基于真实世界中西医结合治疗淋巴结结核疗效观察

Efficacy of combined Chinese and western medicine on lymph node tuberculosis based on real-world

目的 比较西医与中西医结合治疗淋巴结结核的实际临床疗效,并分析不同类型结核(结节型、浸润型、脓肿型、溃疡型)之间的疗效差异,为临床提供更好的治疗依据。方法 基于真实世界,对南京市中西医结合医院瘰疬科与镇江市第三人民医院、淮安市第四人民医院、南通市第六人民医院门诊及病房2017年1月—2020年1月诊治的符合纳入标准的2 538例淋巴结结核患者资料进行回顾性分析,根据患者是否采用中医药治疗分为中西医结合治疗组和西医治疗组,比较2组患者基线特征、治疗疗程、手术率、手术切口Ⅰ期愈合率、结核耐药发生率、不良反应发生率、随访3年复发率。结果 2 538例淋巴结结核患者中,女性患者(1 621例)多于男性患者(917例);患者平均年龄37岁左右,平均病程7个月左右;有肺结核病史或接触史者668例(26.32%);头颈部为最常见发病部位,其次为腋窝、腹股沟;脓肿型和溃疡型更多(916例和762例),合并基础疾病的患者中脓肿型、溃疡型占比较高。治疗疗程在11~18个月。中西医结合治疗组总有效率、治愈率均明显高于西医治疗组[97.79%(1 724/1 763)比78.71%(610/775),P均<0.05];2组中脓肿型与溃疡型患者的手术率均明显高于同组结节型与浸润型(P均<0.05),但2组间脓肿型与溃疡型患者的手术率比较差异均无统计学意义(P均>0.05);中西医结合治疗组中浸润型、脓肿型、溃疡型患者切口Ⅰ期愈合率均明显高于同类型西医治疗组[96.17%(176/183)、94.97%(566/596)、91.92%(455/495)比78.16%(68/87)、71.97%(190/264)、69.63%(149/214),P均<0.05];中西医结合治疗组结核耐药发生率、不良反应发生率、复发率均明显低于西医治疗组[10.21%(180/1 763)、16.28%(287/1 763)、 2.78%(49/1 763)比16.00%(124/775)、23.35%(181/775)、9.94%(77/775),P均<0.05]。结论 真实世界研究发现,中西医结合治疗可以提高淋巴结结核的临床疗效,促进手术切口Ⅰ期愈合,并能有效减少结核耐药、药物不良反应及复发。

Objective It is to compare the actual clinical efficacy of western medicine and combination of Chinese and western medicine in the treatment of lymph node tuberculosis,and to analyze the differences in efficacy among different types of tuberculosis(nodular,infiltrative,abscessed,and ulcerated),in order to provide better evidences for clinical treatment.Methods Based on the real world,the data of 2538 cases of patients with lymph node tuberculosis who met the inclusion criteria diagnosed and treated in the outpatient clinics and wards of Nanjing Hospital of Integrated Traditional Chinese and Western Medicine,Zhenjiang Third People’s Hospital,Huai’an Fourth People’s Hospital,and Nantong Sixth People’s Hospital from January 2017 to January 2020 were retrospectively analyzed,and according to whether or not used traditional Chinese medicine treatment,they were divided into Chinese and western medicine combined treatment group and western medicine treatment group,the baseline characteristics,treatment duration,surgery rate,surgical incision stage I healing rate,incidence of tuberculosis drug resistance,incidence of adverse reactions,and recurrence rate at 3 years of follow-up were compared between the two groups.Results Among 2538 patients with lymph node tuberculosis,there were more female patients(1621 patients)than male patients(917 patients);the average age of the patients was about 37 years old,and the average duration of the disease was about 7 months;there were 668 cases with a history of tuberculosis or exposure(26.32%);the head and neck were the most common location of disease,followed by the axilla and groin;the abscessed and ulcerated types were more frequent(916 cases and 762 cases),abscess type and ulcer type accounted for a higher proportion of patients with comorbid underlying diseases.The course of treatment ranged from 11 to 18 months.The total effective rate and cure rate of the combined Chinese and western medicine treatment group were significantly higher than those of the western medicine treatment group[97.79%(1724/1763)vs 78.71%(610/775),P<0.05];the operation rate of patients with abscess and ulcerative type was significantly higher than that of patients with nodular and infiltrative type in the same group in the two groups(P<0.05),however,the difference in operation rate of patients with abscess and ulcerative type was not statistically significant among the two groups(P<0.05);the incision stage I healing rates of patients with infiltrative,abscessed,and ulcerated types in the combined Chinese and Western medicine treatment group were significantly higher than those of the same type of western medicine treatment group[96.17%(176/183),94.97%(566/596),and 91.92%(455/495)than 78.16%(68/87),71.97%(190/264),69.63%(149/214),all P<0.05];the incidence of TB drug resistance,incidence of adverse reactions,and relapse rates in the combined Chinese and western medicine treatment group were significantly lower than those in the western medicine treatment group[10.21%(180/1763),16.28%(287/1763),2.78%(49/1763)than 16.00%(124/775),23.35%(181/775),9.94%(77/775),all P<0.05].Conclusion Real-world studies find that the combination of Chinese and western medicine can improve the clinical efficacy of lymph node tuberculosis,promote the healing of surgical incisionⅠ,and effectively reduce tuberculosis drug resistance,adverse drug reactions and recurrence.