Effectiveness and Safety of Jinye Baidu Granules(金叶败毒颗粒)for Acute Upper Respiratory Tract Infection:A Systematic Review and Meta-analysis

To evaluate the effectiveness and safety of Jinye Baidu Granules(金叶败毒颗粒)for acute upper respiratory tract infection(AURTI).Database such as CNKI,Wan-fang,VIP,Sino Med,Web of science,Clinical Trials gov,Medline、EMBASE,CENTRAL,Cochrane Library were retrieved to collect randomized controlled trials(RCTs)on Jinye Baidu Granules(金叶败毒颗粒)in treating AURTI from the estabslishment of the database to March 2019.A total of 2 reviewers independently screened the literature according to the inclusion and exclusion criteria,and extracted material and the quality evaluation of the included studies.Quality evaluation adopted Cochrane Handbook 5.1 evaluation standards and tools.Rev Man5.3 was used to perform Meta-analysis for the adopted study.Finally a total of 4 RCTs involving 636 patients were included.Meta-analysis results showed that:compared with conventional Western medicine alone,Jinye Baidu Granules(金叶败毒颗粒)combined with Western medicine in the treatment of acute upper respiratory tract infection can improve the total effective rate of clinical efficacy[RR=0.13,95%CI(0.06,0.29),P<0.00001],shorten the time of antipyretic time for acute upper respiratory tract infection[MD=–1.22,95%CI(–1.43,–1.00),P<0.00001],shorten the time of pharyngeal pain[MD=–1.97,95%CI(–2.97,–0.96),P<0.0001]and shorten the cough disappear time[MD=–1.97,95%CI(–2.97,–0.96),P<0.0001].There were 2 papers reporting adverse reactions during the study period,and one of them specifically reported diarrhea,nausea,vomiting and stomachache in the experimental group.In the control group:diarrhea,nausea and adverse reactions disappeared after drug withdrawal;the incidence of adverse reactions was 3.92%in the control group and 5.88%in the observation group.There was no significant difference between the 2 groups(P>0.05).Based on existing data and methods,the systematic evaluation showed that,compared with Western medicine alone,Jinye Baidu Granules(金叶败毒颗粒)combined with Western medicine alone could improve the total effective rate of clinical efficacy,reduce the time of fever,sore throat,and the disappearance of cough with less adverse reactions.However,due to the low quality of the included study,large samples,multicenter,randomized,double-blind trials and trials are still needed to randomized controlled trials with reference to the CONSORT standard and the STRICTA statement.

Effects of Jinye Baidu Granule (金叶败毒颗粒) on Fetal Growth and Development with Maternal Active Human Cytomegalovirus Infection

To evaluate the effects of Jinye Baidu Granule （金叶败毒颗粒, JYBDG）, a traditional Chinese medicine compound prescription, on fetal growth and development with maternal active human cytomegalovirus infection. Methods： A prospective, randomized and controlled trial was adopted during January 1996 to June 2002. From the pregnant women with an abnormal pregnant history, 240 cases were screened to be infected by human cytomegalovirus （HCMV） by enzyme-linked immunoabsorbent assay （ELISA） and reverse transcription polymerase chain reaction （RT-PCR）. They were assigned according to the random number table to two groups. The 122 cases in the treatment group were administrated with JYBDG, one package each time, three times a day for two continuous weeks, while the other 118 in the control group did not receive any treatment. The negative conversion rate of both HCMV-IgM and HCMV late mRNA, the positive rate of HCMV-DNA in placenta and the intrauterine transmission rate between the two groups were compared, and fetal growth and development in partial fetuses were also observed. Results： The negative conversion rate of both HCMV-IgM and HCMV late mRNA, the positive rate of HCMV-DNA in placenta and the intrauterine transmission rate in the treatment group were 77. 05% （94/122）, 48.98% （48/98） and 21.74% （10/46） respectively, while those in the control group were 38. 14% （45/118）, 67.50% （54/80） and 52.63% （20/38） respectively, all showing significant difference between the two groups （P〈0.01）. Totally 35 normal infants and 11 abnormal infants were born in the treatment group, and the number in the control group was 20 and 18 respectively, and comparison between the two groups showed significant difference （P〈0.01）. Six months of child birth, the scores of both mental development index （MDI） and psychomotor development index （PDI） of infants were higher in the treatment group （20 cases） than those in the control group （20 cases）, but there was no significant difference between the two groups （P〉0.05）. Conclusion： JYBDG could decrease the intrauterine transmission of HCMV and is beneficial to fetal growth and development.

Jinye Baidu granule for wind-warmth lung-heat disease(heat in the lung-wei)： protocol for a randomized, double-blind, parallel, controlled trial

OBJECTIVE: To observe the curative effect of Jinye Baidu granule in the treatment of fever and swollen and sore throat caused by wind-warmth lung-heat disease(heat in the lung-wei) to further identify the indications.METHODS: This randomized, double-blind, parallel, controlled trial will include patients with acute upper respiratory infection and wind-warmth lung-heat disease(heat in the lung-wei). Patientswith serious bacterial infection(white blood cell count > 12 × 10~9, neutrophils > 80%) will be excluded. Patients will be divided into three categories(blocks) according to their condition: fever only, a swollen and sore throat, and combined fever plus a swollen and sore throat. Patients within each of the three blocks will be further divided into a treatment group and a control group via stratified blocked randomization. The treatment group will be treated with Jinye Baidu granule, and the control group will be treated with Fufang Shuanghua granule. The primary outcome measure will be body temperature recovery time for patients with fever, throat symptom score for patients with a swollen and sore throat, and body temperature recovery time and throat symptom score for patients with combined fever plus a swollen and sore throat. Routine blood testing, urine testing, liver function, kidney function and ECG data of all patients will be collected as safety indices before and after enrollment, and adverse events will be recorded during the whole trial course.CONCLUSION: This study protocol will include stratified block analysis according to patients' symptoms, and identify the accurate clinical indications of Jinye Baidu granule. It will also enable safety evaluation from laboratory indices and adverse events, which will provide reliable evidence for clinical treatment.