目的 比较采用聚丙烯聚乳酸复合网片、聚酯网片、聚丙烯网片行李金斯坦腹股沟疝修补术的临床疗效.方法 选取2012年2月至2013年5月天津市人民医院收治的1 080例原发性单侧腹股沟疝患者进行前瞻性研究.采用随机对照研究方法,将入组患者按随机数字表法分为ProGrip组(采用聚丙烯聚乳酸复合网片)、PET组(采用聚酯网片)和PP组(采用聚丙烯网片).患者在局部麻醉下采用标准的李金斯坦无张力疝修补术.采用门诊和电话方式进行随访,随访时间截至2014年5月.随访内容包括并发症发生情况、术后疼痛情况及术后健康相关的生命质量.主要观察指标包括:固定网片时间,手术时间,疝复发情况;术后1周、1个月、6个月、12个月疼痛程度,采用数字评价量表(NRS)评估;术后1个月患者健康相关的生命质量,采用SF-36问卷调查,包括生理机能、生理职能、躯体疼痛、一般健康状况、精力、社会功能、情感职能、精神健康8项.正态分布的计量资料以x-±s表示,多组间比较采用方差分析,两组间比较采用t检验;偏态分布的计量资料以M(范围)表示,重复测量数据采用重复测量方差分析.计数资料比较采用x2检验和Fisher确切概率法.采用Kaplan-Meier法计算术后中、重度疼痛率,Log-rank检验进行分析.结果 筛选出符合条件的患者1 022例,其中ProGrip组患者367例,PET组346例,PP组309例.ProGrip组、PET组、PP组患者固定网片时间分别为(1.3±0.5)min、(4.9±0.9) min、(5.0±0.9) min,手术时间分别为(30 ±5) min、(45 ±7) min、(44±7)min,3组上述两个指标比较,差异均有统计学意义(F=6.21,4.33,P＜0.05).固定网片时间和手术时间ProGrip组与PET组比较,差异有统计学意义(t=1.36,4.39,P＜0.05);ProGrip组与PP组比较,差异有统计学意义(=2.67,2.99,P＜0.05);PET组与PP组比较,差异无统计学意义(t=0.98,0.63,P＞0.05).909例患者术后获得随访,随访率为88.943％ (909/1 022),随访时间为12 ～ 26个月,中位随访时间为13个月.ProGrip组、PET组、PP组患者术后疝复发分别为1、0、0例,3组比较,差异无统计学意义(P＞0.05).ProGrip组、PET组、PP组患者术后1周至12个月疼痛NRS评分分别为0(0 ～2)分～0(0 ～0)分、2(0 ～5)分～0(0～0)分、1(0～4)分～0(0 ～0)分,术后1周至12个月中、重度疼痛患者分别为52例(14.17％) ～0例(0)、87例(25.14％)～0例(0)、89例(28.80％) ～0例(0),3组上述两个指标变化趋势比较,差异均无统计学意义(F=1.66 ,x2=1.52,P＞0.05).ProGrip组、PET组、PP组患者术后1个月生理机能分别为(52±4)分、(50±6)分、(50±6)分,生理职能分别为(50±6)分、(50±6)分、(50±5)分,躯体疼痛分别为(52±7)分、(52±7)分、(52±7)分,一般健康状况分别为(63±4)分、(57±9)分、(58±8)分,精力分别为(63±5)分、(62±6)分、(63±6)分,社会功能分别为(58±4)分、(58±8)分、(57±8)分,情感职能分别为(59±4)分、(57±8)分、(58±8)分,精神健康分别为(65±4)分、(63±5)分、(63±6)分,3组上述指标比较,差异均无统计学意义(F=2.36,3.65,1.98,2.41,6.32,2.33,4.21,3.52,P＞0.05).结论 采用聚丙烯聚乳酸复合网片、聚酯网片、聚丙烯网片行李金斯坦腹股沟疝修补术后并发症、术后疼痛和生命质量相当,且均在术后远期呈现低复发率、低疼痛发生率和较高的生命质量.
目的 比較採用聚丙烯聚乳痠複閤網片、聚酯網片、聚丙烯網片行李金斯坦腹股溝疝脩補術的臨床療效.方法 選取2012年2月至2013年5月天津市人民醫院收治的1 080例原髮性單側腹股溝疝患者進行前瞻性研究.採用隨機對照研究方法,將入組患者按隨機數字錶法分為ProGrip組(採用聚丙烯聚乳痠複閤網片)、PET組(採用聚酯網片)和PP組(採用聚丙烯網片).患者在跼部痳醉下採用標準的李金斯坦無張力疝脩補術.採用門診和電話方式進行隨訪,隨訪時間截至2014年5月.隨訪內容包括併髮癥髮生情況、術後疼痛情況及術後健康相關的生命質量.主要觀察指標包括:固定網片時間,手術時間,疝複髮情況;術後1週、1箇月、6箇月、12箇月疼痛程度,採用數字評價量錶(NRS)評估;術後1箇月患者健康相關的生命質量,採用SF-36問捲調查,包括生理機能、生理職能、軀體疼痛、一般健康狀況、精力、社會功能、情感職能、精神健康8項.正態分佈的計量資料以x-±s錶示,多組間比較採用方差分析,兩組間比較採用t檢驗;偏態分佈的計量資料以M(範圍)錶示,重複測量數據採用重複測量方差分析.計數資料比較採用x2檢驗和Fisher確切概率法.採用Kaplan-Meier法計算術後中、重度疼痛率,Log-rank檢驗進行分析.結果 篩選齣符閤條件的患者1 022例,其中ProGrip組患者367例,PET組346例,PP組309例.ProGrip組、PET組、PP組患者固定網片時間分彆為(1.3±0.5)min、(4.9±0.9) min、(5.0±0.9) min,手術時間分彆為(30 ±5) min、(45 ±7) min、(44±7)min,3組上述兩箇指標比較,差異均有統計學意義(F=6.21,4.33,P＜0.05).固定網片時間和手術時間ProGrip組與PET組比較,差異有統計學意義(t=1.36,4.39,P＜0.05);ProGrip組與PP組比較,差異有統計學意義(=2.67,2.99,P＜0.05);PET組與PP組比較,差異無統計學意義(t=0.98,0.63,P＞0.05).909例患者術後穫得隨訪,隨訪率為88.943％ (909/1 022),隨訪時間為12 ～ 26箇月,中位隨訪時間為13箇月.ProGrip組、PET組、PP組患者術後疝複髮分彆為1、0、0例,3組比較,差異無統計學意義(P＞0.05).ProGrip組、PET組、PP組患者術後1週至12箇月疼痛NRS評分分彆為0(0 ～2)分～0(0 ～0)分、2(0 ～5)分～0(0～0)分、1(0～4)分～0(0 ～0)分,術後1週至12箇月中、重度疼痛患者分彆為52例(14.17％) ～0例(0)、87例(25.14％)～0例(0)、89例(28.80％) ～0例(0),3組上述兩箇指標變化趨勢比較,差異均無統計學意義(F=1.66 ,x2=1.52,P＞0.05).ProGrip組、PET組、PP組患者術後1箇月生理機能分彆為(52±4)分、(50±6)分、(50±6)分,生理職能分彆為(50±6)分、(50±6)分、(50±5)分,軀體疼痛分彆為(52±7)分、(52±7)分、(52±7)分,一般健康狀況分彆為(63±4)分、(57±9)分、(58±8)分,精力分彆為(63±5)分、(62±6)分、(63±6)分,社會功能分彆為(58±4)分、(58±8)分、(57±8)分,情感職能分彆為(59±4)分、(57±8)分、(58±8)分,精神健康分彆為(65±4)分、(63±5)分、(63±6)分,3組上述指標比較,差異均無統計學意義(F=2.36,3.65,1.98,2.41,6.32,2.33,4.21,3.52,P＞0.05).結論 採用聚丙烯聚乳痠複閤網片、聚酯網片、聚丙烯網片行李金斯坦腹股溝疝脩補術後併髮癥、術後疼痛和生命質量相噹,且均在術後遠期呈現低複髮率、低疼痛髮生率和較高的生命質量.
목적 비교채용취병희취유산복합망편、취지망편、취병희망편행리금사탄복고구산수보술적림상료효.방법 선취2012년2월지2013년5월천진시인민의원수치적1 080례원발성단측복고구산환자진행전첨성연구.채용수궤대조연구방법,장입조환자안수궤수자표법분위ProGrip조(채용취병희취유산복합망편)、PET조(채용취지망편)화PP조(채용취병희망편).환자재국부마취하채용표준적리금사탄무장력산수보술.채용문진화전화방식진행수방,수방시간절지2014년5월.수방내용포괄병발증발생정황、술후동통정황급술후건강상관적생명질량.주요관찰지표포괄:고정망편시간,수술시간,산복발정황;술후1주、1개월、6개월、12개월동통정도,채용수자평개량표(NRS)평고;술후1개월환자건강상관적생명질량,채용SF-36문권조사,포괄생리궤능、생리직능、구체동통、일반건강상황、정력、사회공능、정감직능、정신건강8항.정태분포적계량자료이x-±s표시,다조간비교채용방차분석,량조간비교채용t검험;편태분포적계량자료이M(범위)표시,중복측량수거채용중복측량방차분석.계수자료비교채용x2검험화Fisher학절개솔법.채용Kaplan-Meier법계산술후중、중도동통솔,Log-rank검험진행분석.결과 사선출부합조건적환자1 022례,기중ProGrip조환자367례,PET조346례,PP조309례.ProGrip조、PET조、PP조환자고정망편시간분별위(1.3±0.5)min、(4.9±0.9) min、(5.0±0.9) min,수술시간분별위(30 ±5) min、(45 ±7) min、(44±7)min,3조상술량개지표비교,차이균유통계학의의(F=6.21,4.33,P＜0.05).고정망편시간화수술시간ProGrip조여PET조비교,차이유통계학의의(t=1.36,4.39,P＜0.05);ProGrip조여PP조비교,차이유통계학의의(=2.67,2.99,P＜0.05);PET조여PP조비교,차이무통계학의의(t=0.98,0.63,P＞0.05).909례환자술후획득수방,수방솔위88.943％ (909/1 022),수방시간위12 ～ 26개월,중위수방시간위13개월.ProGrip조、PET조、PP조환자술후산복발분별위1、0、0례,3조비교,차이무통계학의의(P＞0.05).ProGrip조、PET조、PP조환자술후1주지12개월동통NRS평분분별위0(0 ～2)분～0(0 ～0)분、2(0 ～5)분～0(0～0)분、1(0～4)분～0(0 ～0)분,술후1주지12개월중、중도동통환자분별위52례(14.17％) ～0례(0)、87례(25.14％)～0례(0)、89례(28.80％) ～0례(0),3조상술량개지표변화추세비교,차이균무통계학의의(F=1.66 ,x2=1.52,P＞0.05).ProGrip조、PET조、PP조환자술후1개월생리궤능분별위(52±4)분、(50±6)분、(50±6)분,생리직능분별위(50±6)분、(50±6)분、(50±5)분,구체동통분별위(52±7)분、(52±7)분、(52±7)분,일반건강상황분별위(63±4)분、(57±9)분、(58±8)분,정력분별위(63±5)분、(62±6)분、(63±6)분,사회공능분별위(58±4)분、(58±8)분、(57±8)분,정감직능분별위(59±4)분、(57±8)분、(58±8)분,정신건강분별위(65±4)분、(63±5)분、(63±6)분,3조상술지표비교,차이균무통계학의의(F=2.36,3.65,1.98,2.41,6.32,2.33,4.21,3.52,P＞0.05).결론 채용취병희취유산복합망편、취지망편、취병희망편행리금사탄복고구산수보술후병발증、술후동통화생명질량상당,차균재술후원기정현저복발솔、저동통발생솔화교고적생명질량.
Objective To compare the clinical efficacies of polypropylene-polyglactic composite mesh, polyester mesh, polypropylene mesh in Lichtenstein repair for inguinal hernia.Methods The clinical data of 1 080 patients with primary unilateral inguinal hernia who were admitted to the Tianjin People's Hospital from February 2012 to May 2013 were prospectively analyzed.A randomized controlled study was performed based on a random numble table.All the patients were allocated into the ProGrip group (Parietex ProGripTM Self-Fixating Mesh), PET group (ParietexTM Lightweight Monofilament Polyester Mesh) and PP group (BardTM Soft Mesh).Patients received standard Lichtenstein tension-free repair under local anesthesia and were followed up by outpatient examination and telephone interview till May 2014.The indexs observed during the follow-up included occurrence of complications, post-operative pain and postoperative health-related quality of life.The following indexes were recorded : time of mesh fixation, operation time, hernia recurrence, pain degree at postoperative week 1 and month 1, 6, 12 by numerical rating scale (NRS), quality of life at postoperative month 1 by SF-36 questionnaire survey including physical function, role physical, body pain, general health, vitality, social function, role emotional,mental health.Measurement data with normal distribution were presented as x ± s.Comparisons among groups were analyzed by ANOVA and pairwise comparison by t test.Measurement data with skewed distribution were presented as M (range) and repeated measurement data were analyzed using the repeated measures ANOVA.Count data were evaluated by the chi-square test and Fisher exact probability.Postoperative moderate and severe pain rates were evaluated by the Kaplan-Meier method and analyzed by the Log-rank test.Results There were 1 022 patients screened for eligibility including 367 patients in the ProGrip group, 346 patients in the PET group and 309 patients in the PP group.The time of mesh fixation and operation time were (1.3 ± 0.5) minutes and (30 ± 5) minutes in the ProGrip group, (4.9 ± 0.9) minutes and (45 ± 7) minutes in the PET group, (5.0 ± 0.9) minutes and (44 ± 7)minutes in the PP group, respectively, showing significant differences among the 3 groups (F =6.21, 4.33,P ＜ 0.05).There were significant differences in the time of mesh fixation and operation time between the ProGrip group and the PET group (t =1.36, 4.39, P ＜ 0.05), and also between the ProGrip group and the PP group (t =2.67, 2.99, P ＜ 0.05).There was no significant difference in the time of mesh fixation and operation time between the PET group and the PP group (t =0.98, 0.63, P ＞ 0.05).Nine hundred and nine patients were followed up for a median time of 13 months (range, 12-26 months) , with a follow-up rate of 88.943％ (909/1 022).The number of recurred hernia in the ProGrip group, the PET group and the PP group was 1, 0, 0,showing no significant difference (P ＞ 0.05).The NRS scores of pain from postoperative week 1 to postoperative month 12 were ranged from 0 (0-2) to 0 (0-0) in the ProGrip group, from 2(0-5) to 0(0-0) in the PET group and from 1 (0-4) to 0 (0-0) in the PP group.The number of patients with moderate and severe pain was ranged from 52(14.17％) to 0(0) in the ProGrip group, from 87 (25.14％) to 0 (0) in the PET group and from 89 (28.80％) to 0(0) in the PP group.There were no significant differences in the changing trends of NRS scores of pain and number of patients with moderate and severe pain among the 3 groups (F =1.66, x2=1.52, P ＞ 0.05).The scores of physical function in the ProGrip group, PET group, PP group at postoperative month 1 were 52 ± 4,50 ± 6, 50 ± 6, the scores of role physical were 50 ± 6, 50 ± 6, 50 ± 5, the scores of body pain were 52 ± 7, 52 ± 7, 52 ± 7, the scores of general health were 63 ± 4, 57 ± 9, 58 ± 8, the scores of vitality were 63 ± 5, 62 ± 6,63 ± 6, the scores of social function were 58 ± 4, 58 ± 8, 57 ± 8, the scores of role emotional were 59 ± 4, 57 ± 8,58 ± 8, and the scores of mental health were 65 ± 4, 63 ± 5, 63 ± 6, respectively, showing no significant differences in above indexes among the 3 groups (F =2.36,3.65,1.98,2.41, 6.32, 2.33, 4.21, 3.52, P ＞ 0.05).Conclusion Patients undergoing Lichtenstein repair for inguinal hernia with polypropylene-polyglactic composite mesh, polyester mesh and polypropylene mesh have comparative of incidence of postoperative complications, postoperative pain, quality of life, and present postoperative long-term low recurrence, low incidence of pain and relatively high quality of life.
