OBJECTIVE: To investigate the ability of repairing bone defect with the compound of coralline hydroxyapatite porous (CHAP), fibrin sealant(FS) and staphylococcus aureus injection (SAI), and the feasibility to use the compounds as bone substitute material. METHODS: The animal model of bone defect was made on the bilateral radius of 54 New Zealand white rabbits, which were randomly divided into the experimental group(the defect was repaired with CHAP-FS-SAI), control group(with autograft) and blank control group(the defect was left unrepaired) with 18 rabbits in each group. The ability of bone defect repair was evaluated by gross observation, histopathological study, X-ray and biomechanical analysis 2, 4, 8 and 12 weeks after repair. RESULTS: (1) In the 2nd week, tight fibro-connection could be found between the implant and fracture site and there were many fibroblasts and capillary proliferation with many chondrocytes around CHAP in the experimental group, while only a few callus formed, and chondrocytes, osteoblast and osteoclast existed in the control group. (2) In experimental group and control group, a large quantity of callus was found 4 and 8 weeks; ossification of chondrocytes with weave bone formation were found 4 weeks and many osteocytes and weave bones and laminar bones were found 8 weeks. (3) In the 12th week, the complete ossification of implant with well bone remodeling, a large number of mature osteocytes and laminar were found in experimental group and control group, and CHAP still existed in the experimental group; the defect area filled with fibro-scar tissue and only many fibroblasts could be seen in blank control group. (4) X-ray findings were the following: In experimental and control groups, callus formation could be seen 2 weeks postoperatively, more callus formed 4 weeks, the bone defect area disappeared and CHAP scattered in the callus 8 weeks; the fracture line disappeared and medullary cavity became united (in control group); and in the 12th week, the cortex became continuous, the medullary cavity became united, and remodeling completed, while bone defect was not still united in blank control group. The maximal torque and torsional stiffness in the experimental group is higher than those in the control group 2 weeks (P lt; 0.05), but there was no significant difference (P gt; 0.05) between the two groups 4, 8, 12 weeks after repair. CONCLUSION: The compound of CHAP-FS-SAI has good biological compatibility, and it can be used for one kind of bone substitute material to repair the bone defect.
ObjectiveTo explore the clinical efficacy and safety of ultrasound-guided intra-articular injection of platelet-rich plasma (PRP) in the treatment of avascular necrosis of the femoral head.MethodsWe retrospectively collected and analyzed the clinical characteristics, imaging data, and clinical outcomes of patients with femoral head necrosis who received ultrasound-guided intra-articular PRP injection in the Department of Rehabilitation Medicine of Sun Yat-sen Memorial Hospital, Sun Yat-sen University between June 2019 and June 2020. All the patients received 4 injections at one-week intervals. The Visual Analogue Scale (VAS), Western Ontario and McMaster University Osteoarthritis Index (WOMAC), and Harris Hip Joint Function Scale (HHS) were evaluated before treatment and 1 month, 3 months, and 6 months after the first injections. Adverse events were recorded. The normally distributed data were presented as mean±standard deviation, and analyzed by one-way repeated measures analysis of variance; the non-normally distributed data were presented as median (lower quartile, upper quartile), and analyzed by Friedman test.ResultsA total of 29 patients were included. According to the Association Research Circulation Osseous classification standard, 2 patients were classified as stageⅠ, 11 as stageⅡ, 11 as stage Ⅲ, and 5 as stage Ⅳ. Before treatment and 1 month, 3 months, and 6 months after treatment, the VAS scores were 7.0 (5.5, 8.0), 4.0 (3.0, 5.0), 3.0 (2.0, 3.0), and 3.0 (2.0, 5.0), respectively, the WOMAC scores were 39.27±11.70, 28.34±8.08, 22.82±6.09, and 24.13±7.55, respectively, and the HHS were 46.0 (40.0, 64.0), 71.0 (57.5, 75.0), 78.0 (68.0, 80.5), and 78.0 (64.0, 80.0), respectively. The time effects in VAS (χ2=65.423, P<0.001), WOMAC (F=46.710, P<0.001), and HHS (χ2=66.347, P<0.001) were all statistically significant. There were significant differences in each index between the values 1 month, 3 months, and 6 months after treatment and those before treatment respectively, and there was also a significant difference in each index between the value 1 month after treatment and that 3 months after treatment (P<0.05). There was no significant difference in any indicator between the value 6 months after treatment and that 3 months after treatment (P>0.05). Significant difference was shown between the value 6 months after treatment and that 1 month after treatment in WOMAC (P=0.016), but not in VAS or HHS (P>0.05). No obvious adverse event was reported during the follow-up period.ConclusionsUltrasound-guided intra-articular PRP injection can effectively alleviate the pain and improve the hip joint function of patients with femoral head necrosis for at least 6 months. However, randomized controlled studies with a larger sample size and longer-term follow-up are needed in the future to confirm the efficacy and safety of PRP injection in femoral head necrosis.
Objective To evaluate the therapeutic results of percutaneous injection of autogeous bone marrow for simple bone cyst and to analyze the prognostic factors of the treatment. Methods From March 2000 to June 2005, 31 patients with simple bone cysts were treated by percutaneous injection of autogeous bone marrow. Of 31 patients, there were 18 males and 13 females, aged 5 years and 7 months to 15 years. The locations were proximal humerus in 18 cases ,proximal femur in 7 cases and other sites in 6 cases. Two cases were treated with repeated injections. The operative process included percutaneous aspiration of fluid in the bone cysts and injection of autogenous bone marrow aspirated fromposterior superior iliac spine. The mean volume of marrow injected was 40 ml(30-70 ml).Results No complications were noted during treatment. Thirty patients were followed for an average of 2.2 years(1.5 years) with 2 cases out of follow-up. After one injection of bone marrow, 9 cysts(29.0%) were healed up completely, 7 cysts(226%)basically healed up,13 cysts (41.9%)healed up partially and 2 (6.5%) had no response.The satisfactory and effective rates were 67.7% and 93.5% respectively. There was significant difference between active stagegroup and resting stage group(P＜0.05). There were no statistically significant difference in therapeutic results between groups of different ages, lesion sites or bone marrow hyperplasia(Pgt;0.05). Conclusion Percutaneous injection of autogeous bone marrow is a safe and effective method to treat simple bone cyst, but repeated injections is necessary for some patients. The therapeutic results are better in cysts at resting stage than those at active stage.
Objective To analyze the adverse drug reactions (ADR) of Ciwujia injection and the relative influence factors. Methods We searched all clinical studies and ADR reports of Ciwujia injection from the China National Knowledge Infrastructure (CNKI) database. The relevant information such as the diseases for treatment; menstruum, dosage and compatibility of Ciwujia injection; the age, gender and allergic history of patients; and the category, treatment and prognosis of ADR were collected and analyzed. Results In the 800 clinical studies, only 97 (12.1%) reported 285 ADR cases, 144 ADR reports including 236 ADR cases. Of the ADR cases, the male to female ratio was 1׃1.34, mainly in 40 to 69 years group; The ADR cases mainly including anaphylactic shock and local pain in ADR reports and clinical studies, respectively; 72.3 percent ADR cases were Ⅲ to Ⅳ class, 4 anaphylactic shock cases died; the diseases for treatment of ADR cases mainly were coronary artery heart disease and cerebral infarction; 27 (11.4%) ADR cases had allergic history; The menstruum of Ciwujia injection mainly were 5% glucose, 0.9% NaCl and 10% glucose, drug incompatibility in 36 ADR cases; The usual dosage of Ciwujia injection was 20-60 ml; 196 (83.0%) ADR cases occurred in first time medication, mainly in the early 30 minutes of medication used. Conclusion (1) In both ADR reports and clinical studies of Ciwujia injection, there are some problems of ADR and adverse drug events (AE) were not easily distinguishable, key information of total prescriptions divided by drug persons were lacking, so we can’t calculate the ADR rate, the reporting quality remained to be improved. (2) To support the rational drug use, the basic researches of Ciwujia injection remains to be further studied, especially the dose-finding studies. (3) As one of the most frequently reported ADR of traditional Chinese medicine (TCM) injection, high quality ADR monitoring, normative ADR reporting and timely analyzing the ADR reason of Ciwujia injection is extremely urgent.
Objective To evaluate the efficacy and safety of local triamcinolone combined with conventional interventional therapy in the treatment of benign airway stenosis. Methods PubMed, Cochrane Library, EMbase, Web of science, wanfang, VIP and China National Knowledge Infrastructure were searched by computer between the establishment of the database and August, 2019, and all literatures on the local treatment of benign airway stenosis using triamcinolone combined with conventional interventional therapy were searched. According to inclusion and exclusion criteria, 2 researchers screened the literatures and performed the data extraction and methodological quality evaluation. Meta-analysis was performed with Revman5.2 and Stata software. Results In total, nine randomized controlled trials were included in this meta-analysis, including 449 patients with airway stenosis. The total result showed that in the comparison of short-term efficacy, there were no statistically significant differences in breathability score (SMD=–0.16, 95%CI –0.45 - 0.13, P=0.27), airway diameter (SMD=0.14, 95%CI –0.13 - 0.41, P=0.30), and cross-sectional stenosis rate (SMD=–0.01, 95%CI –0.36 - 0.34, P=0.96) between the treatment group and the control group. In the comparison of long-term efficacy, the breathability score (SMD=–2.53, 95%CI –3.78 - –1.28, P<0.05), airway diameter (SMD=1.31, 95%CI 0.83 - 1.78, P<0.05), cross-sectional stenosis rate (SMD=2.58, 95%CI: 2.11~3.08, P<0.05), and FEV1(SMD=0.42, 95%CI 0.13 - 0.70, P=0.004) of patients in the treatment group were all better than those in the control group. But in terms of adverse reactions, the incidence of bleeding in the airway between two groups was similar (RR=2.00, 95%CI 0.88 - 4.52, P=0.10), other adverse reactions such as blood glucose and plasma cortisol levels were mild, which can be relieved symptomatically. Conclusion Current evidence suggests that topical triamcinolone combined with conventional interventional therapy for benign airway stenosis has a better long-term clinical efficacy with fewer adverse reactions and better overall patient tolerance, which has clinical application value
Objectives We conducted a literature review of 33 kinds of Traditional Chinese medicine injections (CMIs) on the national essential medicine list (2004 edition) of China in ADR articles to retrieve basic ADR information and research trends related to CMIs and to provide evidence for the research and development as well as the rational use of CMIs, particularly pharmacovigilance and risk management of CMIs. Methods We electronically searched Chinese Biomedical Literature Database (CBM, Jan. 1978-April 2009), the China National Knowledge Infrastructure Database (CNKI, Jan. 1979-April 2009), Chinese Science and Technology Periodical Database (VIP, Jan. 1989-April 2009) and the Traditional Chinese Medicine Database (Jan. 1984 April 2009). We also retrieved the websites of Ministry of Health and State Food and Drug Administration, to collect data about CMIs ADRs reports and regulations from “Newsletter of Adverse Drug Reactions” (Issue 1 to 22). Then we descriptively analyzed all the results on the year published, periodicals and types of study design of included ADR literatures, the major CMIs as well as the regulations about their ADRs. Results (1) There were 5 405 citations found in total and 2160 were removed because of duplication. After screening the title, abstract and full text of the selected papers, 1 010 studies finally met the eligible criteria. (2) The total and cumulative amount of research articles published about CMIs ADRs significantly increases over time. (3) The included 1,010 articles were scattered among 297 periodicals. A total of 55 journals on pharmaceutical medicine, containing 399 articles, accounted for 39.50% of total; 64 journals on traditional Chinese medicine and pharmaceutical medicine, containing only 197 articles, amounted for 19.50% of total. Only 22 periodicals were included on the core journals of the Beijing University List (2008 edition) (8.94% of the total journals in the list), which published 129 articles (12.77% of the total articles published). (4) We categorized the articles included into eight categories based on their content and study methodology. There were: 348 case reports and 254 case series which accounted for 34.46% and 25.15% of the total articles, 119 overviews (11.78%), 116 randomized controlled trials (11.49%), 78 cross-sectional studies (7.72%), 61 ADR literature analyses (6.04%), and 28 non-randomized controlled clinical studies (2.77%). (5) In the three of top ten journals, "Adverse Drug Reactions Journal", "China Medical Herald", and "Chinese Pharmaceuticals" published literature accounted for 5.84%, 3.76% and 2.67% of the total respectively. (6) The reports of ADRs to Shuanghuanglian, Qingkailing and Yuxingcao injections were the most in all reports for CMIs (All the three injections had more than 200 articles, accounting for 41.95% of the total). The Ministry of Health and the State Food and Drug Administration took measures to supervise them. (7) The four kinds of CMIs (Shuanghuanglian, Ciwujia, Yuxingcao, and Yinzhihuang injections) among the top 5 reported ADR literatures were removed from the market or were suspended for sale. The varieties and numbers of reports for CMIs ADRs have relationship with the supervision to them. Conclusions (1) Articles published on CMIs ADRs increased year by year, but overall the research is of low quality and is scattered in a large number of sources. (2) It is very urgent to create a clear standard to grade ADRs of CMIs for the risk management. (3) It is necessary to enforce safety re-evaluation work for CMIs and to promote the clinical rational use.
Objectives To systematically evaluate the clinical characteristics of adverse drug reactions (ADRs) caused by Shuanghuanglian Injection (SHLI) and to provide reference for post-market evaluation and clinical application of SHLI. Methods We searched electronic databases such as the Chinese National Knowledge Infrastructure (CNKI, 1979.1-2009.9), the Chinese Science and Technology Journal Full-text Database (VIP, 1989.1-2009.9), and the Chinese Biomedical Disc (CBMdisc, 1978.1-2009.9). ADR cases were analyzed according to occurrences categorized. Available data was assessed using the Chi-square test including relative ratios (RR) with 95% confidence intervals (95%CI). Different medicine combinations and comparisons between SHL powder injection and SHL injection were calculated using the statistical software Stata 9.1. Results (1) A total of 452 articles were included with a total of 2 799 ADR cases reported. Case reports were the main design type of included literature, which accounted for 84.51%. According to 31165 cases of SHLI treatment and 1 013 corresponding ADRs, the incidence of SHLI ADR was calculated as 3.25%. (2) The ratio of male to female in the reported ADR cases was 1.13׃1. (3) Allergy to Penicillin, which accounted for 13.38% of the total cases, was at the top for past allergic history, followed by sulfonamides and asthma (2.68%). (4) In terms of disease treated respiratory disease accounted for 91.75% of all cases of SHLI ADRs, followed by digestive diseases (5.17%), and urinary diseases (1.11%). (5) Penicillins were the most common combination choice with SHLI, and such combination showed higher ADR risk than SHLI used alone [RR=3.14, 95%CI (2.58, 3.81)]. (6) Multiple systems/organs were involved in SHLI ADRs, and were ranked downwards according to proportion as: skin, digestive system, general reactions, respiratory system, nervous system, cardiovascular system, local reactions, urinary system, hematologic system and others. (7) According to the WHO ADR Classification Criteria, ADR cases were divided into four grades. There were 6.36%, 5.48%, 45.62%, and 2.12% cases of Grade Ⅰ, Ⅱ, Ⅲ and Ⅳ , respectively. And the prognoses of the rest 52.42% cases were reported unclearly. (8) All cases of death were caused by allergic shock, except for one, which was caused by myocardial infarction induced by pain at the injection site. The fastest ADR case occurred 1 minute after being injected. (9) There was a remarkable difference (Plt;0.05) in the rate of ADR caused by SHLI in power form (2.25%) and as a solution (4.14%). Conclusion The clinical manifestations of ADRs caused by SHLI mainly include skin allergic reactions and gastrointestinal reactions. There is an increased risk of ADR induced by combined uses of SHLI and other drugs, especially antibiotics. Compared to the solution, the powder has lower ADR occurrence and higher safety with statistical significance. We propose strengthening management and surveillance on SHLI from manufacturing to application, and improving the level of the risk management for post-market drugs.
Objective To determine the best matching concentration of carbon nanoparticles suspension injection adsorb epirubicin by measuring the combination ratio of carbon nanoparticles suspension injection combined with epirubicin under different matching conditions. And then, to prove the adsorbability of carbon nanoparticles suspension injection adsorb epirubicin in vitro. Methods Firstly, epirubicin-carbon suspension of different concentrations will be prepared. The second, high performance liquid chromatography mass spectrometry（LC-MS） was used to assay the concentration of free epirubicin, and calculate the content of epirubicin that was combinated with carbon nanoparticles suspension injection. The difference of the ratio of carbon nanoparticles suspension injection combined with epirubicin under different matching conditions will be compared in the end. Results The combination ratio of carbon nanoparticles suspension injection combined with epirubicin solution of 5, 10, and 15 mg/ml were 85.6%, 85.7%, and 31.8%, respectively. Conclusions The adsorbability of carbon nanoparticles suspension injection adsorb epirubicin is favourable in vitro. Best matching concentration of carbon nanoparticles suspension injection adsorb epirubicin may be epirubicin solution of 5-10 mg/ml.
ObjectiveTo systematically review the effectiveness and safety of salvianolate injection and Danshen injection for patients with angina pectoris, and evaluate the cost of drug. MethodsWe electronically searched databases including PubMed, CENTRAL (Issue 4, 2013), CNKI, VIP and WanFang Data (2004.1 to 2013.5) for the randomized controlled trials (RCTs) on the comparison between salvianolate injection and Danshen injection for angina pectoris from January 2004 to May 2013. Relevant journals and conference proceedings were also manually retrieved. Two reviewers independently screened literature in accordance with the inclusion and exclusion criteria, extracted the data and assess the methodological quality of included studies. Then, meta-analysis was performed using RevMan 5.2 software. ResultsA total of 10 RCTs involving 1 196 patients were included. The results of meta-analysis showed that, salvianolate injection was obviously superior to Danshen injection in the effectiveness (OR=3.79, 95%CI 2.78 to 5.17, P < 0.000 01) and safety (OR=0.24, 95%CI 0.09 to 0.64, P=0.004), but lack of economic advantages in the treatment of the angina pectoris diseases. ConclusionCurrent evidence indicates that, salvianolate injection is a safe and effective scheme for angina pectoris, and Danshen injection is considered as a economic method. Because of the limited quantity and quality of currently-available research, the aforementioned conclusion should be verified by strictly-designed and large-scale sample RCTs.
ObjectiveTo observe the efficacy and safety of vitrectomy combined with subretinal injection of alteplase (tPA) and intravitreal injection of Conbercept in the treatment of large area submacular hemorrhage (SMH) secondary to polypoidal choroidal vasculopathy (PCV). MethodsA retrospective clinical study. From January to September 2021, 32 eyes of 32 patients with massive SMH secondary to PCV diagnosed in the Affiliated Eye Hospital of Nanchang University were included in the study. Large SMH was defined as hemorrhage diameter ≥4 optic disc diameter (DD). There were 32 patients (32 eyes), 20 males and 12 females. The mean age was (72.36±8.62) years. All patients had unilateral disease.The duration from onset of symptoms to treatment was (7.21±3.36) days. All patients underwent best corrected visual acuity (BCVA) and optical coherence tomography (OCT) examination. BCVA examination was performed using the international standard visual acuity chart, which was converted to the logarithm of the minimum angle of resolution (logMAR) visual acuity during statistics. The central macular thickness (CMT) was measured by spectral domain-OCT. The average size of SMH was (6.82±1.53) DD. The logMAR BCVA 1.73±0.44; CMT was (727.96±236.40) μm. All patients were treated with 23G pars plana vitrectomy combined with subretinal injection of tPA and intravitreal injection of Conbercept. At 1, 3, 6 and 12 months after treatment, the same equipment and methods were used for relevant examinations before treatment. The changes of BCVA and CMT, the clearance rate of macular hemorrhage, and the complications during and after surgery were observed. BCVA and CMT before and after treatment were compared by repeated measures analysis of variance. ResultsCompared with before treatment, BCVA gradually increased at 1, 3, 6 and 12 months after treatment, and the differences were statistically significant (F=77.402, P＜0.001). There was no significant difference in BCVA between any two groups at different time points after treatment (P＞0.05). Correlation analysis showed that BCVA at 12 months after treatment was negatively correlated with the course of disease (r=－0.053, P=0.774). One week after treatment, macular hemorrhage was completely cleared in 30 eyes (93.75%, 30/32). The CMT was (458.56±246.21), (356.18±261.46), (345.82±212.38) and (334.64±165.54) μm at 1, 3, 6 and 12 months after treatment, respectively. Compared with before treatment, CMT decreased gradually after treatment, and the difference was statistically significant (F=112.480, P＜0.001). There were statistically significant differences in different follow-up time before and after treatment (P＜0.001). The number of treatments combined with Conbercept during and after surgery was (4.2±1.8) times. At the last follow-up, there was no recurrence of SMH, retinal interlamellar effusion and other complications. Conclusion Subretinal injection of tPA combined with intravitreal injection of Conbercept is safe and effective in the treatment of large SMH secondary to PCV, and it can significantly improve the visual acuity of patients.