem cell transplantation (allo-HSCT). Methods:172 r/rAML patients who underwent allo-HSCT in department of hematology, Aerospace Center Hospital between January 1st 2017 and December 31st 2020 were retrospectively analyzed The patients were were divided into CD7 + group( n=75) and CD7 - group( n=97) according to the expression CD7 in the initial immunophenotype. Mann-Whitney U and Chi-square test were used to compare the clinical data, molecular and cytogenetic characteristics of the two groups of patients. Kaplan-Meier method was used to analyze the median progression-free survival (PFS) and median overall survival (OS) of the two groups of patients, and Cox regression screenthe prognostic factors of the patients. Results:The median follow-up time was 19 months. The recurrence rates were 23.71% and 50.67%, respectively in CD7 - and CD7 + group (χ 2=13.428 P<0.001). In relapsed patients, 86.96 percentage of CD7 - group did not express CD7 while 86.84 percentage of CD7 + group expressed CD7. The median PFS was 25 and 5 months in CD7 - and CD7 + group (χ 2=8.695, P=0.003), and the medianOS was 34 and 15 months in CD7 - and CD7 + group (χ 2=2.579, P=0.108). Univariate analysis showed that the CD7 +group, had the lower rates of morphological remission (χ 2=10.014, P=0.002), molecular remission (χ 2=22.809, P<0.001), and more male patients (χ 2=5.281, P=0.022). The incidence of CEBPA double-site mutation was higher (23.4% vs 8.2%, χ 2=8.180, P=0.004) and the rearrangement of RUNX1::RUNX1T1 was lower(4.0% vs18.6%, χ 2=8.362, P=0.004)in CD7 +group than in CD7 -group. Multivariate analysis showed that pre-transplant tumor load was the only prognostic factor for PFS (HR, 1.600; 95% CI, 1.203 to 2.127; P=0.001) and OS (HR, 1.737; 95% CI, 1.273 to 2.369; P<0.001) in r/r AML patients. Conclusion:CD7 expression is a risk factor for poor prognosis in r/r AML patients, and CD7 expression is stable after relapse. Positive CD7 can be used as a target for immune targeted therapy.

Objective:To investigate the effect of white noise reduction earplugs combined with eye mask on the sleep quality of ICU patients.Methods:A total of 136 patients who were hospitalized in the ICU ward of the Second People′s Hospital of Liaocheng from April to November 2019 were selected and divided into 3 groups according to the random number table method. Group 1 (3M earplug + eye mask, 45 cases), group 2 (white noise reduction earplug + eye mask, 46 cases), and group 3 (control group, 45 cases). On the first night after enrollment, all patients were given routine care only. On the second and third nights, group 1 was given 3M ear plugs and eye masks, group 2 was given white noise reduction earplugs and eye masks, and group 3 was given routine care only. On the morning of the second and fourth day, patients′ baseline Richards Campbell Sleep Questionnaire (RCSQ), Self-rating Anxiety Scale (SAS) and Self-rating Depression Scale (SDS) scores were assessed.Results:After the intervention, the sleep depth, sleep latency, wake at night, return to sleep, sleep quality, nocturnal subjective noise perception and total score in RCSQ in group 1 were (55.98 ± 19.65), (57.66 ± 19.56), (55.68 ± 16.25), (58.17 ± 11.32), (60.54 ± 16.33), (60.65 ± 12.58), (57.60 ± 17.21) respectively, in group 2 were (56.65 ± 18.36),(61.33 ± 20.33), (65.35 ± 23.22), (60.36 ± 19.35), (63.78 ± 20.36), (66.56 ± 10.21) and (61.49 ± 17.52), in group 3 were (45.96 ± 17.79), (48.36 ± 13.65), (48.21 ± 13.49), (51.36 ± 13.65), (51.33 ± 16.45), (43.06 ± 17.15) and (49.04 ± 15.32). There were statistically significant differences in each dimension and its total scores among the three groups (F values were 4.33-8.35, all P<0.05). Compared with group 3, each dimension and total scores of groups 1 and group 2 were higher than those of group 3, and the differences were statistically significant (t values were 2.37-7.96, all P<0.05). After the intervention, the SAS score of group 2 was (43.32 ± 21.68), which was lower than that of group 1 (57.75 ± 22.68) and group 3 (60.65 ± 19.88), and the difference were statistically significant (t=3.09, 3.99, both P<0.05).Conclusions:3M earplugs or white noise reduction earplugs combined with eye masks can effectively improve the sleep quality of ICU patients, and white noise reduction earplugs combined with eye masks can also relieve the anxiety of patients.

Objective:To preliminarily evaluate the effect of tension stimulation on the biological activity of and expression of fibrosis marker genes in keloid fibroblasts (KD-Fbs) .Methods:Three patients who were diagnosed with keloids and received surgical treatment were collected from the Department of Dermatology, Tangdu Hospital, the Fourth Military Medical University from January to March 2017. Human KD-Fbs were isolated from resected keloid tissues, and subjected to primary culture. The third- to sixth-passage KD-Fbs were divided into tension group and control group to be cultured in the tension-based chamber and control chamber respectively, and subjected to tension stimulation and normal culture respectively. Cell counting kit-8 (CCK8) assay was performed to assess the proliferative activity of KD-Fbs after 1-, 2-, 3- and 4-day culture, and the scratch assay to evaluate the migratory ability of KD-Fbs after 1- and 2-day culture. After 48-hour treatment, real-time quantitative PCR and Western blot analysis were performed to determine the mRNA and protein expression of fibrosis markers type Ⅰ collagen, fibronectin and α-smooth muscle actin (α-SMA) in KD-Fbs respectively. Two-independent-sample t test was used for comparisons between 2 groups. Results:CCK8 assay showed that the proliferative activity of KD-Fbs was significantly higher in the tension group than in the control group after 1-, 2-, 3- and 4-day culture ( t=3.05, 7.00, 16.65, 15.19, respectively, all P< 0.05) . After 1- and 2-day culture, the scratch assay showed that the migration rate of KD-Fbs was significantly higher in the tension group (48.65%±3.96%, 100.00%, respectively) than in the control group (9.36%±1.14%, 50.35%±4.23%, t=16.53, 20.35, respectively, both P< 0.01) . Real-time quantitative PCR showed that the mRNA expression of type Ⅰ collagen, fibronectin and α-SMA was significantly higher in the tension group (3.04±0.20, 2.16±0.10, 3.76±0.24, respectively) than in the control group (1.00; t=17.57, 21.01, 20.25, respectively, all P< 0.01) . As Western blot analysis revealed, changes in the protein expression of the 3 fibrosis markers were consistent with their mRNA expression changes (all P< 0.05) . Conclusion:Tension may participate in the fibrosis in keloids by promoting the expression of fibrosis marker genes, and enhancing the proliferative and migratory ability of KD-Fbs.

Objective:To explore the attitude of clinical nurses toward vital sign monitoring and analyze its influencing factors.Methods:From May to July, 2020, clinical nurses from three Class Ⅲ general hospitals in Liaocheng City were selected by convenient sampling and surveyed using a general information questionnaire, the Chinese version of the Vital Signs Monitoring Attitude Scale, and the Chinese version of the NASA Task Load Index (NASA-TLX) . A total of 747 questionnaires were collected in this study, and 721 of them were valid, accounting for an effective recovery rate of 96.5%.Results:The total score of the 721 clinical nurses' attitude toward vital signs monitoring was (56.48±6.72) . The results of multivariate analysis showed that working years, department, and workload were the influencing factors of clinical nurses' attitude toward vital signs monitoring ( P<0.05) . Conclusions:The positive attitude of clinical nurses toward vital monitoring needs to be improved, and nursing managers can start from human resource allocation to reduce their workload, encourage them to perform vital sign monitoring timely and properly, and identify changes in patients' conditions early.