研究疾病:
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骨结核
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研究疾病代码:
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Target disease:
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Bone tuberculosis
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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横断面
Cross-sectional
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研究所处阶段:
Study phase:
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探索性研究/预试验
Pilot clinical trial
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研究目的:
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探索骨痨汤通过Th17/Treg平衡对骨结核患者免疫紊乱及肝损的调节机制。为骨痨汤减毒增效的临床作用提供确切依据,发掘抗结核疗效特异性指标。
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Objectives of Study:
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To explore the regulatory mechanism of Gulao Decoction on immune disorder and liver damage in patients with bone tuberculosis through Th17 / Treg balance. To provide a definite basis for the clinical effect of Gulao Decoction in reducing toxicity and increasing efficiency, and to explore the specific indexes of anti tuberculosis efficacy.
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药物成份或治疗方案详述:
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骨痨汤:拳参10g、虎杖10g、瓜子金10g、忍冬藤10g、黄芪15g、赤芍10g、怀牛膝10g、徐长卿10g、紫花地丁10g、当归10g。由医院煎药室统一熬制,浓缩成300ml平均分装2袋,早晚各服1袋。
利福平:针剂,0.45g/支,批准文号:国药准字H20041320;生产厂家:重庆华邦制药有限公司;用法:溶解于10ml灭菌注射用水,配5%葡萄糖注射液500ml静滴,每日一次;胶囊,150mg/粒,批准文号:国药准字H21021905;生产厂家:沈阳红旗制药有限公司;用法:450mg口服,每日一次,晨服;针剂使用4周,4周后改为胶囊。
异烟肼片:0.1g/片,批准文号:国药准字H33021636;生产厂家:杭州民生药业集团有限公司;用法:0.3g口服,每日一次,晨服。
盐酸乙胺丁醇片:0.25g/片,批准文号:国药准字H42022126;生产厂家:宜昌人福药业有限责任公司;用法:0.75g口服,每日一次,晨服。
试验组:骨痨汤+标准抗结核(利福平+异烟肼+乙胺丁醇)。
对照组:标准坑结核(利福平+异烟肼+乙胺丁醇)。
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Description for medicine or protocol of treatment in detail:
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Gulao Decoction: 10 g of Radix Codonopsis, 10 g of Polygonum cuspidatum, 10 g of melon seed gold, 10 g of honeysuckle vine, 15 g of astragalus root, 10 g of red peony root, 10 g of Achyranthes bidentata, 10 g of Xu Changqing, 10 g of Viola and 10 g of Angelica sinensis. It is uniformly brewed by the decocting room of the hospital, concentrated into 300ml, evenly packed into 2 bags, and taken in the morning and evening.
Rifampicin: injection, 0.45g/dose, approval No.: gyzz h20041320; Manufacturer: Chongqing Huabang Pharmaceutical Co., Ltd; Usage: dissolve in 10ml of sterilized water for injection, add 500ml of 5% glucose injection intravenously, once a day; Capsule, 150mg / capsule, approval No.: gyzz h21021905; Manufacturer: Shenyang Hongqi Pharmaceutical Co., Ltd; Usage: 450mg orally, once a day, taken in the morning; The injection was used for 4 weeks and changed to capsule after 4 weeks.
Isoniazid tablets: 0.1g/tablet, approval number: gyzz h33021636; Manufacturer: Hangzhou Minsheng Pharmaceutical Group Co., Ltd; Usage: 0.3g orally, once a day, taken in the morning.
Ethambutol hydrochloride tablets: 0.25g/tablet, approval number: gyzz h42022126; Yichang Pharmaceutical Co., Ltd; Usage: 0.75g orally, once a day, taken in the morning.
Experimental group: Gulao Decoction + standard anti tuberculosis (rifampicin + isoniazid + ethambutol).
Control group: Standard pit tuberculosis (rifampicin + isoniazid + ethambutol).
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纳入标准:
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①符合诊断标准;②符合肝肾亏虚证;③年龄在20~80周岁,性别不限;④受试者或家属知情同意,签署知情同意书。获得知情同意书过程应符合GCP规定。
诊断标准:参照《实用骨科学》(第4版):①一般症状:多数患者有低热盗汗、食欲减退、消瘦、结核发病部位钝痛,部分严重者可有肋间神经痛、下肢神经痛或者截瘫;②体征:局部肿胀,肤温高,或有窦道流脓,压痛,脊柱侧弯或后凸,弯腰拾物试验阳性。③实验室检查:血常规可提示贫血,血沉、C反应蛋白升高,结核感染T细胞结果阳性,结核抗体阳性;④影像学检查:X线片上表现以椎体上下缘骨质破坏和椎间隙狭窄为主,部分患者合并腰大肌寒性脓肿,X片表现为腰大肌阴影模糊、增宽、饱满或局限性隆起。CT可见病变部位虫蚀样空洞或死骨,椎旁或腰大肌脓肿。早期MRI可见局部炎性浸润异常信号,中晚期可见脊髓受压和变性。⑤难以诊断者可行穿刺活检:病理或脓液基因检测(X-port)。符合⑤,①或②+③+④,诊断为骨结核。
骨结核肝肾亏虚证:主症:①畏寒;②自汗、盗汗;③纳差、消瘦;④心悸、不眠;⑤面色无华、乏力;次症:①脓水持续外排;②久不收口;③局部皮色发红;舌脉:①舌质淡红;②苔白;③脉细数或虚数;具备主症2项+次症1项,参考舌苔脉象,即可辨证。
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Inclusion criteria
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① Meet the diagnostic criteria; ② In line with liver and kidney deficiency syndrome; ③ Aged from 20 to 80 years old, regardless of gender; ④ The subjects or their families gave informed consent and signed the informed consent form. The process of obtaining informed consent shall comply with the provisions of GCP.
Diagnostic criteria: refer to practical orthopaedics (4th Edition): ① general symptoms: most patients have low fever, night sweats, loss of appetite, weight loss, dull pain at the onset of tuberculosis, and some serious patients may have intercostal neuralgia, lower limb neuralgia or paraplegia; ② Signs: local swelling, high skin temperature, or sinus pus, tenderness, scoliosis or kyphosis, positive bending and picking up test. ③ Laboratory examination: blood routine examination can indicate anemia, increased ESR and C-reactive protein, positive T cell result of tuberculosis infection and positive tuberculosis antibody; ④ Imaging examination: on the X-ray film, the main manifestations are bone destruction at the upper and lower edges of the vertebral body and intervertebral space stenosis. Some patients are complicated with psoas major cold abscess. On the X-ray film, the shadow of psoas major is blurred, widened, plump or localized bulge. CT showed wormhole like cavity or dead bone, paravertebral or psoas abscess. Abnormal signals of local inflammatory infiltration can be seen on MRI in the early stage, and spinal cord compression and degeneration can be seen in the middle and late stage. ⑤ If it is difficult to diagnose, puncture biopsy can be performed: pathology or pus gene test (X-port). According to ⑤, ① or ② + ③ + ④, it is diagnosed as bone tuberculosis.
Bone tuberculosis liver and kidney deficiency syndrome: main symptoms: ① chills; ② Spontaneous and night sweats; ③ Poor appetite and weight loss; ④ Palpitation and sleeplessness; ⑤ Dull and weak complexion; Secondary symptoms: ① continuous discharge of pus; ② Don't shut up for a long time; ③ Local skin color is red; Tongue pulse: ① light red tongue; ② White fur; ③ Pulse number or imaginary number; With 2 main symptoms and 1 secondary symptom, syndrome differentiation can be achieved by referring to the pulse of tongue coating.
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排除标准:
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①排除其他证型骨结核;②排除化脓性脊柱炎、终板炎、脊柱肿瘤、强直性脊柱炎、腰椎间盘突出症等相关鉴别诊断疾病;③排除有心、脑、肝、肾及造血等系统严重原发性疾病者;④排除艾滋病等免疫缺陷疾病;⑤排除精神类疾病;⑥严重过敏体质等患者。
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Exclusion criteria:
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① Other types of bone tuberculosis were excluded; ② Relevant differential diagnosis diseases such as suppurative spondylitis, endplate inflammation, spinal tumor, ankylosing spondylitis and lumbar disc herniation were excluded; ③ Patients with serious primary diseases of heart, brain, liver, kidney and hematopoietic system were excluded; Exclude AIDS and other immunodeficiency diseases; ⑤ Exclude mental diseases; ⑥ Patients with severe allergic constitution.
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研究实施时间:
Study execute time:
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从From
2023-01-01
至To
2025-12-31
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征募观察对象时间:
Recruiting time:
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从From
2023-01-01
至To
2024-12-31
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