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OBJECTIVE To explore general technical considerations for the clinical trial design of drugs targeting lupus nephritis treatment. METHODS By conducting comprehensive research on relevant technical standards both domestically and internationally, synthesizing the experience gained from recent drug development endeavors, and integrating disease characteristics, treatment requirements, and evaluation practices, the holistic design of clinical trials for lupus nephritis drugs were explored from a technical evaluation perspective which including examining participant selection criteria, efficacy indicators, safety evaluations, and proposing key technical considerations. RESULTS and CONCLUSION The recommended research design is a multicenter, randomized, double-blind, parallel-controlled design typically conducted using standard treatment protocols. Including participants who have undergone renal biopsy within 6 months prior to randomization can enhance the representation of baseline characteristics. In terms of efficacy evaluation indicators, relying solely on a single indicator is insufficient to fully capture the effectiveness of the drug; therefore, composite indicators are commonly employed for comprehensive assessment purposes. The primary efficacy evaluation indicator should be the complete renal remission rate, with criteria that accurately reflect clinically significant improvement in kidney function. Secondary efficacy indicators should encompass multiple dimensions aligned with clinical treatment goals for lupus nephritis and include assessments of glucocorticoid and/or immunosuppressant dosage reductions, long-term renal outcomes (such as progression to end-stage kidney disease), as well as evaluations of SLE manifestations and overall activity levels. Safety aspects necessitate vigilant monitoring for risks such as infection, cardiovascular events, malignant tumors, and potential impacts on renal function posed by novel drugs.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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