Objective To evaluate the clinical effectiveness of laparoscopic cholecystectomy and laparoscopic common bile duct exploration (LC+LCBDE) and endoscopic retrograde cholangiopancreatography/endoscopic sphincterectomy with LC(ERCP/EST+LC) in treatment for cholecystolithiasis with choledocholithiasis. Methods From January 2008 to July 2011, 127 patients suffered from cholecystolithiasis with choledocholithiasis underwent either LC+LCBDE(85 cases, LC+LCBDE group) or ERCP/EST+LC(42 cases, ERCP/EST+LC group) were collected retrospectively. The clearance rate of calculus, hospital stay, hospitalization expenses, and the rate of postoperative complications were compared between two groups. Results Eighty-five patients were performed successfully in the LC+LCBDE group, out of which 54 patients had primary closure of common bile duct (LC+LCBDE primary closure group), whereas in 28 patients common bile ducts were closed over T tube (LC+LCBDE+T tube group). Forty-two patients were performed successfully in the ERCP/EST+LC group. There were no differences in the clearance rate of calculus〔100%(82/82) versus 97.37%(37/38), P=0.317〕 and postoperative complications rate 〔(4.71% (4/85) versus 4.76%(2/42), P=1.000〕 between the LC+LCBDE group and ERCP/EST+LC group. The median (quartile) hospital stay in the LC+LCBDE group was shorter than that in the ERCP/EST+LC group 〔12 (6) d versus 17(9) d, P<0.001〕. In the LC+LCBDE primary closure group, both median (quartile)?hospital stay and median(quartile) hospitalization expenses were less than those of ERCP/EST+LC〔hospital stay:11(5) d versus 17(9) d, P<0.001;hospitalization expenses:27 054(8 452) yuan versus 31 595(11 743) yuan, P=0.005〕 . Conclusions In the management of patients suffered from cholecystolithiasis with choledocholithiasis, both LC+LCBDE and ERCP/EST+LC are safe and effective. LC+LCBDE, especially primary closure after LCBDE, is associated with significantly less costs as compared with ERCP/EST+LC. Moreover, patients can be cured by LC+LCBDE through one-stage treatment with the protection of the papilla function and no limits to the amount or size of the choledocholithiasis. The LC+LCBDE is a preferable choice for the appropriate cases of cholecystolithiasis with choledocholithiasis.
The prominent feature and form of clinical diagnosis and treatment of traditional Chinese medicine is individualization, which has generated difficulty for clinical evaluation and has restricted the production of high-level evidence for traditional Chinese medicine for a long time. Based on the complexity and dynamics of individualized information under the characteristics of time and space, this paper references the theory of space-time of system science to analyze the individualized data of diagnosis and treatment of traditional Chinese medicine and summarizes the concept of the long time course for clinical evaluation. Based on the concept of the long time course, this paper starts with the origin of clinical evaluation, which is the construction of clinical problem elements named PICO, introduces dynamic evaluation factors, explores the construction of individualized dynamic evaluation method of traditional Chinese medicine, and provides demonstration and examples for the design and implementation of individualized clinical research in future.
In the process of evidence-based practice, the evaluation of evidence applicability relied on the subjective judgment of clinicians, while the systematic method of which was still in lack. The complex clinical information of traditional Chinese medicine (TCM) enhanced the uncertainty and risk of applying evidence. Based on the analysis of the process of evidence-based practice, this paper introduced the method of TCM evidence applicability evaluation and used the raw data of clinical trials to develop a clinical prediction model to enable the assessment of the evidence applicability on individual patients. The establishment of individual evidence applicability evaluation method could promote the rational application of TCM evidence in the long term.
背景 隨機對照臨床試驗的報告質量欠佳。當今,提高研究透明度至關重要,不充分的報告影響了對試驗結果的可靠性和有效性的評估。臨床試驗報告的統一標準(Consolidated Standards of Reporting Trials,CONSORT)2010 聲明是為提升隨機對照臨床試驗的報告質量而制定的,但其最初關注的是兩組平行對照試驗。多臂試驗常采用多個平行組設計方案,將試驗者以相同概率隨機分配至其中一個治療組,比較多種干預措施的效應,但以三組或者更多的組別為常見。多臂試驗的報告質量差異很大,使得對結果的判斷和解釋變得困難。盡管 CONSORT 2010 聲明的大部分內容同樣適用于多臂試驗,但其中一些要素需要修改,并且在某些情況下還有額外的問題需要澄清。 目的 推出 CONSORT 2010 聲明的多臂試驗報告擴展版,以便于此類試驗的報告。 設計 2014 年 CONSORT 工作組會議后,成立了一個包括所有作者的指南撰寫工作組。工作組在 2014 年至 2018 年間,每兩個月進行會面或電話會議,并通過電子郵件進行交流,討論并制定了修訂清單及其相關文本。草稿隨后發給了包含 36 人的 CONSORT 工作組及另外 5 名在臨床試驗領域的知名專家,以供他們審閱。14 人提供了詳細的反饋意見,工作組經過詳細考慮,形成了擴展版的最終修訂版。 結果 CONSORT 聲明多臂試驗擴展版,擴展了 CONSORT 2010 清單中的 10 個條目,并提供了良好的報告示例及對每個擴展條目重要性的詳盡解釋。核心要點是對多臂試驗的明確定義,并要求清楚地報告涉及所有治療組的目的和研究假設。應明確主要治療方案的比較,并且作者應完整、透明地報告由各組得出的計劃內和非計劃內的比較。如果對多重性進行了統計校正,則應描述所使用的理由和方法。 結論和相關影響 CONSORT 2010 聲明擴展版為多臂平行隨機對照臨床試驗報告提供了具體指導,并有助于在此類試驗報告中提供更高的透明度和準確性。