Schwarzenberg L, Mathé G, Pouillart P, Weiner R, Locour J, Genin J, Schneider M, De Vassal F, Hayat M, Amiel J L, Schlumberger J R, Jasmin C, Rosenfeld C
Br Med J. 1973 Mar 24;1(5855):700-3. doi: 10.1136/bmj.1.5855.700.
Forty-three patients with chronic myeloid leukaemia have been treated with hydroxyurea in order to be subjected to leucopheresis for white cell transfusions. Hydroxyurea decreases leucocytosis when it is administered and the blood granulocyte number increases soon after the drug is stopped. The survival of the patients is not different from the survival of the patients treated with conventional chemotherapy (busulphan, mitobronitol) and it is superior to the survival of patients treated with external radiotherapy or with (32)P. Half of the patients were subjected to splenectomy during first remission for a phase II trial. They were not randomized, but the distribution according to age was similar in the two groups. A slight difference appears in favour of splenectomy so far as survival is concerned, but there were three post-operative deaths out of 18 patients. We conclude that a phase II trial on the value of splenectomy is indicated ethically, but that the patients should be operated on and nursed in a microbiologically controlled environment.
43例慢性粒细胞白血病患者接受了羟基脲治疗,以便进行白细胞单采术以进行白细胞输注。服用羟基脲时可降低白细胞增多症,停药后不久血液粒细胞数量就会增加。这些患者的生存率与接受传统化疗(白消安、米托布罗醇)治疗的患者的生存率没有差异,且优于接受体外放疗或(32)P治疗的患者。一半的患者在首次缓解期接受了脾切除术以进行II期试验。他们没有被随机分组,但两组患者的年龄分布相似。就生存率而言,脾切除术似乎略有优势,但18例患者中有3例术后死亡。我们得出结论,从伦理角度来看,有必要进行关于脾切除术价值的II期试验,但患者应在微生物控制的环境中进行手术和护理。