OBJECTIVE：To evaluate the efficacy of Shengjiangxiexin decoction （SXD）, prepared with a formula from Traditional Chinese Medicine （TCM）, in reducing irinotecan-induced hematological and gastrointestinal toxicitie...OBJECTIVE：To evaluate the efficacy of Shengjiangxiexin decoction （SXD）, prepared with a formula from Traditional Chinese Medicine （TCM）, in reducing irinotecan-induced hematological and gastrointestinal toxicities in patients with UDP-glucuro-nosyltransferase （tJGT）1A1＊28 and UGTIA1＊6 poly-morphisms. METHODS： This clinical trial included 115 patients receiving irinotecan combined with 5-fluorouracil plus I-leucovorin （FOLFIRI） treatment. All patients consented to UGT1A1＊28 and ＊6 gene polymorphism detection prior to chemotherapy. SXD were administered from 1 day prior to chemotherapy to 6 day post chemotherapy. Chemotherapy induced adverse reactions （neutropenia, diarrhea, nausea, vomiting, anorexia and infection） were recorded, and short-term effect of chemotherapy was evaluated regularly. RESULTS： A total of 50 patients had ＊1/＊1 wild gen-otype, 58 patients had single allele variants with genotype ＊1/＊6 or ＊/＊28, and 7 patients had two alleles variants with genotype ＊6/＊6, ＊28/＊28 or ＊6/＊ 28. In ＊1/＊6 or ＊1/＊28 patients （high risk group）, 9 patients （15.5%） developed Ⅰ-Ⅱ grade diarrhea and no patient developed severe diarrhea; neutro-penia occurred in 19 patients （32.8%） and only 3 patients （8.6%） developed sever neutropenia. There were no significant differences in any toxic effects （neutropenia, diarrhea, nausea, vomiting, anorexia or infection） between ＊6 or ＊28 variant patients （high risk group） and wild type patients. No sever toxicity was found in high risk two alleles variants patients （＊6/＊6, ＊6/＊28 or ＊28/＊28）. No significant differences were observed between UGTIA1＊6/＊28 polymorphisms and clinical response of chemotherapy. CONCLUSION： SXD could significantly reduce irinotecan-induced hematological and gastrointestinal toxicities in UGT1A1＊28 or ＊6 variant patients （high risk group）, while this treatment didn＇t affect clinical response of chemotherapy.展开更多
OBJECTIVE: To evaluate the safety and efficacy of Tongkuaixiao ointment(TKXO) in treating moderate-to-severe cancer induced somatalgia.METHODS: Totally 130 patients with moderateto-severe cancer induced somatalgia wer...OBJECTIVE: To evaluate the safety and efficacy of Tongkuaixiao ointment(TKXO) in treating moderate-to-severe cancer induced somatalgia.METHODS: Totally 130 patients with moderateto-severe cancer induced somatalgia were randomly divided into a TKXO group and a control group.The patients were treated with either TKXO applied externally or placebo, with opioid analgesics orally at the same time. Observation parameters were included numerical rating scale(NRS) scores,analgesic efficacy, initiation effective time, persistent analgesic time, equivalent morphine dose,National Comprehensive Cancer Network(NCCN)grade in Impact of Pain Measurement Scores, and safety and satisfaction extent investigation.RESULTS: NRS scores and NCCN grade in Impact of Pain Measurement Scores decreased significantly after 5-days' treatment in the two groups(P <0.0001). Compared to the control group, initiation effective time was significantly shorter(P < 0.05)and persistent analgesic time was significantly longer(P < 0.01), equivalent oral morphine doses of the first day and the whole treatment course were significantly decreased in the TKXO treatment group(P < 0.01 or P < 0.05). No obvious adverse effects were found in the TKXO group.CONCLUSION: TKXO combined with opioid analgesics possesses the advantages of high efficacy,fast action, long persistent action, safety and convenience in use, and it can reduce the dose of opioid.展开更多
基金the National Fund of Natural Sciences:Mechanism of Tiaohe Changwei Decoction in relieving irinotecan-induced late-onset diarrhea(No.81273974)
文摘OBJECTIVE：To evaluate the efficacy of Shengjiangxiexin decoction （SXD）, prepared with a formula from Traditional Chinese Medicine （TCM）, in reducing irinotecan-induced hematological and gastrointestinal toxicities in patients with UDP-glucuro-nosyltransferase （tJGT）1A1＊28 and UGTIA1＊6 poly-morphisms. METHODS： This clinical trial included 115 patients receiving irinotecan combined with 5-fluorouracil plus I-leucovorin （FOLFIRI） treatment. All patients consented to UGT1A1＊28 and ＊6 gene polymorphism detection prior to chemotherapy. SXD were administered from 1 day prior to chemotherapy to 6 day post chemotherapy. Chemotherapy induced adverse reactions （neutropenia, diarrhea, nausea, vomiting, anorexia and infection） were recorded, and short-term effect of chemotherapy was evaluated regularly. RESULTS： A total of 50 patients had ＊1/＊1 wild gen-otype, 58 patients had single allele variants with genotype ＊1/＊6 or ＊/＊28, and 7 patients had two alleles variants with genotype ＊6/＊6, ＊28/＊28 or ＊6/＊ 28. In ＊1/＊6 or ＊1/＊28 patients （high risk group）, 9 patients （15.5%） developed Ⅰ-Ⅱ grade diarrhea and no patient developed severe diarrhea; neutro-penia occurred in 19 patients （32.8%） and only 3 patients （8.6%） developed sever neutropenia. There were no significant differences in any toxic effects （neutropenia, diarrhea, nausea, vomiting, anorexia or infection） between ＊6 or ＊28 variant patients （high risk group） and wild type patients. No sever toxicity was found in high risk two alleles variants patients （＊6/＊6, ＊6/＊28 or ＊28/＊28）. No significant differences were observed between UGTIA1＊6/＊28 polymorphisms and clinical response of chemotherapy. CONCLUSION： SXD could significantly reduce irinotecan-induced hematological and gastrointestinal toxicities in UGT1A1＊28 or ＊6 variant patients （high risk group）, while this treatment didn＇t affect clinical response of chemotherapy.
基金Supported by the Eleventh Five-year National Plan of Sciences and Technology(Clinical Research of Traditional Chinese Medicine External Treatment by Investigating Pathogenesis and Syndrome Differentiation of Cancer Pain,No.2008BAI53B023)Key Project of Beijing Municipal Science and Technology Commission(Standardization of Traditional Chinese Medicine External Treatment in Cancer Induced Pain,Ascites or Pleural Effusion,No.D13110002213004)the Postdoctoral Fund of Sciences(Effects of the Method for Tonifying Kidney to Strengthen the Bone in Treating Bone Cancer Pain,No.2012M510358)
文摘OBJECTIVE: To evaluate the safety and efficacy of Tongkuaixiao ointment(TKXO) in treating moderate-to-severe cancer induced somatalgia.METHODS: Totally 130 patients with moderateto-severe cancer induced somatalgia were randomly divided into a TKXO group and a control group.The patients were treated with either TKXO applied externally or placebo, with opioid analgesics orally at the same time. Observation parameters were included numerical rating scale(NRS) scores,analgesic efficacy, initiation effective time, persistent analgesic time, equivalent morphine dose,National Comprehensive Cancer Network(NCCN)grade in Impact of Pain Measurement Scores, and safety and satisfaction extent investigation.RESULTS: NRS scores and NCCN grade in Impact of Pain Measurement Scores decreased significantly after 5-days' treatment in the two groups(P <0.0001). Compared to the control group, initiation effective time was significantly shorter(P < 0.05)and persistent analgesic time was significantly longer(P < 0.01), equivalent oral morphine doses of the first day and the whole treatment course were significantly decreased in the TKXO treatment group(P < 0.01 or P < 0.05). No obvious adverse effects were found in the TKXO group.CONCLUSION: TKXO combined with opioid analgesics possesses the advantages of high efficacy,fast action, long persistent action, safety and convenience in use, and it can reduce the dose of opioid.
