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OBJECTIVE To compare the efficacy and safety of Saccharomyces boulardii and Bifidobacterium triple live bacteria in the treatment of pediatric diarrhea. METHODS Retrieved from PubMed， Embase， the Cochrane Library， CBM， Wanfang data， CNKI and VIP， randomized controlled trials （RCTs） about S. boulardii （S. boulardii group） versus Bifidobacterium triple liver bacteria （Bifidobacterium group） were collected. After screening the literature， extracting data and evaluating the quality， meta-analysis was performed by using RevMan 5.3 software. RESULTS A total of 9 RCTs were included， involving 898 patients. Results of meta-analysis showed there was no statistical significance in total response rate [OR＝1.69， 95%CI （0.93， 3.09）， P＝0.09]， duration of diarrhea [MD＝－1.39， 95%CI （－3.35， 0.57）， P＝0.16]， the time of abdominal pain disappearance [MD＝0.09， 95%CI（－0.87， 1.05），P＝0.86] or the incidence of adverse reactions [OR＝0.65， 95%CI （0.05， 8.03）， P＝0.74]. The number of stools in S. boulardii group was significantly less than Bifidobacterium group [MD＝－0.91， 95%CI （－1.80， －0.02）， P＝0.04]. The results of subgroup analysis showed that the duration of diarrhea in children with antibiotic-associated diarrhea in S. boulardii group was significantly shorter than Bifidobacterium group （P＜0.05）. CONCLUSIONS The efficacy and safety of S. boulardii are similar to those of Bifidobacterium in the treatment of diarrhea， but S. boulardii is better than Bifidobacterium in terms of stool number， the duration of diarrhea in children with antibiotic-associated diarrhea.
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OBJECTIVE To systematically analyze the related clinical research of therapeutic drugs for rotavirus infection in children， and to provide reference for the improvement of scientific and normative implementation in clinical trials. METHODS PubMed， the Cochrane Library and Embase databases were systematically searched， and English literature on randomized controlled trials （RCTs） about therapeutic drugs for pediatric rotavirus infection published between 2000 and 2022 was included. After literature screening and data extraction， the quality of the included literature was evaluated using the bias risk assessment scale recommended by Cochrane Handbook for Systematic Reviews. The research objectives， overall design， subject inclusion and exclusion criteria， interventions， course of treatment， follow-up visits， efficacy and safety evaluations， and results were analyzed descriptively. RESULTS & CONCLUSIONS A total of 17 RCTs were included， involving 1 345 subjects. The purpose included relieving rotavirus infection-induced diarrhea， promoting rotaviral shedding， improving clinical symptoms such as dehydration， fever， vomiting， and shortening hospital stays， etc. All trials were randomized and single-center studies， mostly double-blind （13 trials） and placebo-controlled （16 trials）， and 64.71% had sample size estimation. The inclusion and exclusion criteria included diarrhea attack， virus detection， clinical symptoms， disease types and drugs， etc. The interventions included probiotics （8 trials）， biological agents （3 trials）， anti-infective agents （3 trials）， etc. Most of treatment course was 1-5 days （13 trials）. A total of 58.82% were designed for follow-up. In the validity evaluation， diarrhea attack， microbiology test and fecal culture， clinical symptoms such as dehydration， fever and vomiting， length of hospital stays or duration of symptoms were included. Vesikari scale， WHO criteria and researcher evaluation were the evaluation criteria. In the safety evaluation， 10 trials were designed for adverse events/adverse reaction observation； only one trial listed ethical approval numbers. The information of literature included in the study covers the basic elements for the design of RCTs of drugs for rotavirus infection in children. Nevertheless， all are single- center studies. Partial studies lack the basis for sample size estimation and related contents of drug combination， and the quality needs to be improved. In the future， the high-quality multi-center clinical trials should be further conducted， with objective measurement indexes as the validity results， and the ethical review and safety evaluation should be emphasized.
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OBJECTIVE To compare the safety of polysaccharide iron complex and ferrous sulfate in the treatment of anemia during pregnancy. METHODS Retrieved from Cochrane Library， PubMed， Embase， SinoMed， CNKI， VIP and Wanfang database， randomized controlled trials （RCTs） about polysaccharide iron complex （trial group） versus ferrous sulfate （control group） in the treatment of anemia during pregnancy were collected from the inception to May 20th， 2022. After literature screening， data extraction and quality evaluation， meta-analysis， sensitivity analysis and publication bias analysis were conducted with RevMan 5.3 software. RESULTS A total of 13 RCTs were included， with a total of 1 318 patients. Results of meta-analysis showed that the total incidence of adverse drug reactions （ADR） [RR＝0.11， 95%CI （0.06， 0.18）， P＜0 000 01]， gastrointestinal adverse reactions [RR＝0.08， 95%CI （0.05， 0.12）， P＜0.000 01]， anorexia and nausea [RR＝0.21， 95%CI （0.09， 0.54）， P＝ 0.001]， abdominal pain [RR＝0.18， 95%CI （0.04， 0.78）， P＝0.02]， diarrhea [RR＝0.18， 95%CI （0.04， 0.79）， P＝0.02]， vomiting [RR＝0.24， 95%CI （0.06， 0.89）， P＝0.03] and gingival melanosis [RR＝0.09， 95%CI （0.03， 0.28）， P＜0.000 1] in the trial group were all significantly lower than the control group. The results of sensitivity analysis showed that the conclusions obtained in this study were relatively robust. The results of publication bias analysis indicated that there was a high possibility of publication bias in this study. CONCLUSIONS The polysaccharide iron complex is safer than ferrous sulfate for treatment of anemia during pregnancy.
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OBJECTIVE To analyze the clinical manifestations and characteristics of adverse drug reactions （ADR） caused by cefotaxime sodium in Shandong province， and to explore the effects of skin test before medication of cefotaxime sodium on serious ADR， so as to provide reference for safe drug use in clinic. METHODS The relevant data of cefotaxime sodium-induced ADR reported by Shandong Province ADR Monitoring Center during December 2019 to December 2021 were collected from National ADR Monitoring System. The ADR classification， age， gender， ADR occurrence time， route of administration， history of allergy， primary diseases， ADR systems/organs involved， clinical manifestations， outcome， skin test or not before medication were statistically analyzed. RESULTS A total of 1 057 ADR reports caused by cefotaxime sodium were included. Among them， there were 867 patients （82.02%） with general ADR and 190 patients （17.98%） with serious ADR. The majority were ＜11 years old （40.30%）. The main route of administration was intravenous drip （96.69%）. A total of 1 033 patients （97.73%） developed ADR 30 min to 24 h after medication. A total of 814 patients （77.01%） had no history of allergy. The primary diseases were respiratory system infection （56.58%）. Main systems/organs involved in ADR were skin and its appendants， digestive system and respiratory system， and its clinical manifestations were rash， pruritus， nausea， vomiting， chest tightness， etc. After withdrawal or symptomatic treatment， 1 050 patients （99.34%） were cured or improved. Before the use of cefotaxime sodium， 850 patients underwent skin test （151 patients occurred serious ADR）； there was no statistical significance in the incidence of serious renzhen202102@163.com ADR， compared with the incidence of serious ADR in 207 patients without skin test （39 patients occurred serious ADR）（P＝0.718）. CONCLUSIONS ADR caused by cefotaxime sodium is mainly seen in patients ＜11 years old， mostly occurring 30 min to 24 h after intravenous drip； skin test before medication of cefotaxime sodium cannot reduce the risk of serious ADR. Before using cefotaxime sodium in clinical practice， patients should be asked about their allergy and medication history in detail. During use， it is important to focus on the patient’s condition within 24 h after medication to prevent serious ADR and ensure the safety of clinical medication.
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OBJECTIVE To compare the efficacy and safety of levetiracetam versus valproic acid in the treatment of pediatric epilepsy， and to provide evidence-based reference. METHODS The databases including CNKI， VIP， China Biomedical Literature Database， Wanfang data， PubMed， Embase and Cochrane Library were searched for the RCTs about levetiracetam （trial group） and valproic acid （control group） were collected from the inception to October 1st， 2021. After literature screening and data extraction， the quality of included literature was evaluated using the bias risk assessment tool recommended by Cochrane system evaluator manual 5.1.0 and RevMan 5.3 software were used for meta-analysis， sensitivity analysis and bias risk analysis. RESULTS A total of 33 RCTs were included， involving 3 116 patients in total. The results of the meta-analysis showed that the effective rate of trial group was significantly higher than control group [RR＝1.06， 95%CI （1.02， 1.11）， P＝0.003]. The subgroup analysis according to different courses of treatment showed that there was no statistical significance in the effective rate between 2 groups after 1 and 3 months of treatment （P＞0.05）； after 6 months of treatment， the effective rate of trial group was significantly higher than that of control group （P＜0.05）. The incidence of adverse drug reaction in trial group was significantly lower than control group [RR＝0.50， 95%CI （0.41， 0.61）， P＜0.000 01]； among specific adverse drug reactions， the incidence of nausea and vomiting in trial group was significantly lower than control group （P＜0.05）； but there was no statistical significance in the incidence of rash， drowsiness， abnormal mood， loss of appetite， dizziness or headache （P＞0.05）. Results of sensitivity analysis showed that study results were stable and reliable. Results of publication bias analysis showed that there was little possibility of publication bias in this study. CONCLUSIONS The short-term efficacy （1， 3 months） of LEV is similar to that of VPA in the treatment of pediatric epilepsy， but long-term efficacy （6 months） of LEV is better than that of VPA； moreover， LEV shows better safety in digestive system.
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OBJEC TIVE To provide reference for clinical comprehensive evaluation of pediatric drugs in China. METHODS Taking pediatric anti-allergic drugs as an example ，the clinical comprehensive evaluation methods of pediatric drugs in medical institutions were explored from the aspects of theme selection ，evaluation content and dimension ，evaluation index ，evaluation method and evaluation result report. RESULTS & CONCLUSIONS During the clinical comprehensive evaluation of pediatric drugs，under the guidance of relevant national guidelines for clinical comprehensive evaluation ，the evaluation topics could be selected according to the three principles of importance ，relevance and evaluability ，and then an appropriate evaluation index system could be developed around the six dimensions of safety ， effectiveness， economy， suitability，accessibility and innovativeness；qualitative and quantitative data integration analysis of the drugs to be evaluated were performed. In the evaluation ， it is necessary to focus on children ’s clinical basic drug use practice and decision-making needs ，normatively，scientifically and reasonably define the core index set and standard data set required by different dimensions of evidence ，standardize the collection and use of real-world data ，and effectively combine other types of evidence to truly play its advantageous role in the clinical comprehensive evaluation of pediatric drugs in China.
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Antipyretic-analgesics are currently one of the most prescribed drugs in children.The clinical application of antipyretic-analgesics for children in our country still have irrational phenomenon, which affects the therapeutic effect and even poses hidden dangers to the safety of children.In this paper, suggestions were put forward from the indications, dosage form/route, dosage suitability, pathophysiological characteristics of children with individual differences and drug interactions in the symptomatic treatment of febrile children, so as to provide reference for the general pharmacists when conducting prescription review.
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OBJECTIVE To eva luate the clinical comprehensive value of desloratadine in the treatment of urticaria. METHODS The clinical comprehensive evaluation index system based on six dimensions such as safety ，effectiveness，economy，suitability， innovation and accessibility were preliminarily determined by using the methods of literature investigation and expert investigation ； the core contents of the evaluation index system were evaluated and screened by Delphi method and analytic hierarchy process ；the importance of the index was assigned by Likert 5-level scoring method ；the evidence from various sources were collected and qualitative and quantitative integration analysis were conducted according to the clinical comprehensive evaluation index system with the help of system evaluation ，drug instructions ，expert guidelines/consensus ，adverse drug reaction monitoring report ，etc； the experts scored its clinical comprehensive value according to the clinical comprehensive evaluation evidence of each dimension of desloratadine ，combined with the weight of the clinical comprehensive evaluation index system ，the clinical comprehensive evaluation score of the tertiary indexes of desloratadine were calculated. The total clinical comprehensive evaluation score was obtained by accumulating the scores of each index ，and compared with loratadine. RESULTS This study successfully constructed the clinical comprehensive evaluation index system of desloratadine in the treatment of urticaria ，including 6 primary indexes ，13 secondary indexes and 30 tertiary indexes. The total clinical comprehensive evaluation score of desloratadine was 93.63 and that of loratadine was 70.91. CONCLUSIONS The clinical comprehensive value of desloratadine is higher than that of loratadine ，which can provide a reference basis for clinical rational drug use in medical institutions ，selection of drug use catalogue and improvement of national drug policy.
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OBJECTIVE：To systematically evaluate the safety of meropenem for neonatal infection ，and to provide evidence-based reference for safe use of it in the neonatal population. METHODS ：Retrieved from PubMed ，Embase，Cochrane Library，ISI Web of Science ，International Health Technology Assessment Network Website ，China Journal Full-text Database ， Wanfang Database ，CBM，Chinese Sci-tech Periodical Full-text Database ，randomized controlled trials （RCTs）about meropenem or meropenem combined other drugs （trial group ）versus the similar drugs that could replace meropenem （control group ）for neonatal infection were collected during the inception to May 1st，2021. After literature screening and data extraction ，the quality of included literatures were evaluated with Cochrane systematically evaluator manual 5.1.0. Meta-analysis was conducted with RevMan 5.3 software. RESULTS ：A total of 25 RCTs were included ，involving 2 090 children. Results of Meta-analysis showed that the incidence of overall ADR in trial group was significantly lower than control group [RR ＝0.53，95％CI（0.44，0.65），P＜0.000 01]. Results of subgroup analysis showed that the incidence of overall ADR in trial group was significantly lower than control group receiving ceftazidime [RR ＝0.55，95％CI（0.41，0.74），P＜0.000 1]，tigecycline [RR ＝0.37，95％CI（0.23，0.59），P＜0.000 1]， ceftriaxone [RR ＝0.53，95％CI（0.35，0.80），P＝0.003]. The incidence of overall ADR in trial group with neonatal purulent meningitis [RR ＝0.63，95％CI（0.44，0.92），P＝0.02]，severe neonatal multidrug-resistant bacterial infection [RR ＝0.37，95％CI（0.25， 0.55），P＜0.000 01]，neonatal severe bacterial infection [RR ＝ 0.67，95％CI（0.48，0.94），P＝0.02] were significantly lower than control group. The incidence of specific ADR such as mail： rash，gastrointestinal reaction ，hemoglobin reduction in trialgroup were significantly lower than control group （P＜0.05）. There was no statistical significance in the incidence of specific ADR between 2 groups，such as elevated transaminase ，secondary fungal infection and renal injury （P＞0.05）. Results of bias analysis showed that when the incidence of overall ADR was used as index ，there was a certain degree of publication bias in this study ，when the incidence of specific ADR was used as index ，there was less possibility of publication bias in this study. CONCLUSIONS：Meropenem is safe in the treatment of neonatal infection ，especially in the treatment of neonatal purulent meningitis，severe neonatal multidrug-resistant bacterial infection and neonatal severe bacterial infection ，it is superior to ceftazidime，tigecycline，ceftriaxone and other antibacterial drugs in safety.
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OBJECTIVE： To analyze the characteristics and regularity of new/severe pediatric ADR in Shandong province， and to promote the safe use of drugs in children. METHODS： A retrospective analysis of new/severe pediatric ADR in the Shandong Provincial ADR database 2016-2017 was conducted in respects of children’s gender and age， primary disease， ADR history， family ADR history， dosage form， route of administration， drug type， systems/organs involved in ADR， clinical manifestations， off-label drug use， drug combination， occurrence time， effects of ADR on primary disease， outcome， etc. RESULTS： A total of 44 742 pediatric ADR cases were collected from Shandong province ADR database from 2016 to 2017， including 27 060 male， 17 664 female and 18 gender unknown. 530 cases were diagnosed as new/severe pediatric ADR， including 334 male and 196 female with ratio of male to female 1.70 ∶ 1. New/severe ADR reports of children aged 1-3 took up the highest proportion （158 cases， 29.81％）. Primary diseases were mainly respiratory disease （190 cases， 25.85％）； there were 10 children with ADR history （1.89％）， 2 with family ADR history （0.38％）. Dosage forms were mainly injection （358 cases， 67.55％）. Route of administration were mainly intravenous drip （431 cases， 81.32％）. The drugs that caused ADR included 20 categories and 162 species， mainly including drug for regulating hydroelectric acid-base balance （148 cases caused by 8 kinds of drugs， 27.92％）， antibiotics （89 cases caused by 33 kinds of drugs， 16.79％）， traditional Chinese medicine and its extract （80 cases caused by 24 kinds of drugs， 15.09％）. The systems/organs involved in ADR were mainly systemic injury （201 cases， 37.92％， main clinical manifestations included chills and fever， etc.）， followed by skin and its appendants （99 cases， 18.68％， mainly clinical manifestations included rash and itching， etc.）， respiratory system （76 cases， 14.43％， main clinical manifestations included dyspnea and cough， etc.）. Off-label drug use were found in 41 cases （7.74％）， including the safety of drug use was not clear in drug instructions （20 cases， 3.77％）； no drug testing was carried out and no reliable references were available （13 cases， 2.45％）， that medicine was prohibited was stated in drug instructions （2 cases， 0.38％）. 106 cases （20.00％） had drug combination， including combined use of two drugs， three drugs and four drugs （62， 36， 8 cases）. ADR occurred mainly within 0-5 min （140 cases， 26.42％）. Among 530 children， ADR had no obvious effect on the outcome of the disease in 457 cases （86.23％）； ADR caused longer course of disease in 57 cases （10.75％）. 278 cases （52.45％） were cured and 243 cases （45.85％） were recovered. CONCLUSIONS： It is necessary to strengthen the monitoring of drug use in children， formulate national standards and relevant laws and regulations for children’s rational drug use， improve the awareness of medical staff to children’s ADR， strengthen the education and publicity of the knowledge about safe drug use in children， and to promote rational drug use.
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Alterations of the lactoferrin gene are associated with an increased incidence of tumor,however,the exact mechanisms involved in the anti-tumor activity of lactoferrin are still unclear.Several studies suggest that lactoferrin can affect the initiation and development of tumors via different mechanisms such as damaging cell membranes,inducing apoptosis,blocking cell cycle,regulating cellular immune response and inhibiting angiogenesis in different cancer cell lines.Further study about the mechanism can provide new ideas for clinical prevention and treatment of tumors.
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Objective@#To analyze characteristics of serious adverse drug reaction from Qingdao and provide reference for clinical applications.@*Methods@#1 130 reports collected by Qingdao Center for ADR Monitoring in 2016 were analyzed using retrospective study method.@*Results@#The antibiotics, traditional Chinese medicine injection and antitumor drug caused the higher proportion of serious adverse drug reaction.Injection was the main way for administration, which induced 73.45% of serious adverse drug reaction.65.00% cases with allergic shock occurred within 10min.Levofloxacin lactate injection caused the highest proportion of serious adverse drug reaction, Danhong injection caused the highest proportion of allergic shock reaction, Reduning injection caused the highest proportion of serious adverse drug reaction in children.@*Conclusion@#Safety monitoring for antibiotics, traditional Chinese medicine injection and antitumor drug should be further strengthened, including children adverse reactions.
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OBJECTIVE:To explore hospital pharmacists service mode and the subject construction of hospital pharmacy. ME-THODS:Through reviewing the transformation process of hospital pharmacy and pharmacist's duty,the present structure,con-tent,working model and achievements of pharmacy in our hospital were introduced based onlarge pharmacyof taking clinical pharmacy as core,paying attention to personnel training,technical innovation,physican,pharmacist and nurse cooperation,multi-ple discipline integration,etc.;the direction of hospital pharmacy was explored. RESULTS:Many adjustments were made to facili-tate the smooth and orderly development of hospital pharmacy under the new situation,as that establish the rational drug use and quality safety system,drug supply and operation management system working mode;that the development strategy of pharmacy was identified asfocusing on the rational drug use,combining the management functionandproviding professional pharmaceuti-cal care for the clinic and patients,providing professional technical support for the hospital decision and medical management;that the construction of clinical pharmacy specialty/key discipline and drug clinical trial technology platform in accordance with the international standard and so on were lined in the project of pharmacy;that quality control circle was cited,pharmaceutical supervi-sion and pharmaceutical care were expanded to the public and the fine;that a fine,professional pharmacist team was cultured. CONCLUSIONS:The construction of future hospital pharmacy needs the concept oflarge pharmacywith multi-disciplinary inte-gration to develop towards standardization,refinement,specialization and modernization.
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OBJECTIVE:To provide reference for the rational drug use of traditional TCM injection. METHODS:Medical re-cords of 792 patients receiving TCM injection were collected from Qingdao Municipal Hospital in the first quarter of 2014(before intervention)and 836 patients collected from the first quarter of 2015(after intervention),and then analyzed comparatively in re-spects of patient’s gender information,rationality of TCM injection,irrational drug use,ADR. RESULTS:After intervention,the use of TCM injection in the hospital became standard gradually,and rational rate increased from 42.42% to 69.98%. Irrational drug use as super-indication medication,overdose,inadequate solvent amount decreased;the ratio of TCM injection prescription cost per capita decreased from 16.64% to 12.59%;the incidence of ADR decreased from 6.94% to 2.51%,with statistical signifi-cance(P<0.05). Except that the amount of Andrographolide for injection,Xuesaitong for injection,Zhengqing fengtongning injec-tion,Reduning injection increased,those of other TCM injection decreased. CONCLUSIONS:Pharmaceutical intervention mea-sures of clinical pharmacists are effective and feasible,and promote rational and standard use of TCM injection.
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AIM: To verify the bioequivalence between sustained released tablet of nepopam and normal one. METHODS: 18 volunteers were randomly devided into two groups. Double periodical crossed design was used, and poly dose of nefopam was administered to 18 volunteers following single dose after one week interval. The concentration of nefopam hydrochloride in serum was determinated by HPLC, and the related parameters came out through 3p97 programme. RESULTS: In the single dose test the drug concentration of sustained released tablet maitained 2040 mg?L -1 for 10 h ,c max was ( 45.8 ?15.7) mg?L -1 ,t peak was ( 3.4 ? 0.8) h , and the corresponding parameters of normal tablet were over 20 mg?L -1 for 7.5 h ,( 72.7 ?26.0) mg?L -1 ,and ( 1.6 ? 0.6) h . The AUC was ( 363.4 ? 107.1 ) and ( 374.8 ?125.7) mg?h?L -1 respectively, and F was ( 1.02 ? 0.25 ). In the poly dose test the c max of sustained released and normal one was ( 31.50 ? 12.65 ) and ( 33.68 ?10.51) mg?L -1 ,c min was ( 13.4 ? 4.4 ) and ( 10.9 ?5.4) mg?L -1 , t peak was ( 2.6 ? 0.6 ) and ( 1.22 ? 0.46) h , and FI was ( 0.77 ? 0.26 ) and ( 1.04 ? 0.18 ) respectively. CONCLUSION: The sustained released tablet is credible and the two types of tablet are equieffective in AUC.