1.Meta-analysis of sealants versus fluoride varnishes for the prevention of occlusal surface caries in children's first permanent molars.
Jingya HAN ; Yajun ZHANG ; Mengzhen JI ; Jingfei SUN ; Shuhan JIA ; Zhifeng WANG
West China Journal of Stomatology 2025;43(3):383-394
OBJECTIVES:
To assess the effectiveness of the comparison between pit and fissure sealants and fluoride varnishes, as well as various types of sealants, in preventing caries on the occlusal surface of children's first permanent molars (FPM).
METHODS:
Conduct a comprehensive search of literature published between January 1, 1988, and May 30, 2024, in the following databases: China National Knowledge Infrastructure, Web of Science, Cochrane Library, Embase, PubMed, China Science Periodical Database and China Biology Medicine database. Meta-analysis and subgroup analyses were performed on the literature that met the inclusion criteria.
RESULTS:
A total of 5 618 pieces of literature were retrieved, resulting in the inclusion of 14 in the study. Meta-analysis showed that there was no statistically significant difference in the efficacy between varies pit and fissure sealants compared to fluoride varnishes, and between varies types of sealants in preventing caries on the occlusal surface of children's first permanent molars within 24 months post-surgery (P>0.05).
CONCLUSIONS
Within 24 months, there was no significant difference in the effectiveness of using resin-based or glass iomomer pit and fissure sealants compared with fluoride varnishes in preventing occlusal caries in FPM in children; within 24 months, there was no significant difference in the effectiveness of using resin-based sealants compared with ART sealants in preventing occlusal caries in FPM in children. ART sealants are recommended over resin-based sealers for children who have no conditions for chair-side manipulation or who are poorly co-operative.
Humans
;
Pit and Fissure Sealants/therapeutic use*
;
Dental Caries/prevention & control*
;
Molar
;
Child
;
Fluorides, Topical/therapeutic use*
;
Dentition, Permanent
2.Efficacy of tranexamic acid in reducing perioperative blood loss in craniomaxillofacial plastic and cosmetic surgery: a systematic review and meta-regression analysis
Hongmei MA ; Chenxi LI ; Yao LIU ; Jingfei HAN ; Jiaojun ZHAO ; Mingchao DING ; Jialin SUN
Chinese Journal of Blood Transfusion 2025;38(12):1770-1778
Objective: To comprehensively evaluate the clinical efficacy of a single dose of tranexamic acid (TXA) in reducing perioperative blood loss in patients undergoing craniomaxillofacial plastic and cosmetic surgery through meta-regression analysis. Methods: Embase, PubMed, Wanfang Data, VIP database, China National Knowledge Infrastructure (CNKI), the Chinese Clinical Trial Registry (ChiCTR) and Cochrane Central Register of Controlled Trials (CENTRAL) were electronically retrieved to collect clinical studies evaluating efficacy of perioperative TXA administration in patients undergoing craniomaxillofacial plastic and cosmetic surgery, from inception to August 2024. Quality assessment of randomized controlled trials (RCTs) was performed using Cochrane Collaboration's Risk of Bias Tool. Based on the results of methodological heterogeneity, corresponding meta-analyses were conducted using either random-effects or fixed-effects models in R programming software. Results: Thirty-one articles were included, involving 2 072 patients who underwent craniomaxillofacial plastic and cosmetic surgeries. Among these patients, 1 051 were in the TXA treatment group, and 1 021 were in the control group. The paired meta-analysis showed that compared with the control group, the use of TXA significantly reduced bleeding volume in perioperative patients [standardized mean difference (SMD)=-1.13; 95%CI (-1.47, -0.80), P<0.001]. Subgroup analysis revealed that TXA significantly reduced intraoperative bleeding volume in patients across different surgeries, with the order of efficacy as follows: orthognathic surgery [SMD=-1.44; 95%CI (-2.07, -0.80), P<0.001], cleft palate repair [SMD=-1.32; 95%CI (-2.14, -0.50), P<0.001], rhinoplasty [SMD=-0.97; 95%CI (-1.63, -0.30), P<0.001], and craniosynostosis [SMD=-0.96; 95%CI (-1.40, -0.53), P=0.040]. The result of the meta regression showed there was no significant difference in the hemostatic effect of TXA on patients with increasing doses (5, 10, 15, 20, 25 mg/kg) (P=0.650). Sensitivity analysis verified that the pooled values were stable and reliable. The Egger's test indicated a certain degree of publication bias (Z=-3.40, P<0.001). Conclusion: Existing evidence suggests that TXA effectively reduces perioperative blood loss in patients undergoing craniofacial plastic surgery, regardless of its dosage administered.
3.Clinical effectiveness assessment of a single dose of tranexamic acid for perioperative blood loss control in patients treated with craniomaxillofacial plastic and cosmetic surgery: a meta-regression analysis of registered randomized controlled trials
Chenxi LI ; Hongmei MA ; Yao LIU ; Jingfei HAN ; Mingchao DING ; Jialin SUN
Chinese Journal of Plastic Surgery 2025;41(1):52-68
Objective:To comprehensively evaluate the clinical effectiveness with respect to a single dose of tranexamic acid (TXA) given preoperatively for blood loss control in perioperative patients accepted craniomaxillofacial plastic and cosmetic surgery.Methods:Embase, PubMed, WanFang Data, VIP, China National Knowledge Infrastructure (CNKI), the Chinese Clinical Trial Registry (ChiCTR) and Cochrane Central Register of Controlled Trials (CENTRAL) were electronically retrieved to collect randomized controlled trials (RCTs) related to appraise the efficacy in perioperative craniomaxillofacial plastic and cosmetic surgery patients used TXA from inception to August 2024. Based on the result of methodological heterogeneity, corresponding paired meta-analyses were carried out with a random-effects or fixed-effects model applying R 4.0.4 software. Subgroup analysis was performed based on type of surgery, patient age, regional distribution of patients, and sample size included in the studies. A meta-regression analysis was performed on studies that reported the effect of different doses of TXA on reducing perioperative bleeding. Sensitivity analysis was performed to verify the stability of the meta result. Egger’s test was used to analyze potential publication bias.Results:A total of 31 RCTs were included, involving 2 072 patients, with 1 051 in the TXA group and 1 021 in the placebo group. The paired meta-analysis random-effects model ( I2=90%) showed that compared with the control group, the use of TXA significantly reduced the amount of bleeding in perioperative patients[standardized mean difference ( SMD)=-1.13, 95% CI -1.47 to -0.80, P < 0.01]. Subgroup analysis revealed that TXA had a significant effect on reducing intraoperative bleeding in patients with different surgeries, ages, regions, and sample sizes. The most effective subgroups were cases in orthognathic surgery ( SMD=-1.44, 95% CI -2.07 to -0.80, P< 0.01), less than 30 year-old( SMD=-1.32, 95% CI -1.68 to -0.96, P< 0.01], Asian patients( SMD=-1.29, 95% CI -1.72 to -0.86, P< 0.01), less than 30 individuals ( SMD=-1.16, 95% CI -1.50 to -0.82, P< 0.01). The result of the meta regression showed there was no significant difference in the hemostatic effect of TXA on patients with increasing doses (5, 10, 15, 20, 25 mg/kg) ( P>0.05). Sensitivity analysis verified that the pooled values were stable and reliable. The Egger’s test indicated a certain degree of publication bias ( P < 0.01). Conclusion:Taken as a whole, existing evidence suggests that TXA can effectively reduce perioperative bleeding in patients undergoing craniofacial plastic surgery, regardless of its dosage administered. However, further clinical researches are still needed to provide more baselined data, transfusion-related indicators, and information on adverse events such as vascular embolism, in order to comprehensively evaluate and analyze the efficacy and safety of a single dose of TXA for perioperative blood loss control in patients treated with craniomaxillofacial plastic and cosmetic surgery.
4.Clinical effectiveness assessment of a single dose of tranexamic acid for perioperative blood loss control in patients treated with craniomaxillofacial plastic and cosmetic surgery: a meta-regression analysis of registered randomized controlled trials
Chenxi LI ; Hongmei MA ; Yao LIU ; Jingfei HAN ; Mingchao DING ; Jialin SUN
Chinese Journal of Plastic Surgery 2025;41(1):52-68
Objective:To comprehensively evaluate the clinical effectiveness with respect to a single dose of tranexamic acid (TXA) given preoperatively for blood loss control in perioperative patients accepted craniomaxillofacial plastic and cosmetic surgery.Methods:Embase, PubMed, WanFang Data, VIP, China National Knowledge Infrastructure (CNKI), the Chinese Clinical Trial Registry (ChiCTR) and Cochrane Central Register of Controlled Trials (CENTRAL) were electronically retrieved to collect randomized controlled trials (RCTs) related to appraise the efficacy in perioperative craniomaxillofacial plastic and cosmetic surgery patients used TXA from inception to August 2024. Based on the result of methodological heterogeneity, corresponding paired meta-analyses were carried out with a random-effects or fixed-effects model applying R 4.0.4 software. Subgroup analysis was performed based on type of surgery, patient age, regional distribution of patients, and sample size included in the studies. A meta-regression analysis was performed on studies that reported the effect of different doses of TXA on reducing perioperative bleeding. Sensitivity analysis was performed to verify the stability of the meta result. Egger’s test was used to analyze potential publication bias.Results:A total of 31 RCTs were included, involving 2 072 patients, with 1 051 in the TXA group and 1 021 in the placebo group. The paired meta-analysis random-effects model ( I2=90%) showed that compared with the control group, the use of TXA significantly reduced the amount of bleeding in perioperative patients[standardized mean difference ( SMD)=-1.13, 95% CI -1.47 to -0.80, P < 0.01]. Subgroup analysis revealed that TXA had a significant effect on reducing intraoperative bleeding in patients with different surgeries, ages, regions, and sample sizes. The most effective subgroups were cases in orthognathic surgery ( SMD=-1.44, 95% CI -2.07 to -0.80, P< 0.01), less than 30 year-old( SMD=-1.32, 95% CI -1.68 to -0.96, P< 0.01], Asian patients( SMD=-1.29, 95% CI -1.72 to -0.86, P< 0.01), less than 30 individuals ( SMD=-1.16, 95% CI -1.50 to -0.82, P< 0.01). The result of the meta regression showed there was no significant difference in the hemostatic effect of TXA on patients with increasing doses (5, 10, 15, 20, 25 mg/kg) ( P>0.05). Sensitivity analysis verified that the pooled values were stable and reliable. The Egger’s test indicated a certain degree of publication bias ( P < 0.01). Conclusion:Taken as a whole, existing evidence suggests that TXA can effectively reduce perioperative bleeding in patients undergoing craniofacial plastic surgery, regardless of its dosage administered. However, further clinical researches are still needed to provide more baselined data, transfusion-related indicators, and information on adverse events such as vascular embolism, in order to comprehensively evaluate and analyze the efficacy and safety of a single dose of TXA for perioperative blood loss control in patients treated with craniomaxillofacial plastic and cosmetic surgery.
5.Mechanism analysis of pseudoaneurysm at the anastomosis based on fluid-structure interaction
Liancai WANG ; Peng SUN ; Hualong BAI ; Pan GUO ; Jingfei ZHANG
Chinese Journal of Medical Physics 2024;41(9):1170-1176
Objective To explore the biomechanical mechanism of pseudoaneurysm formation at the anastomotic site of vascular patch and the inhibitory effect of transforming growth factor(TGF β1)hydrogel on aneurysm.Methods The vascular patch model and the pseudoaneurysm model were constructed separately,and the two-way fluid-structure interaction method was used to numerically simulate the blood-vessel wall dynamic response at the anastomosis.Based on the analysis of mechanical parameters such as postoperative blood velocity,vessel wall shear stress and aneurysm wall displacement,the mechanisms of postoperative pseudoaneurysm formation and inhibition were studied.Results The numerical simulation results showed that the wall shear stress increased when the blood flowed through the front end of the patch.When the pseudoaneurysm has been formed after surgery,the aneurysm wall became significantly thicker following the injection of TGF β1 hydrogel into the aneurysmal wall,and the intratumoral shear stress and the aneurysmal wall displacement were decreased.Conclusion Pseudoaneurysms are easy to form at the front end of the anastomosis after surgery,and the injection of TGF β1 hydrogel into the aneurysm wall can effectively inhibit the formation and progression of pseudoaneurysm.The numerical simulation study provides a numerical basis for the mechanical mechanism study of the formation and progression of pseudoaneurysm after patch angioplasty.
6.The situation and potentially influential factors of Brucellosis awareness in occupational groups
Ping LIU ; Heng ZENG ; Chunguo LIU ; Jingfei WANG ; Lu GAO ; Quangang XU ; Juan LI ; Jingli KANG ; Xiangdong SUN
Chinese Journal of Endemiology 2018;37(9):716-720
Objective To understand the situation of knowledge,attitude and practice (KAP) of sheep farmers and field veterinarians towards brucellosis prevention,and find out the potentially influential factors.Methods From March to September in 2017,1 067 sheep farmers and 401 field veterinarians were selected as participates,and questionnaire survey was carried out.Percentage rate was used to describe the situation of KAP.Nonparametric test was used to compare the KAP score difference.Results The overall awareness in sheep farmers and field veterinarians was 64.2% and 80.1%,respectively.In addition,there were 17.3% (185/1067) sheep farmers and 12.2% (49/401) field veterinarians had never heard of brucellosis.The knowledge awareness in sheep farmers and field veterinarians was 62.6% and 79.0%,respectively,75.8% and 83.8% of them had positive attitude to brucellosis prevention,54.1% and 77.6% of them had good practice habit.They hoped in the future,more information could be received through TVs,and then was internet or broadcasting.Sheep farmers who from first class region,age less than 45 years,education higher than junior high school,feeding time less than 5 years and sheep ever infected with brucellosis (U =4.85,3.08,3.29,2.20,6.62,P < 0.05 or < 0.01),had higher KAP scores than others.Field veterinarians,who had lower education,had lower KAP scores (U =4.29,P < 0.01).Conclusions The awareness of sheep farmers and field veterinarians still need to improve and strengthen.Some suggestions are put forward:improve intervention pattern,optimize content and method,pay attention to use new media.
7."Experimental study on ""Dosage-Time-Toxicity"" relationship of hepatotoxicity induced by cold medicine containing acetaminophen and Chaiqin Qingning Capsules with single administration in mice"
Jingfei GAO ; Xiang AN ; Jieyu SUN ; Xiaomei WU ; Xiang FEI ; Ziyi WANG ; Shuyin ZHANG ; Wenjuan YE ; Manman LIU ; Xuansheng DING
Drug Evaluation Research 2017;40(4):479-486
Objective To study the time-toxicity and dose-toxicity relationship of hepatotoxicity induced by Paracetamol Tablets (PT),Compound Paracetamol and Amantadine Hydrochloride Tablets (CPAH),Compound Dextromethorphan Hydrobromide Tablets (CDH),and Chaiqin Qingning Capsules (CQC) with single dose in mice.Methods In the Time-Toxicity relationship study,Kunming mice were randomly divided into control,PT,CPAH,CDH,and CQC group,and mice of.each drug administration group were randomly divided into nine subgroups according to the time (1,2,4,8,12,24,48,72 and 96 h after administration) of blood collection.The acetaminophen contents in PT,CPAH,and CDH groups were 425.98 mg/kg,and the dose of CQC group was 3 680.50 mg/kg.In the Dosage-Time relationship study,mice were randomly divided into control,PT,CPAH,CDH,and CQC high,medium and low dose group.The acetaminophen contents of high,medium,and low dose were 266.24,425.98,and 681.57 mg/kg in PT,CPAH,and CDH group,and the dose of CQC group was 1437.70,2300.31,and 3680.50 mg/kg,10 mice in each group,sex in half.Blood was collected 12 h after administration.Animal behavior was observed every day,blood and organs were collected at the corresponding time points,serum alanine aminotransferase (ALT),aspartate aminotransferase (AST),and alkaline phosphatase (ALP) level were detected,and the organs index of spleen and thymus,liver were calculated.Results There were no significant changes of ALT,AST,ALP,and organs index after once ig administration of CQC at dosage of 1437.70 mg/kg to 3680.50 mg/kg in mice.The study on time-toxicity relationship indicated that,after once administration of PT,CPAH,and CDH at 425.98 mg/kg,mice showed toxic symptom such as hypokinesia,dry hair and so on,12 h was the most obvious,24 ~ 72 h disappeared.The level of ALT,AST,and ALP in serum increased and reached to the peak at 12 h and then restored near normality after 72,24,and 24 h in PT,CPAH,and CDH group.Their organ index of liver,spleen and thymus all had no significant changes.The study on the dosage-toxicity relationship indicated that,there were no significant changes of animal behavior,ALT,AST,ALP,and organs index after once ig administration of PT,CPAH,and CDH at 266.24 mg/kg.Obvious liver injury can be induced by the three drugs with dosage of 425.98 to 681.57 mg/kg and the level of ALT,AST,and ALP increased significantly with the increase of dosage.Their liver index increased significantly with dosage of 681.57 mg/kg,but the organs index of spleen,thymus had no significant changes.Conclusion There was no hepatotoxicity after once ig administration of CQC with dosage of 3680.50 mg/kg in mice.Mice were once ig administration ofPT,CPAH,and CDH with a large dose,may induce acute liver injury and show obvious time-toxicity and dose-toxicity relationships.
8."Experimental study on ""dose-time-toxicity"" relationship of hepatotoxicity in mice with multiple administration of cold medicine containing acetaminophen and Chaiqin Qingning Capsules"
Jingfei GAO ; Xiang AN ; Jieyu SUN ; Xiaomei WU ; Xiang FEI ; Ziyi WANG ; Shuyin ZHANG ; Wenjuan YE ; Manman LIU ; Xuansheng DING
Drug Evaluation Research 2017;40(5):620-626
Objective To study the dose-time-toxicity relationship of hepatotoxicity in mice with multiple administration of Paracetamol Tablets (PT),Compound Paracetamol and Amantadine Hydrochloride Tablets (CPAH),Compound Dextromethorphan Hydrobromide Tablets (CDH),and Chaiqin Qingning capsules (CQC).Methods Mice were randomly divided into control,PT,CPAH,CDH,and CQC high,medium,and low dose groups.The acetaminophen contents of high,medium,and low doses were 266.24,425.98,and 681.57 mg/kg in PT,CPAH,and CDH groups,and the doses of CQC group were 1437.70,2300.31,and 3 680.50 mg/kg,ig administration,once daily for 5 d.General state and toxicity of mice were observed.The changes of ALT,AST,AKP,TBIL,and ALB levels in serum and organ indexes of liver,spleen,thymus,and kidney were tested on day 1,3,7,11,and 14 after multiple administration.Results CQC with the dosage range of 1 437.70-3 680.50 mg/kg to mice within 14 d,has not yet induced the increase of AST,ALT,AKP,TBIL,and ALB levels and changes of organ indexes of liver,thymus spleen,and kidney compared with normal control (P > 0.05).PT,CPAH,and CDH with repeated dose of 425.98-681.57 mg/kg could induce significant increase of the levels ofALT,AST,AKP,and TBIL which reached the peak on day 1 (P < 0.05),and then gradually decreased on day 3-14.The level of ALB significant decreased on day 1-11 (P < 0.05),and then gradually recovered on day 11-14.The liver index significant increased on day 1-3 (P < 0.05),and recovered on day 7-14.Conclusion Multiple administration of CQC could not induce liver injury in mice within 14 d,while multiple administration ofPT,CPAH,and CDH could induce hepatotocixity in mice with a certain dose,and show an obvious dose-time-toxicity relationship.
9.Experimental study on the"dose-time-toxicity"relationship of hepatotoxicity caused by multiple dose of Chaiqin Qingning capsule (柴芩清宁胶囊) and Ganmaoling capsule (感冒灵胶囊) in mice
Xiang AN ; Jingfei GAO ; Jieyu SUN ; Ziyi WANG ; Xiaomei WU ; Xuansheng DING
Adverse Drug Reactions Journal 2017;19(1):44-51
Objective To investigate the "dose-time-toxicity" relationship of liver injury in mice induced by multiple dose of Chaiqin Qingning Capsule and Ganmaoling capsule. Methods Three hundred and ten healthy SPF mice were divided into 7 groups randomly, in which 3 groups were low, medium and high dose subgroups of Chaiqin Qingning capsule ( 50 mice with male and female half in each subgroup) . The doses of Chaiqin Qingning capsule subgroups were 1437. 70, 2300. 31 and 3680. 50 mg/kg, which were 1. 63 , 1. 64 and 1. 65 times of clinically equivalent dose ( ED) respectively. Three groups were low, medium and high dose subgroups of Ganmaoling capsule (50 mice with male and female half in each subgroup). The doses of Ganmaoling capsule subgroups were 1452. 31, 2251. 08 and 3489. 18 mg/kg, which were 1. 553 , 1. 554 and 1. 555 times of ED respectively. One group was the normal control group (10 mice, half were male). Each subgroup mice were treated with intragastric administration of the corresponding concentration drug suspension by 0. 20 ml per 10 g body weight, and the normal control group mice were treated with intragastric administration of equal volume of distilled water. All mice were treated once daily for 14 days. The general state of mice in each group was observed during the experiment. Ten mice randomly selected on the 1st, 3rd, 7th, 11th and 14th day after multiple administration of the medicine in each subgroup respectively and 10 mice in the normal control group after 14 days multiple administration of distilled water were weighed, and the serum alanine aminotransferase ( ALT) , aspartate aminotransferase (AST), alkaline phosphatase (ALP), albumin (ALB) and total bilirubin (TBil) levels were tested. Then the mice were executed and the organs, i. e. , liver, thymus, and spleen were taken to weigh and calculate the organ index. Results The general state of mice in the normal control group, Chaiqin Qingning capsule subgroups and Ganmaoling capsule low dose subgroup were not abnormal during the administration period. Ganmaoling capsule high dose subgroup appeared 8 mice died within 1 day after first administration, the overall mortality rate was 16%. The high dose and medium dose subgroup of mice showed decrease in activities, dietary, water and body weight significantly on 1st to 3rd day. The symptoms gradually disappeared on 4th to 7th day, and the state gradually returned to normal on 8th to 14th day. The difference of serum level of ALT, AST, ALP, ALB, TBil and liver, thymus and spleen organ index of Chaiqin Qingning capsule subgroups and Ganmaoling capsule low dose subgroup on the 1st, 3rd, 7th, 11th and 14th days after multiple administration compared with those of the normal control group were not statistically significant (all P>0. 05). The levels of serum ALT, ALP and TBil of Ganmaoling capsule high dose subgroup mice after multiple administration on 1st, 3rd, 7th day and the serum AST of mice on 1st and 3rd day were significantly higher than those in the normal control group (P<0. 05, P<0. 01). The serum ALB level of Ganmaoling capsule high dose subgroup mice on 3rd, 7th, 11th and 14th day were significantly lower than those in normal control group (P<0. 05, P<0. 01). The levels of serum ALT, AST, ALP and TBil of Ganmaoling capsule medium dose subgroup mice after multiple administration on 1st and 3rd day were significantly higher than those in the normal control group (P<0. 05, P<0. 01). The serum ALB level of Ganmaoling capsule medium dose subgroup mice after multiple administration on 3rd and 7th day were significantly lower than those in normal control group (P<0. 05, P<0. 01). The liver organ index of mice in Ganmaoling capsule high dose subgroup after multiple administration on 1st , 3rd and Ganmaoling capsule medium dose subgroup after multiple administration on 1st day were significantly higher than that in the normal control group (all P<0. 01). Conclusions Multiple intragastric administration of Chaiqin Qingning capsule in different doses did not induce significant hepatotoxicity. Multiple intragastric administration of Ganmaoling capsule in medium dose or high dose could induce hepatotoxicity in mice, and showed an obvious "dose-time-toxicity" relationship.
10.Experimental study on the"dose-time-toxicity"relationship of hepatotoxicity caused by multiple dose of Chaiqin Qingning capsule (柴芩清宁胶囊) and Ganmaoling capsule (感冒灵胶囊) in mice
Xiang AN ; Jingfei GAO ; Jieyu SUN ; Ziyi WANG ; Xiaomei WU ; Xuansheng DING
Adverse Drug Reactions Journal 2017;19(1):44-51
Objective To investigate the "dose-time-toxicity" relationship of liver injury in mice induced by multiple dose of Chaiqin Qingning Capsule and Ganmaoling capsule. Methods Three hundred and ten healthy SPF mice were divided into 7 groups randomly, in which 3 groups were low, medium and high dose subgroups of Chaiqin Qingning capsule ( 50 mice with male and female half in each subgroup) . The doses of Chaiqin Qingning capsule subgroups were 1437. 70, 2300. 31 and 3680. 50 mg/kg, which were 1. 63 , 1. 64 and 1. 65 times of clinically equivalent dose ( ED) respectively. Three groups were low, medium and high dose subgroups of Ganmaoling capsule (50 mice with male and female half in each subgroup). The doses of Ganmaoling capsule subgroups were 1452. 31, 2251. 08 and 3489. 18 mg/kg, which were 1. 553 , 1. 554 and 1. 555 times of ED respectively. One group was the normal control group (10 mice, half were male). Each subgroup mice were treated with intragastric administration of the corresponding concentration drug suspension by 0. 20 ml per 10 g body weight, and the normal control group mice were treated with intragastric administration of equal volume of distilled water. All mice were treated once daily for 14 days. The general state of mice in each group was observed during the experiment. Ten mice randomly selected on the 1st, 3rd, 7th, 11th and 14th day after multiple administration of the medicine in each subgroup respectively and 10 mice in the normal control group after 14 days multiple administration of distilled water were weighed, and the serum alanine aminotransferase ( ALT) , aspartate aminotransferase (AST), alkaline phosphatase (ALP), albumin (ALB) and total bilirubin (TBil) levels were tested. Then the mice were executed and the organs, i. e. , liver, thymus, and spleen were taken to weigh and calculate the organ index. Results The general state of mice in the normal control group, Chaiqin Qingning capsule subgroups and Ganmaoling capsule low dose subgroup were not abnormal during the administration period. Ganmaoling capsule high dose subgroup appeared 8 mice died within 1 day after first administration, the overall mortality rate was 16%. The high dose and medium dose subgroup of mice showed decrease in activities, dietary, water and body weight significantly on 1st to 3rd day. The symptoms gradually disappeared on 4th to 7th day, and the state gradually returned to normal on 8th to 14th day. The difference of serum level of ALT, AST, ALP, ALB, TBil and liver, thymus and spleen organ index of Chaiqin Qingning capsule subgroups and Ganmaoling capsule low dose subgroup on the 1st, 3rd, 7th, 11th and 14th days after multiple administration compared with those of the normal control group were not statistically significant (all P>0. 05). The levels of serum ALT, ALP and TBil of Ganmaoling capsule high dose subgroup mice after multiple administration on 1st, 3rd, 7th day and the serum AST of mice on 1st and 3rd day were significantly higher than those in the normal control group (P<0. 05, P<0. 01). The serum ALB level of Ganmaoling capsule high dose subgroup mice on 3rd, 7th, 11th and 14th day were significantly lower than those in normal control group (P<0. 05, P<0. 01). The levels of serum ALT, AST, ALP and TBil of Ganmaoling capsule medium dose subgroup mice after multiple administration on 1st and 3rd day were significantly higher than those in the normal control group (P<0. 05, P<0. 01). The serum ALB level of Ganmaoling capsule medium dose subgroup mice after multiple administration on 3rd and 7th day were significantly lower than those in normal control group (P<0. 05, P<0. 01). The liver organ index of mice in Ganmaoling capsule high dose subgroup after multiple administration on 1st , 3rd and Ganmaoling capsule medium dose subgroup after multiple administration on 1st day were significantly higher than that in the normal control group (all P<0. 01). Conclusions Multiple intragastric administration of Chaiqin Qingning capsule in different doses did not induce significant hepatotoxicity. Multiple intragastric administration of Ganmaoling capsule in medium dose or high dose could induce hepatotoxicity in mice, and showed an obvious "dose-time-toxicity" relationship.

Result Analysis
Print
Save
E-mail