Gansu in northwestern China has maintained leprosy elimination at the national and county level, yet localized transmission persists in certain endemic foci. This 70-year analysis (1950-2020) assessed the impact of key control strategies using an interrupted time-series analysis of new case detection rate (NCDR) with break points at the 1958 "survey-isolate-treat" strategy and the 1987 multidrug therapy (MDT) rollout. Among 4,872 registered cases, NCDR rose initially and then declined steadily to 0.027/100,000 by 2020. Significant geographic clustering was observed in southeastern counties (Moran's I = 0.403, P < 0.05). Most cases were male farmers (male-to-female ratio 2.37:1), and Han ethnicity accounted for 75.9% of all cases. The proportion of multibacillary cases increased significantly from 78.0% before 1987 to 84.9% after MDT implementation. Time-series analysis indicated that the 1958 strategy was associated with a sustained decline in detection rates during the high-endemic phase, whereas MDT introduction in 1987 led to an immediate level reduction during the low-endemic phase. These results underscore the complementary role of historical integrated control measures and modern chemotherapy in sustaining leprosy elimination. However, transmission persists, and the rising proportion of multibacillary cases highlights the ongoing need for targeted active surveillance, contact screening, and strengthened early detection to achieve WHO 2030 eradication targets.

BACKGROUNDPrevious studies have suggested that a single dose of rifampin has protective effects against leprosy in close contacts of patients with the disease. Rifapentine was shown to have greater bactericidal activity against Mycobacterium leprae than rifampin in murine models of leprosy, but data regarding its effectiveness in preventing leprosy are lacking.METHODSWe conducted a cluster-randomized, controlled trial to investigate whether single-dose rifapentine is effective in preventing leprosy in household contacts of patients with leprosy. The clusters (counties or districts in Southwest China) were assigned to one of three trial groups: single-dose rifapentine, single-dose rifampin, or control (no intervention). The primary outcome was the 4-year cumulative incidence of leprosy among household contacts.RESULTSA total of 207 clusters comprising 7450 household contacts underwent randomization; 68 clusters (2331 household contacts) were assigned to the rifapentine group, 71 (2760) to the rifampin group, and 68 (2359) to the control group. A total of 24 new cases of leprosy occurred over the 4-year follow-up, for a cumulative incidence of 0.09% (95% confidence interval [CI], 0.02 to 0.34) with rifapentine (2 cases), 0.33% (95% CI, 0.17 to 0.63) with rifampin (9 cases), and 0.55% (95% CI, 0.32 to 0.95) with no intervention (13 cases). In an intention-to-treat analysis, the cumulative incidence in the rifapentine group was 84% lower than that in the control group (cumulative incidence ratio, 0.16; multiplicity-adjusted 95% CI, 0.03 to 0.87; P = 0.02); the cumulative incidence did not differ significantly between the rifampin group and the control group (cumulative incidence ratio, 0.59; multiplicity-adjusted 95% CI, 0.22 to 1.57; P = 0.23). In a per-protocol analysis, the cumulative incidence was 0.05% with rifapentine, 0.19% with rifampin, and 0.63% with no intervention. No severe adverse events were observed.CONCLUSIONSThe incidence of leprosy among household contacts over 4 years was lower with single-dose rifapentine than with no intervention. (Funded by the Ministry of Health of China and the Chinese Academy of Medical Sciences; Chinese Clinical Trial Registry number, ChiCTR-IPR-15007075.).

李文忠教授,男, 1938年2 月出生,江苏镇江市人.1963年毕业于上海第一医学院医疗系后至上海市黄山茶林场职工医院任住院医师.1970年调至中国医学科学院皮肤病研究所工作,任住院医师、主治医师、副研究员、研究员.

Objective:To analyze epidemiological characteristics of leprosy in China from 2016 to 2020, and to provide a scientific basis for further elimination of leprosy.Methods:Data collation and statistical analysis were conducted on annual reports on leprosy epidemic surveillance in China (excluding Hong Kong, Macao, and Taiwan regions) from 2016 to 2020.Results:From 2016 to 2020, a total of 2 697 new cases of leprosy were reported in China, including 46 (1.71%) children, 894 (33.15%) females, 374 (13.87%) floating people, 2 443 (90.58%) multibacillary cases, and 546 (20.24%) cases of grade 2 disabilities. A total of 203 relapsed cases were reported in the meantime. By the end of 2020, there had been 1 893 registered leprosy cases in China, and the number of cases was 68.62% fewer than that in 2010 (6 032 cases) ; there were 36 (1.2%) counties or cities with a prevalence rate above 1 per 100 000, and 72 (17.73%) new cases suffered from grade 2 disabilities.Conclusion:From 2016 to 2020, the reported incidence and prevalence of leprosy in China steadily decreased year by year, and overall, leprosy was still lowly prevalent.

Background: Previous studies suggest protection of a single dose of rifampicin(SDR) from developing leprosy among close contacts. This study aimed to evaluate the effectiveness of a single dose of rifapentine(SDL) to prevent leprosy in household contacts (HHCs) of leprosy cases in areas of low epidemic leprosy in China.Methods: In this cluster-randomised controlled trial, we randomised and allocated 207 clusters (counties) into three arms, the eligible HHCs of patients diagnosed with leprosy since 2010 received SDL, SDR or no post-exposure prophylaxis (PEP) interventions, respectively. The primary outcome was the incidence density of leprosy by the end of 4 th year of annual follow-up. The preventive effect of the interventions was estimated by generalized estimating equations with possion distribution for family function and reported as incidence density ratio (IDR). Safety and economic evaluation of the interventions were done in parallel with the trial. Findings: Enrolled counties were randomly allocated to the rifapentine group (n=68, 2004 participants), the rifampicin group (n=71, 2609 participants), and the control group (n=68, 2837 participants). A total of 22 new leprosy cases occurred during the 4-year follow-up, 1 in the rifapentine group (incidence rate 0.14 per 1000 person-years), 4 in the rifampicin group (0.43 per 1000 person-years), and 17 in the control group (1.71 per 1000 person-years), respectively. The reduction of incidence density in the rifapentine and rifampicin groups was 92.6% (IDR 0.100, 95% CI 0.013 to 0.755, P=0.026), and 78.1% (IDR 0.265, 95% CI 0.089 to 0.794, P=0.018), respectively. No severe adverse event was observed in the three groups. In total, 12 incremental leprosy cases were prevented, resulting in an incremental cost-effectiveness ratio (ICER) of $175·7 in the rifapentine group and $20·3 in the rifampicin group per one additional prevented leprosy case.Interpretation: SDL or SDR is effective, safe, cost-efficient in preventing the development of leprosy in HHCs of leprosy patients under low endemic situations in China. Rifapentine could effectively reduce the incidence density of leprosy in HHCs, especially in HHCs of MB index cases, HHCs of new diagnosed index cases, and spouse of index cases.Trial Registration Details: This study was registered with www.chictr.org.cn. ChiCTR-IPR-15007075.Funding Information: This study was funded by the Ministry of Health of China (201502008) and CAMS Innovation Fund for Medical Science (2016-I2M-1-005, 2017-I2M-B&R-14).Declaration of Interests: We declare no competing interests.Ethics Approval Statement: The protocol and informed consent forms (2014-KY-003) were approved by the Research Ethics Board of the Hospital of Dermatology, the Chinese Academy of Medical Science, and the four other participating units. The written informed consent was required before enrolment.

ObjectivesUnderstanding the nature of Mycobacterium leprae transmission is vital to implement better control strategies for leprosy elimination. The present study expands the knowledge of county-level strain diversity, distribution, and transmission patterns of leprosy in endemic provinces of China.MethodsWe genetically characterized 290 clinical isolates of M. leprae from four endemic provinces using variable number tandem repeats (VNTR) and single nucleotide polymorphisms (SNPs). Attained genetic profiles and cluster consequences were contrasted with geographical and migration features of leprosy at county levels.ResultsConsidering the allelic variability of 17 VNTR loci by the discriminatory index, (GTA)9, (AT)17, (AT)15, (TA)18, (TTC)21, and (TA)10 are reported to be more highly polymorphic than other loci. The VNTR profile generated the low-density clustering pattern in the counties of Sichuan and Yunnan, whereas clusters have been observed from the isolates from Huayuan (N = 6), Yongding (N = 3), Zixing (N = 3), Chenxi (N = 2) and Zhongfang (N = 2) counties of Hunan, and Zhijin (N = 3), Anlong (N = 2), Zhenning (N = 2), and Xixiu (N = 2) counties of Guizhou. In some clusters, people's social relations have been observed between villages. From the 290 clinical isolates, the most predominantly reported SNP was 3K (278, 95.8%), followed by SNP 1D (10, 3.4%), which are typically observed to be predominant in China. We also detected the novel SNP 3J (2, 0.8%), which has not yet been reported in China.ConclusionThe clustering pattern of M. leprae indicates the transmission of leprosy still persists at county levels, suggesting that there is a need to implement better approaches for tracing the close contacts of leprosy patients.

Reports on antimicrobial resistance (AMR) of Mycobacterium leprae, relationship with bacteriological index (BI), and transmission in China are limited. We investigated the emergence of AMR mutations, the relationship between BI and AMR in complete, moderate and lack of BI decline cases, and molecular epidemiological features of AMR cases by enrolling 290 leprosy cases from four endemic provinces. Seven (2.41%), one (0.34%), five (1.72%), one (0.34%), and one (0.34%) strains had single mutations in folP1, rpoC, gyrA, gyrB, and 23S rRNA, respectively. Double mutations in folP1 and gyrA, rpoB and gyrA, and gyrA and 23S rRNA were observed in one (0.34%) strain each. Mutated strains occurred in three out of 81 (95% CI?0.005-0.079, p = 0.083) cases with complete BI decline, in seven out of 103 (95% CI 0.018-0.117, p = 0.008) cases with moderate BI decline, and in four out of 34 (95% CI 0.003-0.231, p = 0.044) cases with lack of BI decline. Most of these mutated strains were geographically separated and diverged genotypically. AMR mutations may not be the main cause of the lack of BI decline. The low transmission of AMR strains at the county level indicates an ongoing transmission at close contact levels.

Abstract. Objective:. To describe the epidemiological characteristics of leprosy in China and to provide evidence for making specific strategies in the leprosy control program. Methods:. We used a descriptive analysis method to analyze the leprosy data from 2017 provided by the Leprosy Management Information System in China (LEPMIS) covering all the provinces of China excluding Hong Kong, Macao, and Taiwan. Results:. In 2017, 634 newly detected cases of leprosy were reported, with a case detection rate of 0.046 per 100,000 individuals. The proportions of cases in children under 15, multibacillary cases, and cases with grade 2 disability were 1.4%, 91.8%, and 20.0%, respectively. A total of 52 relapse cases, among which 28 cases occurred after multidrug therapy, were reported. By the end of 2017, the total number of registered cases was 2,697, with a prevalence rate of 0.194 per 100,000 individuals. Conclusion:. In China, the overall leprosy prevalence is still at a low level, but its distribution is unbalanced, with higher incidence in Yunnan, Sichuan, Guizhou, and Guangdong. To continue making progress toward eliminating leprosy, control efforts must be sustained over the coming years.

目的:建立麻风生物样本库,为解决"消除麻风危害"的关键科学问题提供生物资源.方法:山东省建立项目实施小组,协同相关省市麻风防治工作人员核实完善所在区域麻风患者临床信息,采集患者血液、组织等样本,然后采用相关技术处理各类生物标本,完成入库的同时将临床信息录入生物样本库管理系统.结果:自2005年建库以来,共收集到来自全国19个省份、19个民族的81,532份不同类型样本,其中组织标本35,268份,血液标本33,320份,微生物标本(鼻黏膜拭子)12,944份;以上述样本为基础开展了麻风的系列研究并取得原创性成果.结论:建成了国际上最大的麻风生物资源库,以资源库为基础开展国内外合作并取得一系列原创成果,为完成我国"消除麻风危害中长期规划(2011-2020)",进而为实现世界卫生组织"创造一个没有麻风的世界"贡献中国智慧奠定了基础.

ImportanceDapsone hypersensitivity syndrome (DHS) is the most serious adverse reaction associated with dapsone administration and one of the major causes of death in patients with leprosy, whose standard treatment includes multidrug therapy (MDT) with dapsone, rifampicin, and clofazimine. Although the HLA-B*13:01 polymorphism has been identified as the genetic determinant of DHS in the Chinese population, no studies to date have been done to evaluate whether prospective HLA-B*13:01 screening could prevent DHS by identifying patients who should not receive dapsone. ObjectiveTo evaluate the clinical use of prospective HLA-B*13:01 screening for reduction of the incidence of DHS by excluding dapsone from the treatment for patients with HLA-B*13:01-positive leprosy. Design, Setting, and ParticipantsA prospective cohort study was conducted from February 15, 2015, to April 30, 2018, in 21 provinces throughout China. A total of 1539 patients with newly diagnosed leprosy were enrolled who had not received dapsone previously. After excluding patients who had a history of allergy to sulfones or glucose-6-phosphate dehydrogenase deficiency, 1512 individuals underwent HLA-B*13:01 genotyping. All of the patients were followed up weekly for the first 8 weeks after treatment to monitor for adverse events. ExposuresPatients who were HLA-B*13:01 carriers were instructed to eliminate dapsone from their treatment regimens, and noncarrier patients received standard MDT. Main Outcomes and MeasuresThe primary outcome was the incidence of DHS. The historical incidence rate of DHS (1.0%) was used as a control. ResultsAmong 1512 patients (1026 [67.9%] men, 486 [32.1%] women; mean [SD] age, 43.1 [16.2] years), 261 (17.3%) were identified as carriers of the HLA-B*13:01 allele. A total of 714 adverse events in 384 patients were observed during the follow-up period. Dapsone hypersensitivity syndrome did not develop in any of the 1251 patients who were HLA-B*13:01-negative who received dapsone, while approximately 13 patients would be expected to experience DHS, based on the historical incidence rate of 1.0% per year (P=2.05x10(-5)). No significant correlation was found between other adverse events, including dermatologic or other events, and HLA-B*13:01 status. Conclusions and RelevanceProspective HLA-B*13:01 screening and subsequent elimination of dapsone from MDT for patients with HLA-B*13:01-positive leprosy may significantly reduce the incidence of DHS in the Chinese population.

More than 100 counties, mainly in southwest China, report incidence rates of leprosy >1/100,000. The current study analysed the epidemiology of leprosy in southwest China to improve our understanding of the transmission pattern and improve control programs. 207 counties were selected in southwest China. Leprosy patients and their household contacts were recruited. The data from the medical interview and the serological antileprosy antibody of the leprosy patients were analysed. A total of 2,353 new cases of leprosy were interviewed. The distribution of leprosy patients was partly associated with local natural and economic conditions, especially several pocket areas. A total of 53 from 6643 household contacts developed leprosy, and the incidence rate of leprosy in the household contacts was 364/100,000 person-years. We found that NDO-BSA attained higher positive rates than MMP-II and LID-1 regardless of clinical types, disability and infection time in leprosy patients. By means of combination of antigens, 88.4% patients of multibacillary leprosy were detected, in contrast to 59.9% in paucibacillary leprosy. Household contacts should be given close attention for the early diagnosis, disruption of disease transmission and precise control. Applications of serology for multi-antigens were recommended for effective coverage and monitoring in leprosy control.

Objective To analyze the epidemiological features of leprosy in China from 2011 to 2015,and to provide scientific evidences for prevention and treatment strategies.Methods An epidemiological analysis and a trend analysis were conducted based on the national leprosy surveillance data from 2011 to 2015.Results The leprosy detection rate in China decreased from 0.085 per 100 000 in 2011 to 0.049 per 100 000 in 2015,with an average annual decline rate being 12.9％.A total of 4 775 leprosy cases were newly detected during 2011-2015,including 106 (2.2％) children,1 499 (31.4％) females,518 (10.8％) floating people,4 041 (84.6％) multibacillary cases and 1 134 (23.7％) cases with grade 2 disabilities.From 2011 to 2015,328 relapsed cases were reported,including 153 (46.6％) cases recurring after combined chemotherapy.The prevalence rate of leprosy in China decreased from 0.407 per 100 000 in 2011 to 0.235 per 100 000 in 2015,with an average annual decline rate being 12.9％.By the end of 2015,there had been 3 230 registered leprosy cases and 124 counties with a prevalence rate above 1 per 100 000.Conclusions The detection rate and prevalence rate of leprosy in China were both decreasing continuously from 2011 to 2015.The high-epidemic provinces were Yunnan,Guizhou,Sichuan and Guangdong.However,leprosy control in middle-and low-epidemic provinces can not be ignored.

Objective: To analyse the results of treatment among multibacillary (MB) patients 8 years after treatment with 6 months' multidrug therapy (MDT).Methods: Newly detected and relapsed MB leprosy patients were treated with 6 months WHO-MDT. The patients were followed up for 8 years. The effectiveness of treatment was assessed by clinical status and bacteriological changes.Results: A total of 114 patients were recruited. Forty two patients dropped out from the study for various reasons. Only 72 patients remained for the final analysis. The mean Bacteriological Index (BI) of all patients decreased from 2.93 +/- 1.39 before treatment, to 0 at the end of the eight year follow up period, with an average annual BI decrease of 0.42. The rate of smear negativity of all patients was 100% at the end of follow up. 38 (53%) patients experienced leprosy reactions during the study and one patient relapsed, giving a cumulative relapse rate of 1.3% or 0.035 per 100 patient-years.Conclusion: The finding that all MB cases with initially positive skin smears, who were treated with only 6 months of MB-MDT, became negative within 8 years showed that the response to this regimen is good in a majority of MB cases.

BACKGROUND:Although the World Health Organization (WHO) has defined relapse in leprosy, it is often difficult to confirm a relapse, especially in paucibacillary (PB) patients.OBJECTIVE:To study features of relapse cases in order to determine the information needed to allow better management of relapses in the leprosy control programme.DESIGN:A retrospective survey by questionnaire was carried out at national level at the end of 2012.RESULTS:There were 40 relapsed patients on register. The clinical form of leprosy was TT5, BT4, BB5, BL13 and LL13. Twenty-eight patients had had a positive skin smear test at the start of MDT, with a BI ranging from 0.83 to 6.0. At the time of completing MDT, the skin smear test remained positive in seven patients. After completion of MDT, other family members of 13 patients were identified as new leprosy patients. All relapse cases showed one or more active skin lesions. There were 33 patients with a positive skin smear test at the time of relapse. A total of 23 patients had a biopsy at the time of relapse, including seven patients with a negative skin smear test. The histological features of relapsed BB-LL patients included granulomas containing macrophages or epithelioid cells with sparse lymphocytes and acid-fast bacilli. The histological features of seven patients with negative skin smears showed epithelioid cell granulomas with dense lymphocytes surrounding the granuloma, but without distinct edema in the dermis. The average interval from completion of MDT to the diagnosis of relapse was 168.5 ± 92.6 months with a range of 21-322 months. During the study, nine patients were tested for rifampicin resistance, but none showed any mutation.CONCLUSIONS:Leprosy relapse after MDT usually occurred late and all relapse cases had new active skin lesions. Most patients relapsed with a positive skin smear after previously reaching negative BI status. Relapse with a negative skin smear test should be confirmed very cautiously.

The data of 124 leprosy relapsed cases ( 125 person-times) from 2008 to 2012 was analyzed, of whom there were 2 children cases (≤14 years). 4.03% of the patients had type-I reaction, 10.48% had type-II reaction, 29.03% had new grade II disabilities. 66.13% of the patients were classified as BL and LL when relapsed.

为有效开展社会公众麻风健康教育干预，如期达到《全国消除麻风危害规划(2011-2020年)》规定的麻风流行地区到2020年社会公众麻风防治核心信息知晓率在80％以上的目标，我们于2012年6~7月在浙江绍兴县有关乡镇社区群众中开展麻风防治核心信息知晓情况基线调查，现将结果报道如下。

OBJECTIVES:To understand the situation of child leprosy patients in the low prevalence situation pertaining in China.METHOD:A retrospective survey by questionnaire was carried out in all 32 provinces of mainland of China in 2011. All data concerning child cases detected from January 2005 to December 2009 were collected by professional health workers working at county level.RESULTS:During the study, only 165 questionnaires were collected for analysis. Among 165 child cases, 96 were boys, 69 were girls with an average age of 11-7 years old. 80% of child cases were members of families with other leprosy affected people. 145 (85%) child cases took their MDT secretly (nobody outside the family knew the child suffered from leprosy), and three (1.8%) children died, one each from dapsone syndrome, suicide and severe pneumonia. During follow-up, four child cases developed new disability increasing the Grade 2 disability rate to 13.3% (22/165). At end of the study, 8.2% of children had discontinued their study at school, and 7.5% had moved to a remote place to do casual work, while 6.3% stayed at home. 31% of child patients thought that leprosy caused a negative impact on their daily life. Two children had a hostile attitude toward society due to the stigma caused by leprosy.CONCLUSIONS:In both high and low endemic areas, as long as there is an infectious source of leprosy in the family, there is a possibility for children to develop leprosy. Contact surveys should be done to detect early disease, especially when there are children in the household.

Objective To investigate the prevalence of mental disorders and its influencing factors among cured leprosy patients.Methods General condition questionnaire and Symptom Checklist-90(SCL-90) were used in the survey to evaluate the mental health status of 392 cured leprosy patients selected with cluster sampling from communities in three districts of Zhejiang province,China.Results The prevalence of mental disorders was 24.49 %(96/392) and the scores of somatization(1.56 ± 0.51),depression(1.63 ± 0.54),and phobic anxiety(1.33 ± 0.40) were higher than those of the norms(1.37 ± 0.48,1.50 ± 0.59,and 1.23 ± 0.41),w hereas the scores of interpersonal sensitivity(1.47 ± 0.62),anxiety(1.30 ± 0.39),hostility(1.33 ± 0.40),paranoid ideation(1.23 ± 0.39),and psychoticism(1.24 ± 0.34) were low er than those of the norms(1.65 ± 0.51,1.39 ± 0.43,1.48 ± 0.56,1.43 ± 0.57 and 1.29 ± 0.42),all with marked statistical differences(P < 0.05).Multiple variates logistic regression analyses showed that the influencing factors of mental disorders among the cured leprosy patients included age,health status,economical status,perceived social stigma,disability severity,and magnitude of care from relatives and friends.Conclusion Cured leprosy patients have mental disorders and psychological rehabilitation is imperative in leprosy control activities.

ObjectiveThis study was conducted to evaluate the effectiveness of uniform multi-drug therapy (UMDT) in patients with multibacillary (MB) leprosy.MethodsNewly detected MB leprosy patients were treated with sixmonths of UMDT as recommended by the World Health Organization (WHO). The effectiveness of treatment was evaluated by clinical status and skin smear tests.ResultsAt the start, 114 patients were recruited, examined, and treated. These patients were re-examined and followed annually for up to sixyears. A total of 75 (65.8%) patients completed sixyears of follow-up. Dropouts were attributable to death, severe drug reactions, and other reasons. The meanstandard deviation bacteriological index (BI) of all patients decreased from 3.01 +/- 1.50 before treatment to 0.02 +/- 1.84 at the end of year 6, reflecting a mean annual decrease of 0.50. The rate of smear negativity in all patients was 98.7% at the end of year 6 of follow-up. A total of 53 leprosy reactions were observed. One patient relapsed 13months after the cessation of treatment.ConclusionsA 6-month administration of UMDT is effective in MB leprosy patients. The changes in BI values and the frequency of leprosy reactions were similar to those cited in reports in the literature of patients treated with 1- or 2-year regimens of MDT. However, further research should be conducted to confirm the present results.

麻风病是由麻风分枝杆菌所引起的主要侵犯皮肤和周围神经的慢性传染病。浙江省截止2010年底，累计发现麻风病人16686例，尚有麻风现症病人104例，属于麻风病低流行区。为实现国家规划要求的2020年消除麻风病危害的目标，大力开展麻风病的健康教育工作，促进病人的及时发现治疗，消除麻风病的恐惧与歧视，为广大麻风病受累者在社会的康复融合创造良好的外部环境，这是实现相应控制目标的基础性工程［1］。我国从2012年提出了“麻风病防治核心信息”的理念［2］，并制定了到2020年麻风病流行地区公众防治核心信息知晓率达到80．00％以上的具体目标。因此，深入分析目前社会公众麻风病防治核心信息的知晓情况及其人群特征，对于确立今后有针对性的科学的麻风病健康教育策略十分必要。根据《全国消除麻风病危害规划实施方案（2012-2020年）》的要求，我们于2012年6-7月在我省麻风病流行地区的群众中开展了一次专题调查，现将有关结果报道如下。