Qingkailing injection for the treatment of acute upper respiratory infection in children: a systematic review and meta-analysis

Objective:To systematically evaluate the clinical efficacy and safety of Qingkailing (QKL) injection for pediatric acute upper respiratory infection (AURI).Methods:We searched for randomized controlled trials (RCTs) of pediatric AURI treated by QKL and western medicine (WM) in the China National Knowledge Infrastructure Database,China Science and Technology Journal Database,Wanfang,Chinese Biomedical Literature Database,PubMed and Cochrane Library from inception to August,2016.Two reviewers independently retrieved the RCTs and extracted information.The Cochrane Collaboration Risk of Bias Assessment Tool was used to evaluate the methodological quality of RCTs.The data were meta-analyzed by RevMan 5.3 software.Results:Ultimately,21 RCTs that involved 2364 participants were included,and the quality of RCTs was generally poor.According to the meta-analysis,the combined use of QKL and WM for treating AURI can be effective,with a higher total effective rate,less defervescence time and less recovery time of tonsil and throat inflammation.Twenty-five adverse drug reactions (ADRs) were reported in three RCTs,but there were no serious ADRs.Conclusion:The combination of QKL and WM for treating pediatric AURI can result in better effects,but no definitive conclusions can be made regarding its safety.More rigorous RCTs are needed to support the clinical application of QKL.

Therapeutic window of Qingkailing injection for focal cerebral ischemia/reperfusion injury

The time window in which a drug is effective varies between drugs. The present study investigated the therapeutic window of Qingkailing injection for focal cerebral ischemia/reperfusion in mice. Animals underwent middle cerebral artery occlusion and were injected with Qingkailing （1.5, 3, 6 mL/kg）. Infarct volume and neurological function were assessed after 24 hours of ischemia. In addition, to establish the therapeutic time window, mice were injected with 3 mL/kg Qingkailing at 0, 1, 3, 4, 6, 9 and 12 hours after occlusion. Results revealed that Qingkailing injection significantly reduced infarct volume and improved neurological function in model mice after cerebral infarction for up to 9 hours, demonstrating that the therapeutic window of Qingkailing injection can extend to 9 hours for cerebral ischemia/reperfusion in mice.

Treatment of 104 Cases of Chemotherapy-Induced Leukopenia by Injection of Drugs into Zusanli

From April 1992 to April 1998, 104 cases of chemotherapy-induced leukopenia were treated by injection into Zusanli (ST 36) with a mixture consisting of dexamethasone, 654-2, ATP and inosine. The therapeutic results were satisfactory as reported in the following.Clinical Data In this series, all the 127 cases were definitely diagnosed by pathological examination. Of them, 93 were male and 34 female, ranging in age from 12 to 75 years. 38 cases were carcinoma of esophagus, 22 carcinoma of cardia of stomach, 21 cancer of lung, 11 hepatic carcinoma, 8 lymphoma, 8 mammary cancer, 7 carcinoma of colon, and 12 other kinds of the tumors. Leukocyte count was below 4.0×109/L in all the patients after being treated by chemotherapy.

Qingkailing Injection(清开灵注射液)for Treatment of Children Pneumonia Induced by Respiratory Syncytial Virus:A Meta-Analysis of Rando mized Controlled Trials

Objective： To evaluate the efficacy and safety of Qingkailing Injection（清开灵注射液, QKL） for treatment of children pneumonia caused by respiratory syncytial virus（RSV）. Methods： Randomized clinical trials（RCTs） comparing QKL with ribavirin injection in the treatment of children pneumonia induced by RSV were searched in Pub Med, Science Direct, Cochrane Library, Chinese VIP database, CNKI and Wanfang databases from their inception to March 2014. Meta-analyses were performed using RevMan 5.2 software. The methodological quality of the selected RCTs was evaluated by the Modified Jadad Score. The primary outcome measures were effective rate and the secondary outcomes were relief time of fever and cough. Results： Seven RCTs with 992 cases published from 2008 to 2013 were identified. The meta-analysis results indicated that QKL was more effective in cure rate [risk ratios（RR）=1.32, 95% CI（1.17, 1.50）, P〈0.01], total effective rate [RR=1.07, 95% CI（1.02, 1.13）, P=0.009] and less fever clearance time [mean difference=–0.73, 95% CI（–1.22, –0.23）, P=0.004], compared with ribavirin injection in the treatment of RSV-induced children pneumonia. No dead case was reported in all trials. There were 3 trials mentioned adverse events, 2 reported no obvious adverse event occurred while 1 reported adverse events described as skin hypersensitivity, elevation of ALT, a mild abnormal of hepatic and renal function in both QKL and ribavirin group. Conclusions： QKL was an effective and relatively safe option for the treatment of RSV-induced children pneumonia. These therapeutic effects were promising but need to be interpreted with caution due to variations in the treatment and methodological weakness in the studies.

Qingkailing injection for the treatment of acute stroke: a systematic review and Meta-analysis

OBJECTIVE： To evaluate systematically the clinical efficacy and safety of Qingkailing （QKL） injection in the treatment of acute stroke. METHODS： Searches for randomized controlled trials into acute stroke treated with QKL injection were performed in the China National Knowledge Infrastructure Database, China Science and Technology Journal Database, Wan fang Database, Chinese Biomedical Literature Database, PubMed and Cochrane Library, from January 1979 to March 2013. Two reviewers independently retrieved the RCTs and extracted the information. The Cochrane risk of bias method was used to assess the quality of the included studies, and a Meta-analysis was conducted with Review Manager 5.2 software. RESULTS： A total of 13 studies with 1110 participants were included. The quality of the studies was generally low. The Meta-analysis indicated that the combined use of QKL and Western Medicine was significantly superior to control group therapy in terms of the total effective rate. The relative risk （RR） in the acute cerebral hemorrhage （ACH） sub-group was 1.17 [95% confidence interval （CI） （1.08, 1.26）, P=0.0001]. In the acute cerebral infarction （ACI） sub-group, RR was 1.27 [9.5% CI （1.14, 1.42）, P〈0.0001], and in the ACH and ACI mixed sub-group, RR was 1.34 [95% CI （1.20,1.50）,P〈0.00001]. Additionally, QKL promoted the absorption of hematoma [mean difference （MD）= - 3.73, 95%0 （ - 4.48, - 2.98）, P〈0.000 01], decreased neurological damage in ACI [MD= - 5.60, 95% CI （ - 8.50, - 2.70）, P=0.0002] and ACH [MD= 4.08, 95% CI （ - 8.00, 0.16）, P=0.04], promoted the recovery of awareness [RR=1.56, 95% CI （1.09, 2.21）, P=0.01] and reduced the whole blood viscosity coefficient [MD=- 0.75, 95% CI （ - 1.47, - 0.03）, P=0.04]. There were no adverse drug reactions reported in the included studies. CONCLUSION＂ Based on this systematic review, QKL combined with conventional therapy was effective compared with control treatment. However, because the articles used in the study were not of high quality, further studies should be conducted into the efficacy and safety of QKL in treating acute stroke.

Experimental study on anaphylaxis of Qingkailing injection and its components on Beagle dogs

OBJECTIVE:To study the anaphylaxis of Qingkailing injection(QI) and its components.METHODS:Experimental anaphylactoid and allergic reactions were used.Changes in the behaviors of Beagles and serum levels of histamine,immunoglobulin(Ig)E,IgG,IgM,eosinophil cationic protein(ECP),and interleukin(IL)-4,as well as blood pressure,after injecting QI and its components on the forelimb veins of Beagles were observed.RESULTS:According to comprehensive determination of abnormal behavior scores and changes in serum levels of histamine,IgE,IgG,IgM,ECP,and IL-4,as well as in blood pressure,radix isatidis and hyodeoxycholic acid caused anaphylactoid reactions,and honeysuckle,radix isatidis,hydrolysate,cholic acid and Gardenia jasminoides caused allergic reactions.The anaphylaxis of QI involved anaphylactoid and allergic reactions.CONCLUSION:QI and its components need to be refined further to improve the safety,efficacy,and quality of its use in clinical settings.

Network pharmacology assessment of Qingkailing injection(清开灵注射液)treatment of cholestatic hepatitis

OBJECTIVE:To investigate the targets and mechanisms of action of Qingkailing injection(清开灵注射液,QKL)in the treatment of cholestatic hepatitis.METHODS:A network pharmacology method was implemented using drug and disease databases to target QKL and cholestasis hepatitis,respectively.The functional protein association network STRING database was used to construct a protein-protein interaction network using R language and the Bioconductor toolkit.The org.Hs.eg.db and cluster Profiler packages were used for gene ontology and Kyoto Encyclopedia of Genes and Genomes pathway enrichment analysis,which explored biological functions and pathways of potential targets.Targets were then visualized using Cytoscape 3.6.0 software.RESULTS:We screened 121 compounds in QKL and identified 112 targets for the treatment of cholestatic hepatitis.QKL played a role in the treatment of cholestatic hepatitis through 305 biology process terms,15 cellular component and 29 molecular function terms.The mechanism of QKL action was mainly related to tumor necrosis factor,mitogen-activated protein kinase,and PI3 K-Akt signaling pathways.CONCLUSION:The treatment of cholestatic hepatitis by QKL involved multiple targets,biological functions,and signaling pathways that are closely associated with the disease.

基于UPLC-QTOF/MS的清开灵注射液过敏反应豚鼠血清代谢组学研究

目的:利用代谢组学方法研究清开灵注射液过敏反应豚鼠血清样本,探索其可能存在的特征性生物标志物。方法:利用超高效液相色谱-四级杆飞行时间串联质谱(UPLC-QTOF/MS)技术对清开灵注射液组豚鼠和空白对照组豚鼠血清代谢指纹图谱展开分析,根据主成分分析(PCA)和正交信号校正偏最小二乘判别分析(OSC-PLS-DA)结果筛选出差异性代谢物。结果:清开灵注射液组与空白对照组分别呈现聚类分布,确认出5个生物标志物,包括硬脂酰溶血磷脂酰胆碱、肉豆蔻酰溶血磷脂酰胆碱、二氢神经鞘氨醇、蟾二烯羟酸内酯和3α,12β-二羟基-5β-胆烷酸。结论:建立了利用液相色谱-质谱技术进行清开灵注射液过敏反应豚鼠血清代谢组学研究的方法,为进一步认识清开灵注射液的过敏反应及中药注射剂安全性评价研究提供了新的思路。

清开灵注射液联合阿托伐他汀钙片治疗急性脑梗死患者的效果及安全性

目的 观察清开灵注射液联合阿托伐他汀钙片治疗急性脑梗死(ACI)患者的效果及安全性。方法 选取2021年1月—2023年1月上饶市广信区人民医院收治的68例ACI患者,采用随机抽签法分为A组34例(采用阿托伐他汀钙片治疗)和B组34例(在A组基础上联合清开灵注射液治疗),2组患者均持续治疗7 d。比较2组临床疗效,治疗前后美国国立卫生研究院卒中量表(NIHSS)评分、凝血功能指标、血液流变学指标及不良反应。结果 B组治疗总有效率高于A组(94.12%vs.76.47%,χ^(2)=4.221,P=0.040)。治疗7 d后,2组NIHSS评分、血浆纤维原蛋白水平降低,凝血酶原时间、活化部分凝血活酶时间延长,且B组变化幅度大于A组(P<0.01);2组全血黏度、血小板聚集率、血浆黏度降低,且B组低于A组(P<0.01)。B组药物不良反应总发生率低于A组(5.88%vs.26.47%,χ^(2)=5.314,P=0.021)。结论 采用清开灵注射液与阿托伐他汀钙片联合治疗ACI患者不仅可改善凝血功能和血液流变学,促进神经功能恢复,还能减少不良反应,提高用药安全性。

Potassium Dehydroandrographolide Succinate Injection for the Treatment of Child Epidemic Parotitis:A Systematic Review and Meta-Analysis

Objective： To systematically evaluate the clinical efficacy and safety of Potassium Dehydroandrographolide Succinate Injection （PDSI） in the treatment of child epidemic parotitis （EP）. Methods： Randomized controlled trials （RCTs） regarding PDSI in the treatment of child EP were searched in China National Knowledge Infrastructure, Wanfang Database, Chinese Biomedical Literature Database, PubMed, and Cochrane Library from inception to July 30, 2013. Two reviewers independently retrieved RCTs and extracted information. The Cochrane risk of bias method was used to assess the quality of included studies, and a meta- analysis was conducted with RevMan 5.2 software. Results： A total of 11 studies with 818 participants were included. The quality of the studies was generally low, among which only one study mentioned the random method. The meta-analysis indicated that PDSI was more effective than the conventional therapy with Western medicine for EP in the outcomes of the total effective rate [relative risk （RR）=1.23, 95% confidence interval （CI） [1.14, 1.33], P〈0.01], the time of temperature return to normal, the time of detumescence [mean difference （MD）=-2.10, 95% CI [-2.78, -1.41], P〈0.01], and the incidence of complications （RR=0.14, 95% CI [0.03, 0.72], P=0.02）. There were 6 adverse drug reactions （ADRs） in this systematic review, 2 of which were mainly represented rash and diarrhea in the experiment group, while another 4 ADRs occurred in the control group. Conclusions： Based on the systematic review, PDSI was effectiveness and relatively safety in the treatment of child EP. But further rigorously designed trials are warranted to determine its effectiveness.

预防接种门诊安全注射的难点及措施分析

目的探究儿童预防接种安全注射的难点并提出针对性的干预措施。方法选择2021年1月至2021年5月在我院接种预防的98例儿童作为对照组,2022年1月至2022年5月在我院接种预防的98例儿童作为观察组,分析儿童预防接种安全注射的难点及应对措施。结果观察组中儿童实施预防接种安全注射措施,儿童在预防接种后的0~3 d内注射局部红肿硬结率低于对照组(P<0.05)。观察组儿童家长对接种服务满意度高于对照组(P<0.05)。两组实施接种人员被针头刺伤误伤率无统计学意义(P>0.05)。结论实施安全注射措施可以有效提高接种安全性和接种服务的满意度,效果良好。

热毒宁注射液联合阿奇霉素对小儿肺炎支原体肺炎的疗效

目的探讨热毒宁注射液联合阿奇霉素(AZM)治疗小儿肺炎支原体肺炎(MPP)的疗效与对血清Toll样受体2(TLR2)、肿瘤坏死因子α诱导蛋白8样分子2(TIPE2)、可溶性程序性死亡受体1(sPD-1)的影响。方法通过随机数字表法将2020年10月至2023年8月南京同仁医院收治的82例小儿MPP患儿分为对照组与试验组,各41例。对照组予以AZM治疗,试验组予以热毒宁注射液联合AZM治疗,以7 d为1个疗程,两组均治疗及随访至出院。比较两组治疗效果,康复情况,治疗前后血清TLR2、TIPE2、sPD-1水平,以及住院期间不良反应发生情况。结果与对照组治疗后的总有效率(75.61%)比较,试验组总有效率(95.12%)更高(χ^(2)=6.248,P<0.05)。试验组发热持续时间、住院时间、咳嗽持续时间分别为(4.76±0.51)d、(9.78±0.95)d、(7.03±0.67)d,短于对照组的(7.22±0.76)d、(12.95±0.82)d、(8.89±0.72)d(t=17.210、16.174、12.109,均P<0.05)。试验组TIPE2水平分别为(57.70±5.91)pg·mL^(-1),高于对照组的(42.63±4.23)pg·mL^(-1)(t=13.277,P<0.05);试验组全血CD8^(+)水平,血清TLR2、sPD-1水平分别为(24.76±1.52)%、(4.46±0.89)ng·mL^(-1)、(141.65±26.40)μg·L^(-1),低于对照组的(27.25±1.15)%、(7.03±1.34)ng·mL^(-1)、(176.73±38.35)μg·L^(-1)(t=8.365、10.230、4.825,均P<0.05)。两组住院期间不良反应发生率比较,差异无统计学意义(19.51%vs 12.20%,χ^(2)=0.823,P>0.05)。结论热毒宁注射液联合AZM应用于小儿MPP的效果较好,可促进其康复,调节机体TLR2、TIPE2、s PD-1表达水平,安全性高。

清开灵对人冠状病毒肺炎寒湿疫毒袭肺证小鼠病证结合模型的治疗作用

目的:构建寒湿疫毒袭肺病证动物模型,考察清开灵注射液缓解寒湿症作用的功效。方法:从小鼠证型外观表现,血清中胃动素(Motilin,MTL)、胃泌素(Gastrin,GAS)含量,肺指数及抑制率,肺组织中病毒核酸表达量、炎症因子表达量等方面进行药效学评价。结果:小鼠感染后,肺指数较模型组明显增大(p <0.01);与寒湿感染组相比,低、高剂量给药组肺指数均显著降低(p <0.01),肺指数抑制率分别为82.20%、69.12%。清开灵注射液可明显改善感染小鼠一般状态,显著降低小鼠肺部炎症,降低小鼠肺组织中病毒核酸表达、白细胞介素-6(Interleukin-6,IL-6)等炎症因子含量以及血清中MTL、GAS含量,增大淋巴细胞百分比。结论:清开灵注射液对人冠状病毒肺炎寒湿疫毒袭肺证有明显的治疗作用。

仿制与原研注射用头孢曲松钠治疗社区获得性肺炎患儿药物经济学比较

目的对比注射用头孢曲松钠的国家组织药品集中带量采购(简称国家集采)中选品规(仿制药)与其原研药对应品规治疗社区获得性肺炎(CAP)患儿的药物经济学情况。方法调取新疆军区总医院电子病历系统中2020年1月至2022年8月该院儿科收治的非重症CAP患儿(年龄3个月至14岁)资料292份,根据治疗药物的不同分为A组(140份)和B组(152份),两组分别予注射用头孢曲松钠的仿制药和原研药品规(规格均为每支1.0 g)静脉滴注方案。查阅两组患儿的临床疗效、不良反应发生情况并计算治疗成本;采用成本-效果分析法进行药物经济学比较,并以敏感性分析验证。结果A组与B组患儿的有效率相当(87.14%比89.47%,P>0.05)。A组各项治疗成本(除住院成本外)均显著低于B组(P<0.01);A组体温好转时间显著长于B组,不良反应发生率显著高于B组(P<0.05);B组增量成本-效果比为471.36;敏感性分析结果显示,在总成本降低10%和有效率取95%置信区间下限的前提下,B组增量成本-效果比分别为424.23,364.88。结论注射用头孢曲松钠的仿制药比原研对应品规更具经济学优势。

清开灵注射液辅助治疗小儿脓毒症毒热证的效果及对炎症因子、心肌受损程度的影响

目的探讨清开灵注射液辅助治疗小儿脓毒症毒热证的效果及对炎症因子、心肌受损程度的影响。方法选取沭阳县中医院2020年5月至2023年7月收治的60例脓毒症毒热证患儿作回顾性分析,根据不同治疗方案分为对照组(n=30)与观察组(n=30)。对照组采用常规综合治疗,观察组在对照组基础上联合清开灵注射液治疗。比较两组病情程度、炎症因子水平、心肌损伤标志物水平及凝血功能。结果治疗后,观察组小儿危重症评分高于对照组,快速序贯器官衰竭评分、急性生理与慢性健康评分低于对照组(P<0.05)。治疗后,观察组肿瘤坏死因子-α、超敏C反应蛋白、白细胞介素-6水平较对照组低,白细胞介素-10水平较对照组高(P<0.05)。治疗后,观察组N端脑钠肽前体、超敏肌钙蛋白T、肌酸激酶同工酶水平均低于对照组(P<0.05)。治疗后,观察组纤维蛋白原、D-二聚体水平较对照组低,抗凝血酶Ⅲ水平较对照组高(P<0.05)。结论小儿脓毒症毒热证采取清开灵注射液治疗可有效改善患儿病情,降低炎症因子水平及心肌损伤程度,改善凝血功能,可在临床中借鉴使用。

小剂量艾司氯胺酮预先注射减轻小儿丙泊酚中/长链脂肪乳注射痛

目的探讨小剂量艾司氯胺酮在减轻小儿丙泊酚中/长链脂肪乳注射痛中的作用。方法选择2023年7~12月湖南省儿童医院收治的行全麻手术患儿165例为研究对象,随机分为3组,对照组、艾司氯胺酮组与利多卡因组各55例。艾司氯胺酮组在注射丙泊酚中/长链脂肪乳前预先静脉注射0.2 mg/kg艾司氯胺酮,利多卡因组预先静脉注射0.5 mg/kg利多卡因,对照组预先静脉注射同体积生理盐水。记录注射痛发生率和疼痛评分,以及不良反应。结果艾司氯胺酮组与利多卡因组注射痛发生率分别为20.0%(11/55)和21.8%(12/55),明显低于对照组45.5%(25/55),差异有统计学意义(P<0.05);艾司氯胺酮组与利多卡因组疼痛评分分别为(0.22±0.46)分、(0.27±0.56)分,明显低于对照组(0.87±1.10)分,差异有统计学意义(P<0.05);艾司氯胺酮组与利多卡因组注射痛发生率和疼痛评分比较差异均无统计学意义(P>0.05)。3组患儿不良反应发生率比较差异无统计学意义(P>0.05)。结论小剂量艾司氯胺酮预先处理可降低小儿丙泊酚中/长链脂肪乳注射痛发生率以及疼痛强度,与利多卡因相当,且无严重并发症。

小郁子油子午流注穴位贴敷联合四子散热奄包改善癌性肠梗阻的疗效

目的 探究小郁子油子午流注穴位贴敷联合四子散热奄包治疗对于癌性肠梗阻的临床效果。方法 纳入2022年1月至2023年7月在广州中医药大学顺德医院肿瘤科住院治疗的恶性肿瘤合并肠梗阻患者120例,采用随机对照试验方法进行临床对照观察。对照组给予常规西医治疗,观察组在西药治疗基础上分为三组,分别给予小郁子油子午流注穴位贴敷治疗、四子散热奄包治疗、小郁子油子午流注穴位贴敷联合四子散热奄包治疗。比较临床疗效、腹胀分级、疼痛程度(NRS)、舒适度(VAS)及满意度。结果 观察组临床疗效高于对照组(P <0.05);观察组腹胀等级优于对照组(P <0.05);观察组NRS及VAS评分均低于对照组(P <0.05);观察组治疗满意度高于对照组(P <0.05)。结论 针对癌性肠梗阻患者,为其实施小郁子油子午流注穴位贴敷联合四子散热奄包治疗更有助于改善临床病症,提升治疗效果。

清开灵注射液治疗急性上呼吸道感染的临床研究

目的：探讨清开灵注射液（简称清开灵）对急性发热的疗效。方法：每日采用清开灵１２０、１６０、２００ｍｌ３个剂量，并以洁霉素注射液（简称洁霉素）１８ｇ做对照，观察急性上呼吸道感染患者４００例的疗效。结果：清开灵愈显率８４１４％，洁霉素愈显率７５８３％，前者疗效优于后者（Ｐ＜００１）。清开灵（一次性常规剂量）降低体温平均起效时间（１２６ｈ）较洁霉素（１７６ｈ）短，清开灵对病程１天以内的患者，疗效优于病程３天者。但３个剂量之间，疗效无显著性差异（Ｐ＞００５）。清开灵各剂量组及总体降低白细胞总数的效果，均与洁霉素相仿。清开灵对咽拭子培养有致病菌生长者，体内抗菌作用很好。结论：清开灵是治疗急性上呼吸道感染的高效。

4种中药注射剂皮肤过敏试验方法与意义的探讨

黄芪多糖粉针剂皮下法皮肤过敏试验阳性率12．3％，清开灵粉针剂3．0％，清开灵注射液7．6％，双黄连注射液6．3％。青霉素过敏反应率为0．7％～10％。不同剂型（粉针与液剂），不同浓度等均可能会影响皮试阳性率。皮试阳性不用药。皮试阴性用药，用药后仍有过敏反应发生。黄芪多糖粉针剂皮试阴性，用药后过敏反应发生率为2．1％。清开灵为0．4％（1／224），双黄连注射液为0．9％～2．6％。双黄连注射液在人群中的致敏率为8．6％（31／360包括皮试阳性数加过敏反应数）。清开灵粉针剂组致敏率为4．5％（6／132），清开灵注射液组致敏率9．1％（12／132）。黄芪多糖粉针剂组致敏率15．4％（62／402）。合计致敏率10．8％（111／1026）。青霉素皮下法试验阳性主要表现以皮丘为主，伴有周围红晕，而中药注射液皮肤以红晕为主，皮丘多不明显。皮试对减少黄芪多糖粉针剂、清开灵粉针剂、双黄连注射液用药后过敏反应有一定意义。可作为临床减少不良反应的措施之一。