INTRODUCTION: The use of periarticular (PA) tranexamic acid (TXA) and its efficacy in comparison with intra-articular (IA) TXA have not been well explored in the literature. This retrospective cohort study aimed to compare the effects of IA and PA TXA with analgesic components in reducing blood loss and improving immediate postoperative pain relief and functional outcomes in patients after unilateral primary total knee arthroplasty (TKA). METHODS: A total of 63 patients underwent TKA, and they were divided into the IA TXA delivery group ( n = 42) and PA TXA delivery group ( n = 21). All patients were administered 1 g of TXA. They also received pericapsular infiltration consisting of 0.5 mL of adrenaline, 0.4 mL of morphine, 1 g of vancomycin, 1 mL of ketorolac and 15 mL of ropivacaine. Outcomes for blood loss and surrogate markers for immediate functional recovery were measured. RESULTS: Of the 63 patients, 54% were female and 46% male. The mean drop in postoperative haemoglobin levels in the PA and IA groups was 2.0 g/dL and 1.6 g/dL, respectively, and this was not statistically significant ( P = 0.10). The mean haematocrit drop in the PA and IA groups was 6.1% and 5.3%, respectively, and this was also not statistically significant ( P = 0.58). The postoperative day (POD) 1 and discharge day flexion angles, POD 1 and POD 2 visual analogue scale (VAS) scores, gait distance on discharge and length of hospitalisation stay were largely similar in the two groups. CONCLUSION Our study showed that both IA and PA TXA with analgesic components were equally efficient in reducing blood loss and improving immediate postoperative pain relief and functional outcomes.
Humans ; Male ; Female ; Tranexamic Acid/adverse effects* ; Arthroplasty, Replacement, Knee/adverse effects* ; Antifibrinolytic Agents/adverse effects* ; Retrospective Studies ; Postoperative Hemorrhage ; Blood Loss, Surgical/prevention & control* ; Administration, Intravenous ; Analgesia ; Analgesics/therapeutic use* ; Pain, Postoperative/drug therapy* ; Injections, Intra-Articular

Humans ; Consensus ; Hypersensitivity ; Desensitization, Immunologic/adverse effects* ; Immunotherapy/adverse effects* ; Injections, Subcutaneous ; Allergens

OBJECTIVE: To compare the safety differences between Chinese medicine (CM) and Western medicine (WM) based on Chinese Spontaneous Reporting Database (CSRD). METHODS: Reports of adverse events (AEs) caused by CM and WM in the CSRD between 2010 and 2011 were selected. The following assessment indicators were constructed: the proportion of serious AEs (PSE), the average number of AEs (ANA), and the coverage rate of AEs (CRA). Further comparisons were also conducted, including the drugs with the most reported serious AEs, the AEs with the biggest report number, and the 5 serious AEs of interest (including death, anaphylactic shock, coma, dyspnea and abnormal liver function). RESULTS: The PSE, ANA and CRA of WM were 1.09, 8.23 and 2.35 times higher than those of CM, respectively. The top 10 drugs with the most serious AEs were mainly injections for CM and antibiotics for WM. The AEs with the most reports were rash, pruritus, nausea, dizziness and vomiting for both CM and WM. The proportions of CM and WM in anaphylactic shock and coma were similar. For abnormal liver function and death, the proportions of WM were 5.47 and 3.00 times higher than those of CM, respectively. CONCLUSION Based on CSRD, CM was safer than WM at the average level from the perspective of adverse drug reactions.
China ; Drug-Related Side Effects and Adverse Reactions/epidemiology* ; Humans ; Injections ; Medicine, Chinese Traditional

OBJECTIVE: To evaluate to the efficacy and safety of Shenqi Fuzheng Injection (, SFI) combined with chemotherapy in the treatment of acute leukemia (AL) by meta-analysis. METHODS: PubMed, Cochrane library, Embase, SinoMed, China National Knowledge Infrastructure (CNKI), VIP Journal Integration Platform, Wanfang Database were searched from establishment to November 1, 2018. The randomized controlled trials (RCTs) of SFI combined with chemotherapy in the treatment of AL were included. The Cochrane risk assessment form (RevMan 5.1) was used to evaluate the quality of included studies. RESULTS: A total of 14 RCTs and 1,088 patients was included. The quality evaluation were mostly low risk or unclear. Meta-analysis showed that compared with chemotherapy alone, SFI combined with chemotherapy can improve the total clinical effective rate in patients with AL (RR=1.15, 95% CI: 1.056-1.177; P=0.0001), and relieve adverse reactions caused by chemotherapy drugs, including infection (RR=0.561, 95% CI: 0.397-0.792; P=0.001), nausea and vomiting (RR=0.662, 95% CI: 0.524-0.835; P=0.001), bleeding (RR=0.548, 95% CI: 0.39-0.768; P=0.0001), cardiotoxicity (RR=0.230, 95% CI: 0.080-0.660; P=0.006) and hyperhidrosis (RR=0.348, 95% CI: 0.208-0.581; P=0.0001). The incidence rates of adverse reactions in SFI combined with chemotherapy group were significantly lower than that of the chemotherapy alone group (P<0.01). CONCLUSIONS Shenqi Fuzheng Injection combined with chemotherapy has good efficacy and safety for AL, and it can alleviate the adverse reactions caused by chemotherapy. However, subject to the limitations of the methodological quality of the literature, the conclusions of this study need to be further verified by large-scale and multi-center RCTs.
Drugs, Chinese Herbal/adverse effects* ; Humans ; Injections ; Leukemia/drug therapy* ; Treatment Outcome

This study aimed to comprehensively analyze and compare the differences of different clinical study types currently published in the safety evaluation of Xuebijing Injection. Six databases, namely the Cochrane Library, PubMed, EMbase, CNKI, VIP and Wanfang database, were electronically retrieved to collect all types of studies on the safety of Xuebijing Injection, including randomized controlled trials, case-controlled studies, cohort studies, systematic reviews, and centralized monitoring studies of clinical safety(hospital), in order to comprehensively and objectively evaluate the safety of Xuebijing Injection, and analyze the differences of different research results. A total of 211 literatures were included, involving a total of 46 384 patients treated with Xuebijing Injection, and 423 adverse reactions(ADRs) occurred. They included 191 randomized controlled trials, 3 cohort studies, 15 systematic reviews, and 2 centralized monitoring studies of clinical safety(hospital), and the incidence of adverse reactions was 2.54%(common), 2.31%(common), 0.95%(occasionally), and 0.50%(occasionally). More than half of the 423 cases of ADRs occurred in skin and adnexal system(151 cases) and gastrointestinal system(65 cases), including such manifestations as rash, skin itching, nausea and vomiting, diarrhea. The degree of ADRs was mild. Randomized controlled trials showed that the incidence of ADR was the highest when Xuebijing Injection was used for malignant tumor and multiple organ failure. And the systematic evaluation showed that the incidence of ADR was the highest when Xuebijing Injection was used for spontaneous peritonitis of liver cirrhosis. In conclusion, different study types could lead to significant differences in the results of drug safety evaluation. Sample size, study type, and quality control are the main factors for biased results. Due to large sample size and high-quality, centralized monitoring studies become the better clinical safety evaluation model of drugs at present, and full life cycle management could more objectively reflect drug safety and guide clinical rational drug use.
Case-Control Studies ; Drug-Related Side Effects and Adverse Reactions/epidemiology* ; Drugs, Chinese Herbal/adverse effects* ; Humans ; Injections

To evaluate the efficacy and safety of Compound Danshen Injection combined with Western medicine in the treatment of vascular dementia. Databases of Cochrane Library, PubMed, EMbase, CNKI, SinoMed, VIP, Wanfang Data were electronically retrieved for collecting randomized controlled trial(RCT)about vascular dementia treated with Western medicine alone or combined with Compound Danshen Injection from the year of database establishment to January 2020. Two researchers independently screened out li-teratures, extracted data, and evaluated the risk of bias for inclusion in the study. Meta-analysis was conducted using RevMan 5.3 software. A total of 5 RCTs were included, involving 588 patients, with 299 in treatment group and 289 in control group. Meta-analysis results showed that compared with Western medicine alone, Compound Danshen Injection combined with Western medicine was better in the effective rate(RR=1.23,95%CI[1.14,1.33],P<0.000 01), MMSE score(MD=3.54,95%CI[3.01,4.06],P<0.000 01), ADL score(MD=11.49,95%CI[8.05,14.93],P<0.000 01), the level of CRP(MD=-0.72,95%CI[-1.25,-0.20],P=0.007) and the level of IL-6(MD=-7.64,95%CI[-9.65,-5.63],P<0.000 01). Adverse reactions mainly included rash and skin prick, which did not affect the treatment effect. Based on the findings, the combination of Compound Danshen Injection in the treatment of vascular dementia could improve the effective rates, relieve the mental state damage and improve the daily living ability, with mild adverse reactions and a low incidence. However, due to the low quality of the included literatures, high-quality and large-scale randomized controlled trials are needed for further verification.
Dementia, Vascular/drug therapy* ; Drugs, Chinese Herbal/adverse effects* ; Humans ; Injections ; Medicine ; Salvia miltiorrhiza

Since the safety re-evaluation of traditional Chinese medicine(TCM) injections began in 2009, some TCM injection companies and research institutes have done a lot of work. And with the increase of drug development and drug production technology levels in China, the safety of some TCM injections has been greatly improved. There are safety risks in TCM injections, which are mainly reflected in unclear basis of medicinal materials, simple production process, poor controllability of quality standards, nonstan-dard drug instructions and irrational medication in the use process. This paper describes the research progress of the above-mentioned aspects of TCM injections. In addition, the author team found that adverse reactions of TCM injections are mainly pseudo-allergic reactions. Therefore, a lot of work has been done in detection of pseudo-allergic reactions, mechanism research and risk control. This part of the work is also described in this article.
China ; Drugs, Chinese Herbal/adverse effects* ; Humans ; Hypersensitivity/etiology* ; Injections ; Medicine, Chinese Traditional/adverse effects*

Qingkailing Injection is one of the most commonly used traditional Chinese medicine injections with significant clinical application for the treatment of multiple diseases. This study aims to analyze the systematic reviews( SRs) of Qingkailing Injection,in order to provide reference for the clinical application of Qingkailing Injection and the development of relevant clinical practice guidelines. We searched CNKI,CBM,Wanfang,VIP,Pub Med,Cochrane Library and EMbase to collect SRs from the time of database establishment to August 2020. The eligible SRs were included according to the inclusion and exclusion criteria. AMSTAR 2 was used to assess the methodological quality. The diseases,drugs in combinations and results were extracted and analyzed. A total of 24 SRs were selected,including 10 for the treatment of acute cerebrovascular diseases,9 for respiratory infections,2 for viral hepatitis,1 for chronic obstructive pulmonary disease,and two for the adverse effects of Qingkailing Injection. Only three entries of AMSTAR 2 item were fully reported by over 70%,and the rest were reported by less than 70%,with no report about item 2,3 and 10. Twenty-nine outcome indicators were correlated with the included SRs,of which three mostly frequent outcomes were effectiveness,adverse reaction,and neurological deficit scores,showing a good efficacy of Qingkailing Injection. The common severe adverse reaction was anaphylaxis,and mild adverse reactions were skin and mucous membrane reactions. The most frequently combined drug was antibiotics,mainly Penicillin and Penicillin+Pioneeromycin. The existing evidences showed that the methodological quality of SRs of Qingkailing Injection needed to be improved and Qingkailing Injection had an obvious efficacy. However,the selection of outcome indicators for clinical trials and SRs shall be standardized,and the reporting of basic information,such as drug combination,shall be strengthened to provide more powerful clinical services.
Drugs, Chinese Herbal/adverse effects* ; Humans ; Injections ; Medicine, Chinese Traditional ; Systematic Reviews as Topic

OBJECTIVE: To investigate the effect of intra-articular injection of tranexamic acid on blood loss and blood transfusion rate after minimally invasive unicompartmental knee arthroplasty. METHODS: From January 2015 to September 2017, 90 patients underwent minimally invasive unicompartmental knee arthroplasty were divided into tranexamic acid group and control group, 45 cases in each group. In the tranexamic acid group, there were 22 males and 23 females, aged 62 to 69 (66.1±2.4) years;in the control group, 20 males and 25 females, aged 63 to 71(68.5±5.2) years. The amount of bleeding in the drainage ball at 48 hours after operation was recorded, and the blood transfusion rate and hematocrit level duringthe perioperative period were recorded. The factors influencing perioperative blood loss included gender, age and body mass index (BMI). RESULTS: All patients were followed up for 12.5 to 28.3 (22.8±7.9) months. During the follow-up, the wounds of the two groups healed well, and no deep vein thrombosis and pulmonary embolism occurred. There was no significant difference in postoperative blood loss between the tranexamic acid group and the control group. The postoperative bleeding volume in the tranexamic acid group was (110.0±52.1) ml, and that in the control group was (123.0±64.5) ml (P=0.39). There was no blood transfusion in the two groups. CONCLUSION Intra articular injection of tranexamic acid can not significantly reduce the postoperative blood loss in patients with minimally invasive unicompartment.
Aged ; Antifibrinolytic Agents/therapeutic use* ; Arthroplasty, Replacement, Knee/adverse effects* ; Blood Loss, Surgical/prevention & control* ; Female ; Hemostatics ; Humans ; Injections, Intra-Articular ; Male ; Middle Aged ; Postoperative Hemorrhage ; Tranexamic Acid

OBJECTIVES: Contrast-induced acute kidney injury (CI-AKI) is the third cause of hospital-acquired AKI, and existing clinical prevention and treatment measures such as hydration therapy and/or administration of antioxidants N-acetylcysteine treatment and other treatments still show little effect on the prevention and treatment of CI-AKI. This study aims to explore the effect of Danhong injection on prevention of CI-AKI. METHODS: A total of 12 867 patients, who received coronary angiography, percutaneous coronary intervention, enhanced CT or vascular intervention in a tertiary hospital, were enrolled for this study. Among them, 423 in the treatment group received intravenous drip of Danhong injection, and 12 444 in the control group received routine medicine. Propensity score matching was conducted to balance confounding factors between the 2 groups and then the prevention effect of Danhong injection on CI-AKI was compared between them. RESULTS: A total of 423 pairs of patients were matched successfully. The incidence of CI-AKI in the non-Danhong control group was higher than that in the Danhong treatment group (5.7% vs 2.4%). The difference between the 2 groups was statistically significant ( CONCLUSIONS The results of this study support the use of Danhong injection in the prevention of the Stage 1 of CI-AKI.
Acute Kidney Injury/prevention & control* ; Contrast Media/adverse effects* ; Drugs, Chinese Herbal ; Humans ; Injections ; Percutaneous Coronary Intervention ; Propensity Score ; Risk Factors ; Treatment Outcome