Comparison of intra-articular injection of ArtiAid®-Mini with Ostenil®-Mini for trapeziometacarpal osteoarthritis: A double-blind, prospective, randomized, non-inferiority trial.

OBJECTIVES: This study aims to compare the effectiveness and safety of intra-articular hyaluronic acid (HA) injections of ArtiAid®-Mini (AAM) and Ostenil®-Mini (OM) for the treatment of trapeziometacarpal joint osteoarthritis. PATIENTS AND METHODS: Between February 2018 and April 2020, this 24-week, double-blind, prospective, randomized, non-inferiority trial included a total of 17 patients (8 males, 9 females; mean age: 60.3±9.5 years; range, 42 to 76 years) who were treated with either intra-articular AAM (n=8) or OM (n=9). The primary outcome was pain according to a change in Visual Analog Scale (VAS) at 12 weeks after the last injection. The secondary outcomes included the change of VAS at Weeks 2, 4, and 24 after the injection, satisfaction, range of motion (ROM) of trapeziometacarpal joint, pinch strength, grip strength, and adverse events at Weeks 2, 4, 12, and 24 after the injection. RESULTS: Eight patients with AAM and eight patients with OM completed the follow-up. No significant differences in primary and secondary outcomes were observed between the two groups at baseline and each time point (p>0.05). The intra-group differences were significant in each time point. CONCLUSION: The intra-articular injection of either AAM or OM is effective and safe for patients with trapeziometacarpal osteoarthritis up to 24 weeks.

Patients older than 55 years prefer biceps tenodesis over tenotomy to the same degree as young patients.

BACKGROUND: 55 years of age used to be the cutoff point when deciding between biceps tenotomy and tenodesis for treating biceps tendon pathologies. METHODS: Patients aged ≥18 years who had tendonitis in the long head of the biceps and were admitted for arthroscopic surgery were included. A questionnaire with a series of questions assessing patients' current symptoms, their concerns about their outcomes, and personal demographic information was introduced to the participants on the day before the surgery. The patients' preference toward tenotomy and tenodesis was assessed, and χ2 tests and logistic regressions were used to test the association with the categorical and ordinal variables, respectively. RESULTS: A total of 135 patients enrolled in the study, with 83 males and 52 females, the mean age of which was 56 years (range, 18-75 years). Of all patients, 86 (63.7%) preferred biceps tenodesis as opposed to tenotomy; meanwhile, there was no difference in preference toward tenodesis in each age- and gender-subgroup (range, 55.1% to 71.4%). The different subgroups had specific factors that were predictive of choosing either a tenotomy or tenodesis. In most subgroups, concerns about postoperative arm appearance and the so-called "Popeye" deformity due to tenotomy were factors predictive of choosing biceps tenodesis, whereas concern about longer rehabilitation due to tenodesis was the factor predictive of choosing biceps tenotomy. CONCLUSIONS: Biceps tenodesis is a more preferable choice for patients with biceps tendinopathies in all age and gender subgroups. Patients' concerns on postoperative arm appearance, "Popeye" deformity due to tenotomy, and longer rehabilitation due to tenodesis are the most important predictive factors.

Ultrasonographic Features of Trigger Finger in Patients With Hyperuricemia.

PURPOSE: The purpose of the current study was to compare demographic differences and ultrasonographic features in primary trigger finger and trigger finger in association with hyperuricemia. METHODS: Between October 2008 and February 2010, a prospective review of consecutive cases of 54 patients with trigger finger and hyperuricemia, 76 patients with a trigger finger without hyperuricemia, and 80 control cases were enrolled. The clinical results were analyzed by descriptive epidemiology, an ultrasonographic measurement of the thickness of A1 pulley, cross-sectional area of the flexor tendon and synovium. RESULTS: The middle finger was primarily affected, followed by the index and ring fingers in both trigger finger groups. The thickness of A1 pulley, cross-sectional area of the flexor tendon, and flexor tendon with synovium in trigger finger without hyperuricemia group were significantly larger than that in trigger finger with hyperuricemia and control groups. There was no significant difference between trigger finger with hyperuricemia and control groups. Double-contour sign and tophus were only observed in trigger finger with hyperuricemia group. CONCLUSIONS: Thickness of A1 pulley, cross-sectional area of the flexor tendon, and flexor tendon with synovium were significantly larger in trigger finger without hyperuricemia group. These findings were not evident in trigger finger with hyperuricemia group.

When deadman theory meets footprint decortication: a suture anchor biomechanical study.

BACKGROUND: The optimal insertion angle for suture anchor insertion has long been of great interest. Although greater tuberosity decortication is commonly performed during rotator cuff repair, the effect of decortication on the suture anchor insertion angle remains unclear. The purpose of this study was to compare the pullout strength of threaded suture anchors inserted at 45° and 90° in decorticated and non-decorticated synthetic bone models. METHODS: Two kinds of synthetic bones were used to simulate the decorticated and non-decorticated conditions, for which 40 metallic suture anchors were used. Anchors were inserted at 45° and 90° in both decorticated and non-decorticated models and tested under cyclic loading followed by load-to-failure testing. The number of completed cycles, ultimate failure load, and failure modes was recorded. RESULTS: In the decorticated model, the ultimate failure load of anchors inserted at 45° (67.5 ± 5.3 N) was significantly lower than that of anchors inserted at 90° (114.1 ± 9.8 N) (p <  0.001). In the non-decorticated model, the ultimate failure load of anchors inserted at 45° (591.8 ± 58 N) was also significantly lower than that of anchors inserted at 90° (724.9 ± 94 N) (p = 0.003). Due to the diverse failure modes in the non-decorticated model, specimens with a failure mode of suture anchor pullout were analyzed in greater detail, with results showing a significantly larger pullout strength for anchors inserted at 90° (781.6 ± 53 N) than anchors inserted at 45° (648.0 ± 43 N) (p = 0.025). CONCLUSION: Regardless of decortication, the pullout strength of anchors inserted at 90° was greater than those inserted at 45°. The clinical relevance is that inserting suture anchors at 90° is recommended due to the significantly larger ultimate failure load in both decorticated and non-decorticated bones.

Correlation Between IL-20 and De Quervain's Disease Severity.

De Quervain's disease is a stenosing tenosynovitis of the first dorsal compartment of the wrist. Histopathological studies have reported that the thickening of the first dorsal retinaculum is characterized by degeneration rather than inflammation. However, significant infiltration of mast cells and macrophages was noted in a torn tendon study, which suggested that innate immune pathways are part of the mechanism that mediates early tendinopathy. Recently, Interleukin-20 (IL-20) has been reported to provoke potent inflammation and regulate angiogenesis and chemotaxis, which are important for the pathogenesis of inflammatory diseases. The main purpose of our study was to investigate the correlation between IL-20 and tumor necrosis factor (TNF-α) and clarify the potential predictor of tendinopathy progression. Hematoxylin and eosin (H & E) and immunohistochemistry (IHC) staining were used to score and analyze the clinical outcome. TNF-α, IL-20 and related inflammation cytokines were examined. Moreover, the tenocytes were cultured with a stimulator and were used to examine inflammatory cytokine secretions. A real-time polymerase chain reaction (Real-time PCR) was used to detect the gene expression profile. The IHC data showed that TNF-α is up-regulated in grade III de Quervain's. The analysis data showed that IL-20 is positively correlated with TNF-α and disease severity. The real-time PCR showed that the inflammation stimulator enhanced the expression of IL-20 mRNA expression. Inflammation cytokines such as TNF-alpha, transforming growth factor-ß (TGF-ß) and IL-1 have been used as predictors of de Quervain's; IL-20 is a new predictor based on this study. In the future, IL-20 expression's involvement in the molecular mechanism of the severity of de Quervain's should be further investigated.

Comparison of changes in shoulder functions between biceps tenotomy and tenodesis in an animal model.

OBJECTIVES: Tenotomy and tenodesis of the long head of biceps tendon are effective pain-relieving treatments. However, there is no consensus on the functional outcome after these surgical procedures. We hypothesized that there would be no difference in ambulation parameters after recovery from the surgery between rats that underwent tenotomy versus tenodesis procedures. METHODS: Twenty-four New Zealand rats were used and randomly divided into three groups. Each group received one of the following surgeries: tenotomy, tenodesis, and sham operation. A video-based walking track system was applied for gait analysis at day -1, 1, 3, 5, 7, 14 and 21 for each rat. Temporal and spatial parameters were obtained, and asymmetric index was calculated for each parameter. RESULTS: Compared to the tenotomy and sham-operated groups, the rats in the tenodesis group had shorter stance phase, longer swing time, longer step length, smaller paw length, smaller intermediary toe-spread length, smaller toe-spread length, and larger foot angle right after the tenodesis procedure. After day 14, all parameters were equivalent to those of the sham-operated group. At the end of the study, there were no functional changes found in tenotomy and tenodesis groups compared with the sham-operated group and preoperative status. CONCLUSION: Transient functional alterations in temporal and spatial parameters are found after tenotomy and tenodesis in a rat model. The functional changes in the tenodesis group existed for a longer period than in tenotomy group; however, and all parameters showed no significant differences when compared with the sham group at the conclusion of the study.

Longer stitch interval in the Krackow stitch for tendon graft fixation leads to poorer biomechanical property.

PURPOSE: The purpose of this study was to analyze the effects of different intervals between stitch throws on tendon graft fixation with the Krackow stitch. METHODS: Forty-four porcine flexor profundus tendons were randomly divided into four groups of 11 specimens each. The Krackow stitch with various stitch intervals (2.5, 5.0, 7.5, and 10.0 mm) were evaluated, and named the K-2.5, K-5.0, K-7.5, and K-10.0 groups, respectively. A braided nonabsorbable suture was used to complete each suture-tendon construct. All specimens were pretensioned to 100 N for three cycles, cyclically loaded from 50 to 200 N for 200 cycles, and then finally loaded to failure. Elongation after cyclic loading, ultimate load to failure, and the mode of failure were recorded. RESULTS: There were significant differences in elongation after cyclic loading among the K-2.5 (31% ± 5%), K-5.0 (32% ± 4%), K-7.5 (34% ± 5%), and K-10.0 (41% ± 8%) groups ( p = 0.004); the post hoc analysis showed significantly smaller values in the K-2.5 and K-5.0 groups than in the K-10.0 group ( p = 0.002 and 0.003, respectively). The stitch interval was correlated with elongation after cyclic loading ( r = 0.52, p < 0.001). Ultimate loads to failure and cross-sectional area were not significantly different across the four groups. CONCLUSION: The Krackow stitch with stitch intervals of 2.5 and 5.0 mm had significantly smaller elongation after cyclic loading than with an interval of 10.0 mm in this porcine biomechanical study. The stitch interval was moderately correlated with elongation after cyclic loading.

Biomechanical properties of suprapectoral biceps tenodesis: double knotless screw fixation is superior to single knotless screw fixation.

INTRODUCTION: The purpose of this study is to biomechanically evaluate a new technique of double knotless screw fixation for suprapectoral biceps tenodesis and compare the results with that of the single knotless screw fixation as well as the interference screw fixation. METHODS: 24 fresh-frozen human cadaveric shoulders with a mean age of 68.3 ± 9 years were studied. The specimens were randomly divided into three experimental biceps tenodesis groups (n = 8): single knotless screw, double knotless screw and interference screw. Each tenodesis specimen was mounted on a mechanical testing machine, preloaded for 2 min at 5 N, tested with cyclic loading from 5 to 70 N for 500 load cycles and subjected to an axial load to failure test (1 mm/s). The ultimate failure load, stiffness, cyclic displacement and mode of failure were evaluated. RESULTS: The interference screw fixation had the highest ultimate failure load (215.8 ± 43.1 N) and stiffness (25.7 ± 5.2 N/mm) which were significantly higher than the corresponding results for the single and double knotless screw groups (P = 0.0029). The double knotless screw group had the second highest ultimate failure load (162.8 ± 13.8 N) and stiffness (15.1 ± 4.1 N/mm) which were significantly higher than the corresponding results for the single knotless screw technique (P = 0.0002). The most common mode of failure was suture slippage for both the double (7/8) and single knotless screw (6/8) groups while biceps tendon tearing occurred most often for the interference screw group (6/8). CONCLUSION: In this biomechanical study, the double knotless screw fixation was found to have a significantly greater ultimate failure load and stiffness than the single knotless screw fixation but lower values than the interference screw fixation.

A Biomechanical Evaluation of Various Double Krackow Suture Techniques for Soft-Tissue Graft Fixation.

PURPOSE: The purpose of this study was to compare the biomechanical properties among the different double Krackow suture techniques for tendon graft fixation. METHODS: Thirty porcine flexor profundus tendons were randomly divided into 3 groups of 10 specimens each. Three different double Krackow suture techniques were evaluated, namely, the McKeon's double Krackow (MDK) suture, Wilson's double Krackow (WDK) suture, and Ostrander's modified Krackow (OMK) suture. All suture configurations were completed with a braided nonabsorbable suture. Each suture-tendon construct was pretensioned to 100 N for 3 cycles, cyclically loaded from 50 to 200 N for 200 cycles, and then finally loaded to failure. Elongation after cyclic loading, ultimate load to failure, and the mode of failure were recorded for each specimen. RESULTS: There were significant differences in elongation after cyclic loading among the MDK suture (7.9 ± 3.6 mm, 14% ± 6%), WDK suture (11.6 ± 2.2 mm, 22% ± 3%), and OMK suture (9.6 ± 3.3 mm, 17% ± 6%; P = .018). In addition, although the post hoc analysis showed that elongation after cyclic loading in the MDK suture was significantly less than the WDK suture (P = .004), ultimate failure load and cross-sectional area were not significantly different across the 3 groups. CONCLUSIONS: In this porcine in vitro biomechanical study, the MDK suture had significantly smaller elongation after cyclic loading than the WDK suture; however, high elongation values may have a potential for risk of clinical laxity. The ultimate failure load was not different across the MDK, WDK, and OMK sutures. CLINICAL RELEVANCE: Smaller elongation during cyclic loading in a suture-tendon construct represents a lower possibility of tendon graft loosening after ligament reconstruction surgery. The double Krackow suture techniques are attractive options for tendon graft fixation in ligament reconstruction, and the MDK suture could possibly be the optimal choice among the double Krackow suture techniques.

Effects of decompression on behavioral, electrophysiologic, and histomorphologic recovery in a chronic sciatic nerve compression model of streptozotocin-induced diabetic rats.

PURPOSE: To determine susceptibility to decompression surgery in diabetic and nondiabetic peripheral neuropathy using a chronic compression neuropathy model. MATERIALS AND METHODS: Twenty-four streptozotocin-induced diabetic rats were randomly divided into three groups: group I, chronic compression of the left sciatic nerve for 4 weeks with decompression; group II, similar without decompression; and group III, sham exposing the sciatic nerve only. The other 24 nondiabetic rats were assigned to groups IV-VI, which received compression-decompression, compression, and the sham operation, respectively. Mixed-nerve-elicited somatosensory evoked potentials (M-SSEPs) and compound muscle action potentials (CMAPs) were measured to verify the compression neuropathy in the posttreatment follow-up. Behavioral observations in thermal hyperalgesia tests were quantified before electrophysiologic examinations. Treated and contralateral nerves were harvested for histomorphologic analysis. RESULTS: Chronic compression of sciatic nerve induced significant reduction of amplitude and increment of latency of M-SSEP and CMAP in both diabetic and nondiabetic rats. Diabetic group changes were more susceptible. Decompression surgery significantly improved both sensory and motor conduction, thermal hyperalgesia, and the mean myelin diameter of the rat sciatic nerve in both diabetic and nondiabetic groups. Near full recovery of motor and sensory function occurred in the nondiabetic rats, but not in the diabetic rats 8 weeks postdecompression. CONCLUSION: Behavioral, electrophysiologic, and histomorphologic findings indicate that decompression surgery is effective in both diabetic and nondiabetic peripheral neuropathy.

Lateral Hindfoot Impingement After Nonunion of Fracture of the Lateral Process of the Talus.

Fracture of the lateral process of the talus is a relatively uncommon ankle injury, and the diagnosis is easily delayed. Lateral hindfoot impingement is characteristically related to chronic hindfoot valgus malalignment, with lateral ankle pain localized to the subtalar region. In a review of the published data, lateral hindfoot impingement after nonunion of fracture of the lateral process of the talus was not found. We present the case of a patient with such an injury. The patient was treated operatively and was followed for 18 months.

The Estrogen Receptor-ß Expression in De Quervain's Disease.

Stenosing tenosynovitis of the first dorsal compartment of the wrist (a.k.a. de Quervain's disease) is common but how estrogen is involved is still unknown. We previously reported that inflammation was involved in the pathogenesis of this ailment. In the present study, we extended our investigation of estrogen receptor (ER)-ß expression to determine whether estrogen is involved in the pathogenesis of de Quervain's. Intraoperative retinaculum samples were collected from 16 patients with the ailment. Specimens were histologically graded by collagen structure and immunohistochemically evaluated by quantifying the expression of ER-ß, interleukin (IL)-1ß and IL-6 (inflammatory cytokines), cyclooxygenase (COX)-2 (an inflammatory enzyme), and vascular endothelial growth factor (VEGF), and Von Willebrand's factor (vWF). De Quervain's occurs primarily in women. The female:male ratio in our study was 7:1. We found that ER-ß expression in the retinaculum was positively correlated with disease grade and patient age. Additionally, disease severity was associated with inflammatory factors--IL-1ß and IL-6, COX-2, and VEGF and vWF in tenosynovial tissue. The greater the levels of ER-ß expression, tissue inflammation, and angiogenesis are, the more severe de Quervain's disease is. ER-ß might be a useful target for novel de Quervain's disease therapy.

Synovial osteochondromatosis of the second metatarsophalangeal joint: a case report.

Synovial osteochondromatosis is usually monoarticular, involving a large joint. Common locations include the knee, elbow, shoulder, and hip. It is not very common in the ankle, and it is very rare in the smaller joints of the foot. To our knowledge, and with the exception of 4 cases that occurred in the great toe, this condition has never been described in other metatarsophalangeal joints. In this report, we presented a case of synovial osteochondromatosis in the second metatarsophalangeal joint and reviewed the literature.

Treatment of unstable distal clavicle fractures with Knowles pin.

BACKGROUND: Unstable distal clavicle fractures often need surgical treatment. This report describes a new intramedullary extra-articular Knowles pin fixation method to treat these unstable fractures. MATERIALS AND METHODS: Twelve patients with unstable distal clavicle fractures (Neer type II) had surgery with intramedullary extra-articular Knowles pin fixation. We retrospectively reviewed clinical results for pain, shoulder function, and range of motion, as well as radiographic results, for this institutional review board-approved study. Each patient's operated arm was in a sling for 4 weeks postoperatively. The University of California, Los Angeles shoulder rating scale score was used to evaluate shoulder function. RESULTS: All patients showed radiographically confirmed bony union. The mean period required for healing was 11.5 weeks, and patients were followed up for 6 to 24 months (mean, 15.2 months), during which University of California, Los Angeles scores (mean, 33.9) indicated good clinical results. Three patients had the complication of proximal or distal skin irritation caused by the thread and hub of the Knowles pin. CONCLUSIONS: The Knowles pin fixation method is useful for treating unstable distal clavicle fractures. However, sufficient familiarity with the technique and careful preoperative planning to determine the appropriate length of the pin are necessary to prevent complications and to effect a high union rate.

A simple, modified arthroscopic suture fixation of avulsion fracture of the tibial intercondylar eminence in children.

The purpose of this study was to describe a simple and modified technique for arthroscopic suture fixation in a 12-year-old boy who sustained a displaced type III intercondylar eminence of the tibial. The arthroscopic fixation was modified by using the Arthrex suture lasso device to place two nonabsorbable sutures into the anterior cruciate ligament (ACL). However, the procedure became simple with the help of the Acufex ACL guide to reduce the avulsed tibial spine fragment and to place an appropriate tibial tunnel. Sutures were then passed through the tibial tunnel and secured over a bony bridge with the knee at 20° of flexion. At 6 months, the patient had a full range of motion with normal Lachman and anterior drawer testing, and he had returned to his daily activities. Radiographs showed complete fracture healing. Repair using the Arthrex suture lasso device provides a significant advantage in the treatment of type III and IV fractures of the tibial eminence by obtaining arthroscopic fixation with the substance of the ACL, thus eliminating the risks of comminution of the fracture fragment and hardware removal. This arthroscopic technique restores the length and integrity of the ACL, and provides a simplified, reproducible method of treatment for this injury.

Compression of the radial nerve at the elbow by a ganglion: two case reports.

INTRODUCTION: Radial nerve compression by a ganglion in the radial tunnel is not common. Compressive neuropathies of the radial nerve in the radial tunnel can occur anywhere along the course of the nerve and may lead to various clinical manifestations, depending on which branch is involved. We present two unusual cases of ganglions located in the radial tunnel and requiring surgical excision. CASE PRESENTATION: A 31-year-old woman complained of difficulty in fully extending her fingers at the metacarpophalangeal joint for 2 weeks. Before her first visit, she had noticed a swelling and pain in her right elbow over the anterolateral forearm. The extension muscle power of the metacarpophalangeal joints at the fingers and the interphalangeal joint at the thumb had decreased. Sonography and magnetic resonance imaging of the elbow revealed a cystic lesion located at the area of the arcade of Frohse. A thin-walled ovoid cyst was found against the posterior interosseous nerve during surgical excision. Pathological examination was compatible with a ganglion cyst. The second case involved a 36-year-old woman complaining of numbness over the radial aspect of her hand and wrist, but without swelling or tumor in this area. The patient had slightly decreased sensitivity in the distribution of the sensory branch of the radial nerve. There was no muscle weakness on extension of the fingers and wrist. Surgical exposure defined a ganglion cyst in the shoulder of the division of the radial nerve into its superficial sensory and posterior interosseous components. There has been no disease recurrence after following both patients for 2 years. CONCLUSION: Compression of nerves by extraneural soft tissue tumors of the extremities should be considered when a patient presents with progressive weakness or sensory changes in an extremity. Surgical excision should be promptly performed to ensure optimal recovery from the nerve palsy.

Oral-facial-digital syndrome with vaginal atresia, hydronephrosis and congenital cardiac defect.

Orofaciodigital syndromes (OFDS) are a group of diseases classified according to the phenotype and the mode of inheritance. We report on a female patient with ocular hypertelorism, broad nasal root, midline cleft of the upper lip, lobulated tongue, polydactyly of both hands, polysyndactyly of the right big toe and fifth toe, and polydactyly of the left foot. These clinical manifestations resembled OFDS type I. Other associated features included congenital heart defect, bilateral hydronephrosis, and vaginal atresia. To our knowledge, this is the first reported case of OFDS with vaginal atresia.

[Preventive efficacies of china-made tropisetron hydrochloride and Navoban on chemotherapy-induced nausea and vomiting: a randomized controlled clinical trial].

BACKGROUND & OBJECTIVE: Navoban (import tropisetron hydrochloride) can effectively prevent chemotherapy-induced nausea and vomiting; however, it is too expensive to be used extensively in clinic. This study was designed to compare the antiemetic efficacies and side effects of China-made tropisetron hydrochloride with Navoban. METHODS: A multicenter and randomized controlled trial was carried out. A total of 132 cancer patients were randomized into 2 groups and received 5 mg of China-made tropisetron hydrochloride (group A, 66 patients) or Navoban (group B, 66 patients) intravenously before cisplatin- or adriamycin-based chemotherapy. The gastrointestinal reactions induced by chemotherapy and side effects of the antiemetics were recorded within 7 days after chemotherapy. RESULTS: Acute nausea was prevented completely in 48.5% of the patients in group A and in 43.8% of group B; acute vomiting was prevented completely in 69.7% of the patients in group A and in 67.2% of group B. Delayed nausea was prevented completely in 25.8% of the patients in group A and in 28.1% of group B; delayed vomiting was prevented completely in 47.0% of the patients in group A and in 51.6% of group B. No significant differences in complete control of nausea and vomiting showed between group A and group B (P > 0.05). Both antiemetic regimens were well tolerated, and no difference in adverse events between the 2 groups was observed (P > 0.05). CONCLUSION: China-made tropisetron hydrochloride is as effective as Navoban in the prevention of chemotherapy-induced nausea and vomiting, and only causes mild, infrequent side effects.

[A randomized trial comparing oxaliplatin plus vinorelbine versus cisplatin plus vinorelbine for the treatment of patients with advanced non-small-cell lung cancer].

OBJECTIVE: To evaluate the difference of efficacy, side-effects and quality of life in advanced non-small-cell lung cancer (NSCLC) patients treated with oxaliplatin plus vinorelbine or cisplatin plus vinorelbine. METHODS: Eligible patients were randomly assigned to NL (oxaliplatin + vinorelbine) group and NP (cisplatin + vinorelbine) group in a 2:1 ratio. In the NL group, 70 evaluable cases were treated with oxaliplatin 130 mg/m(2) i.v. on day 2, and vinorelbine 25 mg/m(2) i.v. on days 1 and 8 in 21 days per cycle. In the NP group, 32 evaluable cases were treated with cisplatin 80 mg/m(2) i.v. divided to 2 - 3 days dosing, 21 days per cycle, and vinorelbine administered by the same way as in the NL group. The response rate, time to progression (TTP), one-year survival, side-effects and the quality of life were observed. RESULTS: The response rate was 35.7% vs. 43.8% (P = 0.4), median TTP was 4.7 months vs. 5.5 months (P = 0.6), one-year survival rate was 38.5% vs. 58.6% (P = 0.07) in the NL and NP groups, respectively. Grade I-II neuro-sensory toxicity occurred significantly more frequent in NL group than in NP group (68.4% vs. 36.4%, P = 0.0017). However, Grade I-II granulocytopenia was significantly less occurred in NL group than in NP group (49.4% vs. 70.6%, P = 0.037). There was no statistically difference between the two groups regarding quality of life. CONCLUSION: Due to good efficacy and tolerability, the NL regimen offered a new candidate for treating advanced NSCLC.