研究疾病:
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雄激素剥夺代谢并发症
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研究疾病代码:
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Target disease:
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Metabolic Complications of Androgen Deprivation
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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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病例对照研究
Case-Control study
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研究所处阶段:
Study phase:
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治疗新技术临床试验
New Treatment Measure Clinical Study
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研究目的:
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(1)通过观察治疗前后AMS量表评分、EPIC-26评分、简短疲劳量表评分(BFI)、PSA(前列腺特异性抗原)、T(睾酮)、代谢指标(血压、血脂、空腹血糖、糖化血红蛋白、体重指数、腹围)等前列腺癌进展指标及终点指标的变化,使用主观评分和客观检测指标综合评价治疗方案的有效性。
(2)通过检测患者服用健脾益肾方前后的安全性指标,进一步证实健脾益肾方的安全性。行安慰剂对照,验证脾肾相关理论在HSPC患者ADT后代谢并发症治疗上的可行性,为中医理论研究提供循证医学证据,形成中医药方法治疗HSPC患者ADT后代谢并发症干预的新方案。
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Objectives of Study:
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(1) By observing the changes of AMS scale score, epic-26 score, short fatigue scale score (BFI), PSA (prostate specific antigen), t (testosterone), metabolic indicators (blood pressure, blood lipids, fasting blood glucose, glycosylated hemoglobin, body mass index, abdominal circumference) and other indicators of prostate cancer progression and endpoint indicators before and after treatment, the effectiveness of the treatment plan was comprehensively evaluated by subjective scores and objective detection indicators.
(2) The safety of Jianpi Yishen recipe was further confirmed by detecting the safety indicators of patients before and after taking Jianpi Yishen recipe. Placebo control was conducted to verify the feasibility of spleen kidney related theory in the treatment of metabolic complications after ADT in HSPC patients, provide evidence-based medical evidence for theoretical research of traditional Chinese medicine, and form a new intervention scheme of traditional Chinese medicine in the treatment of metabolic complications after ADT in HSPC patients.
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药物成份或治疗方案详述:
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Description for medicine or protocol of treatment in detail:
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纳入标准:
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(1)年龄在45岁及其以上,80岁以下的男性。
(2)病理学或临床上确诊为HSPC。
(3)在ADT治疗期内。
1)前列腺癌分期在T3N0MO T3N0M1 T3NIMO T3NIMI及以上。
2)睾酮达到去势水平50mg/ml以下。
3)患者出现雄激素缺乏综合征临床症状:AMS量表评分:≥27分。
(4)血清肌酐≤1.5×ULN(正常范围上限),或者计算后的肌酐清除率60ml/min。
(5)肝功能血清胆红素≤1.5×ULN(有文件证明的Gilbert综合征的受试者除外),天门冬氨酸氨基转移酶(AST)或丙氨酸氨基转移酶(ALT)≤2.5×ULN。
(6)预期寿命至少为6个月。
(7)配偶为育龄期妇女的受试者,必须同意在研究期间和末次给药后半年内使用双重防护的避孕措施,且不得捐献精子。
(8)受试者(或由其法定代理人)签署知情同意书,表示他们已经了解研究目的和需要进行的程序,并且愿意参加研究。
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Inclusion criteria
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(1) Men aged 45 and over and under 80.
(2) HSPC was diagnosed pathologically or clinically.
(3) During ADT treatment.
1) Prostate cancer stage is t3n0mo, t3n0m1, t3nimo, t3nimi and above.
2) Testosterone reached the castration level below 50mg/ml.
3) The patient has clinical symptoms of androgen deficiency syndrome: AMS scale score: ≥ 27 points.
(4) Serum creatinine ≤ 1.5 × ULN (upper limit of normal range), or calculated creatinine clearance rate of 60ml/min.
(5) Liver function serum bilirubin ≤ 1.5 × ULN (except subjects with documented Gilbert syndrome), aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 × ULN。
(6) The life expectancy is at least 6 months.
(7) Subjects whose spouses are women of childbearing age must agree to use double protective contraceptives during the study period and within half a year after the last administration, and must not donate sperm.
(8) The subjects (or their legal representatives) sign the informed consent form, indicating that they have understood the purpose of the study and the required procedures, and are willing to participate in the study.
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排除标准:
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(1)具有严重的原发性心血管病变、肝脏病变、肾脏病变、血液学病变、肺脏疾病、或影响其生存的严重疾病,如艾滋病,研究者认为不宜入选者。肝功能ALT、AST、肾功能BUN超过正常值上限50%,肾功能Cr超过正常值上限者,均不予入选。
(2)活动期或有症状的病毒性肝炎或慢性肝脏疾病。一致的感染人免疫缺陷病毒(HIV)和/或乙肝病毒(检测为乙肝表面抗原[HBSAg]阳性/或乙肝病毒DNA[HBV-DNA]定量阳性)或丙肝病毒(检测为抗丙肝病毒[HCV]抗体阳性)和/或丙肝病毒RNA[HCV-RNA]定量阳性在未来24个月内复发概率≥30%的其他恶性肿瘤。
(3)根据研究者判断,存在与受试者参加研究的最佳利益不相符合(如影响受试者的幸福感)或者可能妨碍、限制或干扰研究方案的相关评价。注:研究者应确保受试者在筛选期符合所有入选标准。
(4)不符合纳入标准,未按规定用药,无法判断疗效,或资料不全等影响疗效判断者。
(5)法律上的残疾患者(盲、聋、哑、智力障碍),精神病患者。
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Exclusion criteria:
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(1) With serious primary cardiovascular disease, liver disease, kidney disease, hematological disease, lung disease, or serious diseases that affect their survival, such as AIDS, the researchers believe that they should not be selected. Alt, AST and bun of liver function exceed 50% of the upper limit of normal value, and Cr of renal function exceeds the upper limit of normal value, which will not be selected.
(2) Active or symptomatic viral hepatitis or chronic liver disease. Consistent infection with human immunodeficiency virus (HIV) and / or hepatitis B virus (detected as positive for hepatitis B surface antigen [hbsag] / or quantitative positive for hepatitis B virus dna[hbv-dna]) or hepatitis C virus (detected as positive for anti hepatitis C virus [hcv] antibody) and / or quantitative positive for hepatitis C virus rna[hcv-rna], and other malignant tumors with a recurrence probability of ≥ 30% in the next 24 months.
(3) According to the judgment of the researcher, there are problems that are inconsistent with the best interests of the subjects participating in the study (such as affecting the happiness of the subjects) or that may hinder, restrict or interfere with the relevant evaluation of the research plan. Note: the researcher should ensure that the subjects meet all the inclusion criteria during the screening period.
(4) Those who do not meet the inclusion criteria, do not use drugs according to the regulations, and cannot judge the curative effect, or incomplete data affect the judgment of curative effect.
(5) Legally disabled patients (blind, deaf, dumb, intellectual disorders), psychotic patients.
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研究实施时间:
Study execute time:
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从From
2021-10-01
至To
2024-10-01
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征募观察对象时间:
Recruiting time:
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从From
2022-08-01
至To
2024-10-01
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