Prevalence of and Risk Factors for Community-Based Osteoporosis and Associated Fractures in Beijing: Study Protocol for a Cross-Sectional and Prospective Study.

Background: Osteoporosis (OP) patients are usually asymptomatic until osteoporotic fractures occur, which makes early diagnosis and prevention difficult, and the associated fractures secondary to OP could be preventable with appropriate management. Therefore, early identification and relevant evidence-based management of OP could guide the prevention of subsequent fractures. This study will investigate the prevalence of OP and the incidence of osteoporotic fractures in Beijing community residents to further explore the related risk factors and put forward suggestions for people aged 45-80 years old. Methods: Over 2 years, this study will conduct an OP screening and a prospective follow-up in the Beijing community to investigate the incidence of osteoporotic fractures. The study will undertake bone mineral density detection, collect biological samples, and record information via questionnaires. Discussion: The study aims to investigate the potential risk factors for osteoporosis and explore syndromes from traditional Chinese medicine that are associated with this condition based on large samples from the Beijing community. Data on the incidence of osteoporotic fractures among community dwellers in Beijing over the two-years will be available on the Chinese clinical trial registry: ChiCTR-SOC-17013090.

[Systematic evaluation and Meta-analysis of Xiao'er Chaigui Tuire Granules in treating hand, foot and mouth disease].

The efficacy and safety of Xiao'er Chaigui Tuire Granules for the treatment of hand, foot and mouth disease were syste-matically evaluated. Four Chinese databases of CNKI, CBM, WanFang, VIP and four English databases of PubMed, Cochrane Library, EMbase, Web of Science were retrieved by computers. With Chinese and English words "Xiao'er Chaigui Tuire Granules" "hand, foot and mouth disease" as the subject and keywords, randomized controlled trials(RCT) for the effect of Xiao'er Chaigui Tui-re Granules alone and combined with Western medicine in the treatment of hand, foot and mouth disease were retrieved, and the retrieval time was generally from the establishment of the database to January 20, 2020. Then all the relevant documents that meet the requirements and be included in the quality evaluation standard were screened out, relevant baseline data information was extracted, and a final evaluation was conducted for the quality of relevant literatures. The quality evaluation was conducted by the latest RevMan 5.3 software version-based tools. The reliability of the data relating to the results of the literatures was analyzed by statistical data. A total of 7 RCTs were included. The total sample size was 619, including 321 in the experimental group and 298 in the control group. Meta-analysis results show that: Xiao'er Chaigui Tuire Granules could improve the total clinical effectiveness(RR=1.28, 95%CI[1.11, 1.46], P=0.000 4; RR=1.62, 95%CI[1.06, 2.48], P=0.02); Xiao'er Chaigui Tuire Granules combined with Western medicine could significantly shorten the healing time of oral ulcers in children with hand, foot and mouth disease(MD=-1.11, 95%CI[-1.44,-0.78], P<0.000 01; MD=-2.13, 95%CI[-2.37,-1.89], P<0.000 01; MD=-1.10, 95%CI[-1.38,-0.82], P<0.000 01); on the basis of conventional treatment, Xiao'er Chaigui Tuire Granules combined with Western medicine could reduce the fever time(MD=-1.21, 95%CI[-2.15,-0.27], P=0.01; MD=-1.93, 95%CI[-2.35,-1.51], P<0.000 01; MD=-2.00, 95%CI[-2.60,-1.40], P<0.000 01), with no serious adverse reaction. The results showed that, in the treatment of hand, foot and mouth disease, compared with the conventional treatment method of Western medicine alone, the combined use of Xiao'er Chaigui Tuire Granules had more obvious advantage in effectively shortening the healing time of oral ulcers in children and effectively reducing the antipyretic time. Moreover, it had a better clinical efficacy in treating the patients with hand, foot and mouth disease in the early stage in terms of the improvement and control of symptoms and pathology, with a significantly increased effectiveness and no serious adverse reaction. It could be considered to be combined with therapies based on syndrome differentiation. However, due to the small sample size of clinical studies currently included, and the low quality of clinical studies further included, the quality of the studies included was low, which affected the scientific reliability and quality of the conclusions of the study. Therefore, further clinical results are still required for further confirmation.

[Systematic review on efficacy and safety of Lanqin Oral Liquid in treatment of hand, foot and mouth disease].

Lanqin Oral Liquid is a Chinese patent medicine which contains Isatidis Radix, Scutellariae Radix, Gardeniae Fructus, Phellodendri Chinensis Cordex and Sterculiae Lychophorae Semen. It is known for the pharmaceutical effect on the upper respiratory tract infection as it is beneficial for relieving the swelling of pharyngeal. In terms of Chinese medicine, it offers a clearing action on heat and toxic materials. According to the principle of Chinese medicine, different diseases can be treated by the same therapy as long as they have the same syndrome. Based on this unique diagnosis and treatment approach, Lanqin Oral Liquid was applicable to diseases with syndrome of excessive heat in lung and stomach. It was therefore commonly be used in the therapeutic approach towards hand, foot and mouth disease as well. However, no systematic evaluation had yet been done to verify this Chinese patent medicine on the efficacy and clinical safety for the disease. In order to achieve the manner of evidence-based medicine, this study had adopted a systematic review and Meta-analysis to evaluate the efficacy and safety of Lanqin Oral Liquid in the treatment of hand, foot and mouth disease. All related randomized controlled trials(RCT) were searched in the following data bases: CNKI, WanFang, VIP, SinoMed, Cochrane Library and PubMed. Based on the method provided by the Cochrane collaboration, the study assessed the quality of papers selected and RevMan 5.3 software was used to perform Meta-analysis. Totally 24 studies were included with 3 491 sample size, which 1 826 cases were treatment group and 1 665 cases were control group. From the results of Meta-analysis, the total effective rate of combination of Lanqin Oral Liquid and Western medicines shown better than Western medicine alone in the treatment for hand, foot and mouth di-sease, but mild adverse event were also found(RR=1.20,95%CI[1.16,1.23],P<0.000 01). Incidence of adverse reaction between experimental and control group was statistically insignificant(RR=1.16, 95%CI[0.79, 1.70], P=0.45). No conclusion was able to made in terms of the remission time of clinical symptoms, as the studies included were not qualified for Meta-analysis. As a matter of fact, the number of existing studies related to the Lanqin Oral Liquid were limited with poor quality as well. In other words, high quality studies were essential to further evaluate the efficacy and safety of Lanqin Oral Liquid.

[Meta-analysis of Ganmao Qingre Granules in treatment of children with wind-cold syndrome].

To systematically evaluate the efficacy and safety of Ganmao Qingre Granules in treatment of children with wind-cold syndrome. The study systematically retrieved CNKI, WanFang, VIP, CBM, PubMed, EMbase and Cochrane Library for children cases with wind-cold syndrome treated with RCT. The literature inclusion criteria provided by Cochrane was used to evaluate the litera-ture quality, and Meta-analysis was conducted by RevMan 5.3 software. A total of 6 literatures were included, with a total sample size of 492 cases, including 246 cases in the experimental group and 246 cases in the control group. According to the results of Meta-analysis, the experimental group recorded the hypothermia time(MD=-0.38, 95%CI[-0.53,-0.23], P<0.01), the total clinical effective rate(RR=1.25, 95%CI[1.15, 1.36], P<0.01), the cough relief time(MD=-2.75, 95%CI[-3.05,-2.46], P<0.01), the decrease nasal congestion relief time(MD=-1.45, 95%CI[-1.69,-1.22], P<0.01), traditional Chinese medicine syndrome score(MD=-8.35, 95%CI[-9.35,-7.36], P<0.01), all of them were superior to those of the control group(Aminophenol Huangnamin Granules), with statistically significant differences. Only 2 literatures mentioned no obvious adverse reaction, and the other 4 literatures did not mention any adverse reactions. Based on the results of this study, it was indicated that Ganmao Qingre Granules were effective in the treatment of children with wind-cold syndrome, but with unclear adverse reactions. Due to the insufficient quantity and low quality of included literatures, the efficacy and safety need to be further confirmed by more high-quality clinical studies.

Clinical evidence and GRADE assessment for breviscapine injection (DengZhanHuaSu) in patients with acute cerebral infarction.

ETHNOPHARMACOLOGICAL RELEVANCE: Breviscapine injections (DengZhanHuaSu, DZHS) is a famous Chinese patent medicine authorized by China Food and Drug Administration, which is widely used to treat acute cerebral infarction (ACI) in China. AIM OF THE STUDY: In the present study, meta-analysis has been performed in determining the efficacy and safety of DZHS combined with conventional treatment (CT) for ACI and GRADE assessment. MATERIALS AND METHODS: Randomized controlled trials (RCTs) testing the use of DZHS for treating ACI were screened by searching the databases of the Cochrane Library, PubMed, Embase, and Web of Science as well as four Chinese databases. Meta-analysis was carried out with RevMan 5.3 and Stata 16.0 software. The quality of research evidence was assessed by the GRADEprofiler (GRADEpro version: 3.6). RESULTS: Forty-three studies (n = 4618) were included. When compared to the control groups, the total effective rate of the national institutes of health stroke scale (NIHSS) was higher in the experimental group with DZHS (RR = 1.23, 95% CI = 1.19 to 1.28, P < 0.001; RR = 1.29, 95% CI = 1.21 to 1.38, P < 0.001); clinical symptoms and signs were improved in the experimental group with DZHS (RR = 1.17, 95% CI = 1.10 to 1.24, P < 0.001; RR = 1.25, 95% CI = 1.11 to 1.42, P < 0.001); the incidence of adverse reactions was reduced in the experimental group with DZHS (RR = 0.50, 95% CI = 0.26 to 0.98, P = 0.044); and the NIHSS score was decreased in the experimental group with DZHS (WMD = -3.30, 95% CI = -3.86 to -2.73, P < 0.001). CONCLUSIONS: DZHS combined with CT is conditionally recommended to improve the total effective rate of the NIHSS, clinical symptoms, and neurological deficits and reduce the incidence of adverse reactions, and no serious adverse reactions were noted. The GRADE assessment indicates that the overall certainty quality of evidence is low. Further large-scale, well-designed and high-quality RCTs are needed to confirm the positive results. PROSPERO registration No. CRD42019128856.

[Systematic review and Meta-analysis of efficacy and safety of Xiangsha Yangwei Pills in treatment of chronic gastritis].

To systematically evaluate the efficacy and safety of Xiangsha Yangwei Pills in the treatment of chronic gastritis. Compu-ter retrieval was performed for Cochrane Library, Medline, EMbase, China Knowledge Network Database(CNKI), China Biomedical Literature Service System(SinoMed), Chongqing Weipu Chinese Science and Technology Journal Database(VIP) and WanFang Database(WanFang) randomized controlled trials about Xiangsha Yangwei Pills combined with Western medicine in the treatment of chro-nic gastritis. The retrieval time ranged from the establishment of the library to April 26, 2019. Meta-analysis was performed by RevMan 5.3 software after two independent researchers conducted literature screening, data extraction and quality evaluation according to inclusion and exclusion criteria. A total of 1 720 patients were enrolled in 18 RCT. According to the classification of chronic gastritis, they were divided into three subgroups: chronic gastritis, chronic atrophic gastritis and chronic superficial gastritis. The results of Meta-ana-lysis showed that the efficacy of Xiangsha Yangwei Pills combined with Western medicine in treating chronic gastritis was higher than that of Western medicine. As for the recurrence rate, Xiangsha Yangwei Pills combined with Western medicine was lower than Western medicine. And there was no statistical difference about helicobacter pylori(Hp) eradication rate between Xiangsha Yangwei Pills combined with Western medicine as well as Western medicine. In terms of the incidence of adverse reactions, Xiangsha Yangwei Pills combined with Western medicine was lower than Western medicine, and no serious adverse reaction was reported. The results of this systematic review showed that compared with the conventional Western medicine group, Xiangsha Yangwei Pills combined with Western medicine can significantly alleviate clinical symptoms of chronic gastritis, with fewer adverse reactions. However, due to the low methodological quality of the included studies and the reliability of the impact conclusions, high-quality multi-center, large-sample, randomized, double-blind controlled trials are needed for validation.

Sanjin tablet combined with antibiotics for treating patients with acute lower urinary tract infections: A meta-analysis and GRADE evidence profile.

Numerous clinical studies have evaluated the performance of Sanjin tablets (SJTs) in the treatment of acute lower urinary tract infections (ALUTIs) in China. The present meta-analysis aimed to determine the efficacy and safety of SJT combined with antibiotics for the treatment of patients with ALUTIs and to evaluate the quality of evidence. The Cochrane Library, PubMed, EMBASE, Web of Science, Chinese BioMedical Database, China National Knowledge Infrastructure, WanFang and VIP databases were searched for entries added between inception and December 2018 to identify relevant randomized controlled trials (RCTs). The Cochrane risk-of-bias tool and Consolidated Standards of Reporting Trials for Traditional Chinese Medicine were used for assessing the methodological quality and reporting quality of eligible studies, respectively. Meta-analysis and quality of evidence assessment were performed with RevMan 5.3 and Grading of Recommendations, Assessment, Development and Evaluations (GRADE), respectively. A total of 8 RCTs comprising 790 patients with ALUTIs were included in the present meta-analysis. The cure rate of SJTs combined with gatifloxacin tablets (GTs) was higher than that of GTs alone [relative ratio (RR)=1.30, 95% CI=1.07-1.57, P=0.009]. The cure rate of SJTs combined with levofloxacin tablets (LTs) was higher than that of LTs alone (RR=1.13, 95% CI=1.04-1.24, P=0.006). SJTs combined with LTs was better in improving the total effective rate than LTs alone (RR=1.11, 95% CI=1.03-1.19, P=0.005). The recurrence rate for SJTs combined with antibiotics was lower than that associated with antibiotics alone (RR=0.35, 95% CI=0.13-0.97, P=0.04). The bacterial clearance rate achieved with SJTs combined with antibiotics was higher than that obtained with antibiotics alone (RR=1.41, 95% CI=1.09-1.84, P=0.009). The present meta-analysis demonstrated that, compared with the effects of antibiotics treatment, SJTs combined with antibiotics improved the cure rate, total effective rate and bacterial clearance rate, and decreased the recurrence rate. In addition, no serious adverse reactions were observed in patients with ALUTIs. However, the GRADE quality of evidence was low. Thus, further large-scale and rigorously designed clinical trials are required to improve the quality of evidence.

[Effictiveness and safety of Xueshuantong Injection in treatment of unstable angina pectoris: a systematic review and Meta-analysis of randomized controlled trials].

To assess the effectiveness and safety of Xueshuantong Injection in the treatment of unstable angina pectoris. Literatures were retrieved in PubMed,the Cochrane Library,EMbase,the China National Knowledge Infrastructure Database( CNKI),the Chongqing VIP Chinese Science Database( VIP),the Chinese Biomedical Literature Database( Sino Med) and Wanfang Data. The time limitation ranged from the commencement of each database to April 28,2019. The assessment of ethodological quality was based on the Cochrane Handbook 5.1,and the data were analyzed by using Rev Man 5.3 software. A total of 38 RCTs involving 4 074 patients were included. The included trials were all of low quality. Xueshuantong Injection combined with routine basic treatment( RBT) was superior to RBT alone in alleviating clinical symptoms,with statistically significant differences between the groups( RR = 1. 19,95% CI[1. 15,1. 24]). Xueshuantong Injection combined with RBT was better than RBT alone in the efficiency of anginal symptom( RR = 1.23,95%CI[1.18,1.29]). Xueshuantong Injection combined with RBT reduced the consumption of nitroglycerin,which was more effectively than RBT alone,with statistically significant differences between the groups( RR = 1.64,95%CI[1.23,2.19]). Xueshuantong Injection combined with RBT decreased hs-CRP levels,which was more effectively than RBT alone,with statistically significant differences between the groups( MD =-0.48,95%CI[-0.57,-0.40]). However,there was no statistical difference between groups in the incidence of myocardial infarction. The reported adverse effects of Xueshuantong Injection were mainly dizziness,headache,itchy skin and gastrointestinal symptoms. Xueshuantong Injection combined with RBT can alleviate unstable angina pectoris. However,due to the low quality of included studies,further well-designed multicenter and large-scale RCTs are still needed to evaluate the efficacy of Xueshuantong Injection.

[Systematic evaluation and Meta-analysis on effectiveness and safety of Yupingfeng Granules on recurrent respiratory tract infection].

To evaluate the effectiveness and safety of Yupingfeng Granules in the treatment of recurrent respiratory tract infection.Six Chinese and English databases were retrieved,namely CNKI,Wan Fang,VIP,CBM,PubMed and Cochrane Library. Randomized controlled trials of Yupingfeng Granules in the treatment of recurrent respiratory tract infection were collected and screened. According to the evaluation criteria and tools of Cochrane,the heterogeneity among the studies was analyzed,and the Meta-analysis was carried out by Rev Man 5.3 software. A total of 16 studies were included in this study,with a total sample size of 1 788 cases,including 901 cases in the experimental group and 887 cases in the control group. Among them,11 intervention measures were Yupingfeng Granules combined with Western medicine routine vs routine Western medicine,and 5 research interventions were Yupingfeng Granules combined with pidomod vs pidomod based on routine therapy. Meta-analysis showed that the total effective rate of Yupingfeng Granules combined with Western medicine in the treatment of recurrent respiratory tract infection was better than that of Western medicine( RR= 1. 27,95%CI[1. 21,1. 34],P<0. 000 01). Based on the routine therapy,the total effective rate of Yupingfeng Granules combined with pidomod in the treatment of recurrent respiratory tract infection was better than that of pidomod( RR = 1. 23,95% CI[1. 13,1. 35],P<0. 000 01). A total of 21 cases of adverse events were reported in this study,including 6 cases in the experimental groups combined with traditional Yupingfeng Granules therapy and conventional Western medicine therapy and 15 in the control group. The adverse events were mainly gastrointestinal reactions,such as fatigue,nausea and diarrhea,which can tolerate or disappear with no impact on treatment. The incidence of adverse events in the two groups was not statistically significant( RR = 0. 44,95% CI[0. 19,1. 03],P = 0. 06). The results showed no significant difference in the incidence of adverse events between the two groups during treatment. Based on the routine therapy,no adverse event was reported in Yupingfeng Granules pidomod vs pidomod,indicating that both groups were safe. The analysis showed that Yupingfeng Granules combined with routine Western medicine therapy or combined with pidomod could increase the level of immunoglobulin and T lymphocytes in children. Based on the existing data and methods,Yupingfeng Granules combined with routine Western medicine therapy for recurrent respiratory tract infection can improve the total effective rate,immune function and body immunity,with no serious adverse reaction. However,because of the low quality of the literatures included in this study,it is still necessary to adopt well-designed large-sample clinical trials in conformity to international standards to improve the quality of evidence.

[Systematic evaluation and Meta-analysis on effictiveness and safety of Xiyanping Injection in treatment of acute bronchitis in children].

To evaluate the effectiveness and safety of Xiyanping Injection in the treatment of acute bronchitis in children. The research systematically retrieved four Chinese databases( namely CNKI,VIP,Wan Fang,Sino Med) and four English databases( namely EMbase,Cochrane Library,Medline,Clinical Trail.gov). The retrieval time ranged from the commencement of each database to April2019. According to pre-set inclusion criteria and exclusion criteria,randomized controlled trials( RCTs) of Xiyanping Injection in the treatment of acute bronchitis in children were screened out. The quality assessment of the included studies was performed using the " Cochrane Bias Risk Assessment" tool,and the Meta-quantitatively analysis on the included studies was performed using Rev Man 5.3 software. A total of 648 articles were retrieved,and 10 studies were finally included. Except for one multi-arm test,the total sample size was 1 260,including 630 cases in the test group and 630 cases in the control group. The overall quality of the included study was not high. The results of Meta-analysis showed that in terms of antipyretic time,Xiyanping Injection combined with routine therapy was superior to routine therapy in the shortening of fever time in children with acute bronchitis( MD =-0.94,95%CI[-1.18,-0.70],P<0.000 01); in the overall efficacy,Xiyanping Injection combined with routine therapy was superior to routine therapy( RR = 1. 34,95% CI[1.26,1.42],P<0.000 01) and Yanhuning Injection + routine therapy( RR = 1.28,95%CI[1.19,1.38],P<0.000 01); descriptive analysis showed that Xiyanping Injection was excellent in the overall efficacy in treating acute bronchitis in children. The differences between the two groups were statistically significant( P< 0.000 1). The adverse reactions included in the study were mild adverse reactions,with no impact on treatment. Based on the results of this study,Xiyanping Injection combined with routine therapy or other Western medicine had a certain effect on acute bronchitis in children,especially in improving the overall efficacy of acute bronchitis in children. No serious adverse reactions were observed. And in the time of fever,cough and cough disappearance time,lung voice loss time,Xiyanping Injection + routine therapy or Western medicine therapy was better than routine therapy or Western medicine therapy. However,the small size of included studies,the low quality of the included studies,and the existence of publication bias and the low quality of the evidence had impacts on the reliability of the conclusion. Therefore,more large-sample,multi-center,well-designed,rigorous randomized controlled trials with best case reports are required to further verify the efficacy and safety.

[Efficacy and safety of Shenxiong Glucose Injection in treatment of cerebral thrombosis:systematic review and Meta-analysis].

To systematically evaluate the efficacy and safety of Shenxiong Glucose Injection in the treatment of cerebral thrombosis.Randomized controlled trials( RCTs) of Shenxiong Glucose Injection for cerebral thrombosis were screened out by searching CNKI,Wan Fang,VIP,Sino Med,Cochrane Library,PubMed,EMbase,and Web of Science in a systematic way,and the Meta-analysis on finally included studies was conducted by using Handbook 5. 1 evaluation criteria and tools and Rev Man 5. 3 software. GRADE system( GRADE pro 3. 6. 1) was used to grade the evidence quality of key outcome indicators. A total of 25 studies were included,with a total sample size of 2 286 cases,1 144 in the experimental group and 1 142 in the control group. The results of Meta-analysis showed that the total effective rate of Shenxiong Glucose Injection combined with ozagrel in the treatment of cerebral thrombosis was better than that of ozagrel alone( RR = 1. 26,95%CI [1. 20,1. 32],P<0. 000 01); the total effective rate of conventional treatment plus Shenxiong Glucose Injection and ozagrel for cerebral thrombosis was better than that of conventional treatment combined with ozagrel( RR = 1. 26,95%CI [1. 09,1. 46],P = 0. 002). In addition,Shenxiong Glucose Injection combined with ozagrel could reduce the incidence of adverse reactions( RR = 0. 38,95%CI [0. 24,0. 60],P < 0. 000 1),improve the neurological impairment( MD14 d=-7. 19,95% CI[-9. 16,-5. 22],P< 0. 000 1; MD30 d=-5. 34,95% CI [-5. 85,-4. 83],P < 0. 000 1; MD42 d=-7. 03,95% CI [-7. 79,-6. 28],P<0. 000 01; MD60 d=-6. 18,95%CI [-6. 55,-5. 81],P< 0. 000 01; MD90 d=-4. 90,95% CI [-5. 74,-4. 06],P<0. 000 01),and improve activities of daily living( ADL)( MD = 15. 00,95%CI [12. 20,17. 80],P<0. 000 01). The mortality was only included in one study,and the sample size was small,requiring to be further verified by a large sample size. The adverse reactions mainly included lung infection,skin pruritus,gastrointestinal reaction and so on,all of which could be tolerated or disappeared without affecting the treatment. Based on the available data and methods,Shenxiong Glucose Injection combined with ozagrel for cerebral thrombosis could improve the total effective rate,neurological impairment,and ability of daily living,with no serious adverse reactions. The evidence quality level of GRADE system was low in the evaluation of total effective rate,mortality and incidence of adverse reactions.However,the quality of the included researches was not high,requiring rigorously designed and internationally standardized clinical trials with a large sample size to improve the quality of evidence.

Safety of Shujinjianyao pill in clinical real world: A prospective, observational, multicenter, large-sample study Protocol.

BACKGROUND: Low back pain is a common health problem worldwide, which also is a leading cause of long-term disability and has an important effect on the global economy and society. Usually, conservative therapies are used to treat low back pain. As a kind of Chinese patent medicine, Shujinjianyao pill (SJJYP) has a great curative effect on low back pain. However, its safety has not been studied yet. Therefore, we carried out this clinical trial to observe the safety of SJJYP in the real world. METHODS: First, participants need to meet the medication standards according to inclusion and exclusion criteria. Then, participants are conducted safety examination before taking SJJYP. After qualified screening, participants can be enrolled into the group. Second, all enrolled participants will receive SJJJYP for a period of 4 weeks. During the observation period, participants need to return to the hospital for a subsequent visit after 2 weeks of medication, and come to the hospital for safety check after 4 weeks of medication. Third, telephone follow-up is used to investigate any participants' physical discomfort after 6 to 8 weeks (2-4 weeks after medication withdrawal). After all these steps are completed, clinical observation is finished. If any adverse events occur during this process, we will record them in time. When serious adverse events occur, we will use nested case-control study to explore the causes and mechanisms. DISCUSSION: This study will obtain the safety results of SJJYP in clinical real world, which will offer a scientific basis for clinicians in the treatment of low back pain, and also provide a methodological basis for the safety study of other medicines. TRIAL REGISTRATION: ClinicalTrial.gov registration number is NCT03598153. This study was approved by the ethics committee of Wangjing hospital, China Academy of Chinese Medical Sciences (WJEC-KT-2018-012-P002).

[Systematic review and Meta-analysis of effect of Reduning Injection in treating acute tracheal-bronchitis].

To systematically review the effectiveness and safety of Reduning Injection in the treatment of acute tracheal-bronchitis.Four Chinese databases( CNKI,VIP,Wan Fang,Sino Med) and three English databases( Cochrane Library,Medline,Web of Science) were systematically and comprehensively retrieved. The retrieval time was from the establishment of each database to April 2019.Randomized controlled trials( RCTs) for the treatment of acute tracheal-bronchitis with Reduning Injection were collected. Two researchers independently conducted literature screening,data extraction and risk assessment for bias. Rev Man 5.3 software was used for data analysis. Fourteen studies were included,and the total sample size was 1 652 at last. Meta-analysis results show that in the aspect of total clinical effective rate,Reduning Injection was superior to ribavirin( RR = 1. 37,95%CI[1. 28,1. 47],P<0. 000 01); Reduning Injection combined with conventional therapy was better than conventional therapy alone( RR = 1. 14,95% CI[1. 09,1. 19],P <0. 000 01); Reduning Injection combined with azithromycin was better than azithromycin therapy alone( RR = 1. 21,95% CI[1. 07,1. 37],P = 0. 002). In the aspect of clinical symptoms,the time in average fever disappearance of Reduning Injection therapy was shorter than that of ribavirin therapy( MD =-1.68,95%CI[-1. 72,-1. 49],P<0. 000 01); the time in cough disappearance of Reduning Injection therapy was shorter than that of ribavirin therapy( MD =-2. 57,95%CI[-2. 91,-2. 24],P<0. 000 01); the time in lung rales disappearance,Reduning Injection therapy was superior to ribavirin therapy( MD =-2. 26,95% CI[-2. 71,-1. 80],P<0. 000 01),and Reduning Injection combined with conventional therapy was superior to conventional therapy( MD =-1. 77,95% CI[-1. 95,-1. 59],P<0. 000 01). Based on the findings,Reduning Injection can improve the total effective rate,reduce the average time of disappearance in fever,cough and lung rales,with mild adverse reactions and a low incidence. However,the quality of the literatures included is not high,it is necessary to adopt large-sample-size,rigorously designed clinical trial protocols in line with the international standards,in a bid to improve the quality of evidence.

[Systematic review and Meta-analysis of effect of Yinzhihuang Oral Liquid in treatment of neonatal jaundice].

To systematically review effectiveness and safety of Yinzhihuang Oral Liquid in the treatment of neonatal jaundice. A systematic retrieval was performed throughout China National Knowledge Infrastructure( CNKI),Wan Fang,VIP,Sino Med and PubMed,Medline,Cochrane Library databases from the establishment to April 2019. Randomized controlled trials of Yinzhihuang Oral Liquid in treatment of neonatal hyperbilirubinemia were retrieved. Clinical studies in line with the inclusion criteria were involved for data extraction,and the quality of the included literatures was evaluated by the risk bias assessment tool in the Cochrane review manual. Finally,Meta-analysis was performed by Rev Man 5.3 software. A total of 30 studies were involved,involving 3 923 child patients,including1 940 in observation group and 1 983 in control group. According to the results of Meta-analysis,the total effective rate( RR = 1. 22,95%CI[1. 18,1. 26],P<0. 000 01),level of TBi L after treatment( MD =-38. 78,95%CI[-48. 38,-29. 18],P<0. 000 01),time to jaundice resolution( MD =-1. 76,95% CI[-2. 10,-1. 41],P < 0. 000 01) and daily average decrease value of bilirubin( MD =11. 67,95%CI[8. 89,14. 45],P<0. 000 01) of observation group were significantly better than those of control group,with statistically significant differences. Adverse reactions were reported in nine studies,mainly including diarrhea,vomiting,fever,rash and other symptoms,which did not affect the treatment effect. The effectiveness of Yinzhihuang Oral Liquid combined with conventional therapy in treating neonatal jaundice was better than conventional therapy alone,with little adverse reactions. However,most of literatures included had a low research quality,which impacted the reliability of the conclusion. Therefore,it is suggested to conduct more largesample-size,multicenter,scientifically designed,strictly implemented high-quality randomized controlled trials in the future,in order to study the efficacy and safety of Yinzhihuang Oral Liquid in the treatment of neonatal jaundice.

[Meta-analysis of randomized controlled trials on effect of Tanreqing Injection combined with Western medicine on acute exacerbation of chronic bronchitis].

To systematically review the effectiveness and safety of Tanreqing Injection in treating acute exacerbation of chronic bronchitis( AECB). CNKI,Wan Fang,VIP,CBM,Medline,Cochrane Library,EMbase and Web of Science were retrieved,and randomized controlled trials for the effect of Tanreqing Injection in the treatment of acute exacerbation of chronic bronchitis were screened. The quality of the included studies was evaluated according to the Cochrane Handbook's evaluation criteria. The data was analyzed by RevMan 5.3. Totally 23 RCTs involving 1 901 patients were included,including 952 in the experimental group and 949 in the control group. The Meta-analysis demonstrated that in terms of the disappearance time of fever,the group of Tanreqing Injection combined with the conventional therapy was superior to conventional therapy group( RR =-1. 03,95%CI[-1. 45,-0. 62],P<0. 000 01); compared with the conventional therapy group,the group of Tanreqing Injection combined with conventional therapy had a higher cure rate for AECB( RR = 1. 17,95% CI[1. 13,1. 23],P < 0. 000 01). The group of Tanreqing Injection combined with levofloxacin had a higher cure rate for AECB than the levofloxacin group( RR = 1. 23,95% CI[1. 08,1. 41],P = 0. 002). The group of Tanreqing Injection combined with cefuroxime had a higher cure rate for AECB than the cefuroxime group( RR = 1. 22,95%CI[1. 05,1. 42],P = 0. 01).The group of Tanreqing Injection combined with cefoperazone sodium and sulbactam sodium had a higher cure rate for AECB than the group of cefoperazone sodium and sulbactam sodium( RR = 1. 22,95% CI[1. 04,1. 44],P = 0. 02). The outcomes of disappearance time of cough and expectoration had a huge heterogeneity,so were used for descriptive analysis. The adverse reactions mainly included skin rash,dizziness,gastrointestinal reactions. Based on the available data and the results of the analysis,the group of Tanreqing Injection combined with Western medicine has a higher cure rate for acute exacerbation of chronic bronchitis,and the effect in reducing symptoms disappearance time. In view of the limited number of included studies,small sample size and low methodological quality,the results of this study need to be confirmed with high-level clinical trials.