3.2. Eligibility criteria

Participants, Intervention, Comparison, Outcomes and Study designs (PICOS) of inclusion and exclusion criteria are summarized as follows:

Included population. The standard of cardiotoxicity will be evaluated according to the acute and subacute toxicity standard of anti-cancer drugs established by WHO^[14]; Adopt a first-line standard joint solution based on ADM; A RCT of Shengmai injection in preventing and treating of ADM-related cardiotoxicity.

Exclusion criteria. Patients with severe arrhythmia, acute myocardial infarction, heart failure, severe neurosis, and menopausal syndrome in the past 6 months; Patients with severe primary diseases such as liver, kidney and hematopoietic system and mental illness.

The intervention group has received Shengmai injection treatment or combined with western medicine as a therapeutic intervention, and is limited to RCT for drug treatment. Shengmai injection is the only positive intervention in the treatment group compared with the control group, including placebo, no intervention, and anti-cancer drugs. There are no restrictions on the dosage and duration of medication but in studies comparing Shengmai injection with anti-cancer drugs, specifications, and dosage of anti-cancer drugs used in the treatment groups are the same as used in the control groups.

Control intervention measures can accept simple western medicine treatment, such as malignant lymphoma patients using CHOP regimen [CTX + ADM + VCR + Pred (Cyclophosphamide + Hydroxyldaunorubicin + Oncovin + Prednisone)], breast cancer patients using CAF regimen [CTX + ADM + 5-FU (Cyclophosphamide + Adriamycin + Fluorouracil)], ovarian cancer patients using CAP regimen [CTX + ADM + DDP (Cyclophosphamide + Adriamycin + Cisplatin)], multiple bone marrow tumor patients treated with VAD chemotherapy [VCR + ADM + DEX (Vincristine + Adriamycin + Dexamethasone)], or as a blank control without any treatment. Once the RCT includes any form of external treatment of TCM therapy, the patient will be excluded, including but not limited to moxibustion, acupuncture, and other tests.

Primary outcome indicator. The standard of cardiotoxicity rate will be evaluated according to the acute and subacute toxicity standard of anti-cancer drugs established by WHO^[14]: Grade 0 means normal; Grade I means asymptomatic, but with abnormal heart signs; Grade II represents transient insufficiency of heart function, but does not require treatment; Grade III represents symptomatic, insufficient cardiac function, treatment is effective; Grade IV represents symptomatic, insufficient heart function, treatment is ineffective.

Secondary outcome indicator. Echocardiography: mainly record LVEF which provided as a percentage (%); Electrocardiogram: arrhythmia after chemotherapy, ST- segment changes, T wave changes, QRS low voltage are recorded as ECG abnormalities; Myocardial enzymes: the grading standard of cardiac troponin I (cTnI) is based on the cut-off value recommended by the International United Chemistry and the World Standardization Committee^[15]: the normal value of cTnI < 0.15ng/ml, 0.15 to 0.5 ng/ml indicates mild myocardial injury, and >0.5 ng/ml is severe myocardial damage.

The language included in the study is Chinese or English and will be an RCT. All the nontherapeutic research, animal experiments, case reports, review literature, literature with no control group, duplicate publications, incorrect data, unclear outcome effect, wrong statistical method, the measurement data without the mean and standard deviation will be excluded.