18 juni 2006: Bron: Kanglaite studiecentrum en producent van Kanglaite

Kanglaite injecties geven een zo goed als zelfde respons = aanslaan van de behandeling bij niet-kleincellige longkanker, 12.15% in KLT groep vs 14.29% in de chemotherapie groep, maar als Kanglaite aanslaat is het klinische effect beduidend beter dan een behandeling met chemo. Klinische effect bedraagt voor Kanglaite 78.97%. Plus dat bij Kanglaite veel minder bijwerkingen worden gezien en de kwaliteit van leven hoog blijft. Kanglaite injecties bewijzen dus ook hier weer in een gerandomiseerde fase III trial een meer dan uitstekend alternatief te zijn voor chemo bij niet-kleincellige longkanker. Voor OPS leden hebben we het volledige studierapport inclusief grafieken enz. ter inzage en het adres van de universiteit en het bedrijf waar Kanglaite wordt onderzocht en geproduceerd.br> Summary of Phase III Clinical Trial of Kanglaite Injection in the Treatment of Primary Bronchogenic Pulmonary Carcinoma

Piao Bingkui, Lin Hongsheng, Li Peiwen, Li Xue, Guo Yadong, Wu Liangcun, Liu Aiguo, Zhu Yafang Guang An Men Hospital Affiliated to China Academy of Traditional Chinese Medicine

Abstract

Kanglaite injection (KLT) developed by Zhejiang TCM Hospital was extracted from a traditional Chinese medicinal herb "semen coicis" with modern scientific technology. Approved by the Ministry of Public Health [Approval No.(93) ZL-22] and the Drug Administrative Bureau of Zhejiang Public Health Department, a phase III clinical trial for KLT was performed from July, 1993 to Dec., 1994 in the Clinical Pharmacologic Basis of Shanghai Traditional Chinese Medicine and Pharmaceutical University. Cooperative units were Shanghai Longhua Hospital, Shanghai Chest Disease Hospital and Shanghai Second Pulmonary Disease Hospital. The trial passed an examination by the New Drug Appraisal Committee under the Ministry of Public Health and won a certificate of state second-category new drug and document for production permit in 1995. The phase III clinical trial of KLT was carried out from Feb. 1996 to May 1997 on patients suffering from primary lung cancer to evaluate therapeutic effect and side reaction i.e. efficacy and safety. The trial was performed in line with the “Principles & Guidelines for New Drug (TCM) Clinical Trials" formulated by the Drug Administrative Bureau of the Ministry of Public Health. The units involved in this trial were Beijing Guang An Men Hospital (Chair), Beijing Sino-Japanese Friendship Hospital, Hospital Attached to Zhejiang TCM Institute, Jilin Provincial Tumour Hospital, Nantong Municipal Tumour Hospital and Anhui Provincial Tumour Hospital. The results showed that the effective rate of KLT for primary bronchogenic pulmonary carcinoma (CR+PR) was 12.15% and that for control (chemotherapy) group was 14.29%. According to the TCM classification, KLT had better effect for patients with deficiency of both Qi and Yin. Major clinical symptoms got improved markedly (total efficacy rate 78-97%) among which chest pain, weakness and fatigue, cough and short breath were significantly improved. The survival quality, NK-cell activity, IL-2 level and CD4+/CD8+ radio were raised and patients' immunologic function became enhanced after the treatment which suggested remakable differences between KLT group and control group. The effect of KLT on peripheral blood picture was not evident. No adverse reactions on heart, liver or renal functions were observed. The major side reactions were fever, nausea, phlebitis (with incidence rates 3.74%, 3.74% and 4.67% respectively) and diarrhea (0.47%). Results The response rate (CR+PR) for primary lung carcinoma was 12.15% in KLT group vs 14.29% in chemotherapy group. KLT had better effect for patients with deficiency of both Qi and Yin sympton-sign and could remarkably improve major clinical symptoms (total effective rate as 78.97% ) such as cough, short breath, chest pain, loss of appitite and languidness while KPS of patients and body weight could get increase and life quality became better than that in chemotherapy group. Immunological function examination showed that KLT could raise NK cell activity, IL-2 level and CD4+/ CD8+ ratio value and had no adverse effect on peripheral blood picture.

No liver or renal damage was noted in KLT treated group. No allergic reaction was occurred. The major adverse reactions were fever, nausea, vomit and phlebitis usually lasting for 1-7 days. Fever was subsided after symptomatic treatment and nausea, vomit and phlebitis could disappear spontaneously.

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