Objective To study the efficacy and safety of combined anti-tuberculosis regimen containing bedaquiline in the treatment of multidrug-resistant tuberculosis (MDR-TB). Methods A total of 69 MDR-TB patients treated by joint regimen combined bedaquiline with other anti-tuberculosis drugs between March 2018 and August 2019 in Public Health Clinical Center of Chengdu were taken as the trial group, and 60 MDR-TB patients received treatment without bedaquiline between June 2016 and December 2017 in the same hospital were taken as the control group. The efficacy and safety of the two groups were compared. Results The 69 patients in the trial group included 44 males and 25 females, aged from 21 to 63 years, with an average of (34.6±11.0) years; 58 patients (84.1%) completed the 24-week treatment with bedaquiline, while 11 patients did not complete the treatment, including 3 deaths (4.3%), 1 loss of follow-up (1.4%), 1 withdrawal from the study (1.4%), and 6 discontinuation due to adverse events (8.7%). Among the 54 patients with positive results of tuberculosis on baseline sputum culture, 49 transformed to negative results within 24 weeks of treatment (the negative conversion rate was 90.7%), and the median negative conversion time was 13.0 weeks. The 60 patients in the control group included 45 males and 15 females, aged from 16 to 66 years, with an average of (35.5±13.2) years. Among the 53 patients with positive results of tuberculosis on baseline sputum culture, 30 transformed to negative results within 24 weeks of treatment (the negative conversion rate was 56.6%), and the median negative conversion time was 12.0 weeks. The negative conversion rate of sputum bacteria in the trial group was significantly higher than that in the control group (χ2=16.133, P<0.001). The most common adverse reactions in the trial group were liver function abnormalities (42 cases, 60.9%), prolonged QTc interval (37 cases, 53.6%), electrolyte disturbances (20 cases, 29.0%), and blood system damage (20 cases, 29.0%). In the 37 patients who experienced prolonged QTc interval, there were 8 patients with QTc intervals≥500 ms and 29 patients with QTc intervals ≥450 ms and <500 ms, with a median occurrence time of 16.0 weeks, among whom 25 patients experienced prolonged QTc interval in 4-48 weeks after the withdrawal of bedaquiline. Conclusion The negative conversion rate of tuberculosis sputum culture of patients with MDR-TB treated by bedaquiline combined with other anti- tuberculosis drugs is high, but electrocardiogram should be closely monitored during and after the treatment in order to guard against the potential cardiac toxic effects of bedaquiline.
Objective To evaluate the effectiveness and safety of intraluminal brachytherapy (ILBT) in prolonging survival and the period free of symptoms for patients with unresectable bile duct cancer. Methods We searched MEDLINE (1977 to May 2007), CNKI (1979 to May 2007) and CBM Disk (1979 to May 2007). The qual ity of included studies was assessed according to the guidance in the Cochrane Handbook for Systematic Reviews of Interventions. Results One randomized controlled trial involving 42 patients with unresectable bile duct cancer fulfilled the inclusion criteria. This found that the median survival time was longer for patients treated with endoprostheses and ILBT compared to those treated with endoprostheses alone (387.9 days versus 298.0 days, Plt;0.05). The stent patency time in patients who were treated with endoprostheses and ILBT was longer than for those treated with endoprostheses alone (378.4 days versus 245.5 days, Plt;0.01). The reductions in bil irubin (mol/l) and alkal ine phosphatase (kat/l) before and after drainage in patients who were treated with endoprostheses and ILBT were similar to those treated with endoprostheses alone (Mean ±SD of bil irubin: before: 219.3 ± 40.5, after: 23.1 ± 37.1 versus before: 227.3 ± 39.8, after: 22.5 ± 44.2; Mean ± SD of alkal ine phosphatase: before: 10.3 ± 5.1. after: 3.6 ± 2.9 versus before: 11.7 ± 5.8, after: 3.7 ± 2.9). No severe adverse effects were observed in the trial. Conclusion Current evidence suggests that ILBT for unresectable bile duct cancer may improve the survival time of patients, prolong the time they spend symptom free, improve their quality of l ife and reduce the burden of treatment. However, it may increase toxicity in normal tissues, which can be managed by adjusting radiation dosage. No serious adverse effects were observed in the 42 patients in the trial in this review. More randomized controlled trials with large sample size are needed to provide rel iable results.
Objective To evaluate the effectiveness of mifepristone concomitant with misoprostol for medical abortion. Methods We searched the related original studies worldwide, and controlled prospective studies and systematic reviews based on randomized controlled trials （RCTs）. Nine electronic databases were searched. Ten journals and reference lists of eligible studies were handsearched. Two reviewers independently screened the studies for eligibility, evaluated the quality, and extracted the data from eligible studies, with confirmation by cross checking. Any disputes were decided by a third person. Meta-analysis was conducted using statistical software RevMan 4.2. After heterogeneity test was done （α=0.05 ） , data without heterogeneity were pooled using a fixed effect model, and those with heterogeneity could be solved by sensitivity＂ analysis, subgroup analysis or random effect model. Results We found eight original trials （n = 3 348 ） that compared medical abortion with surgical abortion, nine trials （n =6 116） that investigating the effect of gestational ages on medical abortion, five trials （n = 1 934） on the use of mifepristone and two trials （n =2381 ） on intervals of administration of mifepristone and misoprostol were located. Quality of foreign studies was better than that of Chinese studies. Therate of complete abortion was higher in surgical abortion group than that in medical abortion group with odds ratio （OR） 0. 18 and 95% confidence interval （CI） 0. 11 to 0.27. The rate of incomplete abortion and abortion failure was higher in medical abortion group with OR 3.32, and 95% CI 1.79 to 6.17, OR 7.36, 95% CI 4. 17 to 12.98, respectively. The rate of complete abortion in the group with gestational age over 49 days was lower than that with gestational age under 49 days with OR 0.51 and 95% CI 0.43 to 0.61. The rate of incomplete abortion and abortion failure was higher in the group with gestational age over 49 days with OR 1.66, 95% CI 1.32 to 2.09 and OR 3.37, 95% CI 2.30 to 4. 94.There were no significant differences observed in the rates of complete abortion, incomplete abortion, abortion failed, time of expelling pregnant sac and time of menses recovery between the single and multi-dosage of mifepristone. Except for the rate of complete abortion, which was higher in 〈48h group, there was a comparable effectiveness for different intervals of mifepristone and ntisoprostol. Conclusions This review showes that it is important to improve the quality of Chinese original studies. Although the effectiveness is better in the surgical abortion group, the rate of complete abortion of medical abortion achieved is 91.6% （1 648/1 800）. This is acceptable for clinicians and women who do not want to be pregnance. The rate of complete abortion is lower in the gestation over 49 days, which had a statistically difference, but little clinical significance. It is necessary to consider increasing the gestational age of medical abortion, especially for those women who have contradictions of surgical abortion or are afraid of operation. Effectiveness of single dosage of mifeprostone is similar to that ofmulti-dosage, but single dosage might be more convenient. This review suggests that shortening the interval ofmifepristone and misoprostol administration should be considered and the best and shortest interval time need to be identified with better evidence.
Objective To evaluate the operative procedure and the cl inical effectiveness of open reduction and internal fixation in the treatment of posterior malleolus fractures. Methods Between June 2005 and December 2008, 46 patients with posterior malleolus fractures were treated with open reduction and internal fixation and followed up. There were 29 males and 17 females with an average age of 47.7 years (range, 19-76 years). Fractures were caused by sprain in 17 cases, by fallingin 15 cases, by traffic accident in 12 cases, and by other reasons in 2 cases. The locations were left ankle in 25 cases and right ankle in 21 cases. There were 6 simple posterior malleolus fractures, 13 lateral and posterior malleolus fractures, and 22 trimalleolar fractures, and 5 lateral and posterior malleolus fractures accompanying by injury of deltoid l igament of ankle. According to Lauge- Hansen classification system, 13 cases and 9 cases were rated as supination-external rotation type III and type IV respectively, and 18 cases as pronation-external rotation type IV. According to Naoki’s classification of posterior malleolus fractures, there were 29 cases of posterolateral-obl ique type, 11 cases of medial-extension type, and 6 cases of small-shell type. Seven patients underwent emergency operation and 39 patients underwent selective operation. Results Two patients developed superficial infection, which was cured after dressing change, and the other incisions healed by first intention. Forty-six patients were followed up 37 months on average (range, 18-63 months). All fractures healed after 3 to 6 months (mean, 4.3 months). One patient developed lateral suralcutaneous nerve injury, and 9 patients had mild weight-bearing pain or discomfort. The results of American Orthopaedic Foot and Ankle Society (AOFAS) ankle and hindfoot score were excellent in 17 cases, good in 21 cases, and fair in 8 cases with an excellent and good rate of 83%. The mean visual analogue scale (VAS) score was 1.9 (range, 0-5). Conclusion The anatomic reduction and internal fixation can achieve the satisfactory results in the treatment of posterior malleolus fractures. The best treatment and fixation methods should be chosen based on different types of posterior malleolus fractures.
Objective To systematically evaluate the effectiveness and safety of China-made omeprazole in treating acute non-variceal upper gastrointestinal bleeding. Methods Such databases as PubMed, MEDLINE, Springer, The Cochrane Library, CNKI, VIP, CBM and WanFang data were searched to collect the randomized controlled trials (RCTs) about China-made omeprazole in treating acute non-variceal upper gastrointestinal bleeding, and the references of included studies were also retrieved. The retrieval time was from inception to December 2012. Two reviewers independently screened the literature according to the inclusion and exclusion criteria, extracted the data, and assessed the quality, and then the meta-analysis was conducted by using RevMan 5.1 software. Results A total of 11 RCTs were included. Among all 1 075 patients, 544 were in the treatment group, while the other 531 were in the control group. The results of meta-analysis showed that, there were no significant differences in the total effective rate (OR=0.68, 95%CI 0.35 to 1.33, P=0.26) and safety (RR=1.33, 95%CI 0.45 to 3.91, P=0.96) between the China-made omeprazole and imported omeprazole. Conclusion China-made omeprazole is effective and safe in treating acute non-variceal upper gastrointestinal bleeding in comparison with the imported omeprazole.
【Abstract】 Objective To evaluate the effectiveness of artifical humeral head replacement in treatment of complicatedfractures of the proximal humerus. Method Between January 2005 and January 2011, 18 patients with proximal humerusfracture were treated with artifical humeral head replacement. There were 8 males and 10 females with a mean age of 71 years (range, 52-84 years). Fractures were caused by falling in 11 cases, by traffic accident in 3 cases, and by bruise in 4 cases. The time between injury and admission was 2 hours to 3 days (mean, 1.5 days). According to Neer classification, 8 cases had three-part fracture, 7 four-part fracture, and 3 cleavage fracture of humeral head; 5 cases complicated by shoulder joint subluxation, 2 cases by femoral fracture, 1 case by radial fracture, and 11 cases by osteoporosis. All the patients were treated with modular cemented prostheses. Results The operation time was 60-180 minutes with an average of 80 minutes; the blood loss was 100-400 mL with an average of 200 mL. All incisions healed by first intention without infection or neurovascular injury. Sixteen patients were followed up 3 years on average (range, 1-6 years). No loosening, dislocation of prothesis or heterotopic ossification occurred. According to the Neer scores, the results were excellent in 5 cases, good in 8 cases, moderate in 2 cases, and poor in 1 case at 1 year after operation. The excellent and good rate was 81.2%. Conclusion Artificial humeral head replacement is a good therapy for patients with complicated fractures of the proximal humerus, especially for elderly patients.
ObjectiveTo systematically review the effects of the promotion of appropriate health technology in China and provide reference for improving the promotion of appropriate health technologies. MethodsDatabases including CBM, VIP, CNKI and WanFang Data were searched for studies about the appropriate health technology in China from inception to August 2014. Two reviewers independently screened literature, extracted data, and assessed the methodological quality of included studies by the evaluation criteria for descriptive studies of MAStARI, an assessment tool developed by JBI Evidence-Based Health Care Center. And then, qualitative descriptive analysis method was used to comprehensively analyze the data from four aspects: medical institutions, regulators, technology promotion medical staff and patients. ResultsA total of 23 cross-sectional studies and one before-after study were included. The results of qualitative analysis showed that: 1) the technology utilization rate of appropriate health technology extension institutions was more than 70%, the number of outpatients of township and village organizations increased significantly than that of the county level institutions; 2) director of technology extension and managers of hospital were in favor of the promotion of appropriate technology for its good effectiveness, safety, lower medical costs, and skill improvement of medical staff; 3) medical staff mastered the appropriate health technology, they were willing to promote appropriate technology and spoke highly of it for its safety, feasibility and economic effect, and improved their level of technology; 4) in patients' opinion, the appropriate technology reduced the disease course and cost, they spoke highly of it for its acceptance, efficacy and safety. ConclusionCurrent evidence shows that the promotion of appropriate health technology has achieved good effects. The satisfaction of medical institutions, managers, health service staff and patient is high, but these research results are of poor quality, mostly subjective evaluation, lack of scientific, rational, objective and consistent evaluation criteria, which cannot be used as evaluation evidence for the promotion of appropriate health technology.
To compare the effectiveness of dressing by a combination of traditional Chinese medicine (TCM)-Western medicine (WM) after TCM bath and by the silver sulfadiazine cream (SD-Ag) in treating residual deep burn wound. Methods A total of 128 cases of residual deep burn wound between July 2003 and December 2009 were randomly divided into the TCM-WM treatment group (70 cases) and the WM control group (58 cases). In the treatment group, there were 45 males and 25 females with an average age of 38.6 years (range, 18-60 years), including 34 cases of flame burns, 28 cases of molten steel burns, and 8 cases of chemical burns with an average burn area of 57.6% total body surface area (TBSA) and an average residual wound of 7.4% TBSA. In the control group, there were 50 males and 8 females with an average of 37.9 years (range, 20-59 years), including 26 cases of flame burns, 12 cases of hot water burns, 16 cases of molten steel burns, and 4 cases of chemical burns with an average burn area of 56.5% TBSA and an average residual wound of 6.9%TBSA. There was no significant difference in general data between 2 groups (P gt; 0.05), so the cl inical data of 2 groups had comparabil ity. In the treatment group, the patients had a bath with TCM, and then the wounds were treated with dressing change of combined TCM-WM. In the control group, the wounds were treated with SD-Ag after cleaning the wounds with chlorhexidine solution. The pain, wound heal ing time, and the rate of scar formation were observed in 2 groups after treatment. Results According to wound pain classification after medication, the results were excellent in 23 cases, good in 30 cases, fair in 17 cases in the treatment group; were excellent in 17 cases, good in 20 cases, fair in 13 cases, poor in 5 cases, and fairly poor in 3 cases in the control group. The wound heal ing time of the treatment group (13.45 ± 4.74) days was significantly shorter than that of the control group [(23.87 ± 14.45) days, P lt; 0.05)]. After 2 weeks of treatment, scar occurred in 15 patients (21.4%) of the treatment group and 35 patients (60.3%) of the control group, showing significant difference (P lt; 0.05). Conclusion Based on TCM bath, a combination of TCM-WM for the residual burn wounds is obviously superior to SD-Ag. It has the advantages of rapid heal ing, l ight pain, no obvious scar, and short hospital ization time.
Objective To explore the effectiveness and safety of ziprasidone in the treatment of female patients with schizophrenia. Methods A before-after study design with prospective consecutive data collection was adopted. From June 2006 to May 2007, 30 female patients with schizophrenia discharged from the Second Veterans Hospital of Shanxi Province were included. Ziprasidone 60-120 mg/d was orally administered for 6 weeks. Positive and Negative Syndrome Scale (PANSS) and Treatment Emergent Symptom Scale (TESS) were measured before the treatment and at the end of Week 2, 4 and 6 after the treatment, respectively.Results At Week 6, the significant improvement rate and the total improvement rate were 86.67% and 93.33%, respectively; the incidence of side effects was 86.67%. Conclusion Ziprasidone is safe and effective in the treatment of schizophrenia. Since it will not increase body weight or the level of prolactin, it can be especially applied to female schizophrenic patients.
ObjectiveTo evaluate the safety and efficacy of local sodium citrate anticoagulation for routine hemodialysis in high-risk patients with hemorrhage.MethodsA total of 150 patients who were admitted to West China Hospital from October 2018 to March 2019 for routine hemodialysis treatment with high-risk bleeding were selected as study objects. The patients were divided into without heparin anticoagulation group (group A) and with 4% sodium citrate anticoagulation group (group B) by random number table method, with 75 cases in each group. Biochemical indicators, serum calcium ion concentration, local anticoagulation safety index of citrate and dialysis adequacy index, blood coagulation in dialyzer and tube during dialysis wre observed in the two groups.ResultsThe coagulation events in group B were significantly lower than those in group A (Z=–4.889, P<0.001), and the urea clearance index in group B was higher than that in group A [(1.26±0.12) vs. (0.73±0.13) L/(min·1.73 m2); t=22.418, P<0.05]. There was a significant difference in the changes of urea nitrogen [(3.53±1.05) vs.(3.12±1.11) mmol/L; t=2.323, P=0.021] 24 hours after dialysis; other indicators showed no statistically significant difference (P>0.05). After the filter, serum calcium ion concentrations in group B at different time points were lower than those in group A [2 hours: (0.52±0.07) vs. (0.64±0.08) mmol/L; 4 hours: (0.56±0.09) vs.(0.63±0.09) mmol/L; t=5.198, 0.525, P<0.001], and the coagulation time was higher in group B than that in group A [2 hours: (172.56±14.78) vs. (151.45±19.81) s; 4 hours: (168.45±16.48) vs. (152.88±16.54) s; t=7.396, 5.775, P<0.001]. None of the patients had dialysis-related adverse events.ConclusionFour percent sodium citrate is effective and safe in anticoagulation therapy for hemodialysis patients, and it can reduce the risk of coagulation in dialyzer and ensure the adequacy of maintenance hemodialysis.