multiple myeloma
Conditions
Interventions
two:Zhima Qianzi Capsules
Sponsors
The First Affiliated Hospital of Zhejiang University of traditional Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The diagnosis is MM and BIPN; 2. Age>18 years; 3. The previous chemotherapy regimen contained bortezomib intravenously or subcutaneously; 4. Electromyography indicates peripheral nerve injury; 5. Mecobalamin treatment is ineffective; 6. The liver enzyme is within 3 times of normal, and the creatinine clearance rate is above 3030ml/min; 7. The disease is stable. During the treatment, all nerve cell protective agents and nutritive agents are stopped. There is no chemotherapy nearly one month before the treatment; 8. During the treatment of Strychnos nux vomica, drugs that affect nervous function were stopped for two months (including PI, IMID, poisons, liposomes, vinblastine, PD-1, PDL-1, monoclonal antibodies); 9. ECOG score<3; 10. The patient voluntarily joined the clinical trial and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Exclude neuropathy caused by other causes, such as cervical and lumbar spondylopathy (nerve root compression, spinal stenosis, cervical and lumbar degenerative change), diabetes, cerebral infarction, Guillain Barre syndrome, and exclude serious arteriovenous diseases (venous embolism, lymphangitis); 2. Patients with neuropathy caused by neurotoxicity caused by other drugs, especially other chemotherapy drugs, and nerve damage caused by metabolic toxins caused by renal insufficiency were excluded; 3. Patients with severe heart failure (refer to the 2018 Chinese Guidelines for the Diagnosis and Treatment of Heart Failure [21], patients with heart failure with NYHA grade greater than Grade I), liver (patients with alanine aminotransferase or glutamic oxaloacetic transaminase greater than 3 times the upper limit of normal value), and renal insufficiency (creatinine clearance rate = 40ml/min) were excluded; 4. Pregnant women and lactating women are excluded; 5. The patient has serious psychological or mental disorders; 6. People who are allergic to or intolerant of this product; 7. Alcohol or drug abusers; 8. Any medical history that may interfere with the experimental results or increase the patient's risk according to the investigator's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TCM symptom score;neurotoxicity score;Peripheral neuropathy grade; | — |
Countries
China
Contacts
Public ContactShuyan Liu
The First Affiliated Hospital of Zhejiang University of traditional Chinese Medicine
Outcome results
None listed