替加色罗治疗便秘型肠易激综合征患者有效性、安全性和耐受性的多中心、开放性临床研究

Evaluation of safety, tolerability and efficacy of tegaserod for treatment of constipation-predominant irritable bowel syndrome

目的评价替加色罗(商品名:泽马可)治疗便秘型肠易激综合征(IBS)患者的安全性、耐受程度及患者对替加色罗标准治疗方案的满意度、依从性及可持续性。方法采用多中心、开放性临床研究方法,对全国185个研究中心的5097例门诊和住院便秘型IBS患者,给予替加色罗6 mg,每天2 次,连续治疗4-12周。根据患者对替加色罗治疗方案的满意度、依从性及患者对再次应用替加色罗治疗的意愿,评估替加色罗6 mg、每天2次治疗方案的安全性。结果 185个中心的5095例患者入选本研究,其中男1272例,占24．97％,女3823例,占75．03％。年龄为18-97岁,平均(43．64±15．05)岁, 中位数为41岁。从出现症状开始的平均病程为(2．99±4．10)年。具有便秘症状者4593例(90．15％), 腹痛4111例(80．69％),腹胀3971例(77．94％)。在入选病例中,对治疗非常满意者1096例 (21．51％),满意者3155例(61．92％),不满意者164例(3．22％),非常不满意者10例(0．20％),未发表意见者670例(13．15％)。在男性病例中,表示非常满意或满意者占82．23％,接近于女性的满意度 (83．83％)。年龄≤65岁者对治疗的满意度(84．30％)略高于年龄>65岁者(81．79％)。病程≥1年者对治疗的满意度(82．81％)亦接近于病程<1年者(84．64％)。在具有便秘、腹痛及腹胀症状的患者中均获得较好的满意度,分别为83．69％、83．87％和83．30％。连续服药疗程>8周者对替加色罗治疗的满意度(90．08％)高于疗程<4周者(83．47％)。首次应用或之前的治疗缺乏有效性者对治疗的满意度可达82．58％-84．70％。尽管有部分患者尚不能确定将来是否继续应用,但仍有71．42％的患者表示将来愿意再次接受替加色罗治疗。在治疗期间,共有153例(3．0％)患者出现至少1件不良事件,其中 137例患者的不良事件认为与试验药物相关,包括腹泻71例、腹痛20例及头痛16例。结论替加色罗在中国对便秘型IBS患者的治疗是安全有效的,具有较好的患者满意度及依从性。

Objective To evaluate the safety, tolerability and efficacy of tegaserod （Zelmac） for treatment of constipation-predominant irritable bowel syndrome （C-IBS）. Methods This was a multicenter, open-label clinical study. A total of 5097 patients with C-IBS were recruited from the 185 centers in China. The patients were given tegaserod 6mg bid for 4 -12 weeks. Patients＇ satisfaction, treatment compliance and wiliness for future use of tegaserod were assessed at the end of treatment. Results Among 5095 patients, 1272 were male （24.97%） and 3,823 female （75.03%）, and the patients＇ ages were 18 to 97 years with mean age 43.64±15.05 and median age 41.0. The mean duration of IBS symptoms was 2.99 ±4.10 years. About 90.15% of patients reported having symptoms of constipation, 80. 69% with abdominal pain and 77.94% with bloating. Tegaserod was well accepted by most of patients, 1096 patients （21.51%） reported that they were very satisfied, and 3155 patients （61.92%） reported that they were satisfied with the treatment. Only 3. 22% of patients were dissatisfied, and 0.20% very dissatisfied with the medication. Six hundred seventy patients （13. 15 %） did not give their opinions. About 82.23% of （1046/1272） male patients and （83.83%） of （3205/3823） female patients were satisfied or very satisfied with Zelmac treatment. Patients older than 65 years showed a relative lower satisfaction rate （81.79%） compared with patients younger than 65 years （84.30%）. About 82. 81% of patients with IBS symptoms one or more years were satisfied with tegaserod treatment, the percentage were similar to the patients with symptoms less than 1 year （84.64%）. The satisfaction rate was very high in the patients with predominant symptom being constipation （83.69 %）, abdominal pain （83.87%）, and bloating （83.30%）. Patients who received 8 weeks or more of treatment had a higher satisfaction rate （90. 08 % ） compared with patients who received 4 weeks or less of treatment （83.47 % ）. ;The satisfaction rate of patients who with newly diagnosed IBS or first consultation was 84.70%, and the rate in the patients who lacked efficacy in previous treatment with other medication was 82. 58%. A total of 3613 patients （71.42%） said that they would like to take tegaserod again in the future to treat the IBS symptoms. A total of 153 （3. 0%） patients reported at least one adverse event during the study period, among them, 137 （2. 69%） reported adverse events which were considered to be related to the study medication, mainly diarrhea （1.39%）, abdominal pain （0. 39% ） and headache （0.31% ）. Conclusions Tegaserod has a good safety and tolerability profile for treating C-IBS in China, and it is effective in terms of patient satisfaction and treatment compliance.