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The quality evaluation of the blind method is to evaluate the clinical blind data obtained from clinical trials adopting the blind method and judge the effectiveness of the blind method by investigating the blind effect of different blind objects. A successful blind method can avoid the influence of subjective factors on the test results of subjects and researchers to a certain extent. The quality evaluation of the blind method can reflect not only the effectiveness of the blind method but also the accuracy and credibility of clinical trial results. In recent years， randomized controlled trials have been widely used in the evaluation of the clinical efficacy of traditional Chinese medicine （TCM）， but the quality of the implementation of blind methods is uneven， and the evaluation criteria have not yet been formed. In this paper， the data collection methods， calculation principles， advantages， and disadvantages of two quantitative quality evaluation methods of blind methods， namely James Blinding Index （JBI） and Bang Blinding Index （BBI）， were introduced. The two indexes were analyzed in a randomized controlled trial of acupuncture and moxibustion to relieve postoperative oral pain. The calculation process of the results was demonstrated by R software and visualized by forest map. At the same time， a tool table was designed to facilitate the collection of evaluation data of blind methods in TCM clinical trials at different stages. Finally， the necessity and feasibility of quality evaluation of blind method in TCM research were discussed to provide a basis for evaluating and improving the quality of blind method implementation in TCM clinical trials.
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Target trial emulation， using observational data to emulate a target trial， applies the study design principles of randomized controlled trials to observational studies that aim to estimate the effect of an intervention. The advantage of target trial emulation is that observational data is used to emulate a target trial when it is not appropriate to conduct randomized controlled trials. Target trial emulation can control bias caused by the design of observational studies， and improve the effectiveness of causal inference from observational data. This paper introduced the methodological framework and key points in terms of eligibility criteria， treatment strategies， assignment procedures， grace period， outcomes， follow-up period， effect contrasts， and statistical plan for implementing target trial emulation. This article elucidated the feasibility and necessity of applying target trail emulation in the realm of traditional Chinese medicine researches， and highlighted the challenges encountered in its implementation， such as the need for specialized personnel， data collection and integration， and the control of confounding factors.
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Objective@#Explore the feasibility of POL intervention based on life skills in young students at high-risk of AIDS, and to provide reference for POL intervention.@*Methods@#Nine potential POLs were recruited from young students at high risk of AIDS in Xi’an, and received life-skill-based interventions from May to October in 2017. A unified approach was adopted before the intervention. The effect of intervention was evaluated at 1 month and 3 months after the intervention.@*Results@#The difference in POLs peer status and psychosocial ability scores was not significant after the intervention. The scores of persistence efficacy dimension of condom use efficacy before, 1-month and 3-month after the intervention were (10.56±1.88)(11.11±2.21)(12.89±2.09)(F=6.84, P<0.05) respectively. No significant changes were found in AIDS-related knowledge and behavior before and after the intervention. POL has increased from 108 students before intervention to 216 publicity coverage after three months intervention, however, the difference was not statistically significant. Feasibility analysis of the POL intervention showed that 8 of the POLs considered to be "very useful".@*Conclusion@#Life skill-based POL intervention for young students at high-risk of AIDS has a wide coverage and reasonable acceptance, as well as condom use adherence. The long-term effectiveness still needs to be verified.
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Objective To study the in vitro cytotoxicity of HRZ (isoniazid + rifampin + pyrazinamide) / transforming growth factor (TGF) β1 siRNA nanoliposomes on human macrophages and the underlying mechanism. Methods Self-made nanoliposomes were used to study with the cultured human macrophages in vitro. MTT assay was used to detect cell proliferation. Flow cytometry was used to analyze apoptosis and cell cycle. Electron microscopy was used to observe autophagy. RT-PCR and Western blot were employed to analyze the silenced expression of target gene TGF-β1. Results HRZ/TGF-β1 siRNA nanoliposomes (triple liposome) inhibited macrophage proliferation within certain range of concentration, and cell cycle was captured in G2 phase. The HRZ / TGF-β1 SiRNA nanoliposomes could significantly inhibit the expression of target gene TGF-β1 in human macrophages. Conclusions The self-made triple liposome has evident effect in silencing the target gene. It is a promising biomaterial, which meets the required specifications in terms of cytotoxicity.
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BACKGROUND: Calcium sulfate/poly amino acid compound materials carrying triple anti-tuberculosis drugs have been proved to have excellent slow release performance based on our preliminary studies on the physical and chemical properties and the release properties of the compound materials.OBJECTIVE: To observe the slow release performance of the calcium sulfate/poly(amino acid) compound material carrying triple anti-tuberculosis drugs in a rabbit model of spinal tuberculosis.METHODS: Twenty-four New Zealand white rabbits were used to make L4-5 spinal tuberculosis models and divided into two groups in a random way following removal of tuberculosis lesions. Calcium sulfate/poly amino acid compound material carrying isoniazide, rifampicin, pyrazinamide or calcium sulfate/poly(amino acid)compound material with no drugs was implanted into the defect in the experimental or control group,respectively. At 2, 4, 6 and 8 weeks after implantation, the concentrations of isoniazid, rifampicin and pyrazinamide in the defect region, including the bone tissue, adjacent psoas major and inferior vena cava,were measured.RESULTS AND CONCLUSION: In the experimental group, the isoniazid levels in the damaged bone tissue and psoas major were kept in minimum bactericidal concentration (MBC) at 8 weeks after implantation and in the minimum inhibitory concentration (MIC) at the end of 12 weeks after implantation, while its level in the vein was kept in MBC at 2 weeks and in MIC at 8 weeks. The rifampicin levels in the bone tissue and psoas major were kept in MBC at 4 weeks after implantation and in the MIC at 8 weeks after implantation, while its level in the vein was kept MIC at 4 weeks.The pyrazinamide levels in the damaged bone tissue and psoas major were kept in MBC at 8 weeks after implantation and in the MIC until 8 weeks after implantation, while its level in the vein was kept MIC at 8 weeks. In the control group,there were no levels of isoniazid, rifampicin and pyrazinamide in the damaged bone tissue, adjacent psoas major and inferior vena cava in comparison with the baseline. These results show that isoniazid, rifampicin and pyrazinamide in the defect region can achieve sustained slow release in the rabbit model of spinal tuberculosis after implantation of the calcium sulfate/poly(amino acid) compound material carrying triple anti-tuberculosis drugs. In addition, the local drug concentration and duration in the defect region are better than those in the blood.
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Objective To explore the effect of posterior debridement, grafting and internal fixation for treatment of non-specific lumbar intervertebral infection. Methods Clinical data of 20 patients with non-specific lumbar intervertebral infection treated in General Hospital of Ningxia Medical University from October 2013 to June 2013 were retrospectively analyzed. There were 15 males and 5 females with an average age of 41 years (range, 36-51 years). All patients suffered from single lumbar inter-vertebral infection, including 3 cases at L2/3,4 at L3/4,10 at L4/5 and 3 at L5/S1. All 20 cases underwent one-stage posterior debride-ment, autogenous bone grafting and internal fixation, tissue samples in focus were collected for bacterial culture and pathological examination. The disease controlling statues were evaluated based on laboratory results of ESR and CRP. Imaging examinations were taken to evaluate the fusion of vertebral body. Clinical effects were evaluated using the visual analog scale (VAS) and the Jap-anese Orthopaedic Association scores (JOA) score of lumbar fumction. Results All patients underwent the surgery successfully. The surgery duration time was 90-160 min, average 125 min, and the blood loss was 200-700 ml, average 360 ml. Cerebrospinal fluid leakage occurred in one case. Postoperatively, all patients experienced significant reliefof back pain, improving in the func-tion of movement, and no fever. The lower back VAS score: average (5.35 ± 1.15) points before operation , average (2.76 ± 0.34) points one week after operation, and an average score of (0.85±0.65) points by the last follow-up time. JOA lumbar function score:all patients were effective after operation, the improvement rate was excellent in 65%(13cases), good in 25%(5 cases), and pass-able in 10%(2cases). Comparing with preoperation, the excellent and good rate was 90%. All patients ESR and CRP returned to normal levels at the last follow-up. Ordinary bacterial culture was positive in 8 cases and negative in 12 cases. The pathogens iden-tified were staphylococcus aureus (6 cases), Escherichia coli (2 cases) and staphylococcus epidermidis (2cases). All incisions achieved primary healing. All patients were followed up from 6-18 months (average,12 months), and the symptom of pain relieved significantly. No recurrent infection had happened. A solid bony fusion was found in all patients at 6-14 months (average, 8.5 months) after the surgery. Conclusion Posterior debridement, grafting and internal fixation are effective treatments for non-spe-cific lumbar intervertebral infection, can reduce the time of staying in hospital, this operation is safe and reliable.
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Objective To explore the effect of posterior debridement, grafting and internal fixation for treatment of non-specific lumbar intervertebral infection. Methods Clinical data of 20 patients with non-specific lumbar intervertebral infection treated in General Hospital of Ningxia Medical University from October 2013 to June 2013 were retrospectively analyzed. There were 15 males and 5 females with an average age of 41 years (range, 36-51 years). All patients suffered from single lumbar inter-vertebral infection, including 3 cases at L2/3,4 at L3/4,10 at L4/5 and 3 at L5/S1. All 20 cases underwent one-stage posterior debride-ment, autogenous bone grafting and internal fixation, tissue samples in focus were collected for bacterial culture and pathological examination. The disease controlling statues were evaluated based on laboratory results of ESR and CRP. Imaging examinations were taken to evaluate the fusion of vertebral body. Clinical effects were evaluated using the visual analog scale (VAS) and the Jap-anese Orthopaedic Association scores (JOA) score of lumbar fumction. Results All patients underwent the surgery successfully. The surgery duration time was 90-160 min, average 125 min, and the blood loss was 200-700 ml, average 360 ml. Cerebrospinal fluid leakage occurred in one case. Postoperatively, all patients experienced significant reliefof back pain, improving in the func-tion of movement, and no fever. The lower back VAS score: average (5.35 ± 1.15) points before operation , average (2.76 ± 0.34) points one week after operation, and an average score of (0.85±0.65) points by the last follow-up time. JOA lumbar function score:all patients were effective after operation, the improvement rate was excellent in 65%(13cases), good in 25%(5 cases), and pass-able in 10%(2cases). Comparing with preoperation, the excellent and good rate was 90%. All patients ESR and CRP returned to normal levels at the last follow-up. Ordinary bacterial culture was positive in 8 cases and negative in 12 cases. The pathogens iden-tified were staphylococcus aureus (6 cases), Escherichia coli (2 cases) and staphylococcus epidermidis (2cases). All incisions achieved primary healing. All patients were followed up from 6-18 months (average,12 months), and the symptom of pain relieved significantly. No recurrent infection had happened. A solid bony fusion was found in all patients at 6-14 months (average, 8.5 months) after the surgery. Conclusion Posterior debridement, grafting and internal fixation are effective treatments for non-spe-cific lumbar intervertebral infection, can reduce the time of staying in hospital, this operation is safe and reliable.
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Objective To discuss the clinical efficacy of surgical treatment of pathologic vertebral surgery for thoracic and lumbar tuberculosis. Methods All of 322 cases of thoracic and lumbar spinal tuberculosis patients from December 2003 to June 2014 were retrospectively analyzed in our department. All patients were underwent debridement, fusion and nerve decompres?sion surgery. According to different fixed methods, patients were divided into pathologic vertebral surgery group (fixation complet?ed within lesions invaded motion unit) including 91 males and 100 females, with an average age of 41.53 years, and non?pathologic vertebral surgery group (long segments or short segment fixation) including 61 males and 70 females, with an average age of 42.72 years. We observed the tuberculosis cure rate, degrees of deformity, pain and neurological recovery, operative time, blood loss and complications by follow?up. Results The average follow?up time was 75.52 months in pathologic vertebral surgery group and 76.21 months in non?pathologic vertebral surgery group. The total number of pathologic vertebras in pathologic vertebral surgery group and non?pathologic vertebral surgery group were 277 and 218 respectively, and the average was 1.45 and 1.66. The total number of fixed segments was 277 in pathologic vertebral surgery group and 485 in non?pathologic vertebral surgery group, and the average fixed segments was 1.45 and 3.70. The cure rate was 85.86%in pathologic vertebral surgery group and 85.49%in non?pathologic vertebral surgery group at 6 months postoperatively, and 98.95%and 98.47%at the last follow?up time, with no signifi?cant difference between groups. Graft fusion rate was 89.00%in pathologic vertebral surgery group and 89.31%in non?pathologic vertebral surgery group 6 months postoperatively, 98.38%and 98.47%at the last follow?up time, without significant difference. In lumbar spine, the average correction of Cobb's angle was 12.4° in pathologic vertebral surgery group and 13.1° in non?pathologic vertebral surgery group, and the average angle loss was 1.3 and 1.4°, with no significant difference. In thoracolumbar, the average correction of Cobb’s angle was 10.9°in pathologic vertebral surgery group and 11.1°in non?pathologic vertebral surgery group, and the average angle loss was 1.7°and 1.5° respectively, without significant difference. However, in thoracic, the average correction of Cobb's angle was 10.2° in pathologic vertebral surgery group and 12.7° in non?pathologic vertebral surgery group, and the average angle loss was 3.6° and 2.5°respectively, with significant difference. The mean operation time was 210.45 min in pathologic verte?bral surgery group and 210.45 min in non?pathologic vertebral surgery group, with significant difference. The average blood loss was 726.12 ml in pathologic vertebral surgery group and 726.12 ml in non?pathologic vertebral surgery group, with significant dif?ference. The complication rate was 11.51%in pathologic vertebral surgery group and 11.45%in non?pathologic vertebral surgery group, with no significant difference. Conclusion Pathologic vertebral surgery surgery is a safe, effective and feasible method of operation for treatment of thoracic and lumbar tuberculosis, which can effectively preserve adjacent normal vertebral motion unit features. The thoracic surgery was less satisfactory than the lumbar and thoracolumbar surgery.
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Objective To investigate the feasibility of Antituberculotic?loaded bone cement (ATLBC) prepared by mix?ing the anti?TB drugs Rifampicin (RFP), Isoniazid (INH), Pyrazinamid (PZA), Moxifloxacin (MFX) with Palacos R PMMA bone cement in Total Joint Arthroplasty treatment for Joint Tuberculosis. Methods Forty grams of Palacos R bone cement powder without antibiotics was mixed with 1 or 2 grams of RFP, INH, PZA and MFX respectively. According to ISO 5833:2002 stan?dard, 8 groups of ATLBC standard test specimen were prepared as experiment group and Palacos R PMMA bone cement with?out antibiotics was prepared as control group. Physical properties (such as the average dough time, curing time, maximum tem?perature), mechanical strength (such as the compressive strength, the bending resistance strength, the modulus of elasticity) and the concentrations of eluant drug in different time points of ATLBC were detected. Results In RFP (1 g), RFP (2 g), INH (1 g) and INH (2 g) group, the average dough time and curing time were longer than those in control group, which exceeded the standard scope of ISO, while the average maximum temperature was significantly lower than that in control group. The INH ( 1 g) group and INH (2 g) group hardened after mixing for 14 days. The RFP (1 g) group and RFP (2 g) group hardened after mixing for 30 days. Twenty minutes after mixing and hardening, the compressive strength, bending resistance strength and modulus of elastic?ity were significantly lower than the specified values of ISO standard. The physical properties and mechanical strength in PZA ( 1 g) group, PZA (2 g) group, MFX (1 g) group, MFX (2 g) group and control group were in accordance with the specified values of ISO standard, and they hardened after 20 minutes. In RFP (1 g) group, RFP (2 g) group, INH (1 g) group, INH (2 g) group, PZA (1 g) group, PZA (2 g) group, MFX (1 g) group and MFX (2 g) group, the concentration of eluant could maintain for 3 days, 7 days, 90 days, 90 days, 45 days, 60 days, 60 days and 60 days respectively. Conclusion RFP and INH mixing with Palacos R PMMA bone cement can hinder the aggregation of bone cement so they are unsuitable for preparing ATLBC. PZA and MFX mixing with Palacos R PMMA bone cement do not affect the physical properties of bone cement, with excellent mechanical strength and elu?tion properties. Because the minimal inhibitory concentration of PZA is higher and its antimicrobial activity maintains shorter time, while MFX maintains longer time in antimicrobial activity, it's more suitable for the preparation of ATLBC.
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<p><b>OBJECTIVE</b>To establish a flow cytometric internal standard method for counting platelet-derived microparticles (PMPs) and to study its clinical significance.</p><p><b>METHODS</b>PMPs suspension (platelet poor plasma, PPP) was extracted by gradual centrifugation. According to the size of PMPs, 3 microm and 0.8 microm latex beads were used as internal standards for the quantitation. PMPs were counted by adjusting flow cytometric discrimination and voltage of forward scatter and side scatter.</p><p><b>RESULTS</b>In 30 healthy donors, the average concentration of resting PMPs was (1.2 x 10(5) +/- 5.7 x 10(4))/ml and that of activated PMPs was (1.6 x 10(6) +/- 9.1 x 10(5))/ml. Compared with healthy donors, PMPs mean value was significantly higher (P < 0.001) in 18 patients with coronary artery disease, 12 with acute cerebral infraction and 23 with chronic renal failure [the average PMPs concentration, (6.1 x 10(5) +/- 2.5 x 10(5))/ml, (6.8 x 10(5) +/- 3.4 x 10(5))/ml and (5.9 x 10(5) +/- 3.1 x 10(5))/ml respectively]. However, no significant difference in PMPs concentration was observed in 25 patients with acute leukemia and severe thrombocytopenia during the aplastic phase after chemotherapy [(1.3 x 10(5) +/- 6.1 x 10(4))/ml, (P > 0.05)].</p><p><b>CONCLUSIONS</b>PMPs is a useful indicator in monitoring platelet activation, and plays an important role in thrombotic disease. By flow cytometric internal standard method, PMPs can be counted rapidly and accurately, which may be very helpful in interlaboratory comparative studies.</p>