1.Efficacy and safety of levetiracetam versus valproic acid in the treatment of pediatric epilepsy:a meta analysis
Rui LI ; Chang LIU ; Lujie XU ; Lu LIU ; Meixing YAN
China Pharmacy 2023;34(2):205-211
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.
2.Meta-analysis of the safety of polysaccharide iron complex versus ferrous sulfate in the treatment of anemia during pregnancy
Guangyan WANG ; Lu LIU ; Qiaoli WANG ; Meixing YAN ; Chang LIU
China Pharmacy 2023;34(13):1627-1631
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.
3.Roles of community nurse in case management of frequent attenders
Yan JI ; Jing DING ; Lan DING ; Jing LIU ; Xue CHEN ; Meixing LIU
Chinese Journal of General Practitioners 2020;19(11):1055-1058
Case management includes the development of nursing plans, drug management, changing the living environment, participation in team interventions and follow-up by telephone contact, which can reduce the frequency of patients′ attendance and save the medical resources. This article summarizes the roles of community nurse in case management for frequent attenders to provide reference for case management in the community health care in China.
4.Meta-analysis of the Safety of Meropenem for Neonatal Infection
Lulu ZHEN ; Lu LIU ; Chang LIU ; Meixing YAN
China Pharmacy 2021;32(18):2260-2266
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.
5.Analysis of ADR reports caused by cefotaxime sodium in Shandong province and effects of skin test on serious ADR
Meijuan REN ; Hongmei ZHANG ; Chang LIU ; Rui LI ; Meixing YAN
China Pharmacy 2023;34(10):1233-1236
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.
6.Systematic review on the design of randomized controlled trials about therapeutic drugs for rotavirus infection in children
Shiman GAO ; Chang LIU ; Meixing YAN
China Pharmacy 2023;34(14):1761-1767
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.
7.Meta-analysis of the efficacy and safety of Saccharomyces boulardii versus Bifidobacterium triple live bacteria in the treatment of pediatric diarrhea
Xiaodan ZHANG ; Ruiqin WANG ; Lu LIU ; Meijuan REN ; Meixing YAN
China Pharmacy 2024;35(2):226-230
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.
8.Clinical comprehensive evaluation of desloratadine in the treatment of urticaria
Lu LIU ; Lulu ZHEN ; Meijuan REN ; Rui LI ; Chang LIU ; Meixing YAN
China Pharmacy 2022;33(10):1240-1246
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.
9.Recommendations for prescription review of commonly used anti-seizure medications in treatment of children with epilepsy
Qianqian QIN ; Qian DING ; Xiaoling LIU ; Heping CAI ; Zebin CHEN ; Lina HAO ; Liang HUANG ; Yuntao JIA ; Lingyan JIAN ; Zhong LI ; Hua LIANG ; Maochang LIU ; Qinghong LU ; Xiaolan MO ; Jing MIAO ; Yanli REN ; Huajun SUN ; Yanyan SUN ; Jing XU ; Meixing YAN ; Li YANG ; Shengnan ZHANG ; Shunguo ZHANG ; Xin ZHAO ; Jie DENG ; Fang FANG ; Li GAO ; Hong HAN ; Shaoping HUANG ; Li JIANG ; Baomin LI ; Jianmin LIANG ; Jianxiang LIAO ; Zhisheng LIU ; Rong LUO ; Jing PENG ; Dan SUN ; Hua WANG ; Ye WU ; Jian YANG ; Yuqin ZHANG ; Jianmin ZHONG ; Shuizhen ZHOU ; Liping ZOU ; Yuwu JIANG ; Xiaoling WANG
Chinese Journal of Applied Clinical Pediatrics 2023;38(10):740-748
Anti-seizure medications (ASMs) are the main therapy for epilepsy.There are many kinds of ASMs with complex mechanism of action, so it is difficult for pharmacists to examine prescriptions.This paper put forward some suggestions on the indications, dosage forms/routes of administration, appropriateness of usage and dosage, combined medication and drug interaction, long-term prescription review, individual differences in pathophysiology of children, and drug selection when complicated with common epilepsy, for the reference of doctors and pharmacists.
10.Research about clinical comprehensive evaluation methods of pediatric drugs :taking pediatric anti-allergic drugs as an example
Lu LIU ; Yue XIAO ; Chang LIU ; Suxin QU ; Rong LI ; Baodong YU ; Xiaomei MO ; Kejun LIU ; Meixing YAN
China Pharmacy 2022;33(2):142-145
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.