论文部分内容阅读
目的:探讨硫酸吗啡栓治疗中重度癌痛的临床疗效与安全性。方法:采用多中心、随机、双盲、安慰剂对照试验方法。2005年3月至2006年3月期间中重度癌痛患者132例纳入研究。患者分为2组:治疗组(66例)和对照组(66例)。治疗组中男35例,女31例,平均年龄(52.8±11.9)岁,对照组中男46例,女20例,平均年龄(58.2±10.9)岁。治疗组患者经肛门给予硫酸吗啡栓(20mg)1枚和口服安慰剂1片,对照组患者口服硫酸吗啡片(20mg)1片和经肛门给予安慰剂栓1枚。待患者再出现中度疼痛时,再第2次给药。每日用药剂量不超过100mg,共给药7d。评价硫酸吗啡栓的镇痛效果和不良反应。结果:治疗组和对照组用药前用目测划线分级法测定的疼痛强度分别为7.1±1.3和6.8±1.2,差异无统计学意义(P>0.05)。2组患者用药后15、30min及1.0、1.5、2.0、3.0、4.0、6.0h的疼痛强度均较用药前下降。用药前疼痛强度和用药后各时间点疼痛强度的差值如下:第1次用药后,治疗组分别为0.80±1.33、2.09±1.77、3.27±1.92、4.14±2.05、4.26±2.13、3.70±2.09、3.27±2.11及2.88±2.35,对照组分别为0.74±1.41、1.97±1.93、3.15±2.11、3.82±2.16、3.95±2.13、3.52±2.12、3.00±2.19及2.70±2.23;第2次用药后,治疗组分别为0.92±1.37、5.35±1.53、3.05±1.94、3.38±1.85、3.70±2.02、3.52±2.00、3.05±2.06及2.84±2.22、,对照组分别为0.72±1.03、4.95±1.49、2.77±1.84、3.27±1.98、3.27±1.95、3.05±1.77、2.67±1.68及2.25±1.88。2组用药前后疼痛强度的差异均有统计学意义(均P<0.001),但2组间疼痛强度的差异无统计学意义(均P>0.05)。治疗组和对照组第1次用药后2h镇痛的有效率均为71.21%,疼痛强度分别为2.74与2.86,用药后6h疼痛强度均为4.12;治疗组与对照组第2～7天用药次数分别为2.54～2.97与2.52～3.03。2组用药后2h和6h的有效率、疼痛强度及用药次数比较差异均无统计学意义(均P>0.05)。2组不良反应发生率均为27.27%。治疗组和对照组的主要不良反应分别为呕吐(13.64%与9.09%),恶心(10.61%与10.61%),便秘(6.06%和7.58%),嗜睡(3.03%与6.06%),头晕(3.03%与6.06%),皮肤瘙痒(1.52%与1.52%),组间比较差异无统计学意义(P>0.05),其中治疗组发生复视1.52%,肛门下坠1.52%;对照组发生呼吸抑制1.52%,指尖抽搐1.52%。结论:硫酸吗啡栓对癌痛的镇痛效果与硫酸吗啡片相似,是一种安全有效能良好耐受的治疗中重度癌痛的剂型。
Objective: To investigate the clinical efficacy and safety of morphine sulfate suppository in the treatment of moderate-severe cancer pain. Methods: A multicenter, randomized, double-blind, placebo-controlled trial was used. From March 2005 to March 2006, 132 patients with moderate to severe cancer pain were included in the study. Patients were divided into two groups: treatment group (66 cases) and control group (66 cases). In the treatment group, there were 35 males and 31 females with an average age of (52.8±11.9) years. In the control group, there were 46 males and 20 females with a mean age of (58.2±10.9) years. Patients in the treatment group were given analmorphine sulphate suppository (20 mg) and oral placebo 1 via the anus, and patients in the control group were given one tablet of morphine sulphate (20 mg) orally and 1 placebo suppository. When the patient reappears moderate pain, the second dose is given. Daily dose of not more than 100mg, a total of 7d. The analgesic effect and adverse reactions of morphine sulfate suppositories were evaluated. Results: The pain intensity of the treatment group and the control group before and after the treatment by the visual scoring stratification method was 7.1±1.3 and 6.8±1.2, respectively, the difference was not statistically significant (P>0.05). The pain intensity at the 15th, 30th, and 1.0, 1.5, 2.0, 3.0, 4.0, and 6.0 h after treatment in both groups was lower than before the medication. The differences in pain intensity and pain intensity at each time point after administration were as follows: After the first administration, the treatment groups were 0.80±1.33, 2.09±1.77, 3.27±1.92, 4.14±2.05, 4.26±2.13, 3.70±2.09, respectively. , 3.27±2.11 and 2.88±2.35, and the control group were 0.74±1.41, 1.97±1.93, 3.15±2.11, 3.82±2.16, 3.95±2.13, 3.52±2.12, 3.00±2.19 and 2.70±2.23, respectively; after the second medication The treatment group was 0.92±1.37, 5.35±1.53, 3.05±1.94, 3.38±1.85, 3.70±2.02, 3.52±2.00, 3.05±2.06, and 2.84±2.22, respectively, and the control group was 0.72±1.03, 4.95±1.49, respectively. 2.77±1.84, 3.27±1.98, 3.27±1.95, 3.05±1.77, 2.67±1.68 and 2.25±1.88. Differences in pain intensity before and after treatment in the two groups were statistically significant (all P<0.001), but pain intensity between the two groups was significant. The difference was not statistically significant (all P>0.05). The effective rate of analgesia was 71.21%, pain intensity was 2.74 and 2.86, and the pain intensity was 4.12 at 6 hours after treatment in the treatment group and the control group at the 2nd hour after the first medication. The treatment time was between 2 to 7 days in the treatment and control groups. They were 2.54-2.97 and 2.52-3.03, respectively. There was no significant difference in the efficacy, pain intensity, and number of medications at 2h and 6h after treatment in the 2 groups (all P>0.05). The incidence of adverse reactions in both groups was 27.27%. The main adverse reactions in the treatment group and control group were vomiting (13.64% and 9.09%), nausea (10.61% and 10.61%), constipation (6.06% and 7.58%), drowsiness (3.03% and 6.06%), dizziness (3.03) % and 6.06%), skin pruritus (1.52% and 1.52%), there was no significant difference between the groups (P> 0.05), in which treatment group had double vision 1.52%, anus fell 1.52%; control group respiratory depression 1.52 %, Fingertip convulsions 1.52%. Conclusion: The analgesic effect of morphine sulfate suppository on cancer pain is similar to that of morphine sulfate tablets. It is a safe and effective, well-tolerated treatment for moderate to severe cancer pain.