The uncertain safety and effectiveness of test drugs and medical instruments in clinical trials might pose risks to the subjects, and pregnancy events emerging in clinical trials will increase the risks. At present, most of pregnancy events are recorded and reported as an adverse event, but due to their particularity, it is inappropriate to record and handle them with other adverse events. Pregnancy event closely is related to the interests of the sub-jects and the risk it might face, besides, it is also related to the interest and risk of their spouses and offspring. In order to handle pregnancy event, this paper elaborated responsibilities of researchers, sponsors and subjects accord-ing to the purpose of trials in three aspects, including experiment design, informed consent, and test expand, so that the interest of the subjects could get better protection.

Objective:To study the effect of the psychological counseling on the delivery mode of single birth elderly primiparas with anxiety and depression, and to seek a new and effective intervention way to improve the vaginal delivery rate.Methods:A preliminary screening was carried out for 486 single birth elderly primiparas received in the birth cohort research center of China Medical University from April 2018 to September 2019. Among them, 274 cases had mild, moderate or severe anxiety and depression. They were randomly divided into the observation group and the control group (n=137). The control group was given routine nursing measures and simple psychological education and the intervention group was given extra psychological counseling. Psychological counseling adopted the mode of combination of online and offline. The degree of anxiety and depression and the delivery mode were compared between two groups.Results:Before intervention, the degree of anxiety and depression between the observation group and the control group showed no significant difference. After intervention, the degree of anxiety and depression in the observation group was lighter than that of the control group ( χ2 value was 12.782, 6.647, P<0.05). The proportion of cesarean section, vaginal delivery, forceps delivery accounted for 32.1% (44/137), 67.2%(92/137), 0.7%(1/137) in the observation group, and 45.3% (62/137), 54.7%(75/137), 0 in the control group. The difference between the two groups showed statistical significance ( χ2 value was 5.787, P<0.05). Conclusion:The psychological counseling for the single birth elderly primiparas with anxiety and depression can effectively improve the psychological situation and increase the vaginal delivery rate.

Objective:To analyze the clinical and chest CT features in a family with interstitial lung disease(ILD), and assess the probable causative gene mutations for the family.Methods:In order to identify the etiology of the proband′s ILD, the pedigree was investigated.The clinical data of five proband′s pedigree members were collected, and the chest HRCT examination was performed on four proband′s pedigree members with respiratory symptoms.The human whole exon sequencing was performed on the proband′s blood samples, then its deleterious effects were assessed.Subsequently, the strong pathogenic mutation was validated by Sanger sequencing.Results:According to the family survey, there were five patients with ILD in the family, including three males and two females.One of them died.The surfactant protein C(SFTPC)gene(exon4, c.342G>T, p.K114N)was found in all four surviving patients.The mutation was considered to be originated from the father of the proband, and the pathogenic mutation was considered, which was not included in the databases and was a noval mutation.In addition, the clinical manifestations of different patients in the family were significantly different.Conclusion:The novel mutation of p. k114n in SFTPC gene can lead to ILD in children, and the mutation has incomplete exons in family members.Chest CT and whole exon sequencing play an important role in the diagnosis of ILD in children.

Objective:To investgate the effect of endovascular therapy (EVT) on the requirement for decompressive craniectomy (DC) and functional outcomes in patients with large anterior circulation ischemic stroke.Methods:Patients with large anterior circulation ischemic stroke within 24 hours of onset admitted to the Department of Neurology, West China Hospital, Sichuan University between September 2017 and December 2019 were included. Outcome indicators included DC demand and poor outcome at 3 months. The latter was defined as a modified Rankin Scale score >2. Multivariate logistic regression analysis was used to determine independent factors of DC requirement and functional outcomes at 3 months. Results:A total of 381 patients with large anterior circulation ischemic stroke were enrolled, including 203 males (53.3%), and the mean age was 70.7±14.3 years. The median time from onset to admission was 4.5 hours. The median baseline National Institutes of Health Stroke Scale score was 17 and median baseline Alberta Stroke Program Early Computed Tomography Score (ASPECTS) was 7. Totally 139 patients (36.5%) received EVT, and 64 (16.8%) required DC; 376 patients (98.7%) completed a 3-month follow-up (5 who did not complete follow-up did not require DC, of which 2 received EVT), 312 (83.0%) had poor outcome at 3 months, and 146 (38.8%) died. Multivariate logistic regression analysis showed that EVT was an independent predictor for the requiremet of DC (odds ratio [ OR] 4.42, 95% confidence interval [ CI] 1.81-10.81; P=0.001), higher baseline ASPECTS ( OR 0.80, 95% CI 0.71-0.89; P<0.001) and successful recanalization ( OR 0.37, 95% CI 0.15-0.90; P=0.028) were independent protective factors of reducing the requirement of DC. Successful recanalization ( OR 0.09, 95% CI 0.01-0.72; P=0.023) and antiplatelet therapy ( OR 0.29, 95% CI 0.11-0.76; P=0.012) were independent predictors for reduced risk of poor outcome. In 139 patients who received EVT, 27 (19.4%) received intravenous thrombolysis, 96 (69.1%) achieved successful recanalization, 88 (63.3%) had hemorrhagic transformation, 61 (43.9%) had symptomatic hemorrhagic transformation, and 34 (24.5%) required DC; 137 (98.6%) completed a 3-month follow-up, 116 (84.7%) had poor outcome at 3 months, and 67 (48.9%) died. For patients receiving EVT, a higher baseline ASPECTS ( OR 0.72, 95% CI 0.60-0.88; P=0.001) and successful recanalization ( OR 0.35, 95% CI 0.14-0.90; P=0.029) were independent predictors of reducing the requirement of DC, while successful recanalization ( OR 0.09, 95% CI 0.01-0.71; P=0.022) was an independent predictor for reduced risk of poor outcome. Among 64 patients who required DC, 22 (34.4%) received DC. Receiving DC significantly reduced the mortality within 3 months ( OR 0.25, 95% CI 0.07-0.86; P=0.028), but had no significant effect on functional outcome at 3 months ( OR 0.35, 95% CI 0.03-4.38; P=0.412). There was no significant interaction of either EVT or successful recanalization in the effect of DC on 3-month death ( P for interaction > 0.05). Conclusions:Successful recanalization after EVT reduces requirement for DC in patients with large anterior circulation ischemic stroke and improves functional outcome at 3 months. DC can reduce the mortality in patients required DC, and have no interactive effect with EVT or successful recanalization.

Objective To observe the effects of Shexiang Baoxin pill combined with intracoronary injection of nicorandil on myocardial perfusion and short-term prognosis after primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction. Methods 151 patients with acute myocardial infarction after PPCI were enrolled in this study. Those patients were admitted to our hospital during January 2017 to January 2018. According to the numerical randomization method, 51 patients were selected as routine treatment group (group A), 50 patients with intracoronary injection of nicorandil (group B) and 50 patients received intracoronary injection of nicorandil plus oral Shexiang Baoxin pills (group C). Intra-operative corrected TIMI frame count (cTFC), postoperative TIMI grade 3 blood flow ratio, 2-hour ECG ST segment fallback >50% index, the incidence of major adverse cardiovascular events (MACE) during hospitalization and the incidence of angina and MACE within 3 months after surgery were evaluated. Results cTFC, 2 hours postoperative ECG ST segment fall >50% index in group B and C were better than group A (P<0.05). The results from group C were better than group B. Group C exhibited better results than group B and C in post-operative angina pectoris 3 months after surgery (P<0.05). Conclusion Shexiang Baoxin pills combined with intra-coronary injection of nicorandil can improve myocardial perfusion and short-term prognosis after primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction