OBJECTIVE To investigate the effect of pharmaceutical services guided by root cause analysis （RCA） in a problem-oriented manner combined with knowledge-attitude-practice （KAP） theory on reducing the incidence of protocol violations of investigational medicinal products in pediatric clinical trials. METHODS A total of 617 participants from 69 drug clinical trial projects conducted in our hospital from January 2016 to December 2020 were selected as the control group， and 868 participants from 72 drug clinical trial projects from January 2022 to December 2025 as the observation group. RCA was performed on the protocol violations of investigational medicinal product in the control group to identify the types and underlying causes. The control group received routine pharmaceutical services for drug clinical trials， while the observation group was provided with precision pharmaceutical services from the three dimensions of knowledge， attitude and practice on the basis of routine pharmaceutical services， according to the root causes identified by RCA. The occurrence of investigational medicinal products protocol violations was compared between the two groups. RESULTS The total incidence of protocol violations of investigational medicinal products， as well as the incidences of minor and major protocol violations， were all significantly lower in the observation group than in the control group （ P ＜0.001）. The main types of protocol violations in both groups included missed/under-/over-dosing of medications， non-adherence to administration time， failure to adjust dosage as required， and combined medication/vaccination in violation of the protocol. Regarding the responsible subjects of protocol violations， the incidences of protocol violations attributed to participants and their guardians as well as investigators and accidental factors were significantly lower in the observation group than in the control group （ P ＜0.001， P ＜0.001， P ＝0.025）. However， there were no statistically significant differences in the incidences of protocol violations caused by sponsor-related reasons between the two groups （ P ＞0.05）. CONCLUSIONS Pharmaceutical services led by pharmacists， based on problem-oriented RCA and combined with KAP theory， can effectively reduce the protocol violations of investigational medicinal products rate in pediatric clinical trials， thereby safeguarding the safety and rights of study participants.

ObjectiveTo determine the complications of hypertension among local residents in Minhang district of Shanghai， and provide scientific evidence for key preventive intervention. MethodsWe retrieved the data from the electronic health records， in which hypertensive patients were included for community-based management， in Minhang district of Shanghai from January 1st， 2014 to December 31st， 2018. A total of 38 599 hypertensive patients who had not had hypertension related clinical symptom when included in the electronic health records were enrolled in our study. Chi-square test and Cochran-Mantel-Haenszel test were used to determine the complications of hypertension. ResultsThe incidence proportion of complications was 10.77%， of which cerebrovascular damage was the highest （7.44%）， followed by cardiac damage （3.55%） and peripheral vascular damage （0.81%）. The incidence proportions in patients aged 18‒59， 60‒69， 70 and above were 5.53%， 9.61% and 16.19%， respectively. There was significant difference in the incidence proportions of complications among age groups （χ²=668.670， P<0.05）. Cochran-Mantel-Haenszel test showed that in the hypertensive patients aged 60‒69， the incidence proportion of complications in females was lower than that in males （χ²=5.937， P<0.05）. However， in those aged above 70， the incidence proportion of complications in females was higher than that in males （χ²=11.619， P<0.05）. ConclusionIn patients with hypertension， the incidence proportions of cardiovascular and cerebrovascular diseases remains relatively high in Minhang district of Shanghai. Additionally， both age and gender have influence on the incidence of complications.

Objective To investigate the relationship between plasma homocysteine on admission and the outcome at discharge of acute ischemic stroke.Methods A non-concurrent cohort study was performed and a total of 1 3 1 9 patients with acute is-chemic stroke were continuously included in this study.According to tertile range of plasma homocysteine,patients were di-vided into three group.Logistic regression analysis was used to assess the independent association between plasma homocys-teine on admission and poor outcome at discharge of acute ischemic stroke.Results The difference of plasma homocysteine on admission between the poor outcome and those with good outcome had statistical significance (P<0.000 1).Without the adj ustment of multiple factors,when comparing to the first group,the second and third tertile seemed to have a tendency of increasing the risk of poor outcome at discharge,the OR (95%CI)was 2.111 (1.297~3.437,P<0.05),2.113 (1.361~3.279,P<0.05).After adjustment for multivariate,the second and third tertile also seemed to have a tendency of increasing the risk of poor outcome at discharge,the OR (95%CI)was 1.876 (1.160~3.036,P<0.05),2.396 (1.414~4.062,P<0.05).Conclusion The current study indicated that higher plasma homocysteine level was an independent risk factor for poor outcome at discharge in ischemic stroke patients.It would increase the risk of the outcome at discharge in patients with acute ischemic stroke,and suggests that there is a dose-response relationship between plasma homocysteine level on admis-sion and the poor outcome at discharge.

Objective To examine the association between uric acid (UA)levels of patients with acute ischemic stroke at ad-mission and discharged outcome.Methods The acute ischemic stroke patients of Xinganmeng People’s Hospital in Inner Mongolia,from June 1,2009 to May 31,2012 were continuity included in the present study,the included analysis sample size were 3 440 cases.Poor discharged outcome was defined as the occurrence of disability or death.With reference to the Modi-fied Rankin's Scale (MRs)Stroke Scale,Scores were recorded in the questionnaires,score of 3 or more (MRs≥3)was de-fined as disability.The patients were all grouped by P20,P60,P90 of UA,binary logistic regression were used in studying of risk factors,calculated the odds ratios (Odds ratio,OR)and 95% confidence interval (95% Confident interval,95%CI).All tests were two-sided test and a significance level of 0.05.Results A total of 359 people occurred poor outcomes in the stud-y,accounting for 10.44%.Univariate logistic regression analysis of poor outcome occurred showed that relative to the lowest group(P20,UA≤222.6 mmol/L),the second and third group (UA:222.7 ~ 310.9 mmol/L and 311.0~419.7 mmol/L) OR (95% CI)were:0.70(0.53~0.91)(P <0.05)and 0.66(0.49~0.88)(P <0.05).After adjusted age,body tempera-ture,high blood pressure,hyperglycemia,history of stroke,high triglycerides,high LDL-C and smoking,relative to the low-est level group,the second and third group occurred poor outcoming OR (95% CI)were:0.70(0.53~0.93)(P <0.05)and 0.66(0.48~0.90)(P <0.05).Conclusion Higher levels of uric acid levels in patients with acute ischemic stroke may inde-pendently related with occurred poor discharged outcome.

Objective To explore the adverse effects of recurrence of acute ischemic stroke at discharge.Methods Continuously including 3 440 acute ischemic stroke patients from June 1,2009 to May 31, 2012 in Department of Neurology of the People's Hospital of Xinganmeng of Inner Mongoha Autonomous Region were esearch objects.Poor outcome was defined as the occurrence of disability or death at discharge.Disability was defined as the Modified Rankin ' s Scale (MRs), when MRs was 3 or more.Binary logistic regression was used to analysis the risk factors ,calculated the odds ratios(OR) and 95％ confidence interval (95％CI).Results A total of 359 (10.44％) patients occurred poor outcomes, of whom 136 (37.88％) patients occurred the recurrence of ischemic stroke.Multiple logistic regression analysis showed that age (OR=1.24,95％CI 1.09-1.41), body temperature (OR =1.92,95 ％ CI 1.43-2.57), hypertension (OR =1.73,95 ％ CI 1.33-2.24), high blood sugar (OR=1.67,95％CI 1.26-2.20) ,glycerin trilaurate(OR=0.41,95％CI0.27-0.62) ,smoking (OR =1.37,95％CI 1.01-1.85) and recmrrence(OR=1.49,95％CI 1.15-1.95) were independent risk factors of poor outcome at discharge.The recurrence of acute ischemic stroke can increase the risk of the occurrence of poor outcome at discharge up to 49％.Conclusion Recurrence is an independent risk factor for the poor outcome of acute ischemic stroke, we should focus on secondary prevention of stroke patients at the clinical work and health education to reduce the recurrence of ischemic stroke.

Objective To observe the clinical effect of treating atlanto-axial subluxation by manipulative reduction therapy. Methods 128 patients with atlanto-axial subluxation confirmed by cervical plain X ray were randomized into two groups: 64 in the treatment group treated by manipulative reduction therapy, and 64 in the control group treated by the routine cervical traction. The clinical effect was evaluated by both clinical and X-ray confirmation. Results The X-ray study showed that after treatment the reconstruction of excursion in odontoid process in the treatment group was better than that in the control group significantly (P<0.01). The improvement of vertebra basal artery blood flow in the treatment group was also better than that in the control group significantly (P<0.05). The total effective rate of the treatment group was 95.3%, while the control group was 78.1%. Conclusion The technique of manipulative reduction on atlanto-axial subluxation acts more directly on the cause of the disease than the routine traction, and exerts better results in restoring proper atlanto-axiai joint position and mechanics stability of cervical vertebra.. Thus it is the effective shortcut way with high safety and low cost.