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目的观察对乙酰氨基酚治疗地方性氟骨症临床效果,为氟骨症治疗提供有效药物。方法分为1期和2期进行临床效果观察。1期临床观察46例患者,2期临床观察812名患者。治疗药品为市售非处方药对乙酰氨基酚片(Parac-etamol Tablets),每片0.5g,饭后口服,1次1片,1日3次,连服5 d,停药2 d后继续服用,疗程为1个月。观察治疗前颈、腰、四肢大关节休息痛症状和治疗后变化,及治疗前后关节活动受限和肢体功能障碍体征变化。按照卫生部“新药临床研究指导原则”中的标准,对所观察指标进行总体疗效判定。从治疗开始,观察并记录患者服药物后症状减轻或体征出现改善的起始时间、不良反应及对药物的耐受性。结果 1期临床疗效结果显示,对乙酰氨基酚的总有效率为84.8%(39/46),无效率为15.2%(7/46)。其中轻度患者全部有效(100%,26/26),中度患者有效率为66.7%(12/18);重度患者2人,有效1人。2期临床总有效率为81.0%(658/812),无效率为19.0%(154/812)。在治疗的812名患者中,轻度患者有效率占53.2%(432/812),中度患者占24.0%(195/812),重度患者有效率占3.8%(31/812)。这些患者的耐受性评分为3,即无不良反应。服药3 d后,患者可感关节疼痛减轻,服药7 d后多数患者关节疼痛症状明显减轻。结论对乙酰氨基酚片可以缓解地方性氟骨症的关节疼痛症状,使疼痛症状减轻或消失,也可以缓解或减轻患者的关节活动受限改变,对轻度患者临床表现改善的作用更明显,副作用小,耐受性好。
Objective To observe the clinical effect of acetaminophen in the treatment of endemic fluorosis and to provide an effective drug for the treatment of skeletal fluorosis. Methods Divided into 1 and 2 clinical observation. The first phase of clinical observation of 46 patients, 2 clinical observation of 812 patients. Therapeutic drugs were Parac-etamol Tablets (0.5g per tablet), taken orally once daily after meals, once daily for 3 days on day 1. The patients were treated for 5 consecutive days and stopped for 2 days. Treatment for 1 month. Observed before treatment of neck, lumbar, joint pain and postoperative rehabilitation of large joints, and joint activity before and after treatment and limb dysfunction signs changes. In accordance with the Ministry of Health “new drug clinical research guidelines ” in the standard, the observed indicators to determine the overall efficacy. From the beginning of treatment, observe and record the onset of symptoms, adverse reactions and drug tolerance of the patients after their medication is relieved of symptoms or signs of improvement. Results The results of phase 1 clinical efficacy showed that the total effective rate of acetaminophen was 84.8% (39/46) and the inefficiency rate was 15.2% (7/46). Among them, mild patients were all effective (100%, 26/26), moderate patients were 66.7% (12/18), 2 were severe patients and 1 was effective. The total effective rate of stage 2 was 81.0% (658/812) and the inefficiency rate was 19.0% (154/812). Among the 812 patients treated, 53.2% (432/812) of mild patients, 24.0% (195/812) of moderate patients, and 3.8% (31/812) of moderately severe patients. The patient’s tolerability score was 3, ie no adverse reactions. After taking medicine for 3 days, the pain in the joint was relieved and most of the patients had obvious pain relief after 7 days. Conclusion Acetaminophen tablets can relieve the joint pain symptoms of endemic fluorosis, relieve or disappear the pain symptoms, relieve or lessen the limited changes of joint activities in patients, and have a more obvious effect on the improvement of clinical manifestations in mild patients. Small side effects, well tolerated.