title: [Safety and effectiveness of large dose compound Sophora flavescens Ait injection in the treatment of advanced malignant tumors].
abstract: OBJECTIVE
  To evaluate the effectiveness and safety of large dose compound Sophora flavescens Ait injection in the treatment of advanced malignant tumors.
  
  
  METHODS
  A non-randomized case control trial was conducted. Ninety six patients with pathologically confirmed advanced non-small-cell lung cancer, gastric cancer and colorectal cancer were divided into traditional Chinese medicine group and chemotherapy group, 48 cases each. Patients of the traditional Chinese medicine group received treatment with large dose of compound Sophora flavescens Ait injection (20 ml/d), and 21 days as a cycle.
  
  
  RESULTS
  Forty-seven patients of the traditional Chinese medicine group and 46 patients of the chemotherapy group completed their treatment, respectively. The clinical benefit rate (CBR) in the traditional Chinese medicine group was 83.0%, significantly higher than that in the chemotherapy group (69.6%) (P < 0.01). The Karnofsky performance status and weight improvement in the traditional Chinese medicine group was superior to that in the chemotherapy group (P < 0.05). Except the skin irritation in one patient in the traditional Chinese medicine group, there were no other clinical adverse effects related with the large dose compound Sophora flavescens Ait injection.
  
  
  CONCLUSIONS
  Large dose compound Sophora flavescens Ait injection in the treatment of advanced malignant tumors is safe and effective. The recommended dose is 20 ml/d.
authors.affiliation: The Guanganmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China. lidaorui@sina.com
authors.forename: Dao-rui
authors.initials: DR
authors.lastname: Li
authors.forename: Hong-sheng
authors.initials: HS
authors.lastname: Lin
mesh_terms: D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000302:isolation & purification / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001835:Body Weight / Q000187:drug effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D015179:Colorectal Neoplasms / Q000188:drug therapy / Q000473:pathology; D004338:Drug Combinations; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000009:adverse effects / Q000302:isolation & purification / Q000627:therapeutic use*; D005076:Exanthema / Q000139:chemically induced; D005260:Female; D006801:Humans; D007267:Injections; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D009367:Neoplasm Staging; D010946:Plants, Medicinal / Q000737:chemistry; D029909:Sophora / Q000737:chemistry*; D013274:Stomach Neoplasms / Q000188:drug therapy / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D004338:Drug Combinations; D004365:Drugs, Chinese Herbal