With the international standardization for drugs and clinical trials, China established its management system to supervise the institutions that carry out drug tests and clinical trials. This article presents a systematic research of Beijing Clinical Pharmacological Center, to explore existing problems in clinical trials and propose strategies and measures to cope with these problems, thus facil itate the development of clinical drug trials in Beijing.

BACKGROUNDAn accurate pre-operative tumor staging is the premise for a successful operation, for which a non-invasive evaluation of the nature of lung nodules and the real extent of them is necessary. As the pioneer of functional images, nuclear medicine continues to introduce novel radiopharmaceuticals and new techniques for cancer imaging, including tetrofosmin (TF). The aim of this study is to evaluate the clinical usefulness of 99m Tc-tetrofosmin SPECT ( 99m Tc-TF SPECT) in the diagnosis of lung cancer and mediastinal lymph node involvement.

METHODSThirty-three patients with pulmonary neoplasms took both CT scan and 99m Tc-TF SPECT in one week before their operations or puncture biopsy. Then the sensitivity, specificity and accuracy were acquired according to the pathological outcomings and the results of 99m Tc-TF SPECT and CT were compared in detection of lung cancer and mediastinal lymph node metastasis, respectively.

RESULTSThe sensitivity, specificity, accuracy, positive predictive value and negative predictive value of 99m Tc-TF SPECT for lung cancer were 95.7%, 80.0%, 90.9%, 91.7%, 88.9%, and 73.9%, 70.0%, 72.7% , 85.0% , 53.8% by CT, respectively. The sensitivity, specificity, accuracy, positive predictive value and negative predictive value of 99m Tc-TF SPECT for mediastinal lymph node metastasis were 93.3%, 75.0%, 87.0% , 87.5%, 85.7%, while those of CT were 60.0%, 75.0%, 65.2%, 81.8%, 50.0% respectively. The sensitivity of 99m Tc-TF SPECT was significantly higher than that of CT for lung neoplasms (P < 0.05).

CONCLUSIONS99m Tc-TF SPECT is a useful non-invasive presurgical tool to evaluate primary lung cancers and mediastinal lymph node involvement, and it will play a favorable clinical role in diagnosis and staging of lung cancer.

Objective:To investigate the safety, efficacy and application indication of intra-operative cell salvage (IOCS) in cesarean section.Methods:A total of 1 265 pregnant women who received IOCS blood transfusion during cesarean section in 11 tertiary A hospitals from August 2016 to January 2019 were collected and divided into <1 500 ml group (796 cases) and ≥1 500 ml group (469 cases) according to the amount of blood loss during cesarean section. The general clinical data, ultrasonic imaging data, perinatal and puerperium indicators were analyzed retrospectively. The risk factors of intraoperative blood loss ≥1 500 mL using IOCS transfusion were analyzed by logistic multivariate regression.Results:(1) A total of 848 001 ml of blood was recovered and a total of 418 649 ml of blood was transfused in 1 265 pregnant women who received IOCS transfusions, which was equivalent to 23 258 U red blood cell suspension, greatly saving medical resources. The intraoperative blood loss in <1 500 ml group and ≥1 500 ml group was 800 ml (300-1 453 ml) and 2 335 ml (1 500-20 000 ml), respectively. No amniotic fluid embolism, severe adverse reactions, shock and death occurred in the two groups. (3) Multivariate regression analysis showed that age ≥35 years ( OR=1.5, 95% CI: 1.1-1.9), prenatal hemoglobin level <110 g/L ( OR=1.7, 95% CI: 1.3-2.2), history of uterine surgery ( OR=1.8, 95% CI: 1.3-2.6), placenta previa ( OR=1.9, 95% CI: 1.1-3.1), placenta accreta ( OR=2.6, 95% CI: 1.8-3.9), blood pool in the placenta ( OR=1.6, 95% CI: 1.1-2.3), abnormal posterior placenta muscle wall ( OR=1.8, 95% CI: 1.2-2.6), placenta projecting to the anterior uterine wall ( OR=3.0, 95% CI: 1.3-7.0) were risk factors for blood loss ≥1 500 ml in obstetric transfusion using IOCS technique, with statistical significance (all P<0.05). Conclusion:IOCS is safe and effective in cesarean section, which could save the medical resources and reduces medical expenses, however, it is necessary to strictly master the application indication.