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Current efforts towards safe and effective live attenuated vaccines against African swine fever: challenges and prospects. 目前研制安全有效的非洲猪瘟减毒活疫苗的努力:挑战与前景。
IF 8.1 1区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2021-12-24 DOI: 10.1186/s40249-021-00920-6
Tao Wang, Rui Luo, Yuan Sun, Hua-Ji Qiu

Background: African swine fever (ASF) is a fatal hemorrhagic disease in domestic pigs and wild boar caused by African swine fever virus (ASFV). Since ASF has been introduced into Europe and Asia, the major pig-raising areas, posing a huge threat to the pork industry worldwide. Currently, prevention and control of ASF are basically dependent on strict biosecurity measures and stamping-out policy once ASF occurs.

Main text: The major risks of ASF spread are insufficient biosecurity measures and human behaviors. Therefore, a safe and effective vaccine seems to be a reasonable demand for the prevention and control of ASF. Due to the efficacy advantage over other types of vaccines, live attenuated vaccines (LAVs), especially virulence-associated genes deleted vaccines, are likely to be put into emergency and conditional use in restricted areas if ASF is out of control in a country with a huge pig population and pork consumption, like China. However, the safety, efficacy, and genetic stability of current candidate ASF LAVs require comprehensive clinical evaluations prior to country-wide field application. Several critical issues need to be addressed to commercialize an ideal ASF LAV, including a stable cell line for manufacturing vaccines, differentiation of infected from vaccinated animals (DIVA), and cross-protection from different genotypes.

Conclusion: A safe and effective DIVA vaccine and an accompanying diagnostic assay will facilitate the prevention, control, and eradication of ASF, which is quite challenging in the near future.

背景:非洲猪瘟(African swine fever, ASF)是由非洲猪瘟病毒(African swine fever virus, ASFV)引起的家猪和野猪的一种致死性出血性疾病。由于非洲猪瘟已传入欧洲和亚洲这两个主要养猪区,对全球猪肉产业构成了巨大威胁。目前,非洲猪瘟的防控基本依赖于严格的生物安全措施和发生后的扑灭政策。非洲猪瘟传播的主要风险是生物安全措施不足和人的行为。因此,研制安全有效的疫苗似乎是防控非洲猪瘟的合理要求。由于与其他类型疫苗相比,减毒活疫苗(lav),特别是毒力相关基因缺失疫苗,有可能在非洲猪瘟在中国这样一个养猪和猪肉消费巨大的国家失去控制时,在限制地区紧急和有条件地使用。然而,目前候选ASF lav的安全性、有效性和遗传稳定性需要在全国范围内应用前进行全面的临床评估。要使理想的非洲猪瘟LAV商业化,需要解决几个关键问题,包括用于生产疫苗的稳定细胞系、感染动物与接种动物的区分(DIVA)以及不同基因型的交叉保护。结论:一种安全有效的DIVA疫苗和相应的诊断方法将有助于预防、控制和根除非洲猪瘟,这在不久的将来是一项相当具有挑战性的工作。
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引用次数: 16
Challenges in the control of COVID-19 outbreaks caused by the delta variant during periods of low humidity: an observational study in Sydney, Australia. 在低湿度期间控制由delta变异引起的COVID-19疫情的挑战:澳大利亚悉尼的一项观察研究
IF 8.1 1区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2021-12-23 DOI: 10.1186/s40249-021-00926-0
Michael P Ward, Yuanhua Liu, Shuang Xiao, Zhijie Zhang

Background: Since the appearance of severe acute respiratory coronavirus 2 (SARS-CoV-2) and the coronavirus disease 2019 (COVID-19) pandemic, a growing body of evidence has suggested that weather factors, particularly temperature and humidity, influence transmission. This relationship might differ for the recently emerged B.1.617.2 (delta) variant of SARS-CoV-2. Here we use data from an outbreak in Sydney, Australia that commenced in winter and time-series analysis to investigate the association between reported cases and temperature and relative humidity.

Methods: Between 16 June and 10 September 2021, the peak of the outbreak, there were 31,662 locally-acquired cases reported in five local health districts of Sydney, Australia. The associations between daily 9:00 am and 3:00 pm temperature (°C), relative humidity (%) and their difference, and a time series of reported daily cases were assessed using univariable and multivariable generalized additive models and a 14-day exponential moving average. Akaike information criterion (AIC) and the likelihood ratio statistic were used to compare different models and determine the best fitting model. A sensitivity analysis was performed by modifying the exponential moving average.

Results: During the 87-day time-series, relative humidity ranged widely (< 30-98%) and temperatures were mild (approximately 11-17 °C). The best-fitting (AIC: 1,119.64) generalized additive model included 14-day exponential moving averages of 9:00 am temperature (P < 0.001) and 9:00 am relative humidity (P < 0.001), and the interaction between these two weather variables (P < 0.001). Humidity was negatively associated with cases no matter whether temperature was high or low. The effect of lower relative humidity on increased cases was more pronounced below relative humidity of about 70%; below this threshold, not only were the effects of humidity pronounced but also the relationship between temperature and cases of the delta variant becomes apparent.

Conclusions: We suggest that the control of COVID-19 outbreaks, specifically those due to the delta variant, is particularly challenging during periods of the year with lower relative humidity and warmer temperatures. In addition to vaccination, stronger implementation of other interventions such as mask-wearing and social distancing might need to be considered during these higher risk periods.

背景:自出现严重急性呼吸道冠状病毒2 (SARS-CoV-2)和2019冠状病毒病(COVID-19)大流行以来,越来越多的证据表明,天气因素,特别是温度和湿度,会影响传播。对于最近出现的B.1.617.2 (delta)变体SARS-CoV-2,这种关系可能有所不同。在这里,我们使用来自澳大利亚悉尼冬季爆发的数据和时间序列分析来调查报告病例与温度和相对湿度之间的关系。方法:在疫情高峰期2021年6月16日至9月10日期间,澳大利亚悉尼市5个地方卫生区共报告本地获得性病例31662例。采用单变量和多变量广义加性模型以及14天指数移动平均线,评估了每日9:00 am和3:00 pm温度(°C)、相对湿度(%)及其差异与每日报告病例时间序列之间的关系。采用赤池信息准则(Akaike information criterion, AIC)和似然比统计量对不同模型进行比较,确定最佳拟合模型。通过修正指数移动平均进行敏感性分析。结果:在87天的时间序列中,相对湿度的变化幅度很大。结论:我们认为,在一年中相对湿度较低和温度较高的时期,控制COVID-19疫情,特别是由delta变异引起的疫情尤其具有挑战性。除了疫苗接种外,在这些高风险时期可能需要考虑加强实施其他干预措施,如戴口罩和保持社交距离。
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引用次数: 6
Safety and immunogenicity of inactivated SARS-CoV-2 vaccine in high-risk occupational population: a randomized, parallel, controlled clinical trial. 高危职业人群接种 SARS-CoV-2 灭活疫苗的安全性和免疫原性:随机、平行、对照临床试验。
IF 8.1 1区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2021-12-22 DOI: 10.1186/s40249-021-00924-2
Yongliang Feng, Jing Chen, Tian Yao, Yue Chang, Xiaoqing Li, Rongqin Xing, Hong Li, Ruixue Xie, Xiaohong Zhang, Zhiyun Wei, Shengcai Mu, Ling Liu, Lizhong Feng, Suping Wang

Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (COVID-19) have a substantial burden on health-care systems around the world. This is a randomized parallel controlled trial for assessment of the immunogenicity and safety of an inactivated SARS-CoV-2 vaccine, aiming to determine an appropriate vaccination interval of the vaccine for high-risk occupational population.

Methods: In an ongoing randomized, parallel, controlled phase IV trial between January and May 2021 in Taiyuan City, Shanxi Province, China, we randomly assigned the airport ground staff and public security officers aged 18 to 59 years to receive two doses of inactivated SARS-CoV-2 vaccine at 14 days, 21 days, or 28 days. The serum neutralizing antibody to live SARS-CoV-2 was performed at baseline and 28 days after immunization. Long-term data are being collected. The primary immunogenicity endpoints were neutralization antibody seroconversion and geometric mean titer (GMT) at 28 days after the second dose. Analysis of variance (ANOVA), chi-square, and logistic regression analysis were used for data analysis.

Results: A total of 809 participants underwent randomization and received two doses of injections: 270, 270, 269 in the 0-14, 0-21, and 0-28 vaccination group, respectively. By day 28 after the second injection, SARS-CoV-2 neutralizing antibody of GMT was 98.4 (95% CI: 88.4-108.4) in the 0-14 group, which was significantly lower compared with 134.4 (95% CI: 123.1-145.7) in the 0-21 group (P < 0.001 vs 0-14 group) and 145.5 (95% CI: 131.3-159.6) in the 0-28 group (P < 0.001 vs 0-14 group), resulting in the seroconversion rates to neutralizing antibodies (GMT ≥ 16) of 100.0% for all three groups, respectively. The intention-to-treat (ITT) analysis yielded similar results. All reported adverse reactions were mild.

Conclusions: Both a two-dose of inactivated SARS-CoV-2 vaccine at 0-21 days and 0-28 days regimens significantly improved SARS-CoV-2 neutralizing antibody level compared to the 0-14 days regimen in high-risk occupational population, with seroconversion rates of 100.0%.

Trial registration: Chinese Clinical Trial Registry, ChiCTR2100041705, ChiCTR2100041706. Registered 1 January 2021, www.chictr.org.cn .

背景:严重急性呼吸系统综合征冠状病毒 2(SARS-CoV-2)感染及其引发的冠状病毒病 2019(COVID-19)给世界各地的医疗保健系统造成了沉重负担。这是一项评估 SARS-CoV-2 灭活疫苗免疫原性和安全性的随机平行对照试验,旨在确定高危职业人群接种该疫苗的适当间隔时间:在 2021 年 1 月至 5 月期间正在山西省太原市进行的一项随机、平行、对照 IV 期试验中,我们随机分配了 18 至 59 岁的机场地勤人员和公安人员,分别在 14 天、21 天或 28 天接种两剂 SARS-CoV-2 灭活疫苗。在基线和免疫接种后 28 天进行了 SARS-CoV-2 活疫苗血清中和抗体检测。目前正在收集长期数据。主要免疫原性终点是中和抗体血清转换率和第二剂后 28 天的几何平均滴度 (GMT)。数据分析采用了方差分析(ANOVA)、卡方差分析和逻辑回归分析:共有 809 名参与者进行了随机分组,并接受了两剂注射:0-14、0-21 和 0-28 疫苗接种组分别有 270 人、270 人和 269 人。在第二次注射后的第 28 天,0-14 组 GMT 的 SARS-CoV-2 中和抗体为 98.4(95% CI:88.4-108.4),明显低于 0-21 组的 134.4(95% CI:123.1-145.7)(P 结论:0-14 组的 SARS-CoV-2 中和抗体为 98.4(95% CI:88.4-108.4),明显低于 0-21 组的 134.4(95% CI:123.1-145.7):与0-14天接种方案相比,0-21天和0-28天接种两剂SARS-CoV-2灭活疫苗可明显提高高危职业人群的SARS-CoV-2中和抗体水平,血清转换率为100.0%:试验注册:中国临床试验注册中心,ChiCTR2100041705、ChiCTR2100041706。注册日期:2021 年 1 月 1 日,www.chictr.org.cn 。
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引用次数: 0
Cost yield of different treatment strategies against Clonorchis sinensis infection. 不同治疗策略对抗华支睾吸虫感染的成本收益。
IF 8.1 1区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2021-12-22 DOI: 10.1186/s40249-021-00917-1
Men-Bao Qian, Chang-Hai Zhou, Hui-Hui Zhu, Ying-Dan Chen, Xiao-Nong Zhou
<p><strong>Background: </strong>Clonorchiasis is attributed to the ingestion of raw freshwater fish harboring Clonorchis sinensis. Morbidity control is targeted through the administration of antihelminthics. This study modelled the cost yield indicated by effectiveness and utility of different treatment strategies against clonorchiasis.</p><p><strong>Methods: </strong>About 1000 participants were enrolled from each of 14 counties selected from four provincial-level administrative divisions namely Guangxi, Guangdong, Heilongjiang and Jilin in 2017. Fecal examination was adopted to detect C. sinensis infection, while behavior of ingesting raw freshwater fish was enquired. Counties were grouped into four categories based on prevalence, namely low prevalence group (< 1%), moderate prevalence group (1-9.9%), high prevalence group (10-19.9%) and very high prevalence group (≥ 20%), while population were divided into three subgroups, namely children aged below 14 years old, adult female and adult male both aged over 14 years old. The average of cost effectiveness indicated by the cost to treat single infected cases with C. sinensis and of cost utility indicated by the cost to avoid per disability-adjusted life years (DALYs) caused by C. sinensis infection was calculated. Comparisons were performed between three treatment schedules, namely individual treatment, massive and selective chemotherapy, in which different endemic levels and populations were considered.</p><p><strong>Results: </strong>In selective chemotherapy strategy, the cost to treat single infected case in very high prevalence group was USD 10.6 in adult male, USD 11.6 in adult female, and USD 13.2 in children. The cost increased followed the decrease of endemic level. In massive chemotherapy strategy, the cost per infected case in very high prevalence group was USD 14.0 in adult male, USD 17.1 in adult female, USD 45.8 in children, which were also increased when the endemic level decreased. In individual treatment strategy, the cost was USD 12.2 in adult male, USD 15.0 in adult female and USD 41.5 in children in very high prevalence group; USD 19.2 in adult male, USD 34.0 in adult female, and USD 90.1 in children in high prevalence group; USD 30.4 in adult male, USD 50.5 in adult female and over USD 100 in children in moderate prevalence group; and over USD 400 in any population in low prevalence group. As to cost utility, the differences by treatment strategies, populations and endemic levels were similar to those in cost effectiveness.</p><p><strong>Conclusions: </strong>Both cost effectiveness and cost utility indicators are highly impacted by the prevalence and population, as well as the treatment schedules. Adults especially men in the areas with a prevalence over 10% should be prioritized, in which selective chemotherapy was best and massive chemotherapy was also cost effective. In moderate endemic areas, the yield is not ideal, but selective chemotherapy for adult male may also be ad
背景:华支睾吸虫病是由于摄入含有华支睾吸虫病的生淡水鱼引起的。发病率控制是通过使用抗寄生虫药来实现的。本研究模拟了不同治疗策略对华支睾吸虫病的有效性和效用所表明的成本收益。方法:2017年在广西、广东、黑龙江、吉林4个省级行政区的14个县中,每县约1000人入选。采用粪便检查检测中华梭菌感染,同时询问食生淡水鱼行为。结果:在选择性化疗方案中,非常高流行组单个感染病例的治疗费用为成年男性10.6美元,成年女性11.6美元,儿童13.2美元。随着流行程度的降低,成本也随之增加。在大剂量化疗方案中,高流行组成年男性每例感染的费用为14.0美元,成年女性为17.1美元,儿童为45.8美元,随着流行程度的降低而增加。在个体治疗策略中,非常高流行组成年男性的费用为12.2美元,成年女性为15.0美元,儿童为41.5美元;高流行组成年男性19.2美元,成年女性34.0美元,儿童90.1美元;中等流行组成年男性30.4美元,成年女性50.5美元,儿童100美元以上;在任何低患病率人群中均超过400美元。在成本效用方面,治疗策略、人群和流行程度之间的差异与成本效益方面的差异相似。结论:成本效益和成本效用指标均受患病率和人群以及治疗计划的高度影响。成人尤其是男性在患病率超过10%的地区应优先选择选择性化疗,大规模化疗也具有较好的成本效益。在中度流行地区,产量不理想,但也可采取选择性化疗对成年男性。在低流行地区,所有战略的成本都很高,需要制定新的战略。
{"title":"Cost yield of different treatment strategies against Clonorchis sinensis infection.","authors":"Men-Bao Qian,&nbsp;Chang-Hai Zhou,&nbsp;Hui-Hui Zhu,&nbsp;Ying-Dan Chen,&nbsp;Xiao-Nong Zhou","doi":"10.1186/s40249-021-00917-1","DOIUrl":"https://doi.org/10.1186/s40249-021-00917-1","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Clonorchiasis is attributed to the ingestion of raw freshwater fish harboring Clonorchis sinensis. Morbidity control is targeted through the administration of antihelminthics. This study modelled the cost yield indicated by effectiveness and utility of different treatment strategies against clonorchiasis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;About 1000 participants were enrolled from each of 14 counties selected from four provincial-level administrative divisions namely Guangxi, Guangdong, Heilongjiang and Jilin in 2017. Fecal examination was adopted to detect C. sinensis infection, while behavior of ingesting raw freshwater fish was enquired. Counties were grouped into four categories based on prevalence, namely low prevalence group (&lt; 1%), moderate prevalence group (1-9.9%), high prevalence group (10-19.9%) and very high prevalence group (≥ 20%), while population were divided into three subgroups, namely children aged below 14 years old, adult female and adult male both aged over 14 years old. The average of cost effectiveness indicated by the cost to treat single infected cases with C. sinensis and of cost utility indicated by the cost to avoid per disability-adjusted life years (DALYs) caused by C. sinensis infection was calculated. Comparisons were performed between three treatment schedules, namely individual treatment, massive and selective chemotherapy, in which different endemic levels and populations were considered.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;In selective chemotherapy strategy, the cost to treat single infected case in very high prevalence group was USD 10.6 in adult male, USD 11.6 in adult female, and USD 13.2 in children. The cost increased followed the decrease of endemic level. In massive chemotherapy strategy, the cost per infected case in very high prevalence group was USD 14.0 in adult male, USD 17.1 in adult female, USD 45.8 in children, which were also increased when the endemic level decreased. In individual treatment strategy, the cost was USD 12.2 in adult male, USD 15.0 in adult female and USD 41.5 in children in very high prevalence group; USD 19.2 in adult male, USD 34.0 in adult female, and USD 90.1 in children in high prevalence group; USD 30.4 in adult male, USD 50.5 in adult female and over USD 100 in children in moderate prevalence group; and over USD 400 in any population in low prevalence group. As to cost utility, the differences by treatment strategies, populations and endemic levels were similar to those in cost effectiveness.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Both cost effectiveness and cost utility indicators are highly impacted by the prevalence and population, as well as the treatment schedules. Adults especially men in the areas with a prevalence over 10% should be prioritized, in which selective chemotherapy was best and massive chemotherapy was also cost effective. In moderate endemic areas, the yield is not ideal, but selective chemotherapy for adult male may also be ad","PeriodicalId":13587,"journal":{"name":"Infectious Diseases of Poverty","volume":"10 1","pages":"136"},"PeriodicalIF":8.1,"publicationDate":"2021-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8693485/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39744626","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Bioefficacy and durability of Olyset® Plus, a permethrin and piperonyl butoxide-treated insecticidal net in a 3-year long trial in Kenya. 在肯尼亚进行的一项为期3年的试验中,氯菊酯和胡椒酰丁醇处理的杀虫蚊帐Olyset®Plus的生物功效和耐久性。
IF 8.1 1区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2021-12-20 DOI: 10.1186/s40249-021-00916-2
Paul M Gichuki, Luna Kamau, Kiambo Njagi, Solomon Karoki, Njoroge Muigai, Damaris Matoke-Muhia, Nabie Bayoh, Evan Mathenge, Rajpal S Yadav

Background: Long-lasting insecticide nets (LLINs) are a core malaria intervention. LLINs should retain efficacy against mosquito vectors for a minimum of three years. Efficacy and durability of Olyset® Plus, a permethrin and piperonyl butoxide (PBO) treated LLIN, was evaluated versus permethrin treated Olyset® Net. In the absence of WHO guidelines of how to evaluate PBO nets, and considering the manufacturer's product claim, Olyset® Plus was evaluated as a pyrethroid LLIN.

Methods: This was a household randomized controlled trial in a malaria endemic rice cultivation zone of Kirinyaga County, Kenya between 2014 and 2017. Cone bioassays and tunnel tests were done against Anopheles gambiae Kisumu. The chemical content, fabric integrity and LLIN survivorship were monitored. Comparisons between nets were tested for significance using the Chi-square test. Exact binomial distribution with 95% confidence intervals (95% CI) was used for percentages. The WHO efficacy criteria used were ≥ 95% knockdown and/or ≥ 80% mortality rate in cone bioassays and ≥ 80% mortality and/or ≥ 90% blood-feeding inhibition in tunnel tests.

Results: At 36 months, Olyset® Plus lost 52% permethrin and 87% PBO content; Olyset® Net lost 24% permethrin. Over 80% of Olyset® Plus and Olyset® Net passed the WHO efficacy criteria for LLINs up to 18 and 12 months, respectively. At month 36, 91.2% Olyset® Plus and 86.4% Olyset® Net survived, while 72% and 63% developed at least one hole. The proportionate Hole Index (pHI) values representing nets in good, serviceable and torn condition were 49.6%, 27.1% and 23.2%, respectively for Olyset® Plus, and 44.9%, 32.8% and 22.2%, respectively for Olyset® Net but were not significantly different.

Conclusions: Olyset® Plus retained efficacy above or close to the WHO efficacy criteria for about 2 years than Olyset® Net (1-1.5 years). Both nets did not meet the 3-year WHO efficacy criteria, and showed little attrition, comparable physical durability and survivorship, with 50% of Olyset® Plus having good and serviceable condition after 3 years. Better community education on appropriate use and upkeep of LLINs is essential to ensure effectiveness of LLIN based malaria interventions.

背景:长效杀虫剂蚊帐(LLINs)是一项核心的疟疾干预措施。杀虫剂对蚊虫媒介的效力应至少保持三年。对氯菊酯和胡椒酰丁醇(PBO)处理的LLIN与氯菊酯处理的Olyset®Net的有效性和持久性进行了评估。由于缺乏世卫组织关于如何评估PBO蚊帐的指导方针,并考虑到制造商的产品声明,Olyset®Plus被评估为拟除虫菊酯LLIN。方法:2014 - 2017年在肯尼亚Kirinyaga县疟疾流行水稻种植区进行家庭随机对照试验。对基苏木冈比亚按蚊进行了锥生物测定和隧道试验。监测化学成分、织物完整性和LLIN存活率。使用卡方检验检验网间比较的显著性。百分比采用精确二项分布,95%置信区间(95% CI)。使用的WHO疗效标准是锥体生物测定中敲除率≥95%和/或死亡率≥80%,隧道试验中死亡率≥80%和/或血供抑制率≥90%。结果:在36个月时,Olyset®Plus减少了52%的氯菊酯和87%的PBO含量;Olyset®Net减少了24%的氯菊酯。超过80%的Olyset®Plus和Olyset®Net分别通过了WHO针对LLINs长达18个月和12个月的疗效标准。在第36个月,91.2%的Olyset®Plus和86.4%的Olyset®Net成活率,72%和63%的Olyset®Net至少钻了一个井眼。Olyset®Plus的比例孔指数(pHI)值分别为49.6%、27.1%和23.2%,Olyset®Net的比例孔指数(pHI)值分别为44.9%、32.8%和22.2%。结论:Olyset®Plus比Olyset®Net(1-1.5年)保持高于或接近WHO疗效标准约2年。这两种蚊帐都没有达到WHO的3年疗效标准,磨损很小,具有相当的物理耐久性和生存率,50%的Olyset®Plus在3年后具有良好和可使用的状态。更好地开展关于适当使用和维护LLIN的社区教育,对于确保基于LLIN的疟疾干预措施的有效性至关重要。
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引用次数: 8
The economic impact of schistosomiasis. 血吸虫病对经济的影响。
IF 4.8 1区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2021-12-13 DOI: 10.1186/s40249-021-00919-z
Daniele Rinaldo, Javier Perez-Saez, Penelope Vounatsou, Jürg Utzinger, Jean-Louis Arcand

Background: The economic impact of schistosomiasis and the underlying tradeoffs between water resources development and public health concerns have yet to be quantified. Schistosomiasis exerts large health, social and financial burdens on infected individuals and households. While irrigation schemes are one of the most important policy responses designed to reduce poverty, particularly in sub-Saharan Africa, they facilitate the propagation of schistosomiasis and other diseases.

Methods: We estimate the economic impact of schistosomiasis in Burkina Faso via its effect on agricultural production. We create an original dataset that combines detailed household and agricultural surveys with high-resolution geo-statistical disease maps. We develop new methods that use the densities of the intermediate host snails of schistosomiasis as instrumental variables together with panel, spatial and machine learning techniques.

Results: We estimate that the elimination of schistosomiasis in Burkina Faso would increase average crop yields by around 7%, rising to 32% for high infection clusters. Keeping schistosomiasis unchecked, in turn, would correspond to a loss of gross domestic product of approximately 0.8%. We identify the disease burden as a shock to the agricultural productivity of farmers. The poorest households engaged in subsistence agriculture bear a far heavier disease burden than their wealthier counterparts, experiencing an average yield loss due to schistosomiasis of between 32 and 45%. We show that the returns to water resources development are substantially reduced once its health effects are taken into account: villages in proximity of large-scale dams suffer an average yield loss of around 20%, and this burden decreases as distance between dams and villages increases.

Conclusions: This study provides a rigorous estimation of how schistosomiasis affects agricultural production and how it is both a driver and a consequence of poverty. It further quantifies the tradeoff between the economics of water infrastructures and their impact on public health. Although we focus on Burkina Faso, our approach can be applied to any country in which schistosomiasis is endemic.

背景:血吸虫病的经济影响以及水资源开发与公共卫生问题之间的基本权衡尚未量化。血吸虫病对受感染的个人和家庭造成了巨大的健康、社会和经济负担。虽然灌溉计划是旨在减少贫困(尤其是在撒哈拉以南非洲地区)的最重要的政策应对措施之一,但它们却助长了血吸虫病和其他疾病的传播:我们通过血吸虫病对农业生产的影响来估算血吸虫病对布基纳法索经济的影响。我们创建了一个原始数据集,将详细的家庭和农业调查与高分辨率的疾病地理统计图相结合。我们利用血吸虫病中间宿主钉螺的密度作为工具变量,并结合面板、空间和机器学习技术,开发了新的方法:我们估计,在布基纳法索消除血吸虫病将使农作物平均增产约 7%,在高感染群组将增加 32%。反过来,如果血吸虫病得不到控制,国内生产总值将损失约 0.8%。我们将疾病负担视为对农民农业生产率的冲击。从事自给农业的最贫困家庭所承受的疾病负担远远重于富裕家庭,血吸虫病造成的平均产量损失在 32% 到 45% 之间。我们的研究表明,一旦考虑到对健康的影响,水资源开发的收益就会大幅减少:大型水坝附近的村庄平均减产约 20%,随着水坝与村庄之间距离的增加,这种负担也会减少:本研究对血吸虫病如何影响农业生产以及血吸虫病如何既是贫困的驱动因素又是贫困的后果进行了严格的估算。它进一步量化了水利基础设施的经济性与其对公众健康的影响之间的权衡。尽管我们以布基纳法索为研究对象,但我们的方法可适用于血吸虫病流行的任何国家。
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引用次数: 0
Infection with severe fever with thrombocytopenia virus in healthy population: a cohort study in a high endemic region, China. 健康人群感染发热伴血小板减少病毒:中国高发地区的队列研究
IF 8.1 1区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2021-11-16 DOI: 10.1186/s40249-021-00918-0
Xiao-Lei Ye, Ke Dai, Qing-Bin Lu, Yan-Qin Huang, Shou-Ming Lv, Pan-He Zhang, Jia-Chen Li, Hai-Yang Zhang, Zhen-Dong Yang, Ning Cui, Chun Yuan, Kun Liu, Xiao-Ai Zhang, Jiu-Song Zhang, Hao Li, Yang Yang, Li-Qun Fang, Wei Liu

Background: Severe fever with thrombocytopenia (SFTS) caused by SFTS virus (SFTSV) was a tick-borne hemorrhagic fever that posed significant threat to human health in Eastern Asia. The study was designed to measure the seroprevalence of SFTSV antibody in healthy population residing in a high endemic region.

Methods: A cohort study was performed on healthy residents in Shangcheng County in Xinyang City from April to December in 2018, where the highest SFTS incidence in China was reported. Anti-SFTSV IgG was measured by indirect enzyme-linked immunosorbent assay and neutralizing antibody (NAb) was detected by using PRNT50. The logistic regression models were performed to analyze the variables that were associated with seropositive rates.

Results: Totally 886 individuals were recruited. The baseline seroprevalence that was tested before the epidemic season was 11.9% (70/587) for IgG and 6.8% (40/587) for NAb, which was increased to 13.4% (47/350) and 7.7% (27/350) during the epidemic season, and further to 15.8% (80/508) and 9.8% (50/508) post epidemic. The IgG antibody-based seropositivity was significantly related to the patients aged ≥ 70 years old [adjusted odds ratio (OR) = 2.440, 95% confidence interval (CI): 1.334-4.461 compared to the group of < 50 years old, P = 0.004], recent contact with cats (adjusted OR = 2.195, 95% CI: 1.261-3.818, P = 0.005), and working in tea garden (adjusted OR = 1.698, 95% CI: 1.002-2.880, P = 0.049) by applying multivariate logistic regression model. The NAb based seropositivity was similarly related to the patients aged ≥ 70 years old (adjusted OR = 2.691, 95% CI: 1.271-5.695 compared to the group of < 50 years old, P = 0.010), and recent contact with cats (OR = 2.648, 95% CI: 1.419-4.941, P = 0.002). For a cohort of individuals continually sampled with 1-year apart, the anti-SFTSV IgG were maintained at a stable level, while the NAb level reduced.

Conclusions: Subclinical infection might not provide adequate immunity to protect reinfection of SFTSV, thus highlighting the ongoing threats of SFTS in endemic regions, which called for an imperative need for vaccine development. Identification of risk factors might help to target high-risk population for public health education and vaccination in the future.

背景:由发热伴血小板减少症病毒(SFTSV)引起的发热伴血小板减少症(SFTS)是东亚地区一种严重威胁人类健康的蜱传出血热。本研究旨在测定居住在高流行地区的健康人群中SFTSV抗体的血清阳性率。方法:对2018年4 - 12月全国SFTS发病率最高的信阳市上城县健康居民进行队列研究。采用间接酶联免疫吸附法检测抗sftsv IgG,采用PRNT50法检测中和抗体NAb。采用logistic回归模型分析与血清阳性率相关的变量。结果:共招募886人。流行季前IgG和NAb的基线血清阳性率分别为11.9%(70/587)和6.8%(40/587),流行季期间分别上升至13.4%(47/350)和7.7%(27/350),流行后分别上升至15.8%(80/508)和9.8%(50/508)。与年龄≥70岁组相比,IgG抗体血清阳性与年龄≥70岁组显著相关[校正优势比(OR) = 2.440, 95%可信区间(CI): 1.334-4.461]结论:亚临床感染可能无法提供足够的免疫来保护SFTSV的再感染,因此突出了SFTS在流行地区的持续威胁,迫切需要开发疫苗。确定风险因素可能有助于在未来针对高危人群进行公共卫生教育和疫苗接种。
{"title":"Infection with severe fever with thrombocytopenia virus in healthy population: a cohort study in a high endemic region, China.","authors":"Xiao-Lei Ye,&nbsp;Ke Dai,&nbsp;Qing-Bin Lu,&nbsp;Yan-Qin Huang,&nbsp;Shou-Ming Lv,&nbsp;Pan-He Zhang,&nbsp;Jia-Chen Li,&nbsp;Hai-Yang Zhang,&nbsp;Zhen-Dong Yang,&nbsp;Ning Cui,&nbsp;Chun Yuan,&nbsp;Kun Liu,&nbsp;Xiao-Ai Zhang,&nbsp;Jiu-Song Zhang,&nbsp;Hao Li,&nbsp;Yang Yang,&nbsp;Li-Qun Fang,&nbsp;Wei Liu","doi":"10.1186/s40249-021-00918-0","DOIUrl":"https://doi.org/10.1186/s40249-021-00918-0","url":null,"abstract":"<p><strong>Background: </strong>Severe fever with thrombocytopenia (SFTS) caused by SFTS virus (SFTSV) was a tick-borne hemorrhagic fever that posed significant threat to human health in Eastern Asia. The study was designed to measure the seroprevalence of SFTSV antibody in healthy population residing in a high endemic region.</p><p><strong>Methods: </strong>A cohort study was performed on healthy residents in Shangcheng County in Xinyang City from April to December in 2018, where the highest SFTS incidence in China was reported. Anti-SFTSV IgG was measured by indirect enzyme-linked immunosorbent assay and neutralizing antibody (NAb) was detected by using PRNT50. The logistic regression models were performed to analyze the variables that were associated with seropositive rates.</p><p><strong>Results: </strong>Totally 886 individuals were recruited. The baseline seroprevalence that was tested before the epidemic season was 11.9% (70/587) for IgG and 6.8% (40/587) for NAb, which was increased to 13.4% (47/350) and 7.7% (27/350) during the epidemic season, and further to 15.8% (80/508) and 9.8% (50/508) post epidemic. The IgG antibody-based seropositivity was significantly related to the patients aged ≥ 70 years old [adjusted odds ratio (OR) = 2.440, 95% confidence interval (CI): 1.334-4.461 compared to the group of < 50 years old, P = 0.004], recent contact with cats (adjusted OR = 2.195, 95% CI: 1.261-3.818, P = 0.005), and working in tea garden (adjusted OR = 1.698, 95% CI: 1.002-2.880, P = 0.049) by applying multivariate logistic regression model. The NAb based seropositivity was similarly related to the patients aged ≥ 70 years old (adjusted OR = 2.691, 95% CI: 1.271-5.695 compared to the group of < 50 years old, P = 0.010), and recent contact with cats (OR = 2.648, 95% CI: 1.419-4.941, P = 0.002). For a cohort of individuals continually sampled with 1-year apart, the anti-SFTSV IgG were maintained at a stable level, while the NAb level reduced.</p><p><strong>Conclusions: </strong>Subclinical infection might not provide adequate immunity to protect reinfection of SFTSV, thus highlighting the ongoing threats of SFTS in endemic regions, which called for an imperative need for vaccine development. Identification of risk factors might help to target high-risk population for public health education and vaccination in the future.</p>","PeriodicalId":13587,"journal":{"name":"Infectious Diseases of Poverty","volume":"10 1","pages":"133"},"PeriodicalIF":8.1,"publicationDate":"2021-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8600349/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39636297","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 3
Effectiveness and safety of SARS-CoV-2 vaccine in real-world studies: a systematic review and meta-analysis. 严重急性呼吸系统综合征冠状病毒2型疫苗在现实世界研究中的有效性和安全性:系统综述和荟萃分析。
IF 4.8 1区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2021-11-14 DOI: 10.1186/s40249-021-00915-3
Qiao Liu, Chenyuan Qin, Min Liu, Jue Liu

Background: To date, coronavirus disease 2019 (COVID-19) becomes increasingly fierce due to the emergence of variants. Rapid herd immunity through vaccination is needed to block the mutation and prevent the emergence of variants that can completely escape the immune surveillance. We aimed to systematically evaluate the effectiveness and safety of COVID-19 vaccines in the real world and to establish a reliable evidence-based basis for the actual protective effect of the COVID-19 vaccines, especially in the ensuing waves of infections dominated by variants.

Methods: We searched PubMed, Embase and Web of Science from inception to July 22, 2021. Observational studies that examined the effectiveness and safety of SARS-CoV-2 vaccines among people vaccinated were included. Random-effects or fixed-effects models were used to estimate the pooled vaccine effectiveness (VE) and incidence rate of adverse events after vaccination, and their 95% confidence intervals (CI).

Results: A total of 58 studies (32 studies for vaccine effectiveness and 26 studies for vaccine safety) were included. A single dose of vaccines was 41% (95% CI: 28-54%) effective at preventing SARS-CoV-2 infections, 52% (31-73%) for symptomatic COVID-19, 66% (50-81%) for hospitalization, 45% (42-49%) for Intensive Care Unit (ICU) admissions, and 53% (15-91%) for COVID-19-related death; and two doses were 85% (81-89%) effective at preventing SARS-CoV-2 infections, 97% (97-98%) for symptomatic COVID-19, 93% (89-96%) for hospitalization, 96% (93-98%) for ICU admissions, and 95% (92-98%) effective for COVID-19-related death, respectively. The pooled VE was 85% (80-91%) for the prevention of Alpha variant of SARS-CoV-2 infections, 75% (71-79%) for the Beta variant, 54% (35-74%) for the Gamma variant, and 74% (62-85%) for the Delta variant. The overall pooled incidence rate was 1.5% (1.4-1.6%) for adverse events, 0.4 (0.2-0.5) per 10 000 for severe adverse events, and 0.1 (0.1-0.2) per 10 000 for death after vaccination.

Conclusions: SARS-CoV-2 vaccines have reassuring safety and could effectively reduce the death, severe cases, symptomatic cases, and infections resulting from SARS-CoV-2 across the world. In the context of global pandemic and the continuous emergence of SARS-CoV-2 variants, accelerating vaccination and improving vaccination coverage is still the most important and urgent matter, and it is also the final means to end the pandemic.

背景:迄今为止,2019冠状病毒病(新冠肺炎)由于变异的出现而变得越来越激烈。需要通过接种疫苗实现快速群体免疫,以阻断突变,防止出现完全逃避免疫监测的变种。我们旨在系统评估新冠肺炎疫苗在现实世界中的有效性和安全性,并为新冠肺炎疫苗的实际保护效果建立可靠的循证基础,特别是在随后以变种为主的感染浪潮中。方法:从成立到2021年7月22日,我们搜索了PubMed、Embase和Web of Science。包括在接种者中检查严重急性呼吸系统综合征冠状病毒2型疫苗有效性和安全性的观察性研究。结果:共纳入58项研究(32项疫苗有效性研究和26项疫苗安全性研究)。单剂疫苗预防SARS-CoV-2感染的有效率为41%(95%CI:28-54%),有症状的新冠肺炎为52%(31-73%),住院为66%(50-81%),重症监护室(ICU)为45%(42-49%),新冠肺炎相关死亡为53%(15-91%);两剂预防严重急性呼吸系统综合征冠状病毒2型感染的有效率分别为85%(81-89%)、97%(97-98%)、93%(89-96%)、96%(93-98%)和95%(92-98%)。预防严重急性呼吸系统综合征冠状病毒2型阿尔法变种感染的总VE为85%(80-91%),贝塔变种为75%(71-79%),伽马变种为54%(35-74%),德尔塔变种为74%(62-85%)。不良事件的总合并发病率为1.5%(1.4-1.6%),严重不良事件为0.4(0.2-0.5)/10万,接种疫苗后死亡为0.1(0.1-0.2)/10万。结论:严重急性呼吸系统综合征冠状病毒2型疫苗具有令人放心的安全性,可以有效减少世界各地严重急性呼吸系综合征病毒2型导致的死亡、重症、有症状病例和感染。在全球大流行和严重急性呼吸系统综合征冠状病毒2型变异株不断出现的背景下,加快疫苗接种和提高疫苗接种覆盖率仍然是最重要和最紧迫的事情,也是结束大流行的最终手段。
{"title":"Effectiveness and safety of SARS-CoV-2 vaccine in real-world studies: a systematic review and meta-analysis.","authors":"Qiao Liu, Chenyuan Qin, Min Liu, Jue Liu","doi":"10.1186/s40249-021-00915-3","DOIUrl":"10.1186/s40249-021-00915-3","url":null,"abstract":"<p><strong>Background: </strong>To date, coronavirus disease 2019 (COVID-19) becomes increasingly fierce due to the emergence of variants. Rapid herd immunity through vaccination is needed to block the mutation and prevent the emergence of variants that can completely escape the immune surveillance. We aimed to systematically evaluate the effectiveness and safety of COVID-19 vaccines in the real world and to establish a reliable evidence-based basis for the actual protective effect of the COVID-19 vaccines, especially in the ensuing waves of infections dominated by variants.</p><p><strong>Methods: </strong>We searched PubMed, Embase and Web of Science from inception to July 22, 2021. Observational studies that examined the effectiveness and safety of SARS-CoV-2 vaccines among people vaccinated were included. Random-effects or fixed-effects models were used to estimate the pooled vaccine effectiveness (VE) and incidence rate of adverse events after vaccination, and their 95% confidence intervals (CI).</p><p><strong>Results: </strong>A total of 58 studies (32 studies for vaccine effectiveness and 26 studies for vaccine safety) were included. A single dose of vaccines was 41% (95% CI: 28-54%) effective at preventing SARS-CoV-2 infections, 52% (31-73%) for symptomatic COVID-19, 66% (50-81%) for hospitalization, 45% (42-49%) for Intensive Care Unit (ICU) admissions, and 53% (15-91%) for COVID-19-related death; and two doses were 85% (81-89%) effective at preventing SARS-CoV-2 infections, 97% (97-98%) for symptomatic COVID-19, 93% (89-96%) for hospitalization, 96% (93-98%) for ICU admissions, and 95% (92-98%) effective for COVID-19-related death, respectively. The pooled VE was 85% (80-91%) for the prevention of Alpha variant of SARS-CoV-2 infections, 75% (71-79%) for the Beta variant, 54% (35-74%) for the Gamma variant, and 74% (62-85%) for the Delta variant. The overall pooled incidence rate was 1.5% (1.4-1.6%) for adverse events, 0.4 (0.2-0.5) per 10 000 for severe adverse events, and 0.1 (0.1-0.2) per 10 000 for death after vaccination.</p><p><strong>Conclusions: </strong>SARS-CoV-2 vaccines have reassuring safety and could effectively reduce the death, severe cases, symptomatic cases, and infections resulting from SARS-CoV-2 across the world. In the context of global pandemic and the continuous emergence of SARS-CoV-2 variants, accelerating vaccination and improving vaccination coverage is still the most important and urgent matter, and it is also the final means to end the pandemic.</p>","PeriodicalId":13587,"journal":{"name":"Infectious Diseases of Poverty","volume":"10 1","pages":"132"},"PeriodicalIF":4.8,"publicationDate":"2021-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8590867/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39622664","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The pathology, phylogeny, and epidemiology of Echinococcus ortleppi (G5 genotype): a new case report of echinococcosis in China. 棘球绦虫(G5基因型)的病理、系统发育和流行病学:中国棘球绦虫病新病例报告。
IF 8.1 1区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2021-11-06 DOI: 10.1186/s40249-021-00907-3
Xu Wang, Aiya Zhu, Hongying Cai, Baixue Liu, Gang Xie, Rui Jiang, Ji Zhang, Nanzi Xie, Yayi Guan, Robert Bergquist, Zhenghuan Wang, Yang Li, Weiping Wu

Background: Cystic echinococcosis (CE), caused by the larval stage of the complex Echinococcus granulosus sensu lato (s.l.), is a zoonotic parasitic disease with a high social burden in China. E. ortleppi is a species (formerly genotype 5 of E. granulosus s.l.) with unique epidemic areas (tropical areas), transmission patterns (mainly cattle origin), and pathological characteristics (large and small hook lengths) compared to other species that cause CE. A 19-year-old female patient in an area with no history of echinococcosis in Guizhou Province, China, was diagnosed with E. ortleppi infection in 2019. This study is to understand the source of this human E. ortleppi infection.

Methods: We performed computer tomography (CT) scans, surgical operation, morphological sectioning, molecular diagnosis, phylogenetic analyses, and epidemiological investigation in Anshun City, Guizhou Province, China in 2019.

Results: The patient presented with intermittent distension and pain in the upper abdomen without other abnormal symptoms. Routine blood examination results were normal. However, abdominal CT revealed a fertile cyst with a diameter of approximately 8 cm, uniform density, and a clear boundary, but without an evident cyst wall in the right lobe of the liver. The cyst was fertile, and phylogenetic analyses revealed that the isolates represented a new E. ortleppi genus haplotype. A result of 10‒14 years incubation period with indigenous infection was considered available for the case through the epidemiological survey.

Conclusions: CE due to E. ortleppi infection can be confused with other diseases causing liver cysts, resulting in misdiagnosis. A transmission chain of E. ortleppi may exist or existed in the past in the previously considered non-endemic areas of echinococcosis in southwestern China.

背景:囊性棘球蚴病(CE)是一种由复杂的细粒棘球蚴(Echinococcus granulosus sensu lato, s.l.)幼虫期引起的人畜共患寄生虫病,在中国具有很高的社会负担。与引起CE的其他物种相比,北棘棘球绦虫是一种具有独特流行区域(热带地区)、传播模式(主要来自牛)和病理特征(大钩长度和小钩长度)的物种(原棘球绦虫5基因型)。2019年,贵州省某地区无棘球蚴病史的19岁女患者被诊断为奥特皮埃希菌感染。本研究旨在了解这种人类奥特皮埃希菌感染的来源。方法:对2019年贵州省安顺市患者进行计算机断层扫描、外科手术、形态切片、分子诊断、系统发育分析和流行病学调查。结果:患者表现为间歇性上腹部胀痛,无其他异常症状。血常规检查正常。腹部CT示一肥沃囊肿,直径约8cm,密度均匀,边界清晰,肝右叶未见明显囊肿壁。该囊是可育的,系统发育分析表明,分离物代表了一个新的奥特皮鼠属单倍型。通过流行病学调查,认为该病例的本土感染潜伏期为10-14年。结论:奥氏肠杆菌感染引起的肝囊肿易与其他引起肝囊肿的疾病混淆,导致误诊。中国西南地区棘球蚴病非流行区可能存在或曾经存在过棘球蚴病传播链。
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引用次数: 3
Efficacy of integrating short-course chemotherapy with Chinese herbs to treat multi-drug resistant pulmonary tuberculosis in China: a study protocol. 中国短期化疗结合中药治疗多重耐药肺结核的疗效研究方案。
IF 8.1 1区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2021-11-06 DOI: 10.1186/s40249-021-00913-5
Shun-Xian Zhang, Lei Qiu, Cui Li, Wei Zhou, Li-Ming Tian, Hui-Yong Zhang, Zi-Feng Ma, Xian-Wei Wu, Xing Huang, Yu-Wei Jiang, Shao-Yan Zhang, Zhen-Hui Lu

Background: Tuberculosis (TB) caused Mycobacterium tuberculosis (M.tb) is one of infectious disease that lead a large number of morbidity and mortality all over the world. Although no reliable evidence has been found, it is considered that combining chemotherapeutic drugs with Chinese herbs can significantly improves the cure rate and the clinical therapeutic effect.

Methods: Multi-drug resistant pulmonary tuberculosis (MDR-PTB, n = 258) patients with Qi-yin deficiency syndrome will be randomly assigned into a treatment group (n = 172) or control/placebo group (n = 86). The treatment group will receive the chemotherapeutic drugs combined with Chinese herbs granules (1 + 3 granules), while the control group will receive the chemotherapeutic drugs combined with Chinese herbs placebo (1 + 3 placebo granules). In addition, MDR-PTB (n = 312) patients with Yin deficiency lung heat syndrome will be randomly assigned to a treatment (n = 208) or control/placebo (n = 104) group. The treatment group will receive the chemotherapeutic regimen combined with Chinese herbs granules (2 + 4 granules), while the control group will receive the chemotherapeutic drugs and Chinese herbs placebo (2 + 4 placebo granules). The primary outcome is cure rate, the secondary outcomes included time to sputum culture conversion, lesion absorption rate and cavity closure rate. BACTEC™ MGIT™ automated mycobacterial detection system will be used to evaluate the M.tb infection and drug resistance. Chi-square test and Cox regression will be conducted with SAS 9.4 Statistical software to analyze the data.

Discussion: The treatment cycle for MDR-PTB using standardized modern medicine could cause lengthy substantial side effects. Chinese herbs have been used for many years to treat MDR-PTB, but are without high-quality evidence. Hence, it is unknown whether Chinese herbs enhances the clinical therapeutic effect of synthetic drugs for treating MDR-PTB. Therefore, this study will be conducted to evaluate the clinical therapeutic effect of combining Chinese herbs and chemotherapeutic drugs to treat MDR-PTB cases. It will assist in screening new therapeutic drugs and establishing treatment plan that aims to improve the clinical therapeutic effect for MDR-PTB patients.

Trial registration: This trial was registered at ClinicalTrials.gov (ChiCTR1900027720) on 24 November 2019 (prospective registered).

背景:结核分枝杆菌(Mycobacterium Tuberculosis, M.tb)是世界范围内发病率和死亡率较高的传染病之一。虽然尚未找到可靠的证据,但认为化疗药物与中药联合治疗可显著提高治愈率和临床治疗效果。方法:将多药耐药肺结核(MDR-PTB, n = 258)气阴虚证患者随机分为治疗组(n = 172)和对照组/安慰剂组(n = 86)。治疗组给予化疗药物联合中药颗粒(1 + 3颗粒),对照组给予化疗药物联合中药安慰剂(1 + 3安慰剂颗粒)。此外,耐多药肺结核阴虚肺热证患者(n = 312)将被随机分配到治疗组(n = 208)或对照组/安慰剂组(n = 104)。治疗组采用化疗药物联合中药颗粒(2 + 4颗粒)方案,对照组采用化疗药物联合中药安慰剂(2 + 4安慰剂颗粒)方案。主要观察指标为治愈率,次要观察指标为痰培养转化时间、病灶吸收率及腔体闭合率。BACTEC™MGIT™分枝杆菌自动检测系统将用于评估M.tb感染和耐药性。采用SAS 9.4统计软件进行卡方检验和Cox回归分析。讨论:使用标准化现代医学的耐多药肺结核的治疗周期可能会导致漫长的实质性副作用。中草药用于治疗耐多药肺结核已有多年,但缺乏高质量的证据。因此,中药是否能提高合成药物治疗耐多药肺结核的临床疗效尚不清楚。因此,本研究将对中药联合化疗药物治疗耐多药肺结核的临床疗效进行评价。它将有助于筛选新的治疗药物和制定治疗计划,旨在提高耐多药肺结核患者的临床治疗效果。试验注册:该试验于2019年11月24日在ClinicalTrials.gov (ChiCTR1900027720)注册(前瞻性注册)。
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引用次数: 3
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Infectious Diseases of Poverty
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