Overall Incidence Of Adverse Reactions Research Articles

A Web-Based Survey on Factors for Unvaccination and Adverse Reactions of SARS-CoV-2 Vaccines in Chinese Patients with Psoriasis.

PurposeVaccination is one of the most important strategy to prevent infections and control epidemics, but it also raises concerns about safety in patients receiving treatments. This study aimed to investigate the rate and factors for unvaccination, as well as adverse reactions and deterioration of disease after SARS-CoV-2 vaccination in psoriatic patients.MethodsA web-based questionnaire survey on SARS-CoV-2 vaccination, adverse reactions, and self-reported change of disease condition after vaccination in patients with psoriasis was conducted. Demographic, clinical, and psychological data were collected. Multivariable logistic regression was used in the estimation of associations.ResultsA total of 788 psoriatic patients were investigated, and 68.9% reported SARS-CoV-2 vaccination. Younger age, use of interleukin-17 inhibitors, and symptoms of anxiety were associated with unvaccination. The incidence of overall adverse reactions after vaccination was 30.8%, and no severe adverse reaction was reported. The most common local and systemic adverse reactions were pain at the injection site and fatigue, respectively. Most patients reported no change in psoriasis after vaccination, while 16.6% and 4.4% reported slight and significant deteriorations of the disease, respectively. Nonadherence to treatment, symptoms of anxiety and depression, and perceived stress were associated with self-reported deterioration of psoriasis after vaccination.ConclusionWhile a favorable safety profile of SARS-CoV-2 vaccines is observed, receiving biologic treatment is factor for unvaccination in patients with psoriasis. Deterioration of psoriasis reported by a small proportion of patients is partially attributable to mental and behavioral factors.

Clinical Study on the Efficacy of Silver Ion Dressing Combined with Prontosan Gel Dressing in the Treatment of Diabetic Foot Ulcers and the Effect on Serum Inflammatory Factors.

Diabetic foot ulcers (DFUs) have a high disability rate and have a great impact on patients and society, and the search for effective and economical treatment options is a major clinical concern. In this study, 112 patients with DFU admitted to two hospitals from October 2018 to November 2020 were randomly divided into 56 cases each in the single group treated with Prontosan gel dressing and the joint group treated on silver ion dressing combined with Prontosan gel dressing. Both groups of patients were evaluated for efficacy after 30 days of treatment. The number of days for debridement, granulation tissue growth time, epithelial tissue formation time, and wound healing time were observed and recorded in both groups. The trauma area, visual analogue score (VAS), and levels of inflammatory factors such as vascular endothelial adhesion molecule-1 (VCAM-1), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), and C-reactive protein (CRP) were recorded before and after treatment in both groups. The occurrence of adverse reactions such as edema, fever, infection, and rash during treatment was recorded in both groups for safety assessment. Comparison of the abovementioned data showed that the clinical efficacy of the joint group was significantly higher than that of the single group. The number of days to clear wounds, granulation tissue growth time, epithelial tissue formation time, and wound healing time were significantly lower in the joint group than in the single group. The trauma area, VAS score, VCAM-1, IL-6, TNF-α, and CRP levels decreased in both groups after treatment compared with the pretreatment levels, with the joint group being lower than the single group. The results also showed that the difference in the overall incidence of adverse reactions between the two groups was not statistically significant, and the incidence was low and transient. In addition to the usual treatment regimen of blood glucose control and improvement of microcirculation for patients with DFU, combined treatment with silver ionomer dressings and Prontosan gel dressings can promote ulcer healing and improve foot wound regression. It has a stronger antibacterial effect and can more effectively reduce the inflammatory response of the ulcerated surface with fewer adverse effects, making it an effective and safe method for the treatment of DFU, and has implications for promotion.

Clinical Effect Analysis of Jianpi Bushen Yiqi Decoction on Patients with Chronic Nephritis

Select the actual clinical effect of Jianpi Bushen Yiqi Decoction on patients with chronic nephritis. Methods: A total of 60 patients with chronic nephritis who were admitted to our hospital from January 2018 to January 2019 were selected. They were divided into 2 groups according to the admission order, 30 cases each. The control group was treated with conventional western medicine, and the observation group was treated with Jianpi Bushen Yiqi Decoction on the basis of the control group. The renal function indexes and urinary protein index, clinical efficacy, TCM syndrome scores, and adverse reactions were compared between the two groups. Result: There was no difference in renal function and urinary protein indexes between the two groups before treatment (P> 0.05). After treatment, the indicators in the observation group were better than those in the control group (P <0.05). The total effective rate of treatment in the observation group was higher than that in the control group (P <0.05). There was no difference in TCM syndrome scores between the first two groups (P> 0.05). After treatment, the indicators in the observation group were better than those in the control group (P <0.05). The overall incidence of adverse reactions in the observation group was lower than that in the control group (P <0.05). Conclusion: Jianpi Bushen Yiqi Decoction has a significant effect on chronic nephritis, which can effectively improve the renal function and urinary protein index of patients, with few adverse reactions and great application value.

Study of Scraping with Copper Stone Based on Theory of Midnight-Noon Ebb-Flow in Angina Pectoris with Coronary Heart Disease of Qi Stagnation and Blood Stasis.

Angina pectoris (AP) with coronary heart disease (CHD) is one of the common cardiovascular diseases in clinical practice, which can be classified as “chest paralysis” in Chinese medicine according to its symptoms, and it is described in many ancient documents. Ancient Chinese medicine believes that the main pathogenesis of the disease is poor blood flow leading to paralysis of the heart and veins, so it is often treated by activating blood and removing blood stasis. In this study, 120 patients with AP of CHD of Qi stagnation and blood stasis type were randomly divided into the observation (n = 60) and the control group (n = 60). In the control group, basic care, conventional treatment, and unselected copper acupuncture scraping were used, while in the observation group, copper acupuncture scraping was performed at the right time of the heart meridian (11 : 00–13 : 00) on the basis of the control group, and all patients received the treatment for a total duration of 4 weeks. We collected data on the traditional Chinese medical (TCM) syndrome score, frequency and duration of angina attacks, nitroglycerin dosage, inflammatory factor levels, and hematological indices pretreatment and posttreatment in both groups. Patients' adverse effects during treatment were recorded, and the clinical efficacy and ECG efficacy in both groups were evaluated after 4 weeks. We used SPSS.20 statistical software to statistically analyze the above data, and the results showed that the clinical efficacy and ECG efficacy of the observation group were significantly higher than the control group posttreatment. After treatment, the TCM symptom score, angina attack frequency, attack duration and nitroglycerin dosage, serum interleukin-8 (IL-8), hypersensitive C-reactive protein (hs-CRP), and tumor necrosis factor-α (TNF-α) levels, whole blood viscosity (WBV), plasma viscosity (PV), fibrinogen (FIB), and hematocrit (Hct) were significantly lower in both groups compared with those posttreatment. And the observation group showed a greater decrease when compared with the control group. The results also showed that the overall incidence of adverse reactions was lower in both groups during the treatment period. The above results indicate that while ensuring high safety, the copper stone based on theory of midnight-noon ebb-flow can more effectively improve the symptoms and inflammatory response of the body and reduce the viscosity of the blood in AP with CHD of Qi stagnation and blood stasis, and it has better therapeutic effects.

Impact of CYP2C19 Genotype on Voriconazole Exposure and Effect of Voriconazole on the Activity of CYP3A in Patients with Hematological Malignancies

Voriconazole (VRC) is a first-line drug for the treatment of invasive fungal infections (IFIs) and an inhibitor of CYP3A activity.The aims of this study is to investigate the influence of related factors on the plasma concentration of voriconazole and the effect of voriconazole on the activity of CYP3A in patients with hematological malignancies. A total of 89 patients received an initial dose of 6 mg/kg followed by 4 mg/kg every 12 h were included in the study. Blood samples were collected before and 2 h after administration for subsequent testing and for the extraction of DNA samples. Voriconazole and voriconazole N-oxide in the plasma were detected by LC-MS/MS. The effect of voriconazole on CYP3A activity was evaluated by the ratio of the endogenous biomarkers 6β-hydroxycortisol and cortisol. During the study period, the overall incidence of adverse reactions was 33.6% (with no deaths). The metabolite type of CYP2C19 and combined use of CYP2C19 enzyme inhibitors both had a significant impact on voriconazole exposure. Voriconazole has a long-lasting and potent inhibitory effect on CYP3A activity. The exposure of CYP3A substrate in combination with metabolic enzyme inhibitors voriconazole could increase. Therefore, the combination uses with voriconazole need to be considered carefully and assessed adequately.

A clinical study of camrelizumab combined with chemotherapy and sequential apatinib in the second-line treatment of patients with advanced non-small cell lung cancer.

e21051 Background: Camrelizumab combined with chemotherapy has shown a higher efficiency and survival benefit in clinical studies of the first-line treatment of lung cancer. This study aims to observe the clinical efficacy and safety of camrelizumab combined with chemotherapy and sequential apatinib in the second-line treatment of patients with advanced non-small cell lung cancer in a real environment. Methods: This is a prospective, open, multi-center observational study that includes advanced lung cancer that is older than 18 years old, regardless of gender, with an ECOG score of 0-1, and recurrence or failure after first-line platinum-based dual-drug chemotherapy patient. Results: As of January 25, 2021, a total of 18 patients were enrolled, of which 12 were female (66.67%), 11 patients had an ECOG PS score of 1 point (61.11%), and 15 patients were stage IV (83.33%), patients, 5 patients with tissue poorly differentiation (27.78%), 55.56% of the patients had undergone immunohistochemical testing, and 66.67% of the patients had become positive for the gene. A history of radiotherapy accounted for 11.11%, and a history of surgery on the primary lesion accounted for 27.78%. Previous first-line chemotherapy options were pemetrexed combined with cisplatin (22.22%), pemetrexed combined with lobaplatin (22.22%), pemetrexed combined with carboplatin (11.11%), bevacizumab combined with Platinum dual-drug regimen (38.89%); Among the 10 patients with evaluable efficacy, 0 had CR, 2 had PR, 6 had SD, and 2 had PD. The ORR reached 20.00% and the DCR reached 80.00%. The overall incidence of adverse reactions is low, and the medication process is safe and controllable. Conclusions: In this second-line clinical study of lung cancer, most of the patients enrolled were patients with poor PS scores and later stages, but the effectiveness and safety of carrelizumab in patients with advanced lung cancer were still confirmed. The dominant population and the combined treatment plan are still being studied. Clinical trial information: ChiCTR2000034597.

Safety and immunogenicity of COVID-19 vaccination in patients with non-alcoholic fatty liver disease (CHESS2101): A multicenter study

Background & AimsThe development of COVID-19 vaccines has progressed with encouraging safety and efficacy data. Concerns have been raised about SARS-CoV-2 vaccine responses in the large population of patients with non-alcoholic fatty liver disease (NAFLD). The study aimed to explore the safety and immunogenicity of COVID-19 vaccination in NAFLD.MethodsThis multicenter study included patients with NAFLD without a history of SARS-CoV-2 infection. All patients were vaccinated with 2 doses of inactivated vaccine against SARS-CoV-2. The primary safety outcome was the incidence of adverse reactions within 7 days after each injection and overall incidence of adverse reactions within 28 days, and the primary immunogenicity outcome was neutralizing antibody response at least 14 days after the whole-course vaccination.ResultsA total of 381 patients with pre-existing NAFLD were included from 11 designated centers in China. The median age was 39.0 years (IQR 33.0–48.0 years) and 179 (47.0%) were male. The median BMI was 26.1 kg/m2 (IQR 23.8–28.1 kg/m2). The number of adverse reactions within 7 days after each injection and adverse reactions within 28 days totaled 95 (24.9%) and 112 (29.4%), respectively. The most common adverse reactions were injection site pain in 70 (18.4%), followed by muscle pain in 21 (5.5%), and headache in 20 (5.2%). All adverse reactions were mild and self-limiting, and no grade 3 adverse reactions were recorded. Notably, neutralizing antibodies against SARS-CoV-2 were detected in 364 (95.5%) patients with NAFLD. The median neutralizing antibody titer was 32 (IQR 8-64), and the neutralizing antibody titers were maintained.ConclusionsThe inactivated COVID-19 vaccine appears to be safe with good immunogenicity in patients with NAFLD.Lay summaryThe development of vaccines against coronavirus disease 2019 (COVID-19) has progressed rapidly, with encouraging safety and efficacy data. This study now shows that the inactivated COVID-19 vaccine appears to be safe with good immunogenicity in the large population of patients with non-alcoholic fatty liver disease.

The efficacy of hypofractionated radiotherapy (HFRT) with concurrent and adjuvant temozolomide in newly diagnosed glioblastoma: A meta-analysis

PurposeThe efficacy of hypofractionated radiotherapy (HFRT) in glioblastoma (GBM) without age restrictions remains unclear. The aim of this meta-analysis is to access the survival outcomes of HFRT in these patients. MethodsA comprehensive electronic literature search of PubMed, Web of Science and Cochrane Library was conducted up to June 1, 2020. The main evaluation data were the overall survival (OS) rate at 12 months and 24 months and the progression-free survival (PFS) rate at 6 and 12 months. The secondary evaluation data was the incidence of radionecrosis and adverse events. The study was performed using R “meta” package. ResultsEleven studies met the inclusion criteria, which totally contained 484 participants. The 12-month OS and 24-month OS rate of HFRT in GBM were 71.3% and 34.8%, while the 6-month PFS and 12-month rate were 74.0% and 40.8%. Compared to low-BED (biological equivalent dose) schedules (<78Gy), high-BED schedules may increase survival benefit both in PFS-6 (P=0.003) and PFS-12 (P=0.011), while the difference did not show on OS. Different dose per fraction had no significant effect on both OS and PFS. Incidence of radionecrosis was 14.2%. Although the overall incidence of adverse reactions cannot be quantified, the toxicity of HFRT was acceptable. ConclusionsCompared with survival data for standard treatment, HFRT seemed to improve overall survival and progression-free survival, while high BED schedules may future increase benefit on PFS. Meanwhile, the toxicity of HFRT was tolerable. Further randomised controlled clinical studies are needed to confirm these findings.

Evaluation of Immune Response and Disease Flares in Metabolic-Associated Fatty Liver Disease (MAFLD) Patients Following SARS-CoV-2 Vaccination: A Prospective Study

Background: The ongoing COVID-19 pandemic has led to the focused application of resources toward developing vaccines to prevent COVID-19. However, the efficacy and safety profiles of vaccines against SARS-CoV-2 in patients with metabolic associated fatty liver disease (MAFLD) are still unknown. We aimed to evaluate the safety, tolerability, seroreactivity, and disease flares after SARS-CoV-2 vaccination in MAFLD patients.Methods: For this prospective observational study, we recruited patients receiving two doses SARS-CoV-2 vaccine (CoronaVac). Neutralizing antibody to the SARS-CoV-2 spike receptor-binding domain and IgG to SARS-COV-2 spike-specific were evaluated on Day 0, Day 28, Day 57, and Day 180. All participants with available data were included in the safety and immunogenicity, and disease flares analyses.Findings: 50 MAFLD patients and 50 healthy controls receiving a 0-28 interval vaccination procedure were enrolled. The seroconversion rates of neutralizing antibodies were 16% in MAFLD group (Log10 Geometric Mean Titers (GMT): median 0·783, IQR: 0·719-0·971) and 32% in non-MAFLD group (0·884, IQR: 0·716-1·027) on day 28, and 82% in MAFLD group (1·206, IQR: 1·053-1·467), 90% of non-MAFLD group (1·360, IQR: 1·130-1·464) on day 57, respectively. However, the neutralizing antibody titer in two groups fell below the seropositivity cut-off value on day 180 (MAFLD group 0.928, IQR: 0·773-1·057 vs. non-MAFLD group 0·907, IQR: 0·810-1·009). There was no significant difference in the overall incidence of adverse reactions after two-dose vaccinations between two groups. Furthermore. disease flares were not found in MAFLD group after two-dose vaccinations. On multivariable analysis, NAFLD fibrosis score was negatively associated with seropositive of neutralizing antibody on 180 days (OR 0·03, 95% CI 0·001-0·58, P = 0·022).Interpretation: Two-dose regimen of CoronaVac vaccination in MAFLD patients was safe and well tolerated. MAFLD patients showed a robust immune response after SARS-COV-2 vaccination, which conferred 82% protection against COVID-19 and vaccination does not affect MAFLD disease status.Clinical Trial Registration Details: This trial had been registered in Chinese ClinicalTrials.gov (ChiCTR2100042717).Funding Information: Project of Key Medical Disciplines of Hangzhou, the Health and Science and Technology Planning Project of Hangzhou municipal Health Commission (No. A20210205).Declaration of Interests: JP Shi reports grants from Project of Key Medical Disciplines of Hangzhou for the Department of infectious & Hepatology. QR Zhu reports grants from the Health and Science and Technology Planning Project of Hangzhou municipal Health Commission, during the conduct of the study. All authors declare no competing interests. Ethics Approval Statement: The study was approved by local Hospital Ethics Committee (2021(E2)-KS-049) and written informed consent was obtained from patients involved before enrolment when data were collected.

Efficacy, safety and compliance of immunotherapy in the treatment of allergic rhinitis: a Meta-analysis

Objective: By use of Meta analysis to compare efficacy, safety and compliance of subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT) on allergic rhinitis (AR). Methods: Cochrane Library, Pubmed, Embase, CNKI Database, Wan Fang and Chinese Sci-tech Journal Database (from established time to May of 2018) were searched for trials about the AR treated by SCIT and SLIT. The relevant literatures were screened, and the randomized controlled studies were chosen. Nasal symptom scores, visual analogue scale (VAS) scores, adverse reactions and compliance were used as the outcome indicators, and the methodological quality of the literatures was evaluated strictly. The extracted data were analyzed by RevMan 5.3 and Stata 14 software. Results: A total of 20 randomized controlled studies were included, the overall quality of which was relatively high. No publication bias was found. There was no significant difference in nasal symptom scores, VAS scores and compliance between SCIT and SLIT (SMD value was 0.03, 0.14, respectively, RR=1.12; 95%CI value was -0.17-0.23, -0.03-0.31, 0.92-1.35, respectively, all P>0.05); SLIT group resulted in lower overall incidence of adverse reactions than that of SCIT group (RR=1.79, 95%CI: 1.42-2.26, P<0.05). Conclusion: Both SCIT and SLIT have similar eppecacy and compliance for treatment of AR, while adverse reactions are more frequently observed in SCIT.

Clinical effect of ultrasound-guided thoracic paravertebral nerve block on anesthesia and postoperative analgesia in patients undergoing radical resection of lung cancer

Objective To observe the clinical effect of ultrasound-guided thoracic paravertebral nerve block on anesthesia and postoperative analgesia in patients undergoing radical resection of lung cancer. Methods From August 2016 to August 2018, 88 patients who had undergone selective radical resection of lung cancer in the Traditional Chinese Medicine Hospital of Jinhua were divided into study group and control group according to random number table, with 44 cases in each group.The patients in the control group were given epidural block combined with general anesthesia.The patients in the study group were given ultrasound-guided thoracic paravertebral nerve block combined with general anesthesia.The hemodynamic parameters such as SpO2, MAP and HR were monitored before and after anesthesia(T0), after blocking anesthesia administration(T1), after induction and extubation(T2), after skin incision(T3) and extubation(T4). The serum levels of NE, Cro, hs-CRP and TNF-α were measured before and after operation.The VAS scores were scored at different time points after operation.The adverse reactions after anesthesia were observed. Results The values of MAP and HR at each time point of T1-T4 in the control group were significantly lower than those at T0(t=5.067-14.839, all P 0.05). At 6h, 12h, 24h and 48h after operation, the levels of serum NE, Cro, hs-CRP and TNF-α in both two groups were significantly higher than those before operation(t=16.289-38.520, all P<0.05), and the levels of serum NE, Cro, hs-CRP and TNF-α in the study group were significantly lower than those in the control group at all time points after operation(t=4.925-12.162, all P<0.05). The VAS scores of resting state and cough state at different time points in the study group were significantly lower than those in the control group(t=6.593-8.424, all P<0.05). The overall incidence of adverse reactions in the study group[18.18%(8/44)] was significantly lower than that in the control group[38.64%(17/44)](χ2=4.526, P=0.033). Conclusion Compared with epidural anesthesia, ultrasound-guided thoracic paravertebral nerve block combined with general anesthesia can effectively maintain the stability of blood flow, reduce the level of post-operative stress and inflammatory reaction, alleviate the degree of post-operative pain response, and prevent the occurrence of adverse reactions after anesthesia, which is worthy of clinical application. Key words: Ultrasonography; Anesthesia, epidural; Nerve block; Lung neoplasms; Pulmonary surgical procedures; Hemodynamics; Analgesia

Effects of general anesthesia maintenance without muscle relaxants for double-balloon enteroscopy: a randomized controlled trial

Objective To evaluate the feasibility and safety of maintaining general anesthesia without neuromuscular blockade in oral double-balloon enteroscopy. Methods Totally 120 patients undergoing oral double-balloon enteroscopy under general anesthesia were randomly assigned into two groups: the observation group and the control group. The observation group was not given muscle relaxants for anesthesia maintenance, while the control group was given muscle relaxants punctually. Observation indexes were monitored, including the mean arterial pressure (MAP), heart rate (HR), peak airway pressure (Ppeak) and end-tidal CO2 partial pressure (PETCO2) before anesthesia (T0), immediately after intubation (T1), at the time of endoscopy placement (T2), at the end of endoscopy withdrawal (T3), and at the time of waking-up (T4). The cases of spontaneous breathing recovery before the end of endoscopy, postoperative recovery time, extubation time, length of PACU stay, postoperative adverse reactions and satisfactory rates were recorded. Results Twelve cases were removed by the exclusion criteria, and the remaining 108 cases completed the study, including 56 cases in the observation group and 52 cases in the control group. The one-time success rate of induction was both 100% in the two groups. There were no significant differences in MAP, HR, Ppeak, and PETCO2 between the two groups at each observation point (all P>0.05), and the same is true for within group comparison with T0 (all P>0.05). The recovery rate of spontaneous respiration in the observation group was significantly higher than that in the control group [100% (56/56) VS 42% (22/52), χ2=44.73, P=0.000]. The awaken time, extubation time and length of PACU stay were 6±2 min, 10±3 min, and 11±4 min, respectively, in the observation group, compared with 15±5 min (t=-12.64, P=0.000), 17±5 min (t=-8.90, P=0.000), and 17±7 min (t=-5.73, P=0.000) in the control group. None of the patients required assisted ventilation. Hypoxemia occurred in 2 cases and nausea in 3 cases in the control group, while only nausea occurred in 1 patient in the observation group. The overall incidence of adverse reactions was not statisticaly different between the two groups (P>0.05). Anesthesia satisfaction rate of two groups was 100%. Conclusion It is feasible and safe to perform oral double-balloon enteroscopy without muscle relaxants during maintaining under general anesthesia, with quick recovery of spontaneous breathing and awakening, early extubation and less cost. Key words: Anesthesia, intravenous; Without muscle relaxants; Double-balloon enteroscopy

Efficacy analysis of probiotics combined with standard therapy for eradication of Helicobacter pylori in children

Objective To evaluate the efficacy and safety of compound Lactobacillus acidophilus tablets or Saccharomyces boulardii Sachets combined with standard protocols for eradication of Helicobacter pylori(Hp) in children. Methods From March 2017 to March 2018, 120 children aged 3-10 years with Hp infection were admitted into the Department of Gastroenterology, Maternal and Child Health Hospital of Hubei Province, including 67 male and 53 female childen.They were divided into 3 groups (control group, compound Lactobacillus acidophilus group, Saccharomyces boulardii Sachets group) by the method of random number table.Control group was given Clarithromycin+ Amoxicillin+ Omeprazole, for 14 days orally; compound Lactobacillus acidophilus group and Saccharomyces boulardii Sachets group were given drugs respectively on the first day, 500 mg of compound Lactobacillus acidophilus was added, twice a day or 250 mg of Saccharomyces boulardii Sachets group, twice a day orally, for 14 days, respectively.The adverse reactions in children were observed during the treatment, andurea 13C breath test or the stool Hp antigen test was performed at least 4 weeks by the end of the treatment, and the children with negative results were judged to be eradicated successfully.The ulcer healing, Hp eradication rate and incidence of adverse reactions(nausesa, vomiting, loss of appetite, constipation, diarrhea) among the 3 groups were observed and the Hp eradication rate and the incidence of adverse reactions (nausea, vomiting, loss of appetite, constipation, diarrhea) were compared. Results The eradication rates in the control group, the compound Lactobacillus group, and Saccharomyces boulardii Sachets group were 80.0% (32/40 cases), 85.0% (34/40 cases), and 87.5% (35/40 cases), respectively, and the difference was not statistically significant (P=0.646); the ulcer healing rate was 100.0% of 101 Hp eradicators in 3 groups, and the ulcer healing rate of 19 cases without Hp eradicated was 48.15%, and there was a significant difference between them (χ2=51.30, P 0.05). The overall incidence of adverse reactions in Saccharomyces boulardii Sachets group (P=0.021) and the incidence of diarrhea (P=0.002) and loss of appetite (P=0.021) was lower than that in the control group, and the differences were statistically significant.There was no significant difference in the incidence of adverse reactions between the two probiotic groups (P>0.05). Conclusions Both compound Lactobacillus acidophilus tablets and Saccharomyces boulardii Sachets group can reduce the overall incidence of adverse reactions and the incidence of diarrhea and appetite declines in children′s standard Hp eradication regimen without affecting Hp eradication rate. Key words: Helicobacter pylori; Eradication therapy; Probiotics; Child

Influence of different timing of Saccharomyces boulardii combined with bismuth quadruple therapy for Helicobacter pylori eradication

Objective: To assess the efficacy and safety of different opportunity of Saccharomyces boulardii (S. Boulardii) Sachets combined with bismuth quadruple therapy for Helicobacter pylori(H. pylori)eradication. Methods: This experiment was a prospective study. A total of 300 H. pylori-infected patients were enrolled and randomized assigned into three groups. Quadruple therapy group received pantoprazole 40 mg+bismuth potassium citrate capsule 220 mg+amoxicillin 1 000 mg+furazolidone 100 mg, bid, oral for 14 days. The simultaneous probiotic group received pantoprazole 40 mg+bismuth potassium citrate capsule 220 mg+amoxicillin 1 000 mg+furazolidone 100 mg+S. Boulardii Sachets 500 mg,bid,oral for 14 days.There after probiotic group:S.Boulardii Sachets was added on the first day after the end of 14 days in the quadruple group, for 500 mg, bid 14 days. The eradication rates and adverse reactions of the three groups were compared. Results: The eradication rates of H.pylori were 89.0%,90.4% and 91.3% in the quadruple therapy group, the simultaneous probiotic group and the there after probiotic group according to Per-protocol(PP) analysis,respectively,with no statistical difference (P=0.870). According to intention-to-treat(ITT)analysis, 81.0%, 85.0% and 84.0%, respectively, the difference was not statistically significant (P=0.732).The overall incidence of adverse reactions and the incidence of diarrhea and nausea in the simultaneous probiotic group, and the there after probiotic group were lower than those in the quadruple group(P<0.05),and the difference was statistically significant.The overall incidence of adverse reactions and diarrhea in the simultaneous probiotic were lower than those in the there after probiotic group (P=0.021, P=0.007), and the difference was statistically significant. Conclusions: S. Boulardii Sachets combined with quadruple therapy at the same time or after eradication treatment can not improve the H.pylori eradication rate,but can reduce the overall incidence of adverse reactions and the incidence of diarrhea and nausea. It is safer to add S. Boulardii Sachets at the same time than after eradication therapy.

Post-marketing study on clinical safety of ginkgo diterpene lactone meglumine injection in 6 300 patients with ischemic stroke

To further evaluate the safety of ginkgo diterpene lactone meglumine injection in the clinical use in ischemic stroke patients. Clinical safety study was conducted in 82 clinical units and 6 300 cases were completed and included from June 2013 to December 2014 by using multicenter, prospective, open and uncontrolled design methods for clinical research. A total of 29 cases of adverse reactions were observed in the experiment. Adverse reaction ratio (ADR) was 0.46%, and about 86.21% (25 cases) of them was mild with transient response which could be alleviated or disappeared without intervention; about 13.79% (4 cases) was moderate, including 2 cases of headache, 1 case of dizziness and 1 case of rash; no serious adverse reactions were found. The adverse reactions occurred in this study were pre-known adverse reactions or common adverse reactions of Chinese medicine injection. The overall incidence of adverse reactions was low, and the risk was controllable.

Post-marketing safety surveillance of Diemailing Kudiezi injection: real world study in 30 233 cases

This study was aimed to obtain the incidence of adverse drug reaction (ADR) of Diemailing Kudiezi injection, explore its characteristics, related risk factors and application in real world. A prospective single cohort study was conducted from 25 hospitals (including Chinese medicine hospitals and Western medicine hospitals) for 4 years. 30 233 consecutive inpatients using Diemailing Kudiezi injection were observed. Their general information was analyzed by using statistic frequency description. Association rules were used to analyze the correlation between comorbidities or drug combinations; the influential factors for ADRs were initially screened by using cross contingency method and Chi-square test, and then Group LASSAO method was used for further analysis. 54 patients with adverse drug events and 30 patients with ADRs were reported among 30 233 patients, with a total ADR incidence of 0.099%[95%CI (0.06%, 0.13%)]. There were 27 patients identified as the "general" ADR, one patients with "severe" ADR (anaphylactic shock) and two patients with new ADRs. ADR occurred most in 30 min after using Diemailing Kudiezi injection, in a total of 16 patients. The most ADRs were palpitation, vomiting, chills, pruritus and rash, 6 times for each symptom. Diemailing Kudiezi injection was well tolerated in the general population. The overall incidence of adverse reactions was rare, with high safety. However, the real incidence of ADRs may be underestimated in this study, and the blood samples were not obtained for the patients, so further mechanism studies shall be conducted.

Acute Adverse Reactions to Nonionic Iodinated Contrast Media for CT: Prospective Randomized Evaluation of the Effects of Dehydration, Oral Rehydration, and Patient Risk Factors.

The objective of our study was to determine the effects of dehydration and oral rehydration on the incidence of acute adverse reactions to iodinated contrast media administered during abdominal and pelvic CT in outpatients. For our prospective randomized study performed at a single institution, adult outpatients undergoing contrast-enhanced abdominal CT were randomly divided into a rehydration group (n = 2244 patients [1379 men and 865 women]; mean age, 65.2 years; age range, 18-90 years) and a control group (n = 3715 [2112 male patients and 1603 female patients]; mean age, 65.8 years; age range, 17-96 years), which included an age- and sex-matched subgroup (adjusted control group, n = 2244). The rehydration group received an oral rehydration solution (500 mL of liquid in which osmotic pressure is adjusted to enhance gastrointestinal absorption) before abdominal and pelvic CT. Patients were also divided into subclinically dehydrated (n = 997) and hydrated (n = 4962) groups according to their answers to a questionnaire that they completed before the CT examination. The patients were interviewed about contrast-induced adverse reactions before they left the CT room, and the reactions were categorized as allergiclike or physiologic. The incidence of reactions was compared between the rehydration and control groups and between the subclinical dehydration and hydrated groups. The rehydration and control groups were compared with an unpaired t test or a chi-square or Fisher test. The overall incidence of an acute adverse reaction was 4.3% (254/5959); the acute adverse reactions included 136 allergiclike and 118 physiologic reactions. Fourteen allergiclike and nine physiologic reactions were moderate grade, and none was severe. There was no significant difference between the rehydration group and adjusted control group in the overall incidence of adverse reactions (99/2244 [4.4%] vs 100/2244 [4.5%], respectively; p = 0.9422) or between the subclinically dehydrated group and hydrated group in the incidence of allergiclike reactions (25/997 [2.5%] vs 111/4962 [2.2%], p = 0.6062) and physiologic reactions (22/997 [2.2%] vs 96/4962 [1.9%], p = 0.5793). Younger age was a risk factor for both allergiclike and physiologic reactions (p ≤ 0.0019). Dehydration and oral rehydration did not affect the incidence of acute adverse reactions to iodinated contrast material for abdominal and pelvic CT in our randomized prospective trial.

Clinical study of radical resection for locally metastatic bladder cancer after neoadjuvant chemotherapy

Objectives To investigate the clinical effect of radical resection for locally metastatic bladder cancer after neoadjuvant chemotherapy. Methods A retrospective analysis of 37 patients with local metastasis of bladder cancer who were divided into observation group (20 cases) and control group (17 cases) according to their therapy. Patients in observation group were treated by cisplatin and gemcitabine neoadjuvant chemotherapy followed by radical resection surgery and patients in control group were treated by radical resection surgery only. The effect of chemotherapy, tumor size before and after, adverse reactions and survival rate were recorded and observed. Results The effective rate of chemotherapy was 75.0% (15/20), and the diameter of tumor was significantly decreased after treatment(P<0.01). The overall incidence of adverse reactions was 70.0%(14/20), and most of them were I or II grade. The median survival time of the observation group was 41 months which significantly higher than 26 months in control group (P<0.05). Conclusions Neoadjuvant chemotherapy can achieve a high response rate, significantly reduce the tumor, prolong the survival time of patients combined with surgical operation . Key words: Urinary Bladder Neoplasms; Cystectomy; Neoplasm Metastasis; Chemotherapy, Adjuvant

Safety of compound Qinghuang powder in patients with myelodysplastic syndromes

Objective To evaluate the safety of compound Qinghuang powder for myelodysplastic syndromes（MDS）. Methods A total of108 patients with MDSwere collected, 60 patients were treated with Qinghuang powder（Qinghuang powder group）and 48 with compound Qinghuang powder（compound Qinghuang group）. The treatment time of 3 months was as one course, and all the patients were treated for more than one course. The patients who developed adverse reactions in the Qinghuang powder group changed to receive compound Qinghuang powder. The adverse reactions were recorded during the treatment. Results The overall incidence of adverse reactions in the compound Qinghuang powder group was significantly lower than that in the Qinghuang powder group（18.75% vs. 41.7%; χ^26.492, P〈0.05）. None in the compound Qinghuang powder group and 3 patients in the compound Qinghuang powder group developed moderate to severe adverse reactions. The incidences of various adverse reactions in the compound Qinghuang powder group were lower than those in the Qinghuang powder group, especially, lower limb swelling （4.17%vs. 25%;χ^29.205, P〈0.05） epigastric discomfort（18.75% vs. 41.67%; χ^26.492, P〈0.05）. Twenty patients who developed adverse reactions in the Qinghuang powder group changed to receive compound Qinghuang powder. Among them, 5 patients （25%） maintained adverse reactions. The various adverse reactions after changing to compound Qinghuang powder were decreased, especially, facial swelling （10% vs. 30%; χ^22.50, P〈0.05）, leg swelling （5%vs. 45%;χ^28.533, 〈0.05）, and abdominal pain and diarrhea（10%vs. 30%;χ^22.50, P〈0.05）. No patient developed liver or kidney dysfunction after the treatment with Qinghuang powder or Compound Qinghuang powder. Conclusion Compound Qinghuang powder is safer than Qinghuang powder in the treatment of MDS. Key words: Myelodysplastic Syndromes; Qinghuang powder; Realgar; Arsenic; Traditional Chinese Drug adverse reaction

Comparison postoperative analgesia between fentanyl and tramadol in laparoscopic cholecystectomy

Objective To observe the effects of intravenous injection of fentanyl and tramadol on postoperative analgesia in laparoscopic cholecystectomy of clinical efficacy.Methods 80 cases treated with laparoscopic cholecystectomy were randomly divided into the fentanyl group (group F) and tramadol group (group Q).VAS score,adverse reaction incidence and patient satisfaction,were observed after the administration of 0.5,1,2,4,8,12h.Results In group F after administration of 0.5,1,2h,VAS score was better than that of group Q; group F after administration of the drug 4,8 h VAS score was inferior to group Q;two groups of patients in postoperative 12h VAS scores showed no significant difference in group F;the overall incidence of adverse reactions was higher than that of group Q,patients' satisfaction was higher than that of group Q.Conclusion Intravenous fentanyl in laparoscopic cholecystectomy operation postoperative overall are superior to the analgesic effect of tramadol,with high patient's satisfaction. Key words: Analgesia; Cholecystectomy, laparoscopic ; Fentanyl; Tramadol